Hubert H. Humphrey Building
Room 505A
200 Independence Avenue, SW
Washington, DC 20201
SUBJECT: Patient Medical Record Information (PMRI)
MR. BLAIR: Good morning. Let us begin. I am Jeff Blair, Chair of the Committee, and before I have all of our Committee members and staff people introduce themselves, let me just explain for the benefit of those that are listening on the Internet some of the introductory remarks and what we are going to be doing today.
These are the hearings that are part of the Health Insurance Portability and Accountability Act, the administrative simplification provisions. It is that provision which is focusing on studying uniform data standards for patient medical record information and the electronic exchange of that information. This particular hearing is proceeding along the information gathering phase of our activities.
We have been holding hearings now for almost 10 or 11 months, and we are focusing on the different focus areas that are part of our work plan to gather information. So, those items include related again to the Uniform Data Standards for Patient Medical Record Information, they include the message format standards, the medical terminologies, the relationships to a national health information infrastructure, the issues related to data quality, accountability and integrity, issues related to privacy, confidentiality and security, business case issues, and I think I have hit them all.
This morning we have a number of panelists who will be joining us on a number of different topics. For the most part we have heard from developers of message format standards and developers of medical terminologies. This is going to be our last information-gathering hearing, and we are hearing mostly from users of these standards and terminologies.
We have some folks who are going to be testifying with respect to data quality, and we have some folks who weren't able to testify earlier back in March and May, and so, they have an opportunity to come and be with us today. So, we are going to be hearing from them as well.
At this point let me go around our table here and have each of our Committee members and staff people introduce themselves.
Simon, could I start with you?
DR. COHN: Just to clarify for our Internet listeners, this is a meeting of the National Committee on Vital and Health Statistics, the Work Group on Computer-Based Patient Records, just in case you are wondering which work group this is.
My name is Simon Cohn. I am a member of the Committee and Chair of the Subcommittee on Standards and Security.
DR. ZUBELDIA: My name is Kepa Zubeldia. I am with ENVOY Corporation, a member of the Committee.
MS. BEBEE: My name is Suzie Bebee, and I am a staff member from the National Center for Health Statistics.
COL. RAY: I am Colonel Lynn Ray, and I am the representative from DOD Health Affairs.
DR. MIDDLETON: Blackford Middleton, MedicaLogic.
MR. KELLY: John Kelly, Aetna.
MS. DEMSTER: Barbara Demster, Healtheon Corporation.
DR. FITZMAURICE: Michael Fitzmaurice, Senior Science Adviser for Information Technology with Agency for Health Care Policy and Research, liaison to the national Committee and co-lead staff with Bob Mayes to the Computer-Based Patient Records Working Group.
CAPT. MAYES: Captain Bob Mayes, Health Care Financing Administration.
MR. BLAIR: Okay, and other people in the audience if you can get close to a microphone to introduce yourself, that will help. If not, then just speak out, please?
DR. KAPUSNICK-UNER: Joan Kapusnick-Uner from First Data Bank.
MS. AMADIATIN: Margaret Amadiatin, Margaret A Consulting.
MR. ECKMER: Tim Eckmer with Multim(?) Information Services.
MR. PETERS: Rick Peters from iTrust and ASTM.
MR. KIBBE: David Kibbe from Future Health Care.
MR. DICKINSON: Gary Dickinson, First Aid Technologies.
MR. WAEGERMANN: Peter Waegermann, Medical Records Institute and NCHISP.
MR. BOWERS: Hank Bowers, Mount Vernon Pathology Associations.
MR. BLAIR: Thank you.
Okay, we have made a few changes on our agenda for today. The agenda that you have in front of you has four individuals who would testify. You probably will notice that it has the schedule very tight. Gary Dickinson has indicated that he is available this afternoon to testify, and also, needed a little bit more time. So, Gary has volunteered to move to a 2 o'clock slot which will give which will give our other remaining three testifiers for this first panel about 20 minutes to speak and then after each of them gives their testimony we will have about 10 or 15 minutes for questions from the Committee and other staff members.
So, on our first panel here we should have Peter Waegemann and Rick Peters and Blackford Middleton. Sorry?
DR. COHN: No, Middleton, John Kelly and Barbara Demster.
MR. BLAIR: I apologize. I am out of sync here, and could I just ask each of you on our first panel to introduce yourselves, please?
DR. MIDDLETON: Blackford Middleton from MedicaLogic, and, Jeff, if you are willing, I would like to propose a change in the order of presentation. My notes and handouts are being copied for the work group, and John Kelly has agreed to go first.
MR. KELLY: I am John Kelly, from Aetna US Health Care.
MS. DEMSTER: And I am Barbara Demster from Healtheon Corporation.
MR. BLAIR: Excellent. John, did you want to go first?
MR. KELLY: Mr. Chairman, other members of the Committee, visitors here in the room and on the Internet, I am delighted to have an opportunity to be here. I would like to briefly introduce myself and then discuss some of the activities in which my organization is engaged that I think may serve as useful background for some of the deliberations of the Committee.
I am Director of Physician Relations for Aetna US Health Care. Aetna US Health Care is the largest private managed care organization in the country. We currently are responsible for the health care of a little over 20 million Americans in this country.
We have contracts with over 300,000 practicing physicians in the country and provide the health benefits for over 100,000 employers throughout the country. What I would like to do is to comment on the uses of information and information technology within our organization. The kind of information that becomes available to us is relatively traditional information that would come to an insurance organization. We have provider information. So, we know who the providers are that care for our members. We know who our members are.
We know particular services that they receive so that we know, and we see that information through claims information that comes to us through encounter information. We, also, receive pharmacy information and laboratory results information.
What we do with that information is to process various functions such as eligibility, to pay claims, to review utilization but we, also, use it to analyze the care provided to our members, and we use it as a way of helping to improve the care that is provided on our behalf and so, what I would like to do here today is to tell you a little bit about the ways we use those data that come to us, and the way I will do this is I have an overhead or set of PowerPoints that I would like to go through reasonably quickly and then after going through them come back and discuss some general issues.
We have the membership information that comes to us, the provider information. We, also have hospital discharge information, the claims, the encounter, the pharmacy claim, various patient management data, laboratory data. All of those data come to us electronically, and what we do is to consolidate that into a single warehouse which then is available to us for various kinds of analyses.
One of the functions that we do is to place members into various clinical categories, and so using some of this information we will determine, make a conclusion that an individual has certain kinds of clinical characteristics and then use that as a way of determining the kind of services that they are currently receiving to make an assessment about services that they could be receiving, that they currently are not receiving, and then we use that as a way of communicating internally to develop certain of our programs internally as well as to communicate externally, communicating with practicing physicians as well as to individual members.
Currently a certain amount of that information is distributed electronically. It is distributed exclusively electronically inside of the organization. Outside of the organization certain of our partners are connected to us through the Internet, but for the bulk of the communication it is done in traditional paper form.
We send out over 10 million letters a year to our members based upon the information that we generate. We send out well over 100,000 performance reports to physicians each year based upon this information.
One of the activities in which we engage then is to actually risk stratify the members so that what we will do is based upon various rules that have been created, we will take the administrative data which is available to us, put individuals into various risk categories so that if a n individual has received certain services that would make us think that they have a particular condition such as congestive heart failure we could determine that based upon a hospital discharge, a physician's records, the fact that they are taking a certain medication or the results of certain kinds of diagnostic services, and then we will put them into certain risk categories and then use that as a way of designing certain kinds of interventions to help guide their care.
Part of the reason we do that is what we see is that individuals who are in different risk categories have very different kinds of experiences. The data that I put up here show an extraordinary difference in the use of hospital services.
Those who find themselves in the highest risk categories typically have over 3000 hospital days per year per 1000. Those in the lowest risk category typically have under 200 days per year per 1000 in the hospital, so about a 25-fold difference in the use of hospital services, but one example of many different ways in which we see the consequences of individuals having different risk profiles.
For those who are in the higher risk categories we put them into certain kind of disease management programs, and then what we do is we monitor the results of those. We have around 100,000 members who have congestive heart failure and the results of putting them into this program have led us to see reductions in the use of acute care services.
We have seen improvement in the use of pharmaceuticals, such as ACE inhibitors. We have seen significant improvement in medication compliance rates and, also, based upon the members' personal statements regarding the quality of life we see significant improvement.
So, one key message that I would like to make here is that these kinds of efforts in which we use technology to identify our members, to risk stratify them and then ultimately to communicate with them and with their physicians work.
There are variety of ways that we use to communicate. I have mentioned paper form. Obviously there is telephone. For some we communicate through the Internet. In some instances there are significant delays in getting this information because by the time we will get a claim that comes to us and are able to go through the kinds of analyses to put an individual in a particular category, oftentimes weeks or months can pass.
At the same time to have to aggregate this information and to communicate in traditional forms, also, can lead to significant delays, and so, one program that we put into place has been one where we will actually take the database that we have that is updated on a periodic basis as we have new information come in, and then we will match that against our pharmaceutical claims database which is refreshed daily, and by comparing those two databases what we are able to do is identify individuals who have found themselves in a different risk category, and let me just give you a specific example which i that we will run our file of asthmatics. We have a little over 100,000 asthmatics that we are responsible for.
We will run that against all the pharmacy claims on a daily basis and see which particular asthmatics have now begun to take steroids and then determine if they were not previously on steroids and right now we are finding that we identify about 200 people a day who fall into that category. We will then contact them and we will contact their physician and so what we see here, and again, the results of that program, and we have seen about a 50 percent reduction in the use of inpatient hospital services and about the same level of reduction in the use of the emergency department.
So, another message here is that by having access to accurate, reliable and timely information which we are then able to share with physicians and with the members can have significant positive impact on their care.
We have seen exactly the same kind of impact. I have described it for patients with congestive heart failure. I have described it for asthma. We have seen exactly the same kind of impact on patients with diabetes.
Having said all of that, what I would like to suggest to the Committee is that there are several huge opportunities that we have actually with traditional sources of information already available to us, not having to change the kind of information that any party is to collect, so traditional information, enrollment information, encounter information, claims information, pharmaceutical information, laboratory results which we are now beginning to bring into our data warehouse, this kind of information can be exceedingly useful in identifying individuals, services they received, opportunities for improvement and then as we improve our ways to analyze that information and then most importantly distribute the information, it can have significant positive impact on the care of individuals throughout the country.
Having said that, what we have in our view are a number of major challenges, one of which has to do with the extent to which there is electronic connectivity between physicians and organizations such as ours. Absent electronic connectivity information comes to us in paper. It comes in slowly. It is replete with errors, and then the process of managing the paper data is just slow and not nearly as efficiently as if the data come in to us electronically.
Secondly, as I have suggested, if we have the ability to distribute information back to the physician, back to the members electronically it speeds up our ability to be able to have an impact on the care that they receive, and so one of the major initiatives that we have begun and a particular technology that we think is so useful in this is the ability to access the Internet.
Some of the information that we have seen indicates that the minority, less than half of the physicians and perhaps less than two-thirds of the physicians in this country, currently have access to the Internet in their offices and so that is a significant barrier for easy communication between organizations such as ours and physicians, and the same would be true for communication between organizations such as ours, physicians and individual members. So, clearly any effort that would accelerate the use of the Internet or access to the Internet in physicians' offices we think would be extremely positive.
I think at this point what I will do is I will stop just because what I wanted to do here was to give you a sense of the ways in which an organization such as ours can take traditional data sources, use them to evaluate care being provided to individuals, share that information to physicians, share it with members and then to see the impact on the care that they receive, and so, what I would be happy to do is to respond to any questions or any comments that any of the Committee or other attendees would have.
Thank you very much.
MR. BLAIR: Mr. Kelly, thank you very much for your testimony. We are going to receive testimony from the other panel members, and then we will have questions at the end addressed to all the panel members.
So, who would like to go next?
MS. DEMSTER: While Blackford waits for his handouts, I will go next. I am Barbara Demster, Compliance Officer for Healtheon Corporation, and one of the first questions asked by the Committee was what is patient medical record information? Technology advances in recent years have turned this fairly straightforward question into a complex one. Advances have expanded information management options to such an extent that they are propelling the health care industry to rethink the patient medical record paradigm.
We have moved from the provider community's traditional linear paper record to the concept of a virtual health record. Patient medical information is gathered from multiple Legacy systems that address specialized functions such as census, admission and discharge data, billing data, laboratory orders and results, radiology testing and results, pharmacy.
The virtual record is created from transactions such as laboratory results collected on servers located possibly thousands of miles apart. These transactions can be integrated in display and presented to the user transparently as the patient record.
Using the power of persistence accessing different databases appears seamless to the user. The patient medical record information may be presented as document images, diagnostic images, graphics, video clips or audio clips.
The virtual record is available any time of the day or night to any authorized user with an Internet browser and proper security access credentials.
Regarding consumer and population records technology brings new capabilities at a time when consumers are taking more active control of their health. Internet users, whether they be providers or consumers have unparalleled access to health information. As physicians spend less time with their patients consumers have assumed more responsibility for managing their own care.
According to the April 1999, DELOIT(?) 2 survey 43 percent of Internet users go on line to gather health care information.
Consumer and health care professionals alike are concerned with the validity of the information contained on the Internet and how consumers can determine valid information from spurious. Physicians are, also, concerned with the proliferation of non-peer-reviewed material.
This can be particularly frustrating for both consumer and physician as medical professionals have honest disagreements on supposedly quality peer-reviewed data.
Consumers are self-educating via the Internet and taking a more active role in sharing medical decision making with their physicians.
As active participants in their health care, consumers are keeping records and technology allows the easy exchange of information between patient and providers.
We commend the NCVHS work group on national health information infrastructure activities in describing the characteristics of health records.
This effort clearly recognizes the overlap and interdependence of the personal health record, the population health record and the care giver health record. These three records share common data elements as well as common problems in the lack of standard formats and lexicons.
Regarding lack of common standards, the incredible power of the web to gather patient information from disparate systems on incompatible databases, software and platforms brings to bear one of the major challenges i health care, the lack of a standard lexicon.
We need to develop common semantics and usage and that is not to imply that there should be one single vocabulary for all purposes, but there should be more effort put into bringing together and reconciling terminologies.
The lack of a common lexicon actually thwarts the power of the computer by allowing the collection of valuable information that cannot be used for quality assessment due to lack of conformity of terms or comparability.
The lack of a medical lexicon from commonality of definitions and terms with crosswalks places serious limitations on the industry's ability to assess effectiveness and efficiency.
These standards are needed for assessing the quality of care rendered, the efficiency of care delivery and assuring data integrity throughout the data interchange process.
The importance of common definitions and terms is quickly understood in the following example which is simple but very illustrative of the physician who writes an order to take the patient's vital signs every 15 minutes. He is thinking temperature, blood pressure and respiration. The nurse who implements the order thinks temperature, pulse and respiration. The quality reviewer who abstracted the information for the outcome study thought blood pressure, pulse and respiration. The confusion is evident. This example shows what can happen among clinical professionals who think they are communicating. The need for common terminology, definitions and standards is imperative for data integrity, not only for clinical uses but, also, in the information technology side of the operation.
From development of software to administering production environments, data standards are critical to assuring data reliability and integrity. Developers must design a system that will provide this. Most developers application and database administrators do not have any clinical background. Yet, it is imperative that they know what valid, reliable content for a data field should look like.
Application administrators monitor system data integrity continuously to ensure that what was received is what was expected. Without common standards there can be no coordination or consistency across vendors.
A common accepted standard for something as simple as name format would have major impact on dollars spent writing interfaces between systems as well as improve the ability to match patients across systems, a major data quality issue, not to mention the potential impact on quality of care.
As an industry we are currently matching patients across databases the hard way using complex algorithms known to result in a percentage of false negatives and false positives.
Enterprise master person indices currently match millions of people across multiple states. The implementation of the unique health identifier will aid in the matching problem although it will not address the main quality issue. As consumers seek a more active role in sharing decisions in their health care health care organizations are enabling them to have on-line access to provider records. Consumers want access to their medical information and they want it in language they can understand.
A recent random survey of patients at Baylor College of medicine found 85 percent of patients want web access to their medical record; 65 percent want the ability to add information such as history to their record, and 31 percent want the information contained in their record translated to everyday English.
The lack of standards has long had a debilitating effect on the health care industry. Without a common data model, data formats, data interchange specifications and common lexicon there can be no expectation to have conformable data. It is estimated that 10 percent or more of the information technology budget has to do with plugging the holes created by non-conformable data standards. Lack of standards for record format, minimum data sets and data dictionaries cause problems across all systems.
The private sector has been struggling with these issues for some time, and we believe that strong government leadership will be required to facilitate the development of data standards and mandate their usage to bring conformity in data quality to our health care databases.
Regarding accountability and data disclosure and the matter of controlling disclosure of information technology has been our downfall and now can be our salvation.
Prior to photocopy technology medical secretaries reviewed requests for information and created an abstract from the medical record that was responsive to the nature of the request. With the advent of the photocopy machine abstractors were replaced in the name of efficiency by the machine.
No copy machine was too fast or too big to answer the demand for medical information. We shifted from needing information to requesting reports. The efficiency of the copy page compromised the confidentiality of other information on the page that was not relevant to the requester's need.
Computers bring the ability to isolate data elements and act on them. This ability dovetails with the need to develop minimum data sets for responding to common recurring information needs within the delivery system. Not only would this address the serious issue of confidentiality but it would, also, improve data capture as well as data quality.
Regarding privacy, security and confidentiality as the health care industry expands its computer-based records patients and providers need to feel assured of the security and confidentiality of health data. The current state of privacy legislation does not encourage confidence in the privacy of health information divulged to care givers.
Withholding the critical health information from care givers seriously compromises the treatment rendered and degrades the quality of the database for research and other quality improvement efforts. Collection of quality population data for trending research and public health purposes demands that there be comparability of data.
Data standards as well as protections assuring anonymity and security of information are necessary to allow collection of quality population data.
Laws as well as standards need to be in place to assure consumers that privacy, confidentiality and security of information will be enforced.
Finally, there is a general skepticism about the security and securability of computer-based information and the Internet.
Just as technological advancements in the medical field such as fiberoptics have dramatically changed the invasive nature of care in recent years, so have security capabilities improved. We think it incumbent upon all of us in the public and private sector to undertake a campaign on educating the general public as well as the provider community on how the Internet can be made safe for transmission of health data.
I would like to thank the Committee at this time for allowing us the opportunity to present these important issues.
Thank you.
MR. BLAIR: Thank you, Ms. Demster.
Dr. Middleton?
DR. MIDDLETON: Mr. Chairman, unfortunately my handout is still in the copier. I beg your tolerance, and perhaps we can adjust the schedule slightly, maybe do some questions now of the speakers that have presented. Rather than doing it from memory, I would appreciate having the handout to give to you my considered thoughts.
MR. BLAIR: Sure.
Committee members and staff folks, do you have questions for our first two panelists?
DR. FITZMAURICE: I have a question, Jeff. This is Michael Fitzmaurice. I would like to ask John Kelly, you had talked about stratifying members of Aetna insurance plans into risk categories based on the data you received. What is the risk that you look at? Do you look at risk of high expenses, risk of hospitalization, risk of death, risk of loss of health status? What are the dependent variables that you look at to classify patients?
MR. KELLY: Dr. Fitzmaurice, those are among some of the risk factors that we look at. What we look at is what we do is certainly there are, also, quality factors that we are very much interested in. We are interested in looking at individuals who fall into a particular clinical category, and we look to see to what extent they are receiving care which is consistent with various recommendations which have been developed so that that could mean preventive services, such as immunizations. We will look to see whether somebody has had immunizations. We will look to see whether they have had mammograms, other kinds of screening. We will look for those who are in high-risk categories of the sort that I described to see which particular medications they are on, how frequently they are seeing their physician, to what extent they have had recommended services, such as those recommended by the National Committee for Quality Assurance and similar kinds of information, and what we find consistently is that there are significant numbers of our members who are not receiving optimal care, and that means that we see individuals who would be candidates for receiving certain preventive services who are not receiving them, individuals who should be receiving certain medications who are not receiving them, individuals who should be monitored with a certain frequency and are not receiving those kinds of services, and so, what we do here is we, in effect establish comparisons between the services that individuals are receiving and various relatively widely-used recommendations, then to use that as a way of intervening through the use of information, dissemination of information.
DR. FITZMAURICE: Let me step on the other side? If I am a patient or if I were a physician which I am not, how do patients and physicians feel about being contacted about their medical problems by Aetna and being told, "You are not receiving the optimal care, and maybe you should look into it."? It sounds like, you mean something is wrong.
MR. KELLY: I think a couple of parts, and I am glad you asked the question. The first part of it here is we find that -- I will give you a concrete example, and then I will speak more generally. When we reviewed our files to look at women who had received mammograms and sent letters to physicians to give them lists of individuals who fell into certain age categories and who had not received a mammogram during the prior 2 years we found that we got some improvement in the use of mammograms. When we sent letters to individual members what we found was we got a significant improvement in the use of mammograms. So, we find that involving members or patients in their own care is certainly something which can have tremendous positive effect. We find the same true in our various disease management programs which is contacting the individuals directly and sharing with them. So, whether it is a woman who is pregnant, a diabetic reviewing the kind of medications that they are receiving, how often they are seeing their physician and the rest, I would have to say that that information is well accepted and can have significant positive impact.
Every once in a while we do get a question from a member which will say, "How did you know?" but I think this is an area in which the need for organizations such as ours as well as physicians and members to have the ability to freely exchange personal health care information is absolutely critical if we are going to put into place strategies to improve the quality of care.
MR. BLAIR: Being flexible here, our handouts for Dr. Middleton's presentation have arrived. So, Bob Mayes and Dr. Cohn had questions. So, let me kind of keep that in the queue so that as soon as you are finished with your presentation then we will go to Bob and Dr. Cohn for questions.
Blackford, are you ready to present?
DR. MIDDLETON: All set, Mr. Chairman.
Thank you very much for your forbearance and flexibility. My name is Blackford Middleton. I am from MedicaLogic, Incorporated where I am the Senior Vice President for Clinical Informatics. I am responsible for guiding product development with respect to clinical informatics requirements, application, function and features and as interim chief security officer, health information management security policy and requirements.
Prior to joining MedicaLogic I was medical director for information management and technology for Stanford Health Services, 1992 to 1995. In this capacity I led the design and implementation of an integrated clinical information management system based upon vendor software offerings. System interfaces, data standards for integration were critical to that work.
I am, also, currently Chairman of the Computer-Based Patient Record Institute, a non-profit association of technology companies, professional associations, provider organizations, standards development organizations and academic institutions devoted to the adoption of computer-based patient record technology to improve health care delivery.
With respect to the first issue, how would you define or describe patient medical record information, MedicaLogic considers any and all information contained within a paper-based or electronic computer-based medical record, patient medical record information. We recognize that this may not necessarily be all of the information relevant to the patient's whole health and well-being. The NCQA provides a useful framework for examining the relevant information space for patient medical record information in their work as depicted in Figure 1.
Here we see that the NCQA begins with those data viewed as automated and standardized within the health care enterprise such as these shown on the screen and in your handout, and these are circled by health plan system data which may adopt a variety of automated techniques and multiple coding schemes for representation. These are followed in a further orbital by non-health plan system data which similarly may be in multiple automated systems using multiple coding schemes, and these are further followed by data in medical records, paper records or electronic medical records, and these are oftentimes the more subtle findings of the clinical narrative, observations and processes of care.
Finally, however, these are, also, followed by data not standardized coming from outside of the traditional health care environment, if you will and oftentimes not collected yet perhaps extremely relevant to the care delivery process or a patient's health and well-being or in fact the health and well-being of a population.
Additionally NCQA describes a framework for adoption of automation technology or electronic information management technology within the clinical environment as shown in Figure 2.
They begin with a standardization of data elements and methods for capture, automate these methods in computer-based patient records and suggest linking these data, obviously with standards-based interfaces and ultimately sharing the data as appropriate between other providers, public health agencies and the like.
It is our belief at MedicaLogic, however, that the historical perspective on information sharing must be extended now as has been alluded to by previous speakers to consider the use of the Internet for information exchange and interoperability between medical records systems, health care delivery enterprises and increasingly between the patient and provider themselves.
With respect to the second issue, the second question, why is comparable patient medical record information required, and what functions does it serve, reporting from the CPRI in 1996, efficient and effective health care delivery is dependent upon accurate and detailed clinical information. Those with more detailed reliable and comparable data for cost and outcome studies, identification of best practices and management will be more successful in the marketplace. The use of guidelines and other decision support tools to enhance the quality of health care depends upon the use of common terms and concepts in patient records and the knowledge support resources as we have heard from Barbara Demster and John Kelly.
Similarly the business practices of performance bench marking, measuring and interpreting outcomes, continuous care improvement and allocating limited resources to optimize quality and effectiveness require comparable data and a standardized approach to information that adequately captures the details of clinical variation.
The function or purpose of comparable patient medical record information is its use, therefore, in managing the process of health care delivery both financial and clinical across the continuum of care and throughout a person's lifetime.
The functions that comparable patient medical record information must serve are data aggregation for individual patient care, information communication, interoperability between disparate information systems, information communication or interoperability between disparate health care enterprises and data aggregation across individuals to inform population analyses and support public health surveillance and maintenance of community health and well-being.
The need for comparable patient record information arises from the purposes described above which result in a need to exchange information between systems in three contexts, within a health care enterprise, between health care enterprises and in the emerging paradigm of business-to-business transactions mediated across the Internet or e-health care. I will discuss each of these briefly in turn.
Within a health care enterprise such as a large integrated delivery network, hospital or academic medical center, there are many systems typically devoted to different aspects of acquiring or managing subsets of the patient's clinical information.
Figure 3 depicts a typical hospital or IDN systems environment where potentially dozens of systems exist to perform unique functions in support of the business or clinical process of care delivery.
Often these systems may each store patient data such as patient identifiers, insurance information, demographics, as well as clinical information. This results from the fact that most health care enterprise information systems managers do not have the confidence that one system can readily acquire, store, transmit and update even basic patient information, and the complexity of assigning one system as master, others as slaves and the associated human work flow implications. Thus multiple systems keep copies of the same information and from the patient's perspective the same data is gathered over and over again in different departments of the same health care enterprise, a frustrating experience indeed.
This implies, of course, that clinicians seeking information for clinical decision making must turn to multiple systems to gather the data they need. Toward the end of the 1980s health care enterprises began to strive for systems, quote, integration to allow a user to retrieve information from multiple systems from a single terminal using multiple desktop terminal sessions with the ancillary systems.
Figure 4 presents a schematic showing how multiple ancillary systems may present multiple system sessions at a single terminal for the user.
While useful, this did not achieve data integration which is what is required to properly inform clinical decision making.
In Figure 5, a schematic is presented which describes the next phase of clinical computing, data integration through use of clinical data repositories, information warehouses and the like as we have heard about from Dr. Kelly.
In this approach the issues of data comparability become very important as data from disparate systems are integrated within a common logical data model. Thus, the format and representation of the data from the ancillary system supplying data to the repository became very important and creating these repositories required extreme attention to data representation issues to assure data integrity across the repository.
The approach was reasonable, nevertheless, for enterprises which had control of all the ancillary data sources so that they could reasonably determine the exact methods of data acquisition, the context of acquisition, information bias or error resulting from human error in entry, design flaws in the human-computer interface or data representation and formatting anomalies in ancillary systems.
A well-described phenomenon of modern health care delivery, however, is the movement of patients between multiple health care delivery systems and providers. Patients may receive care from a variety of traditional providers as part of their routine care, for example, a primary care physician, a subspecialist, a surgeon, we all may have multiple providers and sites of care, but, also, increasingly are receiving health care services from other alternative care providers who may be outside of the patient's traditional health care delivery system.
Information exchange even between traditional health care delivery systems even when their data management is highly automated is usually impossible because of the lack of sufficient standards for data representation and reproducible implementation methods to allow robust exchange of this health care information. Thus, such exchanges are reduced to paper-based exchanges as Barbara alluded to, copying and faxing the health record.
Figure 6 presents a schematic representation of a possible national health care information infrastructure which may facilitate appropriate information exchange between all parties participating in the health care delivery process.
The components you see here are the hospital backbone the hospital environment itself, the communicating parties across the Internet, other hospitals, clinics, the employers, state, federal health authorities and even the patient's home. Clearly an increasing number of financial transactions are being performed across secure networks between enterprises, payers, including the government, pharmacy benefit managers, etc., but these are essentially claims level data without much clinical detail.
The recent emergence of Internet health records, that is medical records shared between provider and patient calls for an increasing level of interoperability between disparate and potentially unaffiliated systems to fully support the notion of electronic commerce in health care. Such potential transactions are depicted in Figure 7. Thus, the time is right for a deliberate and considered approach to defining data interoperability standards for health care.
As outlined above since the participating entities in business-to-business e-health care transactions will typically be unaffiliated trading partners as opposed to entities within a single health care enterprise, or even within a single integrated delivery network the need for data interoperability standards has never been greater.
Realization of the full promise of the adoption of information technology as a critical component of administrative simplification and improved health care delivery efficiency requires quick, coordinated and incremental steps now to promote such standards.
With respect to Issue C, how comparable does the PMRI need to be for these purposes, how precise, how accurate, let me offer a couple of definitions to set the stage.
Simplistically when we say that data is structured, we mean that it is represented in an information model or framework that represents the relationship between various elements in the model. For example, tobramycin is an aminoglycoside, is a drug, is a therapeutic agent, etc. The object drug may have attribute aminoglycoside and a dependent attribute tobramycin. The information model provides a means for expressing semantic relationships between terms in the structured hierarchy. The levels of abstraction in information modeling are arbitrary but should meet the requirements for using the data to support business and/or clinical processes.
When we say that data is coded, we mean that the structured data is instantiated with a value which may be drawn from a code set or from a controlled vocabulary or from a set like numbers.
For example, we might structure the database to record the concept diagnosis for a particular visit but unless we control the vocabulary data entry personnel might enter hypertension or high blood pressure, high BP or HTN in the diagnosis slot. So, we need to code the data or control the vocabulary; 401.1 represents hypertension. Now, we can successfully perform an automated search to find all such hypertensive patients.
With EMR the clinician interacts to varying extents directly with the computer and since we can apply more powerful and user-friendly tools to assist him or her, we expect to collect a greater amount of data in structured and coded form.
However, usability is an obstacle which must be continually addressed. The functions that comparable PMRI must serve were listed above, data aggregation for individual patient care, information communication between disparate systems, information communication between disparate health care enterprises and data aggregation across individuals to inform population analyses and support public health surveillance.
The key tension in addressing the question above we believe is the balance between information structure and coding of the data versus usability of health care information systems or interpreted another way the balance between information utility and system usability.
Figures 9 and 10, this is Figure 8. I forgot to point it i out. It is a representation of the fourth generation clinical computing using the Internet for interoperability. Figures 9 and 10 depict the trade-offs between structured data entry and system usability. As the degree of structured data capture goes up, the information utility rises, but the burden of structured data gathering may eclipse the utility of the information from the user's point of view.
On this graph you see 100 percent free text on the left, 100 percent structured encoded text or information on the right, and clearly usefulness of data may go up as it is increasingly structured. However, there is a profound impact on usability that needs to be at the core of these deliberations because if we cannot get the data we won't be able to do anything with it.
Notice, I believe, also, there is a drop off in usefulness of data with overcoding or specification bias, if you will, that is if the information is overcoded, and the value set that users may choose from is limited, then in fact, there may be a specification bias arising because the clinician can't, in fact, say what he or she needs to say.
Figure 10 then shows what we believe is the optimum mix, somewhere in the middle, that is enough data needs to be structured to inform population analyses, real-time clinical decision support, post hoc analyses as Dr. Kelly was alluding to and the rest but on the other hand we cannot structure everything and get the user to do it today.
Given the complexity of describing a comprehensive information model for health care information, it is my belief that to practically address data interoperability problems in health care system the industry should strive to incrementally model key information elements, those that are most relevant to critical data exchange for health care system efficiency and quality.
What medical terminologies do you use or include within your systems? This is Issue 4. In MedicaLogic clinical systems problem list data, medications, allergies, all laboratory data, orders, procedures are all represented with structured clinical lists derived from standard controlled terminologies or standard codes including ICD, CPT, ASTM, LOINC, SNOMED and DSM. Advance directives and certain clinical observations are represented in proprietary format due to the lack of generally accepted standard controlled terminologies.
The following tables summarize MedicaLogic approach, and the details are offered in the appendix. Here are the codes we use for problem coding within the application, our clinical systems, ICD or SNOMED and we use different axes within the SNOMED resource to do different things within the problem list. I am sorry, it is only Figure 11 pertaining to coding.
What difficulties do you have using existing medical terminologies? Please refer to Figure 12, challenges. The biggest challenge is to balance coded data requirements which necessitate structured data input by the user as described above with usability of clinical systems.
Another challenge is to find a close matching structured data element from a standardized structured vocabulary given that there may not be parity in term definition, granularity, intended use with the user's requested term.
Another challenge is that none of the widely used structured vocabularies include a robust information model underpinning the structure to support understanding of semantic relationships between terms as identified above.
Another challenge is that the user interface terminology, what is seen on the screen, that is and information model may be necessarily different from the canonical or reference terminology and information model used within the system. A simple example of this problem occurs when a reference model and terminology is developed in English and then a translation to another language is intended or attempted.
With respect to issue 6 what suggestions do you have to address these problems? Figure 13 lists some of my suggestions for the Committee for your consideration. I would suggest a prioritized incremental approach to solving this problem as follows: Without consideration of funding responsible organizations or agencies, politics or etc., first establish national identifiers. This is critical to systems interoperability. Second, establish a minimal set of critical quality measures or outcome measures as Dr. Kelly was alluding to that really drive the business processes of care today. Third, establish minimal required data sets to support derivation of these critical quality measures. Fourth, establish acceptable standard controlled vocabulary and codes for the minimum data set, and lastly, establish acceptable methods to gather the minimum data set at the point of care.
How may this be accomplished? Given the fractured nature of US standards development in health care, the multiple clinical demands with varying degrees of content overlap and varying degrees of capability in terminology development and the emergence of e-health care in this country I believe the US Government should adopt a sponsoring role to fund and coordinate a public-private effort dedicated to the rapid development of appropriate and acceptable controlled vocabulary standards which when placed in the public domain will trigger the widespread adoption of health care information management technologies and enable the information revolution in health care.
With respect to issue 7, if coordination among medical terminologies is of value, what type or form should it take? The first question refers to crosswalks and mappings. Functionally crosswalks or mappings is the state of the art today. Given a robust and flexible messaging standard in the form of HL-7 most vendors are interfacing their systems with remote systems successfully using HL-7 and accommodating mappings in a semi-automatic process.
More work needs to be done to make the HL-7 interfaces being widely deployed easier to create and maintain.
It is critical in this context, however, to distinguish interoperability on three levels. In the simplest sense a message from one machine received by another represents a low level of interoperability. The receiving machine then has that information which may be displayed to the user in some fashion. I will call this basic interoperability. At an intermediate level messages between machines should be interpretable at the field level, that is a structured data field containing information on ear exam should be able to pass that information on to another machine and have it appropriately stored in a comparable structured data field for ear exam in the receiving system. Neither system has understanding, however, of the content of the message necessarily. For example, it may be inflamed eardrum, blue canal or what have you. In fact, the content can be nonsensical. I call this structured interoperability.
At the highest level, taking advantage of both structuring and codification of the message a receiving machine can interpret the message in the context of its information model, that is the object ear exam may have an attribute "inflammation" which could have a value positive and thus trigger knowledge-based tools, guidelines, protocols, alerts, etc., in the receiving machine.
I refer to this as semantic interoperability. With respect to issue B, definitions of terms or concepts, given that we live in a world filled today with Legacy clinical information systems, wide heterogeneity in systems and little commonality today in concept definitions, methods for data acquisition and usage I believe that we should first focus on improved interoperability between systems at level 2 as described above.
As systems evolve we can incrementally extend the information models to achieve semantic interoperability. With respect to issue C, convergence to a single reference terminology or model, ultimately I think we will progress toward a single reference information model and reference terminology model. However, I think that the benefits that can arise with a relatively modest commitment to coordination around structured interoperability are very considerable and attainable while work continues toward a common terminology model.
With respect to question 8, are current initiatives to coordinate medical terminologies adequate? No.
With respect to question 9, if not, should the government play a role to facilitate the coordination of medical terminologies? What actions could generate results in a 1-to-4-year time frame? I believe a prioritized framework for structured interoperability standards, building upon current HL-7 efforts and new efforts arising in the e-health care arena could lead to tangible benefits in a 1-to-4-year time frame. The key to success will be appropriately identifying the critical quality measures to drive the business processes and have immediate impact on health care costs or quality, define the minimal data sets and encourage their adoption by major health care IT vendors.
B, what actions could generate results in a 5-to-10-year time frame? Ongoing funding for leading academic research to discover the best methods and approach toward a common reference model and terminology must continue but more tightly coupled to industry so that large-scale demonstration projects may be run to assess the impact of this work.
Thank you for your time and the invitation to present.
MR. BLAIR: Thank you very much for your testimony. Let me just pick up on some of the questions that had been queued up before you gave your presentation? Bob Mayes and Dr. Cohn had questions and then I will open it to the rest of the Committee and staff folks who have questions.
CAPT. MAYES: Great, thanks, Jeff. Actually much of Dr. Middleton talked about speaks directly to the question I had. I actually would have a little bit of disagreement in your staging of the various phases that you would go to. Although semantic management is perhaps the most difficult, I would suggest perhaps that it actually reflects the business process that you are automating, and so until you can begin to achieve some sort of semantic management, this focus on the syntactical or representational aspects of data management, while necessary is insufficient, and it may be difficult to demonstrate why anybody should worry about whether or not you have coded it this way or that, if you cannot demonstrate how that actually leads to better business outcomes which involve the semantic management. Along that thread my original question was going to be to Dr. Kelly, and that is that we have talked about data management and standardization of data. However, when we look at organizations such as your own and other successful organizations, whether it is Kaiser or Intermountain Health, some of these that have demonstrated the great utility of these types of systems, what we actually see is exactly what I have just described. They have taken sort of standardized data representations but then they have really applied semantic management to that through the development and use of a variety of information models and analytic structures because it is through the use -- just having the data, no matter how standard it is is really of no utility if you cannot do an analysis.
Now, within the context just of population and quality of care based because that is my main area of interest, and that is what you do, would you one, say that the information models and the analytic frameworks that your organization has developed, are they generalizable across other organizations that we are interested in population analyses or quality improvement and do you think that there would be a possibility to begin to develop some standard, and this goes to what Dr. Middleton was talking about at least in small chunks, some standardized models or submodels and frameworks that would be non-proprietary, that would begin to demonstrate the utility of what you get when you do actually standardize all this data and pull it together?
MR. KELLY: I think in response to the question, yes. I think these models clearly are generalizable. I think that focusing in on the utility is absolutely critical.
I think what I am most struck by is the huge gap between what I would say the opportunity that we have and what is actually occurring. I think many of us have been in this area for a long, long time and have found even though there has been just a myriad of new tools and technologies but still striking, I would come back to, I think that there is a cultural issue which we face here which is really identifying the benefits, identifying successful models and then promoting them, and I think that is probably an area which I would at least suggest the Committee might focus somewhat on because what we find is that there are many physicians' offices that aren't even using basic technologies, that many physicians don't even use a computer in their clinical practice. If there is a computer in the office it is used exclusively for billing and most of the other administrative processes are automated as well, and so, at least a suggestion I would have is that particularly at a time when many of the physicians in this country are finding that they are under some significant challenge because of some of the changes which are going on, exactly the same occurring within hospitals, I think that identifying some of the more successful models, generalizing them and promoting their use would be attractive.
I guess there is one other comment I would make that has been striking to me, that over the last decade there continues to be a relatively small number of case studies which keep coming back. It tends to be the same organizations we keep hearing about, and I would have to say that that is an unacceptable state of affairs, that what we really need to so is in my view set some goals, set some time tables and begin to try to help encourage those who may be sitting on the fence to move forward.
MR. BLAIR: Dr. Middleton, did you have any comments or responses to Bob Mayes' observations before I go on to Dr. Cohn?
DR. MIDDLETON: Thank you, Mr. Chairman. I guess I will offer the following. I think there is a bit of a philosophical divide which unfortunately stymies some of the work in this area, that is that one almost philosophically takes the orientation of semantic modeler, if you will and no disrespect intended versus the orientation towards what I have described as the structured interoperability which doesn't begin with semantic modeling. It begins with a structured modeling, if you will but does allow the information exchange to occur and then translation to representation, to local representation as need be.
It is an intermediate step to be sure. I think that the question before the Committee then is to, given the current state of affairs and our status quo, if you will, how do we most rapidly achieve the benefits you have asked us to demonstrate or looked at or have been demonstrated elsewhere, and a lot of the most impressive work that has been dependent upon very elegant semantic modeling has not been generalized for one reason or another, and some of the very basic work, and I will point to some of the commercial work, frankly, in this area, is being widely adopted and facilitates the structured interoperability without necessarily the full-blown semantic intent, if you will. So, I think the point would be then I believe there are two philosophical orientations, and it is reconciliation of these together and then the incrementalism if you will that I think is fundamental to our success.
CAPT. MAYES: I agree with what you say. I am a little sensitive to it because since I work for an organization that actually dictates a lot of structured type of data entry, one of the I think correct criticisms that we have is that we oftentimes ignore the semantic layer because different parts of our organizations come up with these different structures, and they don't always match, and they, in fact, sometimes increase burden when a little bit more focus on, gosh, you know, I mean this discussion about MDS and OASIS that was a little bit earlier was a good example, and people saying, "You are asking the sort of same questions, but you are asking them different ways. You have defined them semantically slightly different. So, you have in fact increased burden rather than decrease it."
So, I agree with you that there has to be a meeting of that. It is not an either/or type of thing.
DR. COHN: I would sort of comment when I am dealing with government mandates and compliance issues within my organization usually our discussion is not are we going to do but more how high do we jump. So, we will meet whatever you request.
Now, actually I have two comments or I guess questions. No. 1 is that I was hoping that Ms. Demster and Dr. Kelly that you could both submit to the Committee your testimony ---
MS. DEMSTER: I plan to.
DR. COHN: -- that you gave to us verbally and hope we can get copies of it so that we can use it in our analysis.
Now, I was sort of struck by the variety of comments being made by this particular panel. I mean on the one hand we are talking about semantic interoperability which causes me some moment to think about what that exactly means, but in truth I do understand, but it seems like it is something that is pretty far out there and then Dr. Kelly describing the fact that gee, many, many providers out there don't even have computers or if they do they are just using them for billing right now, and there is a big gap we have here.
Now, we heard at our last hearings which were once again public and user comment from Dr. Jesse where, Dr. Kelly, I think you know talking about what he felt was one of the great values of some increased standardization in this area, and it didn't have to do that it was going to solve the problem tomorrow but that it was going to lower the barrier entry and decrease the risk for many providers and others to go out and purchase systems, get more involved with computerization.
Computerization as we all know is going to improve the quality of health care and help save the health care system money. Now, you obviously have commented perhaps at a more basic level of just look what we can do with the data we have today, but does what Dr. Jesse said make some sense to you, and if indeed, that is the case, what else do we need to do to provide incentives to the health care system to help move them forward in computerization?
MR. KELLY: I will make a general comment which is that I think that it is almost a case of helping people, I will use the vernacular, get religion, and I think that there is an awful lot of people who either have not focused on this issue or have so many other issues that they are focusing upon that some of the kinds of more detailed discussions that have occurred here today are just simply not something they are focused upon, and so, I think that I will just give you a couple of examples. Still so much of what goes on in health care is delivered through paper, and so, if for example, we were to move to more electronic sharing of information on just very basic kinds of information, an organization like Bob's sending out information electronically rather than sending it out in paper form, and for example, we just recently posted all of our coverage policies on the Internet. Increasingly we are going to move to the point where all of our communications with physicians are going to be electronic, not paper.
Now, in order for that to be successful then what we are going to have to do is to move to a climate in which physicians particularly recognize that they have to have access to the computer. Having access to a computer with Internet capability is the equivalent of having a phone. You cannot do business without it, and I think that until we get over that hurdle then the rest of the discussion here just although critically important, and as soon as we get people connected then all of the rest of this becomes important but until people are connected I would say that this will continue for many people to be a somewhat arcane conversation.
MR. BLAIR: Would you want to comment on that, Blackford?
DR. MIDDLETON: Yes, thank you. It is a great question. I think it goes to the heart of the issue of really how to proceed and while I am very interested in sort of the ultimate goal of modeling and really the Holy Grail of informatics if you will, what I realize now in being required to build usable acceptable systems that people will pay for is that the fundamental drivers today are not semantic interoperability to be sure. They are does my note support the level of service I am billing for, the E&N issue. Does my note contain a problem list and a method to write a prescription that is on formulary? This is where the practice of medicine is today.
In my own practice I use an EMR. I have been on line and whatnot for a few years now, and I stopped dictating because I can gather the data at the point of care in a facile manner that supports the needs of both my clinical practice and the health care enterprise.
I think the Committee has a dilemma. On the one hand you need to address the larger issue of how to proceed as a nation, if you will, with respect to the fundamental long-range problem versus what do we do today. That is why the points I make hopefully you will take away are I believe there are minimal things we can do now, identify the quality measures that Dr. Kelly is interested in and figure out how to get them from the point of care with a system that gathers them and refers them to him in a seamless and efficient manner. Where it is at in my opinion is at the point of care. If the data coming in are garbage then all that happens downstream will be garbage, too.
MS. DEMSTER: I, also, believe that we are seeing physicians move rapidly to adoption of computer technologies when you compare the past few years. It is remarkable, the curve. I, also, feel that we have certain, speaking as a compliance officer, we have certain problems in our systems in terms of health care delivery organizations would love to put a computer and a browser in every physician's office so they can set up these networks for communication, but our compliance regulations, fraud and abuse, anti-kickback, those types of issues are raised where they are compromised in this activity where they cannot actually provide those computers.
So, I find that as a major hindrance.
DR. COHN: I had a follow-up question which you are beginning to answer a little bit, Barbara which is looking at this issue of incentives we have seen and I think all of us are very well aware that the value of computerization in the health care system, the values are distributed unequally, and indeed we would be expecting that there are probably large players, probably Healtheon is a group that would derive a lot of benefit if all physicians were computerized.
MS. DEMSTER: We would love to have one on every doctor's desk.
DR. COHN: Yes, I am sure, but one would, also observe that Aetna, other large health plans, not to just single you out would derive significant benefit probably as much or more than physicians and practices would with the decreased cost of communication, getting claims or equivalent encounter information and other things. So, I mean you have already described a case where you were trying to get things out but you were being inhibited by government action or by laws.
John, what is your view from Aetna in terms of providing incentives or have you tried it? Is it something that is on the table for large health plans?
MR. KELLY: It is certainly something that we are currently considering. We do have certain incentives for people who interact with us in certain ways. Obviously we already interact with a number of integrated delivery systems electronically, and we move substantial amounts of data back and forth on the Internet every day for those particular delivery systems, and that is found helpful.
I guess though I would say that this is an area where even an organization of the size of ours this has to be something which really becomes essentially a national campaign in which there is a recognition that using these kinds of technologies is something which is just so fundamentally important, that is of advantage to every major sector of the delivery system. So, whether it is those who are public payers, private payers, whether it is providers, physicians and other, hospitals and individual members, I think that that is an area which we very much are interested in helping to accelerate that, and so I think exploring ways to do that.
I guess I would still have to come back though, Dr. Cohn to the issue of what Blackford touched upon and Barbara touched upon. It is essentially the issue of the business case. It is why move in this area, you know, I mean a lot of this has been talked about for a long, long time, and it is very hard to find anybody who is opposed to quality. It is a very short list of people who will stand up and say, "I am not interested in it," but then when you actually then get into the next step though of am I prepared to implement a system; am I prepared to share information, to Dr. Fitzmaurice's question, I think there are some very fundamental questions here, and we still see this with some of the physicians with whom we contract when we actually share information to them. There is obviously a certain amount of uneasiness.
So, I think there is a lot of these cultural issues that we really have to begin to focus upon and then I think it will then allow the technologies to come along.
MR. BLAIR: Dr. Middleton?
DR. MIDDLETON: Is there time for follow-up? The question is great about incentives. One of the things that the Providence health system does where I have the luxury of practicing one-half day a week is they have a quality incentive program targeted to physicians which looks at physician compliance with a variety of wellness indicators, preventive care and process indicators for their care delivery within the clinic, things like if the patient is known to be a smoker and that is known in the database, did you take the time to counsel on smoking cessation, etc., and so those physicians are highly motivated to gather the data because they are going to be judged by it. That is a key issue I believe.
If the physician knows that these are data he or she gathers, and they are going to be used to be judged with those data, then there is much more confidence in the data themselves and in the process because they are involved.
Secondly, I think we cannot ignore the consumerism movement underfoot in this country. We are moving towards defined benefit contribution plans perhaps, you know, managed by the individual employee himself or herself as opposed to the employer managed benefit plan.
I think the consumer is going on line as has been pointed out already looking for health care information, looking for credible health care information and looking for information about themselves, their own health care process, their own providers and institutions and the like, and there are many examples now of health care performance statistics being published on the web.
In New York State you can look up CABG surgery outcome statistics on individual providers. I think as patients become increasingly responsible for their own health care or participatory in their own health care and responsible for their health care benefit they are going to demand the data to choose their institutions and their providers at some level, perhaps not at the individual physician but at some level.
I believe consumerism is going to drive some of this work for us, some of this trend for us. Lastly I think it is just with respect to the consumerism movement, we, also, would like to have an application at every physician's desk top across the country. The MedicaLogic Internet health record is such a thing which can gather data and transmit it to Aetna US HealthCare, to our data center, what have you, but you know that is nice but perhaps more important is the fact that the consumer now can have access to a secure abstract of the medical record and really be involved in maintaining these clinical data for the assessment of quality, the control of their health care and health and well-being.
DR. ZUBELDIA: I have first a comment on the incentives and then a question. It is interesting to see how Internet service providers can give away computers for free, and some computer chains are giving away computers for free, and you can give away a terminal to check eligibility that costs more than a computer and for some reason there is still a problem. Maybe it is a psychological problem, but there is still a problem with giving away a computer to do the same thing, and even if it costs less, that little terminal with a printer. So, I would like to put that in your mind and maybe address that, but I have a question that I would like to frame first before asking the question to all three of you. If I am going to get my mail, and I travel half the distance to my mailbox, then travel half the distance again and again theoretically I will never reach the mailbox but I will be close enough to pick up my mail.
We are looking at medical record nirvana here. You are saying that it is usually impossible because of the lack of sufficient standards and standard definitions and implementations to achieve this medical record nirvana, but I think that John Kelly has shown that with very simple information like claims you can achieve great results.
Are we giving the wrong concept by projecting that it is impossible because we don't have perfect standards to do things when in reality we can do things with imperfect standards today? How can we bridge that gap and say from saying we cannot do it, bridge the gap and say, "Yes, we can do it. It may not be perfect, but this is what we can do," how can we best do that? I would like for all three of you to address that if you can.
MS. DEMSTER: I think one of the, I am not saying that things are totally broken. I think that where we are we are doing great things with what we have done, but we can do so much better if we did not waste our time and our money on doing fixes for inexact standards. If we had common standards across the industry, we could take that 10 percent out of the IT budgets that we are now doing in trying to force non-compatible data into some compatible format. We can take those resources and apply them to better outcomes, and, also, I think there would be massive impact on the quality of care that we could reap huge benefits if we could standardize across the health care industry in our data sets and do more effective outcomes research and just impact the quality of care as the bottom line, and I think that is where we are all going.
MR. KELLY: I think you really asked what is really the critical question here, and if I could give a quick anecdote, about 10 years ago I happened to be in a different capacity working with the American Medical Association and worked with HCFA, and we looked at the issue of how we improve cardiac care in this country. We convened a whole variety of individuals, and various parties identified almost 2000 different measures that we should collect on cardiac patients so that we could have meaningful information. These were the folks who developed all the major databases.
At the end of the day we came down to the conclusion that there really only were three things we wanted to focus upon, beta blockers, aspirin and thrombolysis, and today 10 years later what we find is that still have a long way to go in that area, and so, a comment I would make, and I think it is exactly on is that there is tremendous value in simplification focusing prioritization. Dr. Middleton suggested the same which is setting up a limited number of areas to focus upon and then making progress on those because I think that I fully agree with you that if as we keep looking for what is, if you want, the ideal way to collect information which could require complete re-engineering of clinical processes, how information is managed in the offices and the rest, that in trying to accomplish that we will miss many opportunities that are sitting right in front of us today and that could be achieved over the course of the next 2, 3 or 4 years.
DR. MIDDLETON: I think I would only echo what Barbara and John have already said, that is in my testimony this is exactly the direction I believe we should go, to simplify, incrementalize progress to make it attainable and focus on those areas that are relevant to the folks paying the bill, whether it is the government, other payers or what have you.
At the same time, however, this needs to recognize that this fundamental equation between the data gathering and its subsequent use cannot be ignored and in fact it is to the physicians', the clinician users' favor if you keep it simple.
So, the notion of structured interoperability is where we are today. I can reliably export the clinical record data that is structured when it is things like serum sodium and name generally things like that.
If you ask me to export to a clinical data warehouse or a clinical algorithm of some kind findings on ear exam, it gets much more tricky real quickly, but that may not be relevant. It may be relevant to the clinical process of care, but if we can disambiguate, you know what we need to run the process of medicine versus the clinical thinking things we have to do to take care of people, I think the process requirements, i.e., business requirements can be radically simplified, established in some minimal quality data set way, then the minimal data set to support it and then the interoperability standards surrounding those subsets of data. That I think would be extraordinarily powerful and enabling.
DR. ZUBELDIA: Do we have enough standards to do that today?
DR. MIDDLETON: The big ones in use obviously in the claims and sort of clinical process arena are the ICD, CPT, DMS to a limited degree, LOINC are major sort of structured standards, if you will that allow representation of those kinds of items in structured fields. That is enough. That is what is going into the data warehouse today.
MR. BLAIR: At this point I think we need to take our 15-minute break.
Our next panel will convene promptly at ten-forty.
Thank you.
(Brief recess.)
MR. BLAIR: Our second panel for today, this is for those listening on the Internet, this is the CPR work group of the National Committee on Vital and Health Statistics. This is our continuing hearings on data gathering for having information on uniform data standards for patient medical record information and the electronic exchange of that information.
Our second panel is here, and I am going to invite you all to introduce yourselves, please?
DR. KIBBE: I am David Kibbe from Future HealthCare, Incorporated.
MR. WAEGEMANN: Peter Waegemann, Medical Record Institute and American National Standards Institute's Health Care Informatics Standards Board as well as the Chair of US TAG of ISOTC215 on Health Informatics.
DR. PETERS: Rick Peters from iTrust and representing ASTM.
MR. BLAIR: And among the three of you is a preference for who would wish to go first?
DR. KIBBE: I would be glad to.
MR. BLAIR: Okay, thank you, Dr. Kibbe.
DR. KIBBE: Good morning, Mr. Chairman, Committee members and guests. My name is David Kibbe. I am a family physician and the Chief Executive Officer for Future Health Care, Incorporated.
I am honored to have been asked to provide testimony to assist the Committee in developing and understanding the issues related to patient medical record information. As the CEO of a start-up company whose business case depends entirely on clinical information exchange over the Internet, I hope my testimony will give you an idea of the challenging environment and marketplace we and other e-health companies face, and what I would like to do is tell you a little bit about my company, just briefly, then talk about the context for our company, that is the marketplace forces that are working on e-health and then return to some recommendations that I think will help us to do our job better and to help our clients be more successful.
Future HealthCare is a young information technology firm that designs and hosts web-based clinical information systems for case management and disease management purposes. Our clients are hospitals, mostly community-based hospitals in the 200-to-350-bed range, integrated delivery systems and large physician networks.
Our flagship product canopy is designed to help hospital-based case managers effectively coordinate the care of complex illness patients and high-risk patients who have multiple chronic and/or destabilizing illnesses and to share important clinical information with care givers in sites throughout any given community, such as nursing homes, home health agencies and physicians' offices.
So, in referring back to Dr. Kelly's previous comments about disease management we are targeting those populations most in need of disease management. Our products are designed in a native environment of the Internet and meet current HCFA standards for security and confidentiality of Internet transmission and maintenance of patient identifiable information on the Internet.
New technologies sometimes have the power to not only obsolete old technologies but change the very nature of a profession or an industry. Andy Groh, the Chairman and cofounder of Intel Corporation talks about the strategic inflection point in an industry that is the critical juncture where old models of conducting business begin to rapidly be replaced by a new model as a critical mass of technological, cultural and regulatory change occurs.
Those who embrace the change and participate in the development of the new technologies will, also, help to shape the new business model. I believe we are very close to the strategic inflection point in health care and in the health care information technology business brought about largely by the widespread use of Internet technologies as a core business model component.
This linkage between business processes, demand for health care information and the Internet after all is what is meant when we refer to e-health or e-health care. So e-health is both a product of and a stimulus to new technology and its use.
What I call transforming factors are driving the e-health marketplace in a very dramatic, fast-paced fashion. Briefly these transforming factors are substitution which occurs as new technology permits new and more efficient ways of delivering existing goods and services, for example, on line retail pharmacies are substitution examples, disintermediation which is the process of removing the middle man in an exchange for replacing one middle man with another, resulting in lower total cost to the customer, innovation which as I define it is the use of the technology to perform some entirely new task that the old technology did not permit and which generally was not anticipated but is valuable.
A personal health web site is an example of that kind of innovation, and then finally but very importantly completion of the technology which occurs over time as ease of use of a technology leads to widespread adoption. Complete technologies don't have to be messed with to make them work properly, and just as an aside, I think it is important that most of us recognize that Internet technologies are still mostly largely incomplete which is why many health care folks are not using them as widespreadly as we would like them to.
I tend to view these factors as being related in a cyclical fashion, perhaps even in a spiral fashion, each spurring the next onward and encouraging further development in the marketplace. Disintermediation is particularly important from a business and economic perspective because without the incentive of a more efficient exchange of product or service, and here we are talking primarily about information as the entity being exchanged, new technologies generally don't pay for themselves and are less likely to be adopted.
Under the pressure of this cycle Internet technologies are becoming widely disseminated in health care across a broad spectrum of businesses.
I would like to take a few moments to describe what I believe are the major emerging sectors of the e-health marketplace. There are currently at least five broad segments within e-health differentiated by the products and the business models of the companies operating within each sector. Roughly in order of their presentation to the marketplace these five segments are listed in your handout, and I will go over them briefly here, content providers, portals, e-commerce companies, connectivity integrators and finally Internet applications providers.
Content providers are everywhere one looks these days in the World Wide Web. They include electronic medical publications in journals such as the Journal of the American Medical Association and many others, university and academic web sites and disease-specific specialty sites such as the web site for the Alzheimer's Association, www.alzs.org which shows that some of these are very difficult to pronounce even if they are easy to spell. Whether free to the public or sometimes available through subscription, content providers often have advertising.
Portals which are, also, sometimes called infomediaries provide content, but they are, also, making available a wide and growing range of information products and services, such as free e-mail accounts, expert health care advice, chatrooms for patients with specific conditions, on-line financial services and others.
They are often funded by advertising dollars, but they may, also, rely heavily on networking of services between these different companies, and I think you will recognize right away that there is a good deal of overlap.
Portals are sometimes judged by how many eyeballs they generate, in other words the number of visitors they attract and very well-known health care portals include Dr. Koop dot com, web MD dot com and on health dot com.
E-commerce businesses use the Internet to streamline and automate the purchase of retail health care products such as pharmaceuticals and health supplies. They are among the few e-health companies actually earning revenues and some are making significant profits. Examples include drugstore dot com, planning Rx dot com and one-stop home health care.
The connectivity integrator companies are attempting to link the Internet via the Internet some or all of the major parties to health care transactions including payers, employers, patients, providers and physicians.
Their business plans all involve making administrative transactions more efficient as well as utilizing databases of information for marketing, research and client support purposes.
Due in large part to the perception that administrative costs are a disproportionate share of medical care expenses and that there are huge potential savings to be gained in this sector these companies have fared very well in the stock market. Healthion, Quintiles, Transnational and ClaimsNet are representative examples from this segment.
Finally there are e-health companies of which we at Future HealthCare or representative, namely, the Internet software applications providers. These companies which include MedicaLogic, Axilodel(?) Aboton(?) and Prime Time Software and others are engaged in a completely new model of health care software sales and distribution offering their users the ability to access software programs physically running on servers anywhere in the world via a secure connection to the Internet.
Unlike traditional stand-alone PC and client server software companies the business model here includes a very conscious role as host and security guarantor for health data and information residing on the company's machines or servers.
We are, in effect, creating a patient's view of personal health information that is easily accessible by patients, their families and all authorized care givers.
Clearly the locus of control over health care data and information is undergoing a magma shift referred to in a number of different ways by some of the previous speakers.
Perhaps one thing that is not immediately obvious in such a short description of a small but very active segment of the business world is that all of these e-health companies are interactively gathering and exchanging data and information from patients, physicians, hospitals and sometimes even family members right now.
The accessibility, low-cost connectivity and personal adaptability of the Internet provides tremendous opportunities for enterprising and imaginative health care professionals and their partners who can capitalize on the inefficiencies and inconveniences of the trillion-dollar American health care industry, and this is, I think, a phenomenon which is creating huge new stores of personal health data and information, most of which are entirely unregulated and unmonitored.
So, given this environment, what will help my business become more successful and our clients more capable of providing better medical care? Very simply put it is a set of standards that will make importing and exporting data into and out of our software from various e-health sources inexpensive.
I am less concerned about perfecting current codes and coding systems or in the fashioning of entirely new ones than I am in making what we currently have universally accepted, easier to access and less costly to use, in other words, we need Leggos(?) not Legacy systems without a lot of legislation.
For example, I think it is definitely true that the ICD-9 coding system is not adequate for conveying all clinical concepts. Everyone would agree, but I would rather be able to access and view a colleague's imperfect concepts and perhaps interpret them with my own imperfect understanding of them than to have none at all.
The almost universal adoption of HL-7 is an example of what I think we need more of in order to encourage solutions for consumer health problems using information technology more broadly in health care and making the e-health market more robust and competitive.
The universal adoption of LOINC would, also, be very valuable to all e-health businesses. I believe that government should take a proactive role in working with the private sector to shape the e-health environment which is, I think perhaps verging on being beyond control anyway.
Actions that I believe would be valuable include sponsoring conferences of users and developers of e-health standards to define problems, issues and research studies to show the value of uniformity of PMRI for business uses, patient management uses, technology assessment and others, and I would agree with some of the earlier speakers that we need to focus very, very seriously on the business uses because that is where the pain is being felt right now.
Funding of standards, developing of organizations that will produce specific standards that fill gaps identified at conferences and these sorts of hearings, adopting of PMRI standards for HHS programs that need to exchange information rather than inventing program-specific new codes and definitions of clinical terms, developing standards directly through government initiatives when this makes sense which could include buying the rights to existing coding and vocabulary systems to make them available at low cost to users nationally like my company, promoting research in the most important uses of PMRI as e-health continues to develop, for example, quality measures, cost-of-care measures, chronic illness and emergency medicine registries, etc., and I would agree with the earlier speakers there as well that I think we have a lot of those measures already available to us. We just aren't using them widely enough, and then finally, establishing safe harbors for patient information into which and from which authorized users including patients can access important clinical and administrative personal health information.
Again, thank you for this opportunity, and I look forward to questions and discussion.
MR. BLAIR: Thank you, Dr. Kibbe.
I understand that Dr. Ozbolt has joined us. Is that correct?
DR. OZBOLT: Yes, I am here.
MR. BLAIR: Great. Let me just put in context here our schedule for the panel will go until noon. So, I have to ask each of you to keep your comments within 15 minutes as you have done, Dr. Kibbe, and that will allow us 20 minutes at the end for questions.
So, who would like to be next?
MR. WAEGEMANN: I will be trying to be shorter than 15 minutes, and I would designate my time to Rick Peters. Thank you for inviting me back here. It is a pleasure to be here. I have been asked to talk a little bit about international standards. Why do we need international standards? Health care cannot stop at borders anymore. We are moving toward an international field. We have to realize that millions of people are traveling every day from one country to another. They need health care. We need to understand that there are many international providers, provider organizations who do have hospitals or clinics in different countries where they run it on an international basis. We even have some areas which I have pointed out in my handout where we have up to 70 percent of the population of certain towns in border areas who go to a hospital or to a health care institution in another country. We have this, for instance, in Belgium and Germany, at the Canadian border here in the US and so on.
Of course, a fourth reason is that we need to think about e-health care as we just have heard. Telemedicine, telecare, telepharmacy services all are international. We need to realize that when we are considering standards for patient medical record information that this has to be international, and we cannot just do something nationally.
Now, I have listed on the handout two pages of major standards, and it would not be, 15 minutes would not be sufficient. Probably an hour would not be sufficient to go through all of them. I just want to call your attention to a few highlights. One is that I have listed some of the more advanced countries, and it is worthwhile to keep in mind that if you take, for instance, Sweden, that they established in the early seventies a standard for medical record structure according to Dr. Larry Reed's problem-oriented medical record and 80 percent of the country there has a standard on where information is to be filed and how it is to be structured.
We could go down the list of what has been done in Australia, New Zealand, France. France, for instance, is currently struggling exactly with the same issue as the HIPAA legislation. It is a parallel process of creating standards all by themselves, and it is in some ways amazing that we have two very parallel processes in the United States and France going on without looking across borders what the other one is doing.
When we look at the regional standards process what we need to look at is particularly 7TC251 which has been in place now for a long time and has been working on many, what people considered more academic issues. It has been reorganized, and I have listed in my handout the major work items at this point, very important and I think most of the people in the United States who are somehow concerned with standards should be looking at this.
I want to spend, however, a few minutes on ISOTC215 on health informatics just being formed about a year ago and it has five working groups right now. In working group one we will be working on a general domain model for health care and we are working on a number of additional issues on ownership and access rights which really would be of interest to everyone here at the same time or a general country identifier, just an identifier for patients, devices, care givers, whether they come from the United States or Canada or Japan or Malaysia.
The most important ones probably are the functional requirements within an architecture for an electronic health record. What we are trying to do there is to look at recurrent European care standards, the good electronic health record standards and model and at the same time models like the HL-7 and some of the work being done in the United States, in Australia, in Finland, in Sweden and combine it into a worldwide standard on an architecture which will provide a reference for information which probably will go in the future as most people believe on the information highway on the Internet in a secure way and then such an architecture can provide the indexing infrastructure and the database requirements for an electronic health record.
In Working Group 2 which is being led by the United States and Dr. Ed Hammond is the convener of it we have many activities in regard to messaging and this is a very active group.
Working Group 3 is on concepts and presentation and again there is quite some activity there.
Working Group 4 is looking at security issues on an international basis, what we need particularly, also, for the Internet.
We are working right now and hope to have as the first ISO standard a PKI standard, a standard for public key infrastructure for health care, and Working Group 4 if we like it or not is on health cards. We have to realize that there is very strong activity particularly driven by Europe. We have right now in the German area about 90 million smart cards being issued. At the meeting last week numbers were being mentioned that there will be in about a year's time about 150 million smart cards worldwide being used for health care purposes, and this working group is working on standards.
I really have two requests to this Committee and the first one is that we need more participation. We need participation from government agencies much more because of the importance of the international work and we need more participation, also, from the general medical community in informatics to be part of the process, part of the US TAG part of the issue there.
What we have to realize here is that it is not easy to be a member of an ISO group. If I just look at the next meetings we have one coming up in Tokyo. If you are part of Working Group 1 there is one in February or March in New Zealand. There is another one in London. There is another one in Vancouver. It takes substantial travel funding. We are the only country at this point or only major country where we do not have government funding, where we are totally relying on volunteers and as chair of the US TAG I can tell you it is very difficult to get a consistent team of individuals, of experts to represent the US interests on an international basis. It really would help a lot to get some funding for travel and for the expense of people participating in that.
The second one is that we really must make sure that we have more participation from government agencies and from companies and individuals.
Thank you very much.
MR. BLAIR: Thank you, Peter.
Rick, I am assuming that you want to go next; is that correct?
DR. PETERS: That will be fine. I am going to try to get my slides to behave here, and it doesn't look like the resolution will be ideal, but I do have handouts, hopefully, for people to be able to use. They are in the wrong order, and I will explain that as I go along.
MR. BLAIR: Could I just mention one thing as you are getting things in focus here? I just wanted to clarify for those people that are listening on the Internet I wasn't sure whether it was entirely clear but Mr. Waegemann is Chair of the United States Technical Assistance Group to the ISO, and his comments were with respect to urging further support to represent US interests which are done through the US TAG, and I just wanted to make sure that that was clear.
DR. PETERS: I think I am going to deal with the resolution problem here. So, I will just turn this off and I will speak off of the slides. Does everyone have a copy of those? I will go through them in detail.
Again, thank you all for asking me back to speak here. I am sure most of you are sick and tired of seeing my face or hearing from me, but I will give you my highly biased opinion again.
The request came after a discussion that we had at NCHSB several weeks ago regarding the state of the current health care information systems industry. I was asked to come back and talk about that.
It will be a little less structured than the formal presentations, but it will cover some of the ground that Dr. Kibbe covered and I will probably give some support to John Kelly and Barbara and Blackford's discussions early on.
The first thing I would like to do is go to slide 2 which is general industry trends, and what I would like to define for you overall is that the general industry is relatively frozen in health are IT at this point. What has happened is really two key things. One, Y2K issues have really limited --
PARTICIPANT: Would you like to do the slides?
DR. PETERS: Let me delay for a minute and then I will try it on the other computer and see if I can get it to work.
MR. BLAIR: Would it be okay if you needed a little more time on that? Should we switch and have Judy go first? That would give you time to --
DR. PETERS: Judy wants to use the computer, also.
MR. BLAIR: Oh, she needs to use it, okay.
DR. FITZMAURICE: Jeff, I wonder if I might ask Peter Waegemann a question while we are --
MR. BLAIR: Certainly, go right ahead.
DR. FITZMAURICE: Peter, you talked about the standards being considered by the ISO Technical Committee on Health Informatics. In the United States we have a large focus on administrative data and are just beginning to focus on the clinical data. What is the focus of the ISO Technical Committee? Is it more on the clinical data or on the administrative business data?
MR. WAEGEMANN: Thank you. Yes, it is on clinical data because the administrative part is very different in each country, and it is very difficult at this point to focus on the administrative area although ISO Working Group 1 has been discussing over and over the need for reimbursement, the need for administrative interchange between countries and insurance systems, but it is not an active work item and focus is on clinical issues.
MR. BLAIR: While we are waiting, does anyone else have questions?
DR. YASNOFF: Yes, this is Bill Yasnoff. I have a question for Dr. Kibbe. You mentioned in your list of suggestions for the government buying the rights to existing coding of vocabulary systems to make them available at low cost. Could you be more specific, perhaps give an example of how you think that might work?
DR. KIBBE: I don't want to infringe on anybody's commercial rights, shall we say, but I think it is well known that there are certain proprietary coding systems out there that are used widely and I think that what we need is to make sure that they are available and where the cost is a barrier to making them available I think it is reasonable to ask the government to be involved in pushing that agenda forward. That is probably not as specific as you want to be, but I want to be very careful. I don't want to offend anybody. I am sure you understand.
DR. YASNOFF: I do, and if you will take an unnamed vocabulary where cost is a barrier could you outline how you think such a thing would work?
DR. KIBBE: Sure. For example, if I have to spend, if my organization or any organization that wants to use the code has to pay a license fee for the code, even if it is a reasonably small amount of money that is one thing, but then if I have to pay further monies for books on how to interpret those codes and pay an ongoing stream of revenue essentially to be able to use that code, I think that is when it becomes a barrier.
DR. YASNOFF: Are you suggesting, for example, that government take a coding system and negotiate with that system and say, "We would like the rights to distribute this free of charge in exchange for a grant of X indexed by inflation in perpetuity to maintain and expand the coding system," or are you suggesting that the government --
DR. KIBBE: That sounds pretty reasonable to me.
DR. YASNOFF: Okay, are you suggesting that the government take over the coding system, in other words that these coding systems should become part of the government itself? I am just trying to get some idea of what exactly you are suggesting.
DR. KIBBE: I think I am not suggesting anything quite that specific. I think we need to look at the areas where first of all I think we need more information about where the blocks, the availability problems lie; which coding systems are we really talking about; are we really going to -- what coding systems are going to be part of our national infrastructure and therefore are really important to focus on and then where are the potential availability barriers as a way of getting at solutions as to how to knock some of those down.
DR. YASNOFF: Thank you.
MR. BLAIR: For the benefit of the Committee members as well as those folks listening on the Internet, let me just clarify a little bit. This is the second time that Dr. Peters has testified to the Committee. They are in different capacities. Formerly he testified with respect to guidance on our focus areas from the standpoint of being a vendor of electronic health records and clinical information systems.
We have asked him back today because Michael Fitzmaurice and I both had a chance to see the presentation you are about to hear at ANSI's Health Care Informatics Standards Board which was a review of the trends in health care and the technologies and how they are affecting standards, and we were very impressed with that presentation, felt that would help the Committee.
In terms of Judy Ozbolt, Dr. Ozbolt, she, also, has testified to us once before, and the reason that we have asked her to return is that during this summer she convened a group of the developers of nursing vocabularies and we have asked her to come back to give us an update on what has come out of that.
So, now, Dr. Peters, can we turn this back to you?
DR. PETERS: I think we are set and ready to go. Thank you very much for your patience, everyone.
Let me start right back in again as Jeff had mentioned talking about specifically what is going on in the health care IT industry and how that has a profound effect on standards and probably has a reflection back on the discussions earlier today and on Dr. Kibbe's presentation.
Essentially if you look at the IT industry as a whole, the industry is relatively frozen, and it is frozen for a number of specific issues, some of them logical, some not.
No. 1 is Y2K that a lot of people have expounded on and essentially two things have happened. Y2K in the first two quarters of this year has significantly changed hospitals' buying patterns and has decreased IT spending particularly towards existing systems.
The other is that in the practice management industry on the physician side there has been so much fallout over practice management non-compatibility for Y2K issues and vendors dropping out of the industry or major vendors who I will not name at this point, but who have severely irritated their physician customers by offering either very expensive solutions or by saying that solutions were only going to be available to a limited number of their customers. So, confidence in that industry from the physician side has been hampered, and the revenues for those companies have gone down.
Also, consolidation in the health care IT industry has been a disaster up to this point, if you really look back historically. The first example was Medafis(?) several years ago that had consolidated a lot of hospital billing and physician billing organizations and I think Gary Dickinson who will talk this afternoon can tell you what effects that has had on some of their acquisitions including his own company, very viable companies that were in need of funding that got consolidated by larger organizations and have struggled somewhat because of the changes inherent in that, and nobody could be more blatant in this than Mackeson(?) HBOC which I will go over some of the problems that they have had but this has had probably the most serious detrimental effect on the HIS industry of any industry shake out that has occurred over the last 5 to 10 years.
Also, people are watching with some fascination the roll-up of Eclipsus(?) which is acquiring a lot of small companies and building an HIS competitor to SMS and HBOC and Healtheon which started as a pure Internet company along the lines that Dr. Kibbe had mentioned some of the new vendors are and some things I will discuss in a moment, but it has now become a consolidation play rolling up a variety of vendors, some of them existing vendors such as MediAmerica which is an existing ETI vendor.
The other issue is that non-delivery of software in a purely functional perspective, i.e., promises made under contract or under bid to promise specific software functionality to given customers and not delivering that has had a profound impact on the customers' desire to take risk.
This coupled with the fact that if you look at HBOC's problems it was basically related to revenue realized on non-delivery of product and everything forms a circle. Why is the industry in such a slump? There are a number of things that are obvious. One is that there are radical changes in the health care market and specifically in reimbursement itself.
Managed care is on everyone's black list, and being at the Intel conference several days ago which several of the rest of you were as well I think what was very interesting was to hear Oliver Goldsmith and, Simon Cohn, you may find this relatively funny as well, Oliver Goldsmith who represents Kaiser Permanente basically for the Southern California Permanente medical group which is a physician group in Southern California stated that Kaiser was not a managed care plan, and it wanted to get out from under that moniker because managed care was getting beaten on so hard.
So, it is a very interesting perspective but basically managed care has been the whipping boy or has gotten a black mark for many of the problems that we are having at this point.
Also, hospital revenues have crashed in Q1 and Q2 of this year. That has, also, had a profound effect on hospitals but also, on the IT side of the industry.
Why did they crash, and what does this crash mean? Hospitals have been profitable across the board for the last 20 years and specifically highly profitable to the 5 to 10 percent margin range over the last 4 to 5 years. At the same time, hospitals are crying poor and as you well know which was announced in the Wall Street Journal this morning Congress moves to ease Medicare cuts with bills increasing reimbursements, and who is the major recipient of this? Hospitals. Are people crazy or is Congress crazy? Absolutely. Hospitals are crying poor when they have been making money hand over fist over the last 5 years. They have had a slump in the early part of this year. At the same time premiums are going up in managed care and managed care payments are going up.
You have to wonder about what is really going on behind the scenes there, but basically what you are seeing is mismanagement. You are seeing the same situation that we had in the eighties where you have got hospital cost overruns and no effective management of that, an area that we all know information systems would help. At the same time you have them not buying information systems because they are running out of cash, finally, and you, also, have the issue that Y2K is bothering them because they are trying to keep their Legacy systems alive.
The other is that capitation risk contracting has stalled except at the state payer level, i.e., with Medicaid plans, and at Medicare. Most of the private insurers have stopped or are not market expanding their capitation risk other than in disease management or subspecialty as a payment scheme that has a profound impact on the IT industry, for example, Medical Managers brand new product came out, and it is a risk management and capitation management product with no specific market because it is only 20 percent in any given specific market, i.e., capitation. It is not specifically growing.
Also, there is a loss of investor confidence in the IT sector in health care, and this has had a profound impact on availability of funds for existing companies. If you look at the market cap of HBOC its market cap is zero. If you look at Mackeson's market cap prior to the acquisition of HBOC and you look at their price now of their stock and their current market cap the acquisition of HBOC is valued by the investor community at zero dollars. In fact, it is negative.
HBOC's market cap is below, i.e., Mackeson's market cap is below Cardinal and Mackeson which does the same business as Cardinal, i.e., they are a drug wholesaler, supply wholesaler actually has more market share than Cardinal does.
Cardinal has three times the market cap and most of this decrease is due to the HBOC acquisition. Cerna(?) has a market cap of 470 million which sounds like a lot. That is only probably three times to four times revenue which is low in this market, particularly in an expanding stock market. IDX may be two to three times revenue at $474 million. Healtheon, current market cap as of yesterday was $280 billion, not counting the acquisition credit that they will get from the companies that they are acquiring at this point. That is $280 billion over $45 million in real revenue, and that revenue is an Internet revenue. That revenue is outsourcing revenue.
So, you have got a very, very interesting dynamic going on here. If you go to the next step and again this may get a little too much into detail, but I thought it was worth it, let us look at the 52-week stock price which is the fluctuation stock of these major players. Mackeson is at a low; 24 and 15/16ths was their lowest for the year. They are only at 25 right now. Cerna is at 14 with a high at 28. They are at half their market cap from earlier this year. IDX is at 17 with a top of 50 in the last 52 weeks. Healtheon the numbers look the same, but you have to understand something here. Healtheon at $40 a share has a phenomenal market cap. These other stocks are trading low.
Healtheon will stay stable and potentially go up. No one in the stock market believes that any of the existing IT vendors will go up. These prices will stay flat, and they finally feel these are decent valuations of these companies. That is a scary fact in that it is going to limit their availability of capital.
What is happening in the market then and where are investor dollars going? Investor dollars are going into the new areas of the Internet, and these are the areas that Dr. Kibbe laid out, and I have got a number of different divisions probably a little more than he had, but I like to talk to these in terms of a trend because I think this has a profound impact on what we are talking about in standards.
The current hot investment activity, and here we are talking about investment that has been to the tune of about $500 million up to this point of real cash coming from venture funds and investment banks and institutional investors probably will be at least that much if not double next year of investment in new companies. It has been specifically in the connectivity vendors, Healtheon, Point Share, Carinsite(?) Connetra(?) Aboton, Esterion(?) and a variety of other companies.
It has been at consumer and provider health sites and portals, the consumer sites predominantly being on health, Dr. Koop dot com, web MD, the physician portals being Medscape, Medcast, other companies like that and if you look at the portal space overall there are probably 150 portals that are either health care consumer specific or physician specific that are either existing on the net right now or are out seeking funding, a phenomenal number of companies chasing dollars in that market.
The other site is on-line claims and ETI. Claimsline(?) net was an example. Quintiles was used as an example which is Envoy NEIC, Envoy NEIC being a traditional vendor but has good access to capital through Quintiles and the acquisition, and claims dot net which has not done very well in the stock market because of over promising, but there are other companies out there, and there are probably two or three that are funded at this point and moving into the market that will have an impact on the on-line claims and ETI side of things.
On-line pharmacy very interesting market. There are really three major players now although there are probably 25 companies out there in the on-line pharmacy market.
The three major players are Planet Rx, Drugstore dot com and CVS dot com which used to be Soma dot com. CVS dot com has Merck Medco and the PBM there. Drugstore has the No. 2 PBM in the country and Planet Rx has the No. 3 PBM in the country. So, basically the pharmacy benefit managers now have on-line pharmacies aligned with them. That industry will start to consolidate phenomenally quickly.
Planet Rx and Drugstore dot com have gone public both to the tune of multiple billion dollar valuations and with phenomenal amounts of cash. They each raised between 70 to 80 million dollars in cash in their public offerings over the last 2 months.
The other interesting thing in this sector is there are seven companies out there either funded such as e-physician or seeking funding that are going to do prescriptions on line on the palm pilot. That is their only core business, seven companies just seeking funding in that area, and I promise you all of them will get funded which may be absurd but it will absolutely happen. Money is flowing into this industry at an unbelievable pace.
Internet practice management, another area, Carinsite(?) with medical manager and the acquisition of Medical Management by Senetic(?) is moving into that area. IDX has a product that they are moving into that area that they got through an acquisition for Famous. There are other companies like mine and four or five others that are in the practice management space. Also, the Internet electronic health record, Blackford Middleton's company, MedicaLogic is reconfiguring itself as MedicaLogic dot com and already has an offering in place and an offering where they will actually provide computers and actually a very nice approach to say that at a fixed dollar amount doctors can get computers, software and an Internet-based electronic medical record, and that is deliverable now, not tomorrow, not a year from now.
There are probably 15 companies in that space. There are new Internet companies like Eclipsus that are relatively well known, but there are probably 5 to 10 other companies that are emerging in that area, and existing vendors like Epic and my former company, Oceania that are trying to catch up with MedicaLogic on the move onto the Internet from existing Legacy side.
The other is administrative outsourcing, ERP and ASP which is application service provision. That is now where the vast majority of money will probably flow in the next 6 to 9 months.
Where are these companies going in terms of technology and how does that differ from the existing industry? If you look at infrastructure alone, 60 percent of these companies are intranet and this has to do with security concerns and other things like that or they were formed at 1 or 2 years ago when the Internet itself didn't have security technology and the intranet was the way to go.
Twenty percent are pure Internet and are doing relatively secure, some very secure transactions on the Internet and 20 percent are still client server which is the companies trying to move over into the Internet space.
Client architecture active X about 20 percent, HTML about 60 percent of vendors and XML 20 percent. XML is a growing sector here. HTML is the declining sector in this area.
Server architecture NT 60 percent, Unix 40 percent and main frame zero. No one who is developing new Internet applications is running on the Internet other than Legacy vendors who are trying to put Legacy front ends on Legacy products. I mean on main frames, not the Internet.
Security password 60 percent and PKI, public key infrastructure, private key digital signatures that sort of thing breaks down to about 60 percent, 40 percent, and PKI is probably the rising sector particularly with the CA work that is going on. Intel has announced a CA, the various private CAs that are in existence, the State of California is trying to put together one with a CMA. So as certificate authorities become more ubiquitous public key infrastructures will become more predominant as a security mechanism over the Internet.
Pricing and revenue models this is the shocker, and this is a big shocker to Legacy vendors. Ninety percent of the new vendors are doing it on a subscription model and 10 percent with licensing, and I will explain a little bit how this impacts existing vendors as we move forward.
Primary way this affects the vendors is in terms of how you look at revenue and cost. If you look at the top line on this screen, traditional system licensing, if you figure that a flat price or an amortized price over the years that a vendor would pay for software, it is relatively high at this point for any given product. It doesn't matter if it is a physician office system, an EMR or existing hospital Legacy system. If you look at the price to end users what is happening which is the next line down, it is being driven down by all the new vendors and by prescription pricing, and if you look at traditional development costs which is the middle line it is relatively flat if not going up because developers are becoming more and more expensive as Internet and other companies start to snap them up and there is so much money pouring into software development at this point.
Developers on the West Coast are paid anywhere from $75,000 to $150,000 to $200,000 for programming. You can get $50,000 to $75,000 one year out of college as a software programmer in this day and age. It is unbelievable.
So, the supply is relatively constrained. Also, if you look at Internet development costs they are markedly lower than traditional development costs and that is probably when it is going that way and that is the only way to track and keep some margin based on the falling price to the end users.
So, if you can look at this chart as one way, it is pricing out the Legacy vendors as we speak on direct price alone, much less the fact that they are going to subscription model, and the simple thing, a transition from a subscription model which is where somebody pays for software on a monthly basis and pays essentially nothing up front versus the Legacy model is if you look at a public company that has to realize revenue and they are using a standard licensing model, they have a $5 million software sale. They realize that as revenue in a given year, and they have built up for the public markets an expectation of let us say $50 million of revenue on a yearly basis. The subscription model, they have to get that $5 million over the course of 12 months or more likely over the course of 5 years.
So, they are going to see a significant dip in the revenue that they realize immediately which will have a profound impact on how Wall Street begins to look at them. So, it is going to be difficult for people to transition from Legacy to Internet whereas Internet companies are wildly over valued.
What has happened in the market dynamics, also? In 1970s and 1980s we had two things that we were really looking at, administrative systems and then hospital HIS and practice management, basically systems to generate claims in a fee-for-service environment, very straightforward. What happened in the 1990s, and some of this occurred in the eighties which was a transition to the notion that we would have community health information networks, a lot of investment money went into networks which were expansions on the approach of how we would pay for health care and how it would be administered which basically hasn't panned out, and everyone I think knows that, particularly as managed care has started to have problems.
Third is electronic medical records. Myself, Blackford Middleton and a variety of others really believed in the late eighties and through the nineties that electronic medical records would drive the adoption of clinical systems and would start to drive the administrative side of things. Regrettably that hasn't happened at the rate any of us would have assumed or had hoped. There is a variety of reasons for that, but it is basically a fact that we have to state and face up to.
So, what are the current market transition and what is going to happen in the year 1999 has already happened going into the year 2000, into the next decade. Primary driver is going to be in the current sense connectivity, and it is going to be to the payers and this is something that John Kelly mentioned earlier, and he said that there is a significant number of their members who are not receiving optimal care.
The very strong feeling in the industry is that if you can connect the payers and the providers or the payers and the patients you can have some significant impact, and I think John gave you some examples of that that are very germane, nd this is a viable industry in its own right which is connectivity to the payers. This is where Healtheon, Point Share, Aboton, Carinsite, a variety of other players are moving, Healtheon on a national basis, Point Share in rolling up the Pacific Northwest and Carinsite in going after New York by buying the Think Network which was the New York payers and a number of their hospitals.
Health Portals, which is the consumer side of it was a very strong area of investment up until now. It is falling off as an area of investment because no one is making any money there. No one thinks you ever will although it will drive consumer interest and we know it has had a profound impact on medical decision making.
What is emerging is connectivity in a so-called "health" infrastructure which is, also, represented by Healtheon, Point Share, Carinsite, Aboton and a variety of others, Connetra and essentially this is as Barbara Demster had mentioned from Healtheon this morning and it is very valuable is the notion of a virtual medical record, the notion that if you can tie together enough of the transactions you will have a significant amount of data on patients that will be of value to the payers and the providers. It doesn't matter if it is even just lab or claims or other things like that. This goes back to Kepa's question.
There are good data out there if you can aggregate it, and these connectivity players are a good way to aggregate it because they bring a lot of additional capital in that the TINs(?) never had and they bring a lot of new energy in in a cheap infrastructure, i.e., the Internet and can start to aggregate this data and provide benefit.
The next level that is emerging is application services which is the outsourcing of practice management. Next you will see outsourcing of hospital information systems, hospital registration and other things like that. SMS, for example, has already announced an Internet strategy to start to outsource which is what they traditionally did before Client Server came on board, and you will se Client Server start to fade away and an Internet infrastructure and outsourcing become predominant.
What is going to drive this in the future? It is not going to be one of these specific plays. It is going to be cost, i.e., who is going to provide the cheapest way to integrate services either through outsourcing, connectivity or other things like that, and who is going to provide that cheap cost to the payers, to employers, the providers, i.e., the hospitals and the physicians and to the consumers?
The next issue is going to be functionality because there is going to be a running battle with the amount of money that is being poured into this to provide very comprehensive functionality at a relatively decent price.
How does this affect us and the standards issues? One, I think as David had mentioned and I think Blackford brought up as well, the e-health vendors, e-health, there are a million different words for it are outrunning the standards efforts. There is no question about that. Two, privacy and confidentiality are back as real, real concerns. It is unbelievable what some vendors are doing out there in two areas, one in how flimsy the security they are using on the Internet when good security is easily available and two, the other issue is, and I think Dr. Kibbe brought this up as well, and that is the notion that people are starting to aggregate data, and they are going to use it for things that we do not want them to use it for.
The other issue is that the new vendors have already defined what a medical and health record is. There isn't a vendor out there who is doing electronic medical record who doesn't have a complete map of the record, and there aren't any, there isn't really anyone out there if I can use proper English here that is in the connectivity side who doesn't have a model of how to aggregate data and build a virtual health record.
So, all of our efforts to define the content and the structure are somewhat being beaten to death by the fact that people are already doing that and they are already providing some operability.
We, for example, and a number of other vendors already have systems, as does MedicaLogic, as does Healtheon that talk to other vendor systems, and we already have interoperability. We are just interested in standards to move that forward.
Also, investment dollars and not revenue and profit are driving change. Revenue makes no difference in the current environment for funding, and that is going to persist in health care IT for a little while because there is no real way to make money right now.
So, you are going to have a lot of investment dollars and people thinking about what is a good idea driving where we are going rather than real ways to make money or answering real needs, and this is why you see profound impact, and for Barbara's company, Healtheon, New York Times magazine has a feature article on Jim Clark and the founding of Healtheon and how profoundly he is going to change health care. Very few people in health care and health care IT know Jim Clark or necessarily believe that health care is going to be radically changed by Healtheon, but they do believe that Healtheon together with Point Share, Carinsite, Connetra, and small companies like David's company and others that are going to start to do data analysis and better ways to aggregate it are going to have a profound effect. There is no question about it, and there is an entire other industry which is the investment banking industry. This is just one report from Bank of Boston that shows all the different companies. There are 40 companies in here that none of us have ever heard about for all intents and purposes in health care IT.
Let me get back on track. The other thing is that since there is such a capital switch and a capital influx into new companies and due to the fact that all these companies are changing the way information is paid for and that revenue doesn't matter anymore, plus the fact that HBOC has put such a hole in the HIS industry and such a hole in the trust of customers to the larger vendors, the Legacy vendors are really vulnerable.
This is good for the new upstarts, but it is bad for the industry as a whole because the Legacy vendors already have a lot of data. They have done a lot of work. They are far more knowledgeable in some of the key things that need to be done than a lot of these new upstarts that are coming in. If you really look at the vast majority of health care companies that are in the e-health space on the Internet very few health care knowledge is involved in those companies in management or in design or other things like that. It is something we really need to bring to the fore.
What are some solutions, and I will end with this and one more slide? One, I really believe and you guys know this is my bias, but I will say it for the umpteenth time, privacy and confidentiality needed to be defined yesterday and they need to enforced. So, we either need Congress to act; we need the Department to act, and we hope that Congress is not going to preempt the Department's options to invoke at least some privacy guidelines if we will take them like that, if we cannot call them regulations, and we hope that people will start to enforce these and stop people from using data unnecessarily or for the wrong things.
Also, standard organizations of the Federal Government need to quickly target key standards and get them in place, and I have said this before, and I will parrot something that Blackford said to back that up.
Also, the new e-health care vendors and I think Barbara brought this up; Blackford did and so did David and Peter, they need to be brought into the standards process. They need to be brought into settings like this and heard from.
Also, they need feedback from all of us who have been involved in this for a long time so that when we get interoperability we actually can work together, and finally, what are the targets that I would do? One of the things is something that you know I have pushed for a long time. Clinical document and message structure which is interoperability needs to be done. HL-7 and ASTM and ISO TC215 and SEN(?) have good efforts under way. I think we need to push them to move as quickly as possible in those regards.
We need some coordination which is happening. At the last meeting there was good HL-7, ASTM, ISO and SEN representation. We need to encourage these and push it as fast as possible. Also, document message and record security, this is the biggest hole in the Internet right now which is the fact that we don't have good interoperability on security. We are all doing security, but we are doing it in different ways, and your messages become vulnerable to attack if we don't have a good overall infrastructure to do that. I think PKI is good in terms of that, but we need to push the CA side of it. We need to push the work that AFEC(?) is doing and other in terms of putting together test cases to run this stuff. We need to bring those more formally forward because very few people in the health care e-health sector understand what is happening in the EDI sector in terms of security.
National consensus on access rights and ethical data aggregation and use, we need this. Hopefully regulations from the Department will help or passage of some kind of bill from Congress. We really need to understand that because there are some very unethical things that are proposed and a number of different portal sites, web MD being one example basically state emphatically, and they have every right to state this because it is part of their business plan that they will sell their data to other people to use. There are many of us in health care who believe that this is not legitimate or should not be part of the specific business plans. If we can get this on the table soon enough companies like web MD and others can modify their business plans to take any shortfall that they would have in terms of assuming they would make money off the sale of data, but we need to be forward about this. We need to be straightforward. We need to be ethical when we say, "We need to do."
Internet EDI, this is something that KEPA(?) has been involved with, and AFEC(?) and others have. We need to push that because X12 in the current standards under regulations are very good but everybody is pushing, and we heard from Cowlings last week that even the payers in California would love to have health are EDI on the Internet rather than just through X12 or valuated private network transmission, and it is really verification of something, too, something that Healtheon, Point Share, Connetra and Carinsite are pushing for. All of them would very much appreciate from the standards side of it some greater standardization of eligibility data, and the last is terminology. I do agree that terminology is a key issue, and instead of saying very many things on that, I would point to Blackford Middleton's testimony, Page 7, Paragraph 2. Let us take Blackford's proposal which is to get a public and private, hopefully non-profit entity together to push terminology forward and get it settled. I would propose that we use ASTM and HL-7 to drive the XML side of it and USEN(?) and TC215 to back us up, use Multim first data bank and Lexicom(?) to help us with the terminology from the pharmacy side and to use SNOMED and MEDSEN(?) which are the leading two standards for terminology to work on the actual wording and things like that, bringing the National Library of Medicine and others in on the process.
I propose that you pick some physicians. I propose Blackford Middleton as one, Paul Tang as another, Tom McNamara who is from Multim as another, Peter Elkin from Mayo, possibly something like David as another. I would volunteer one physician from our organization. We have three or four who could qualify and I think that we could get a number of people together who could help in this process and could move it relatively quickly.
So, to end, again, my basic statement is that the industry is going nuts because of investor money that is driving a non-traditional view of the health care IT industry, driving new ways to do business.
What this has done to us on the standards side is it basically is going to, I hope, push us forward, but I fear if we don't move fast enough we will be trapped by the fact that people will start to do things or will start to exchange data in ways that one, are not contributory to patient care, but two, may be detrimental in the long run to privacy and security, the same old story from me.
MR. BLAIR: Okay, let me just add a personal disclaimer. I will say on behalf of myself, and maybe Michael might want to join me, that we asked Dr. Peters to present to us because we felt that he has a great deal of insight into these trends and how they relate to standards, not because of any examples specifically that he may have used.
DR. FITZMAURICE: I would say the same is true, Jeff. I heard Rick Peters and then I heard David Kibbe at virtually two consecutive weeks and was impressed with their overview of the system. In many areas I don't know enough to agree with them or disagree with them, but they present a view that the world is changing and something that we need to see.
MR. BLAIR: A very important message.
Dr. Ozbolt?
DR. OZBOLT: Thank you very much. I appreciate the opportunity to come back and give you an update, a progress report since the last report in the spring, and I am going to need to be able to reach a mouse or an arrow key here to make the slides go forward.
The packets that I distributed have the full written text of my testimony. I will just hit the highlights today in view of our time considerations.
There is, also, a printout of the slides that I will be using, and all of the papers that are referred to in the testimony.
There is a paper that was delivered at the Health Informatics Society of Australia in August the vocabulary of health informatics for the new millennium which is just a bit of history and issues and where we may be going.
There is a report of our conference toward a reference terminology model for nursing and there is a proposal for a new work item to ISO, and I will be telling you about all of those things.
I am the Independence Foundation Professor of Nursing and Professor of Biomedical Informatics at Vanderbilt University. I, also, serve on the Board of Directors and the Executive Committee of AMIA, the American Medical Informatics Association and on a couple of committees for the American Nurses Association that are concerned with informatics and terminology. Today I will be reviewing briefly definitions and requirements for patient record information.
I will report on the progress that we have made toward arriving at comparable nursing data and then talk about issues for government attention and action.
It is reasonable to ask why we should be concerned with nursing data at all. It generally is not around, but nurses, in fact, provide important and expensive services. The quality and effectiveness of those services affect the survival, the quality of life and the health of our population, and they, also, affect the consumption of resources for health care. We, therefore, need data to assess and improve the quality and effectiveness of these nursing services.
What data do we have? We have data in a variety of places on staffing and cost. We know how many nurses we deployed and what it cost us to do that. We have some data about patient satisfaction although patient satisfaction data tends to be concerned with the quality of the hotel services and the interpersonal relationships. Were the nurses nice?
We don't have any data about the problems that were addressed, the goals that were pursued, the interventions provided or the outcomes achieved. Why not? Our patient records do not have standard terms and codes for the problems, interventions, goals and outcomes that are the focus of nursing care.
Our narrative notes which was our traditional way of recording are very idiosyncratic. They vary across patients and nurses and places and times. The result is that important data that we might use to assess quality and control costs are missing or unreliable or non-comparable. Of course, there are sets of nursing terms, and in your spring hearings you heard, I believe, from the authors or responsible parties for all of those sets of terms that the American Nurses Association has recognized as being useful, and there are nine of those now.
There are other sets of nursing terms in other countries around the world and yet none of these has emerged as a standard and furthermore these sets of terms are so different in the way they were conceived and developed and organized that it is not possible to merge them into a single unified standard, and something that we have just begun to acknowledge recently in the past couple of years is that these sets of terminologies that have been developed really lack a number of essential requirements for standards.
So, as of the time that I spoke to you in May the status quo was that we had no nursing data in public health databases, that we had multiple nursing terminology sets competing for acceptance and that our nursing terminology sets lacked important characteristics that we would want to have in standard reference terminologies.
So, I told you we were going to try to fix that. We had a conference at Vanderbilt June 10-13. There were 36 invited participants. It was a working conference. We didn't have an audience because we were asking people to do something very difficult, to give up treasured positions, to acknowledge ignorance in some areas, to learn from one another, and all of these people were acknowledged experts in one field or another, but no one person had all the pieces of expertise.
We had all of the authors of the nursing vocabularies recognized or even considered by the American Nurses Association. We had a number of experts on language and standards. We had federal officials from the National Library of Medicine, from the Division of Nursing at HRSA. We had officers of professional associations. We had health care providers and we had a number of representatives of the health informatics industry who, along with the National Library of Medicine and HRSA provided financial sponsorship for the conference.
It was a wonderful conference. It was hard. It was exciting, and it was the right people to deal with the issues. There was a point in the discussions when we were trying to talk about the difficulties of developing standards for nursing terminologies and how these standards had both to be compliant with things like the HL-7 reference information model and they, also, needed to influence the shape of other standards, and one of the participants said, "Well, if we have to be in concert with HL-7, we need to be talking to HL-7," and we said, "Here is the Chair-Elect. Here is the Chair of the Patient Care Data Committee. Here is the Chair of the Vocabulary Committee. Let us have the conversation," and it was very exciting.
We learned a number of things. One of the things that we recognized was that users do employ what we call colloquial or entry or interface terminologies to enter and retrieve data. These are what users see, what they are familiar with, and we acknowledged that the recognized nursing terminologies by and large are of this sort. They are colloquial terminologies, and we acknowledged that different colloquial terminologies are needed for different specialties and different sites. Who better than the operating room nurses to tell us what kinds of terminologies they need to describe their practice? Who better than the labor and delivery nurses to tell us the terminology they need for their practice, but we, also, need to have reference terminologies that contain all of the allowable terms to refer to the concepts in the practice, and these reference terminologies need to be structured according to the semantic relationships among the concepts. This was a new idea that we had to, some of us who had not thought of that before had to get our minds around.
We thought that a comprehensive standard reference terminology is what is required for an interlingua so that we can track a concept from one colloquial terminology to another.
Stuart Nelson was there. Stuart Nelson at the National Library of Medicine is in charge of the MSH, the medical subject headings, and Stuart pointed out that the unified medical language system which has a wonderful way of mapping from concept to concept for all of these terminologies is not going to be the long-term solution because as each colloquial terminology evolves the work of mapping that evolved and evolving terminology to every other evolved and evolving terminology is just going to grow exponentially. We cannot expect that to be our long-term solution, whereas if we had a reference terminology, each of the colloquial terminologies could map only to the reference terminology, and we could trace our way like through the Metro system. Everybody goes to Metro central and then changes to the line that they need to be on, but to build a reference terminology we first have to construct a reference terminology model that identifies and names the core concepts and their defining attributes and depicts the semantic relationships among these.
We can do this, we think in a stepwise fashion. First, we will take a set of terms and define and develop a draft model from those terms. Then we will take another set of terms and test the model against those terms. Then we will critique, revise, rewrite until we finally have a robust model.
We recognize that success requires collaboration and that we need to share our expertise to think together and to critique one another's work.
We didn't stop at the conference. We volunteered for task forces that are doing the work of drafting and testing parts of the model. We are going to get together at the AMIA meeting here in Washington in November.
We have set aside some meeting rooms, and our task forces will be working, and we will get together, as many of as can in some plenary sessions and compare and figure out where we need to go from here. We are writing papers for publication, describing what we are doing and the results. We are preparing presentations for conferences, and we will have a report at the AMIA meeting, and we are continuing to collaborate. The members said that they wanted to be known as the nursing vocabulary summit group, and they want to meet again at Vanderbilt next summer. So, we are going to try to work that out.
Once we got that done and sent off the first paper by July 1, to the EMEA(?) nursing informatics conference which will be held in New Zealand in April-May of 2000, a member of the Scientific Program Committee for that conference is Evelyn Hovenga who chairs EMEA's Nursing Informatics Interest Group. Evelyn read the paper and said, "Look, this is just what EMEA needs to do. We have been wanting to put forward a proposal to ISO for a new work item, and this development of a reference terminology model is exactly what we should all be working on. So, would the Nursing Vocabulary Summit Group which is just an informal voluntary association join with EMEA in drafting this proposal?"
We did so. It was submitted to the US TAG August 31, and approved and will be balloted at ISO in Tokyo in November.
We have started working on our colleagues in Europe who are very active in terminology development in the United Kingdom to join with us and make a worldwide EMEA effort and in the meantime our American group is carrying on with out own efforts.
We expect to do the international work by a process of collaboration similar to what we are using in the US, that is the group agrees on our goals and some tasks that we think will help us achieve the goals. Members volunteer for task force groups to work on these jobs, and we keep in touch by the Internet and get together at conferences wherever we can.
We are going to meet again probably June 8-11, at Vanderbilt again. Our international colleagues will be doing related work in their own countries. We will try to get together with them both at AMIA; there is an EMEA Nursing Informatics meeting happening just after the AMIA meeting, and again in New Zealand, and we will do our best to bring this work forward together.
Now, what do we need the government to do? If the US is going to continue its strong role both within the US but better as part of an international effort volunteer work and devotion of the heart is critical to getting it done, but we, also, need some support, and we think that might be a reasonable way to go is what we have called a collaboratory, probably supported by contract rather than a set of competing research grants because we really have established a collaborative process, and we would like to have a mechanism that supports that collaborative process rather than a competitive process. Probably the main contract would go to an institution and PI who would take responsibility for the overall coordination as well as some specific research and subcontracts to the institutions of all the collaborating investigators.
We would, also, need to provide for working conferences because we do need to get together and critique one another's work and learn from one another's work, and we need to provide for the dissemination of results.
It seems to us that government organizations that have an interest in this work include the National Library of Medicine, the National Institute for Nursing Research, AHCPR and for the dissemination of results the Division of Nursing at HRSA.
Why bother? What is the public good if we do this? In the near term we will get an ISO standard reference terminology model for nursing. We will, also, strengthen the collaboration and the consensus in matters of nursing terminology and we will have a basis for building a reference terminology for nursing.
The midterm benefits will be that reference terminology for nursing, a set of standard nursing terms and data and information systems that are locally in the vernacular, they are colloquial terminologies, but they are mapped to the RT. That fact will then enable us to have comparable nursing data across sites, across systems, across time. That then will justify nursing data and public health databases and enable the mining of clinical data in these large databases so that we can assess the quality and effectiveness of nursing care and learn from that and improve our practice.
The long-term benefits then will be new knowledge of how nursing contributes to health outcomes. We will, also, be able to have data-based and knowledge-based initiatives to improve care at reasonable cost, and that will bring us a little bit closer to our Holy Grail of better health care and better health at affordable cost.
Thank you.
MR. BLAIR: Thank you all for outstanding testimony. Dr. Peters has to leave, and so, could we direct questions first to him because I think he only has about 5 minutes before he has to go, and Bob Mayes already has a question for you, Dr. Peters.
CAPT. MAYES: Rick, one of the biggest struggles that we have had in introducing Internet-based technologies on the federal side of this arena is linked back to the privacy and confidentiality. I mean constantly I run up against the fact that people do not want the government to have large databases about them, and in fact, the more I try to aggregate the data, the more I try to leverage the absolute benefits that I can get by going through Internet technology, the more I run into this wall and actually maybe Dr. Kibbe and others could talk about this as well. Is this not happening on the private side or is this something that is just waiting to happen to jump on them, and they are going to find out? I just cannot understand why they seem to be immune to this big concern, and is it just a matter of the public not realizing what is going on?
DR. PETERS: There is certainly a factor in that, but it is really multifactorial if you will bear with me. One is that there is always promise about aggregating this data. No one has really done it yet. They have at the payers' side, and we have known that for a long time. The public and physicians may not be as aware of that, but again, that is claims data and it is understood why it is done. It has been done at the clearinghouse level for a long time as well. It has been done on claims for pharmacy. We know that, but you know, have Healtheon, Pointiere(?) Connetra, Aboton, Carinsite(?) aggregated much data yet? No. Do they have a business plan to do that? Absolutely. Is it really known what they are exactly going to do? No.
So, I think that you are right. You are under greater scrutiny because people know and suspect you of doing this whereas they don't know or suspect the vendors of doing this, but 100 percent that is their business plan. There is some feeling on two sides. One, there is the feeling by some vendors that it doesn't matter. They are going to do it anyway, probably not the best attitude towards the public because the public will bite you for that.
The other side of it is that if we don't get together, and this may be what David was saying earlier, and I will defer to him on it, his opinion, if we don't get together and define ethical use and define how we are going to do this, I believe that we are going to get profound backlash because we are going to get the exact same response in the private sector that we do in the Federal Government, and i don't think there is any greater trust of industry in this country than there is of the Federal Government to do the right thing. So, I think people are asleep at the wheel in terms of expecting it to happen.
On the other hand, the good vendors, and I get from David's talk that they are probably a very good vendor in regard to that, they believe that this ought to be done for ethical uses for data analysis, for research, for other things like that.
MR. BLAIR: I think Kepa has a question for Dr. Peters.
DR. ZUBELDIA: Dr. Kibbe.
MR. BLAIR: Oh, I am sorry. I can get back to that. I am going to extend our time to about twelve-fifteen because I think there is going to be a lot of questions here. So, we will extend the time and move things out a little bit later in the afternoon here. So, maybe we could just focus because I think Dr. Peters has to leave in just a few minutes.
DR. PETERS: And I defer to David because he will have some good comments on this, I assure you.
MR. BLAIR: Okay, and we will pick up your answers right after.
Kepa, you had another question?
DR. ZUBELDIA: Yes, a question I have is with all this money being dumped on Internet companies and with the general lack of interest for formal standards that has been shown by many of them, what can be done to prevent a balkanization of the standards because it looks like every one of those companies wants to develop its own standard, and they call it a standard because they have developed it, and we will end up in a few years the same way we were 3 or 4 years ago in EDI for administrative data. We will end up in exactly the same place. What can we do about it?
DR. PETERS: This is right on the money, and you are sort of feeding me bait, I know, in terms of asking me that, but there are two fundamental things. One is with all this money going after it, and you are well aware of the Wall Street and investment banking approach and the venture capital side of it, there is a feeling by the larger vendors in this area that they don't need standards because they are going to dominate the market, and this will be de factor standards. In other words, they will control it. Therefore, whatever they come up with will be accepted by everyone.
There is another, and this is probably a little more logically based, and that is that any Internet standards aren't that important because with XML you could translate things so easily that it really doesn't matter the format that it is.
This goes back, however, to the semantic questions and the questions on terminology which we have punted that on claims because we have ICD and CPT and HCPCS and those sorts of things, but it is going to bite us because yes, you can translate and map things back and forth, but I think as Blackford said as well, mapping is a shortstop. So, I think those are the two things people are hiding behind. One is the pride that they are going to dominate, and they don't need standards because of that. The other is that you don't need standards because technology will make them obsolete.
You know my opinion, and that is that is wrong. What we need to do is move quickly because the other side of it is that if the standard is there none of the vendors have shown any resistance to use it. So, if they could be out there quickly then people would pick them up in 2 seconds.
MR. BLAIR: Do you have time to accept any more questions, Dr. Peters?
DR. PETERS: Probably, yes.
MR. BLAIR: Okay, who else has another question?
DR. FERRANS: I have a question. This is Richard Ferrans. I wanted to thank you for your testimony, and I think you were right on the mark about where things are heading. I, also, wanted to echo the issues of security and that this is going to bring up new security questions. Every time I go up on Capitol Hill the first thing that they ask whenever we are talking about something with informatics is how does this relate to privacy and security; it is always the first question, and I share your concern.
I think that if people are going to consumer portals and looking up diabetes, it probably means they have diabetes and the ability to resell that information does have privacy implications, and currently there is no regulation on that.
I did want to ask you how, you know, I think it is easier for larger companies, and when I say, "Larger," in terms of personnel; even small companies with large market capitalization will have difficulty getting people to participate in standard development organizations because they run lean.
How do we encourage them to participate and to really get involved in the standards process?
DR. PETERS: I would recommend we use our industry knowledge and contacts, and we sort of use a spider web to pull in those people who we know in those organizations are interested in that.
You certainly have to do some advertising in terms of trying to get the knowledge out there, be it through letters or requests or things like that, but, also, it is pulling a few key people. The other thing is that it is an exploding industry, but it is still, also, interesting to see how many familiar faces are involved in it, either spun off from other companies or who are coming at it from either the security side of the industry or from the software side who understand the standards level.
The one thing you see about the computer industry that is even better than health care is that with the Internet there is a strong interest in standards through the World Wide Web consortium and through the IETF. So, there is an understanding that standards are of great benefit there, and we sort of need to use that model. So, you won't find among the developers in these organizations strong resistance to standards. In fact, you will see an interest in that because they know it decreases their costs.
I think it is just a matter of how do you pull in the right people and target them.
DR. FERRANS: The other quick point, we had talked about issues of data quality and data integrity, and if we really develop applications service providers that are providing hospital information systems essentially over the Internet, that does bring up new questions about that, new issues.
DR. PETERS: It does, and that is unregulated. I will hope that the customers of ASP services will do significant due diligence on the vendors and will have in their contracts profound restrictions. I am hoping from their experience with the Legacy world which was very good about providing quality and other things like that that they will maintain that level of risk aversion and acuity.
Risk aversion hampers new innovation at some level, but on the other hand when you are dealing with patient information and stuff like that you have got to have that as a key element. So, I agree, I have some trepidation, but I hope that the customers in that regard because I don't really know how we or the Federal Government or anybody wold step in and regulate that.
MR. BLAIR: Michael?
DR. FITZMAURICE: Yes, Rick, you mentioned the need for standards, that they will adopt them if they are out there. Kepa says that if we let the market do it all by itself it is going to be balkanized and each one is going to have its own standards. How would you advise the government or how would you have the Committee advise the Secretary in its report to take action, assuming action is needed?
We have heard today that the government might buy up some coding systems, giving fair price and then making them available and integrating them. I have kind of extended that comment. There has, also, been the suggestion, and maybe I heard it off line that a private institute be set up somewhere with some government funding but a partnership, also, from the industry.
We find it difficult to involve the small vendors who are running lean as Richard said. Yet we need some kind of overall coordination, not only nationally but internationally. It is possible that some large international company could come in and redirect a lot of health information by buying up managed care organizations and imposing an information structure that may not be compatible with the way care is delivered in any one particular country, whether it is our country or another country.
So, if we now step back and say that we have a report to give to the Secretary of HHS in August of the year 2000, we see the health information technology field changing very rapidly, kind of erratically but people are going searching for how to use the Internet. We think they will grab hold of standards if they are out there. Who should start consolidating, formulating, developing the standards and then secondly, is there a role for government implementation? Oh, gee, let the market decide if something is good enough to implement. So, A, how do we promote and accelerate the development of needed standards, and secondly, what do we do about implementation?
DR. PETERS: My thoughts obviously are only my thoughts. I would fuel the process with cash if that was available. I believe that travel costs in terms of sponsoring meetings and things like that would be worth it. I would try to get industry to contribute anything that they possibly can, much less their personnel but maybe some resources or even finance meetings, whatever; anything to sort of fuel the process in terms of cash would be one good thing.
I don't think money is going to solve it though. I think coordination is required. I, personally, believe that ANSI HSB has been too restrained, unwilling to or unable to step forward and say, "These are the standards we will work on, and these are the STOs that will be targeted with that. Here is your deadline to get it done. Now, let us rock and roll."
I think that the Federal Government and all of us pushing that would, I think we have got if I step back, I think we have got standards organizations, and I think we have some processes in place. We just have to push it and move it forward, and if there are obstacles in that, and we know that there are obstacles they are going to have to be stepped around, and that is where as I say to finance them and also some outside participation may help us in that.
If there is any resistance at any organization to do these standards right now, then I think that you have to take a majority vote and a simple majority. If the majority thinks it ought to be done, let us do it. Let us not let one or two or three or four things get in our way to do so, and so, I think that proactive interaction would do it.
I do think public-private is better than purely public or purely private or purely STO, but do I know the mechanism for that? No. Do I think there will be resistance? Absolutely. Do I think we should go around that? Absolutely.
MR. BLAIR: Dr. Peters, thank you. You stayed beyond the time you promised us, and could we now have questions for the other members of the committee?
DR. PETERS: Thank you all very much. I really appreciate the opportunity.
DR. BLAIR: Yes, and I think, Dr. Kibbe, you had indicated you had an answer to Bob Mayes.
DR. KIBBE: Robert had asked the question, I think, do people fear, for example, my company gathering in and holding onto their data the way they fear the government having large stores of aggregated data, and the short answer is no. I think there is clearly a willingness on the part of our clients to allow us to be guarantors of that data which is in some cases extremely sensitive, not only clinical data but financial data that is being stored.
On the other hand, we take extremely seriously our role as guarantors and as I think most of the companies who are launching into this kind of technology, playing this role, but I would agree very strongly with Rick that we need to have more than just future health care ethical standards.
We need to work on what are those ethical standards that need to be written. We do that. I mean our attitude is it is not our data. We have no right to do anything with it other than what our software is intended to do for the client unless we get their specific permission to do something with it, and in some cases we have done that, for example, to pool anonymous data from different hospitals in order to give those hospitals bench marks.
I think that there is a real need for that whole set of issues to be discussed and opened up because I think I am very frightened, and I think many people who are running businesses like I am that somebody is going to misuse it very badly, and it is going to give us all a dark name and give us a problem.
There is a fundamental underlying paradox here, however, that is cultural, and if you look at what we are all frightened about security issues and we have gone so far, I think as a society to sort of block the master patient index effort which is extremely important. I mean I think everybody realizes unless we have numbers with people that we can map we are really going to have interoperability problems forever.
On the other hand, the behavior of most people who are using the Internet as a means of communicating whatever kind of information it is are giving up their security and their confidentiality all the time. I mean think of the number of web sites you go to where you give them some information about yourself or your buying habits or your address and so forth in order to be able to get some cool application or functionality that they have, and I think the market is doing that as well.
I mean I perceive that that is not just individual behavior. That is a market behavior. In other words if someone who seeks a vendor like us who is offering a new product, a new service that is going to save them money or improve quality care and it is at an affordable price, they seem to be willing to give up some of that confidentiality, the worries that they are displaying when they talk with you about the problems of aggregated data at the federal level. It is Big Brother. We are little sister or something like that, I don't know. We are not Big Brother yet.
MR. BLAIR: Okay, do we have other questions for Mr. Waegemann or Judy Ozbolt?
DR. ZUBELDIA: I have a question for Peter Waegemann. In the standards arena at the international level we are clearly at a disadvantage. We go to the standards meetings as volunteers, US volunteers that are currently working on health care or currently working on security or whatever, and the counterparts on the other side of the table are government representatives that not only they have the funding, their job is to represent their government in standards and organizations.
Besides giving the money, what else can we do to improve that situation?
MR. WAEGEMANN: It is not always true that people on ISO working groups are government employees. These are experts who are being drafted by the government and are paid for expenses and so on, and I should say sometimes quite handsomely. If you take the UK and so on, they realize that anyone who is going to an ISO meeting and is traveling for more than 6 hours should travel on business class. Now, we are talking about substantial money being provided by governments from Australia, from the UK, from all of those countries. There is a national consensus on processes which we don't have one company or from one standards organization or provider.
MR. BLAIR: Do we have other questions?
DR. FITZMAURICE: Over here, Jeff. We have so many standards to choose from and nursing vocabularies as well. It is hard to do it but it looks from your presentation that it is hard to build on any one particular one. The way you are going about it, maybe the inventors of those nursing vocabularies and with others, a vocabulary standard should be built in developing a model and getting reference terminology. Have I described it fairly clearly?
DR. OZBOLT: Yes.
DR. FITZMAURICE: Is it a model that should work not only for nursing vocabulary but for a lot of other vocabulary efforts?
DR. OZBOLT: Yes, it is hard, but yes, it should work. I think the hard part was at first overcoming the fear of trying to do it. It is probably no secret that amongst the developers relationships had not always been perfectly cordial. They were competing and perhaps licensing these things if they were not in the public domain might contribute a revenue stream and so on, but finally we just reached a point of saying, "You know what, we need to fix this," and brought together the people who were in a position to make the decisions. The format we used I think was a good format. We are fortunate that adjacent to Vanderbilt there is a gothic style small college. It is where the Methodists used to train their missionaries. The rooms are very spartan.
DR. FITZMAURICE: Nurses are a lot like missionaries in their zeal for a formula.
DR. OZBOLT: It was a perfect environment. People did not complain that they didn't have luxurious rooms and televisions and so on. We worked very hard. We had a public-private funding mix, a grant from the National Library of Medicine, a grant from the Division of Nursing at HRSA. We had the vendors who wanted to participate in the process. Each came up with a piece to help fund the process. We used our public support for paying government rates and so forth to the experts who weren't primarily interested in this but who knew about standards and language and paid travel allowances for people to get there. Private monies were for having delightful dinners and parties in the evenings. So, they work hard all day and then in the evening they could relax and have private gatherings, and people established a level of trust for getting back to working together, but the point is getting people together and saying we will do this, and we will think about it together. We will be honest and say that sometimes we don't know the answer, but let us see if we can figure it out.
DR. FITZMAURICE: Now, Judy you are working internationally. So, I assume you are going to have other countries involved with this vocabulary effort. That is different from almost every other effort that I know about that started like this. Usually you want to do it nationally and then work your will on the international community. Yet you have gone international right away. Can you briefly tell me why?
DR. OZBOLT: Partly it is thanks to the Internet and thanks to EMIA and AMIA where we already know some of the people internationally. For our meeting we did invite some international representatives. We invited Kathy Hanna from Canada and Amar Maren from Brazil and Nick Hardicker from the United Kingdom, but --
DR. FITZMAURICE: Are you concerned that the concepts will be different from different countries, and so there will be such a mish mash that --
DR. OZBOLT: There will probably be some different concepts, but it will be interesting to see if we can find a way to make it all work.
If we are saying that we are starting not with the term sets but with the model, that is we are starting with trying to develop a model and so, we say, "Okay, given a sample of terms what set of concepts would seem to accommodate that?" but anyway it is a matter of working through EMIA, our nursing informatics group and then we will have a working group in EMIA that is dedicated to this, and I will be the US representative to that. We decided not to have a US person to head that working group because we don't want to be the 800-pound gorilla in this process, and anyway I think this collaborative model is one that seems to be working and could potentially be emulated.
MR. BLAIR: I have to draw this panel to a close. Maybe you could catch each other on the lunch break. It is difficult to get through the lunch at the Penthouse on the seventh floor. So, you do need to grab lunch and be back in 1 hour. I encourage you to get up there promptly to get on the line. It is a little slow up there, and we will reconvene at one-fifteen this afternoon. Thank you, everyone for outstanding testimony.
(Thereupon, at 12:30 p.m., a recess was taken until 1:28 p.m., the same day.)
AFTERNOON SESSION 1:30 PM
MR. BLAIR: Is Gary Dickinson in the room? No? Okay.
I think we are going to be running about 20 or 25 minutes late. We have a representative from First Data Bank, Dr. Uner, is that correct?
DR. KAPUSNIK-UNER: Kapusnik-Uner.
MR. BLAIR: We had hoped that we would have her back in May. It was impossible for First Data Bank to testify back in May. So, we are very happy to have her here and so, she is going to be testifying from the standpoint of a developer of medical terminologies and then Floyd Eisenbach from Shared Medical Systems will be testifying from the standpoint of the user of standards and medical terminologies, and do either of you have a preference as to which one goes first?
DR. KAPUSNIK-UNER: No.
MR. BLAIR: Okay, then Joan, could I ask you to go ahead and start?
DR. KAPUSNIK-UNER: Thank you very much. You all have a handout, I believe. Today I am representing First Data Bank. I do wear a lot of times a lot of hats, but today I am very happy to represent First Data Bank.
Some people have intimated slightly that we have come late to this party, but in fact we have been following the testimony of the CPR work group and have actually been impressed with the developing consensus on a number of issues just by virtue of having these proceedings.
Today I will give you First Data Bank's history, and it will explain why we are part of the solution for the success of adoption of uniform data standards for patient medical record information and the electronic exchange of such information.
I am a clinical pharmacist by training, having received my doctorate at the University of California, San Francisco. Most of my professional consulting practice, research and publications and teaching has been in the area of infectious disease and AIDS pharmacotherapy.
About 3-1/2 years ago I had a professional midlife crisis and decided to reach out of the box and took a position as senior knowledge engineer at First Data Bank. In my new professional role, my goals were to formalize and computerize some of the complex drug therapy decision support that I had been performing in my clinical practice.
Many pharmacists routinely perform a variety of decision support functions some of which has been computerized for consistency and reliability. The types of important interventions resulting from this decision support are well-documented in the medical literature, most recently a few weeks ago in JAMA, Journal of the American Medical Association.
This decision support is performed as a part of providing what is called by the pharmacy profession pharmaceutical care, something that is well established.
Drug databases and knowledge bases are at the backbone of such pharmaceutical care. The relevance and importance of pharmacy interventions has, also, been previously described to this work group by my esteemed colleague, Ronald Jordan on May 18, of this year.
Mr. Jordan was representing the American Pharmaceutical Association as well as NCPDP. A take-home message from Mr. Jordan's testimony is that successful computerization and interoperability has been achieved to a significant degree within the pharmacy profession and among the many other interested parties such as PBMs and payers across their diverse systems. What are the lessons to be learned? This feat has been achieved with the help of diligent and creative vendors and the NCPDP's standards like the script standard for messages that accept drug prescription orders from prescribers, send the order to the system filler where again, DUR regularization occurs before dispensing.
The NCPDP organization members have been consensus building for many years and have worked well with their business community partners.
Now, back to First Data Bank, its history and its role. I am going to be going more along with the slides at this point in time.
First Data Bank is a part of the Hearst Corporation. We were founded in 1977 by our CEO and pharmacist founder Joseph Hirschman. We became part of the Hearst Corporation in 1980. We have had 22 years of solid growth throughout the health information spurs and starts in the seventies as well as throughout the blast in the eighties.
We have four offices, and we are international. We are considered a trusted source, a proven source. We do have immediate feedback from probably many of you in this room within your systems. Based on our huge international installed base we do get this feedback regularly. We do have a long experience and expertise in the integrated electronic information era, and our scope luckily is limited to drug-related information. So, we do have a fairly defined role in scope.
Who comprises our staff? We have 36 pharmacists, most of whom have advanced degrees, as I do who worked in many different venues as clinical practitioners.
We have other extensive staff, including physicians, nutritionists and pharmacy technicians. Who are our customers? The vast array, and it covers most of the sectors currently in the health industry and interestingly what has put us into warp time as you heard earlier today is the Internet and ventures in health using the Internet.
We are in web time. Our organization is vast. It requires a lot of professional expertise and a lot of bodies to actually maintain and develop the currency that is necessary of such databases. We have eight different departments and again 350, approximately, employees.
We have successfully mastered certain challenges, and I will note some of those now. We do have continuous internal maintenance. Our internal database is updated by the minute daily, for example. We do do the customization that is necessary for all the different views of such drug information. Our customers do get frequent updates, and so that is not a problem, and these updates can be incremental which is an important factor. We do have a sustainable business model for our vocabulary.
Many people throw around these acronyms, NDDF, MDDB, PIF, Multilex, QMR, etc. These are all different databases within First Data Bank. So, we don't have a single database or product. We have many drug model databases and many products derived from those.
We are international as I mentioned and so to complicate matters we do have our IDDF, our international drug database, and we have many flavors of such things to take into consideration the uniqueness of the various countries around the world and how medicine is practiced there.
We do have many native language speakers within our staff that allow us to understand better the uniqueness of how drugs are used in these countries. These individuals, also, understand the pharmacopeia or the compendia or drug information sources from those individual countries. They have knowledge of the government on regulatory idiosyncrasies and they, also, have first-hand knowledge of global mappings that need to be done to make the information useful.
We do have a significant global government services department, as well. Government is no exception. It is almost like its own country. It needs certain things, and it needs them that way for many good reasons, and we have maintained the formularies as they are called for many of the Medicaid systems. We have been the historians for a lot of the data that has been derived over time for the government, including the infamous HCPCS and their, again, idiosyncrasies.
What is a drug? It is sort of like what are vital signs. To an individual person it means an absolutely different thing. If you ask a patient what drugs are you on, if you ask a doctor what drugs would you like to prescribe, if you ask pharmacists what drugs do you need to order to fill your shelves, if you ask nurses what drugs do you need to administer, a drug is different to everyone, and so all these levels of granularities and reasonable abstractions of those physical things need to be modeled very carefully.
So, the viewpoints of the many different users need to be considered. In the era of the CPR, the EMR the needs have expanded and again, package drug codes are the routine, the NDC level information, the package drug size. What exactly physically did the patient get is potentially describable by the NDC.
Manufactured drugs, another level of abstraction that is important for realizing what inactive compounds, quote, inactive may be allergenic but inactive that a patient may have received, clinical drugs, sort of the generic equivalent levels, ingredients and therapeutic classes. An example was given this morning about an aminoglycoside or an antibiotic. These are higher level abstractions that are not even specific drug descriptions but class descriptions, and then lastly the EMR has brought us new levels of abstraction specifically, quote, order friendly descriptions.
A lot of requirements have been put forward rather rapidly with the Internet and, also, with new regulations for prescribing drugs. One of which that has been brought forth fairly recently is the fact that there is a need for imprints and pictures of drugs for patients as well as for dispensing.
First Data Bank not only has to know about the drugs from the various levels and views and abstractions, but it, also, has to understand well the actual conditions for which these drugs are administered, the side effects that may result from their administration, etc., and so we do have again many databases within our company that help us to describe these entities.
Specifically indications which are labeled or unlabeled are used to assess appropriateness of therapy used to infer diagnoses, are used to assess dosing of particular medications. Drug disease contraindications, we need to be able to describe the various contraindications related to pregnancy, lactation and other co-occurring illnesses that may be serious in a particular patient and therefore there may be a quote, contraindication to such drug therapy, and then lastly, adverse drug effects associated with drug side effects so that we need to be able to describe these side effects in medical terms such that if a patient does experience one of these side effects that it is codable and computable to that degree.
So, we have a lot of conditions and databases to consider. So, internally we actually map these databases to one another. So, we have internal mappings. For example, our infamous or famous FDBDXs are diagnosis-related codes that have dome primordial derivative of an ICD-9. We have a medical conditions database, and we do need to map these to one another to keep our interoperable systems alive between our vendors, and then we do map to outside vocabularies, ICD-9, ICD-10-CMs and specifically we are involved in the beta test, the SNOMED-RT.
The UMLS is a very important process in which we are now more fully involved in and the UMLS 2000 will include drug-related concepts and those will be cueed(?) and I know that you know a lot about that in this Committee. So, I don't need to explain that.
We are, also, part of another initiative, Metaphrase(?) by Apolon(?) or Lexical(?) Technology. Both of these are meant to be meta thesauri such that concepts related to drugs and/or diseases, other health care terms are identified and interoperating can occur after these vocabularies have been cueed.
We have partnered with Kaiser to formally go ahead and start development with SNOMED-RT and our initial part of that is to do the beta test with SNOMED-RT, and the goal there is to create decision support at the level of granularity that the Kaiser National EMR will live and so the decision support can occur at various levels of medical terminology vocabulary.
Then lastly, something that I brought up at the beginning is NCPDP. We continue to participate in the consensus building with NCPDP, and they have many ongoing processes that do help with interoperability.
I am not going to ask you to read this slide. The initial part of the slide just basically reiterates the instructions of the National Committee on Vital and Health Statistics and their task at hand, and that is to collect this important testimony and to prepare some recommendations, and specifically the first question that this group of panelists, I believe, was made to ask is what is a comparable EMR; what does that mean, and what functions does it serve, and I will read directly from my slide in case you cannot read it. This is my view, obviously. I haven't had consensus within my company, but this is a general view that a comparable EMR would allow unambiguous documentation and interpretation of important patient data as well as physician support across systems. It would allow flexible data aggregation now and for the future.
We actually don't know what kind of data aggregation we might want to do in the future, and this is relevant to the clinical and administrative questions to be answered, quote, in outcomes studies. How comparable does the PMRI need to be for these purposes and in my mind this is sort of the million dollar question. We have heard today about the fact that a lot of good has been done, for example, within Aetna and within the other companies, but this really is the million dollar question. What is good enough depends on the task at hand and its criticality, the need to interoperate at some level but not at all levels, and so this gets back to the EMR nirvana. Perhaps we are trying to interoperate at too many levels as a starting point, and so my software programmers would say that this sounds like a requirement phase, and they would stick us in a room and make us stay there until we figured it out and not come out to eat or drink or go home or anything, and so we would need to obtain official use cases to guide us, perhaps enumerate these use cases specifically for the HIPAA mandated CPR. This would help in scoping the interoperability issues. Different parties do need to lump and split data at different levels of granularity, but these use cases could then be prioritized.
What medical terminologies for PMRI do you use or include within your system? This is not applicable to First Data Bank as we are a vocabulary developer, but we actually do utilize software. We create software as well. We create cross reference tables for our customers who need them. Internally we interoperate, but the most important question is for our users, how do we facilitate them to interoperate amongst all of the terminologies that they utilize, and at this point we would help to identify, I believe, the more superior of the vocabularies, and I know that perhaps we are not supposed to mention things by name, but I will mention SNOMED-RT in that we have spent quite a bit of time and effort evaluating it and its content as well as structure, and it does seem to be superior in all ways to ICD in structure as well as content because of its hierarchical nature, its definitions, its robust group of synonyms, both professional, perhaps and lay terms, and we need it. We need it to describe our complex concepts in the drug world. We need it to describe things like, and I gave an example here, an indication for drug like ganciclovir where it is being used to treat CMV retinitis in an AIDS with a CD4 T cell count of less than 50. We need these specific concepts clearly represented in a hierarchy so that we can precoordinate perhaps a term and so that the syntax of such a term is clear and so that we have evaluated other terminologies and think that this is a superior medical vocabulary.
Suggestions, and they said that I could say anything I wanted here, and so, I am going to say something slightly off track. With my years of clinical practice it seems to me that one of the major obstacles with a computerized medical record is that clinicians don't have the time allocated to them to properly use such tools, important tools. We wouldn't think of telling a neurosurgeon when handed a brand new laser device to quickly cut the time in half of the neurosurgical procedure to use this brand new tool set, and yet that is sort of what we are doing in some sense with the electronic medical record that is fully running with decision support point of care, etc., tools, and so I would say on a philosophical note that I think time is an important element here for success.
With reference to medical terminologies, I believe the government can help to define the CPR use cases to set the bar at a minimal level as it has been described before by others, by Paul Tang and others.
Incentives have been mentioned over many testimonies and again incentives for early adopters of these new terminologies, for example, might be very important. Support terminology related outcomes research and whatever relevant new terms might come out of, quote, whatever we used to call outcomes research will be called something different tomorrow, but that is the general sense and include in that outcomes research that might go on with reference to the UMLS.
The National Library of Medicine is expert at interoperability, concept definitions, mappings, and it would be great to see some outcomes research come from such an important project, and lastly support unique vocabulary initiatives, things that are very important, like, for example, and again, naming names the enterprise vocabulary server by Apolon seems to be a very important jump start for many institutions that may have variable interface terminologies and may want to map to reference terminologies.
What coordination among medical terminologies, mappings? So, we have already sort of discussed mappings. We need mappings. Mappings are hard though and time intensive. They need to be done by experts. They cannot be done by volunteerism. Common definitions and terms, NCPDP within their script standard has defined some success with a defined structure, not necessarily defined code sets but NCPDP has been successful with defined structure.
HL-7 initiatives, the 3.0 version of the RIM(?) should, also, help dramatically especially the drug parts of that RIM. Convergence to a single reference terminology model, I can tell you internally we are converging to a single reference terminology. In other words, the world of drugs is changing over time, and we are converging internally to our own single one reference terminology for drugs. Doing it in the outside world is a little more difficult, but perhaps is achievable through HL-7 again. What other coordinations need to occur? Development coordinations here the question is, and it seems like the question keeps being asked slightly in a different way, but I gave different answers.
Again, concerns about development issues, development should not occur with volunteerism and perhaps valid values should be left between business partners, users and domain experts, and then lastly what are the current initiatives to be coordinated and again, the UMLS 2000 is going to be a substantial, I am told, improvement and enhancement, and it would be very interesting to see what kind of interoperability can be derived from using the UMLS in systems specifically because drug vocabularies have been submitted from all the major vendors to the UMLS 2000, and lastly I don't want to run over, just as a last note, I want to make sure that you know that we want to be part of a solution here, and there are lots of hard questions and a lot of hard work that people have done, but we would like to be part of a solution.
Thank you.
MR. BLAIR: Thank you, Joan. That was very informative, and Floyd Eisenberg?
Let me just ask, Gary Dickinson, you are next here. I don't know how long Floyd will go, and I know you are pressed for time. So, I just wanted to make sure that you were here so that you are available when Floyd is done.
Okay, I am sorry for the interruption. Floyd, go ahead.
DR. EISENBERG: Thank you. Mr. Chairman and members of the Committee, I am Floyd Eisenberg, a physician consultant with SMS. My experience spans clinical practice. I, too, had my midlife crisis. I used to practice in infectious disease. I don't know if you put us both at the same time on purpose without knowing that, as well as quality management activities in a managed care organization and information technology now with SMS.
SMS, now in its 30th year is focused exclusively on serving information technology needs of participants in the health industry. On behalf of SMS I thank you for the opportunity to provide testimony this morning on the important subject of data quality, accountability and integrity.
We have heard this morning and early this afternoon about many aspects of data quality. I will focus primarily on vocabulary and measurement issues from the perspective of knowledge integration through a software vendor and applications service provider, and I did provide a handout. I will not speak to all the details within the handout, but it is available.
SMS is firmly committed to supporting industry standard message formats and vocabulary across the entire line of integrated solutions for the health care industry.
We have actively participated in development of these standards for over a decade assuming a number of leadership roles during that time.
Now, even though much progress has been made, there is still much work to be done. Considerable inefficiencies and costs are still associated with non-standard interfaces. Financial standards are significantly more advanced than clinical vocabularies, and the bulk of installation and support costs in SMS' experience are incurred developing interfaces that require mapping between non-standard vocabularies.
The huge administrative costs within the health industry can be significantly reduced through standardization. We are committed to assimilating these standards as they are defined and committed to continue our participation and leadership in this area.
SMS' view of patient medical record information is basically electronically maintained information about an individual's lifetime health and health care, replaces paper medical record as the primary source of information for meeting all clinical, legal and administrative requirements.
It is not a recreation of the paper record but enables health care providers to re-engineer the health delivery process because it makes extensive health information readily available to the care provider when decisions are being made and as a by-product provides a source to aggregate data for outcomes analysis.
Clinical and financial decision making are data and evidence driven rather than empirically formed. The role of vocabulary models is standardizing messages for a comparable patient-centered medical record. The essential model is a vocabulary model. It is vocabulary that enables the diverse and fragmented elements of the health delivery system to operate as a whole serving all stakeholders and facilitating effective and efficient health outcomes across a continuum.
Information that is meaningful, interoperable and sharable is the essential objective requiring an underlying vocabulary and the format in which it is communicated. It must be standard, and it is key to achieving the comparable PMRI.
The CPR is made possible by improvement in underlying technology, particularly the growing reach and throughput of electronic networks. The primary barrier now in achieving a viable CPR is the lack of universal standards allowing data and knowledge integration across diverse and fragmented organizations and health networks.
The role of data quality, I would like to discuss specific elements of data capture and coding, translation, auditability, decoding, presentation. Data capture as we heard from the last speaker is one of the most significant issues. Getting a clinician to enter data into a system or change a process so the data is entered and usable by others is a change in process. Methods currently exist to capture documentation through imaging, keyboard entry, mouse clicks, bar codes, light pens, touch screens, dictation and transcription and, also, voice recognition.
The key to encouraging a clinician to use the information technology is the existence of a critical mass of information in the system so that the clinician can access the information required and, also, that the documentation is fast, adds value to the individual user and can be easily demonstrable.
It, also, must be simple. Encoding captured data such that it can be used for analysis and measurement is the next issue. As an example or as several examples of standardization that would provide more consistent coding of data, they include bar coding and text parsing methodology. A national standard in these and other encoding areas would enable health systems with products from several vendors to more cost effectively manage the data entry process.
Translation of encoded information into measurable data is, also, a complex process, but is essential to document the care delivered in a usable, sharable and analyzable form. Standard terminology is important. The adoption of a standard reference terminology would facilitate translation and linkage between clinical and administrative terminologies. A reference terminology commonly called controlled medical terminology essentially defines all fundamental atomic context independent terms used to describe health care and the relationship to one another. It becomes the hub and driver of the information system, controlling the use of interface data model and information model. It must be vendor neutral, technology neutral, patient neutral, product and process neutral.
General reference terms can be precoordinated into terms or problems which are appropriate for quick selection and entry during documentation and once the PMRI contains the neutral terminology a vocabulary can be post-coordinated or encoded into administrative terms such as ICD-9 or ICD-10 diagnoses for financial and administrative management.
Efforts to unify terminology such as SNOMED-RT, UMLS and to provide crosswalks between the many that exist are progressing. For example, we have heard this morning about the recent nursing terminology conference at Vanderbilt University which reviewed many nursing terminology sets.
This strategy would create a more consistent terminology approach to drive information systems and database development to reduce redundant documentation efforts during the clinical process and provide a consistent way for clinicians to organize, analyze and justify activities.
It should be mentioned that the controlled medical terminology is not a static process but requires significant investment in ongoing maintenance.
Appropriate encoding will enhance the integrity of data. Sharing and use of the vocabulary will increase as consistency and integrity increases and conversely consistency and integrity will improve as sharing and use increases. The result is an improvement in data quality.
What I would like to address is, also, the issue of having data in a system is not solely for the purpose of providing clinical care. It is for being able to measure that care and improve the care delivery process at the same time. Many efforts for standardization exist to improve the quality of care and financial outcomes.
Standard vocabulary would allow the workload to be driven by patient standard requirements within the construct of the most cost effective treatment alternatives. Much of the requirement for structured data is, also, driven by accrediting bodies such as the JCHO and NCQA.
Each of these organizations has developed measures to address outcomes of care, specifically ORYX from JCAHO and HEDIS from NCQA. Each of these types of measures requires not only administrative data but medical record review data which requires extensive review of written records and text information to be able to obtain the information required to do studies.
In addition to the complexity of the chart review process itself physician offices have the administrative burden of making available those requested by each health plan and each system with which the office participates.
Information systems can simplify data collection for quality and financial outcome measures. However, the existence of multiple methodologies and measurement sets remains problematic. The Performance Measurement Coordinating committee, a joint effort of NCQA, JCAHO and the American Medical Accreditation Program is one effort by national standard setting organizations to establish measures that can be used across the health care marketplace.
To provide similar comparison of outcomes among health care providers, such as integrated delivery networks and health enterprises standard definitions must be established. The Federal Government can have a significant impact in the standardization of vocabulary by taking several actions.
A, provide leadership by adopting a single vocabulary standard that integrates the many existing terminologies. This step will eliminate confusion in the provider and vendor communities and facilitate patient-centric clinical information transfer from one practitioner to another.
B, place the adopted standard in the public domain. This step is required to achieve data sharing among disparate providers in a climate of cost sensitivity. Continuous maintenance will be required for the adopted clinical vocabulary standard to keep pace with evolving medical terminology and advancement. The "owner" of this standard should remain in the public sector.
C, encourage nationally recognized sources of evidence-based clinical care recommendations to publish accepted guidelines and protocols in standard format such that they can be placed in operation as true plug-ins.
D, provide incentives for accrediting and regulatory agencies and organizations to develop vocabulary and problem-based clinical quality measures. Such measures should standardize performance measurements for multiple health care delivery models. They should, also, eliminate the requirement for duplicate and costly data collection by incorporating existing data entered electronically at the point of care, and I thank you on behalf of SMS and myself for the opportunity to speak to this organization and group.
Thank you.
MR. BLAIR: Thank you, Dr. Eisenberg.
Committee members, do we have questions?
Gary, maybe we could integrate you in, and that way we can then take questions for the group as a whole. Are you prepared to give your presentation at this time?
MR. DICKINSON: Yes.
MR. BLAIR: Gary has alerted us that his presentation is a little longer than the other presentations, and he will be taking about 25 minutes.
MR. DICKINSON: That is about right.
My name is Gary Dickinson, and I am manager of Health Care Standards for Per Se Technologies, Incorporated, formerly known infamously as Mediphis which was mentioned this morning.
Per Se Technologies is a global leader in delivering integrated financial and clinical software solutions, comprehensive business management services and Internet-enabled connectivity. Per Se Technologies enables health care provider organizations, integrated delivery systems and physician practices to simultaneously optimize quality of care delivered and profitability of business operations.
Ranked the third largest HIT and services company worldwide, Per Se Technologies employs 6400 and supports more than 18,000 physicians and 2000 health care organizations.
Per Se Technologies processes more than 80 million health care claims annually, and its solutions manage over 20 million patients lives on line.
I co-chair the HL-7 special interest group on accountability, quality and performance. I, also, lead the architecture subgroup of ISO Technical Committee 215 on Health Care Informatics Working Group 2 on Messaging and Communications.
As Per Se's representative I am active in a wide variety of standards development activities in the US and internationally, focusing primarily on health care informatics standards.
The first question is how do you define or describe the PMRI. Last March Dr. Al Buck of the JCHO offered the following description of PMRI in his written NCVHS testimony. Since Dr. Buck and I collaborated on the specific description I have taken the liberty to paraphrase it here again. For each individual patient or health plan member PMRI forms an essential chronicle of health status and interventions. It can include demographics, orders, schedules, clinical pathways, for example, care plans and protocols, observations, diagnoses, problems, allergies, medications, etc.
For clinical service events PMRI describes the clinical and operational context and ascribes accountability, who, what, when, where and as applicable why, how and under what conditions.
PMRI is encompassed in a personal health record for individual patients and health plan members. PMRI is, also, a foundation to the operations business record for health care providers and to the service record for individual health care professionals.
PMRI forms a longitudinal chronology with essential views. The first view is prospective or a future view of pending and scheduled events, including preventative and wellness.
The second view is concurrent which is a view of now, what events currently scheduled are in progress or events currently in progress, I am sorry.
The third view is retrospective which is a past or historical view of completed events.
Question 1B, why is comparable PMRI required and what functions does it serve? First, it ensures trust and confidence. Second, it ensures validity of assessment, for example, to the assessor and to the assessed. In the first case I have here the assessor is the health care professional. The assessed is the patient or subject of care.
The assessor may be an accreditation agency such as JCHO and the assessed is a health plan or health care provider organization.
The third is a reporting agency or a report card agency, if you will, such as NCQA as the assessor. The assessed, of course, is the health plan or health care provider. Also, regulatory agencies can be an assessor, and of course, they would, also, tend to assess health plans and health care providers.
The PMRI, also, ensures the value of health services to consumers and to purchasers. It allows clinical findings and trends to be validated and/or contrasted, for example, health status indicators, vital signs, diagnostic results.
It allows population measures and trends to be validated and/or contrasted, for example, epidemiological surveillance, public health indicators and immunizations.
It allows measures of clinical operation to be validated and/or contrasted, for example, quality indicators, performance and outcome measures, costs, allocations and deployments. It highlights areas in need of improvement. It validates the results in improvement programs.
Question 1C, how comparable does PMRI information need to be for these purposes, and what are the consequences if the PMRI is not accurate? Comparability, accuracy, precision, consistency, continuity, completeness and persistence are essential characteristics of data integrity and quality.
There is a direct trust correlation between these issues. The greater the assurance of data integrity and quality the greater the level of trust. The health care industry is awash with many examples where conclusions are suspect and/or cannot be fully validated due to issues of underlying data integrity and quality. This problem is pervasive and seriously compromises many clinical claims payment reporting and measurement systems. The most impaired are often those furthest downstream from the point of data origination.
Consider particularly where data is managed or stewarded by multiple systems from its point of origination which is usually the point of service or point of care to its ultimate point of use, which, also, may be a point of report, where data has traversed one or more points of interchange between systems via interfaces or mediators, for example interface engines or hubs, where data has passed through one or more points of translation or remapping, for example, translations from one coding classification scheme to another, clearinghouse remapping of source of target data sets, also, language translation and where data is converged from multiple highly disparate sources.
Question 2, what is the role of data quality, accountability and integrity to achieve comparable PMRI? To ensure the utmost degree of confidence and trust there are imperative characteristics or requirements which must be both measurable and verifiable. They form crucial requirements for information management practices, both manual and automated system architectures and health care informatics standards, particularly data interchange of vocabulary standards.
Question 2A, is the current state of data quality, accountability and integrity impairing our ability to measure outcomes, quality or performance? As suggested previously the impairment is profound and pervasive. The impairments are manifest. The disparity is introduced by and inherent in the industry's continuing reliance on multiple disparate systems data and functional architectures, lowest common denominator data interchange standards, mediation between applications using interface engines or hubs, data translation from original to transmuted form, translated form, remapping to alternate data structures, data type conversion, data aggregation summarization and derivation.
The response to the next question identifies additional areas of impairment.
Question 2B, what are the specific problems or limitations impacting data capture and coding translation, transformation, auditability, decoding or presentation processes? In the HL-7 SIG(?) on accountability and quality and performance we have focused on specific data integrity and quality issues. Our findings are as follows: In the area of accountability the designation of accountable health care parties is often inconsistent or incomplete, including individuals such as health care professionals, authors, scribes, verifiers of data content, stewards and users of data content, organizations, for example, health care providers, health plans and payers, business units, for example, department services and specialties.
It is, also, an accountability issue related to the designation of accountable parties who -- the designation of accountable health agencies is often inconsistent or incomplete. In this case we are talking about software and medical devices. The designation of health care parties with ascribed accountability for the provision, performance and completion of health services is often inconsistent or incomplete.
The designation of health parties or agents with ascribed accountability for data origination, amendment, verification, translation, stewardship, access and use, transmission and receipt is often inconsistent and incomplete.
Designation of accountable actions is often inconsistent and incomplete and going on then there is a need in the area of persistent evidence, for example, persistent evidence of accountability for data origination is often missing or difficult to track, who, what, when, where, how, under what conditions and what context.
Persistent evidence of accountability for data amendment is often missing or difficult to track, including the previous data state and the new data state.
Persistent evidence of accountability for data verification is often missing or difficult to track. Persistent evidence of accountability for data stewardship, access, use, chain of custody is often missing or difficult to track from point of origination to point of use.
Persistent evidence of accountability for data translation is often missing or difficult to track, who, what, when, where, by what convention or method, by what authority, the Fuhrman 2 coding classification scheme, the original unaltered data and the newly translated data state.
Persistent evidence of accountability for data remapping including data type conversion is often mission or difficult to track. Persistence evidence of accountability for data duplication, disclosure, transmission and receipt is often missing or difficult to track.
Complete auditability of data content is often impossible or difficult at best. Tracking end-to-end information flow and accountable actions by accountable parties along that path, across multiple points of interchange, among and between multiple disparate systems, original and successive data states forward, downstream and backward, upstream data are audit trails.
Another area that we have data quality issues is in the area of, a big area, obviously, data definition. Common and uniform data definitions are often lacking both for atomic data elements and for data aggregation, such as data sets.
Persistent evidence of accountability for data definitions is often missing or difficult to track, who, what, when, where and by what convention or method, by what authority, the previous definition and the new definition, and of course, data definitions often change over time, and in the area of coding and classification, the use of coding and classification schemes is often inaccurate, inconsistent or incomplete.
Coding classification schemes are deployed unevenly with some organizations including virtually all data, some a more limited set and some almost none at all.
Some organizations extensively deploy recognized national and international coding classification schemes. Some rely mostly on local or proprietary schemes. Many use some combination thereof. National and international coding and classification schemes are often supplemented with local or proprietary codes and classifications.
Coding and classification schemes both national and international and local are often supplemented with data in the form of free form text.
Some organizations deploy national and international encoding at the clinical front end for example, where health care professionals are prompted to encode data directly at the point of service or care.
Some encode as an automated back-end function after the fact. Some use a manual back-end encoding scheme method. Some encode as a function of downstream data interchange via mediators or interface engines.
In the area of data translation, data translation is often inaccurate, inconsistent or incomplete. For example, translations from one coding and classification scheme to another and translation of human language.
Data translation is often conveyed downstream with the newly translated data content but not always the original unaltered content.
Such lapses breach data authentication and validation conventions and expose data content to repudiation of authorship.
Data translation is often accomplished without specific notation and/or without persistent evidence of translation which may occur to an identical term which is probably the rare case, translation to some presumed equivalent but not identical term, translation to a term with greater precision or granularity, translation to terms of lesser precision or granularity, translation to arbitrary non-equivalent terms simply because there is nothing better to choose from or translation to no terms again because there is nothing good to choose from.
Data aggregation summaries or derivations in the area of data aggregations, summaries and derivations data is often aggregated, summarized or derived incorrectly or inconsistently. Sampling methods are often incorrect or inconsistent. Data is often reported with inconsistent units of analysis, inconsistent time spans, dissimilar populations, etc.
Special occasions for functions of data aggregation, summarization and derivation are often interpreted incorrectly. Defaults are often incorrect and cohorts are inconsistent over time. Additional data quality issues, for both data elements and data sets persistent evidence of data integrity quality checks is often missing or difficult to track from the point of origination to the point of use, for example, checks for accuracy, consistency, context comparability, continuity and completeness.
Data integrity quality edits and reviews are often lacking or inadequate. Data is inaccurate and unrecognized as such. Data is inaccurate but within acceptable limits.
Data is often embedded in text strings not as discrete data elements. Subsequent data extraction functions from free form text strings are invariably impaired.
Clinical data is often subject to origination, amendment, verification, translation or interpretation by individuals who lack sufficient clinical knowledge and/or mastery of clinical terminology.
Medical judgment often leaves health care professionals to varied interpretations and conclusions from the same data. So, these are some of the issues that we have addressed in the SIG with the help of JCHO and others in terms of some of the things that they have discovered in their reviews and of course, in the ORYX performance measurement system.
Question 2C, what techniques, methods, standards or technologies are needed to address these problems and limitations? In response to this and as a lead in to the next several questions I would like to describe several initiatives in which I am currently engaged, each focused on a key aspect of accountability and data integrity and quality.
The first is the HL-7 SIG on accountability, quality and performance which I co-chair with Carla Rubeli of JCHO. The SIG itself does not craft standards but rather acts in an advisory capacity to the HL-7 Technical Steering Committee on Technical Committees. We have charted a careful and deliberate approach to ensure that industry needs are appropriately identify and that recommendations and requirements statements are properly founded.
In its brief tenure a number of state work activities as follows. We identified obviously the top data quality issues that I just enumerated. We have focused on points of authority and points of reference on which to base the SIG objectives and work plan. Sources include JCHO, NCQA, Department of Health and Human Services, HCFA, GC Pair Project, IOM, NRC and NIST, ISO and many others or several others.
So, the principles and objectives, the SIG has drafted a white paper outlining key principles, objectives and areas of focus including insured trust, the trust and accountability constituency, health information rights, including privacy and confidentiality of individually identifiable information, health information and obligations including accountability, health information components and composition, health care parties and their accountable actions, health care agents and their accountable actions, the scope of accountability, the unit of accountability, trust in the information flows, authentication, attestation, non-repudiation and digital signature, auditability, chain of custody, faithfulness, persistence and non-alterability, data definition, data registration, data integrity and quality.
The SIG has drafted a roster of health care parties who make up the trust and accountability constituency for health data and information. The first of these is subjects of health information including individual patients, health plan members, individual health care professionals and caregivers, individual originators of health information including authors, scribes and verifiers. This includes organizations who may be subjects of the record, business units of those organizations and obviously others such as the next of kin, employers, guarantors and so forth who find their identity in the health record in some form or another.
The second category is accountable parties participating in the provision, performance and completion of health services and his accountable actions are or should be ascribed in the health data and information, and these, of course, include individual health care professionals and care givers, organizations such as health care providers and their business units.
The third category is accountable parties participating in the origination of amendment, verification, translation, stewardship, use, transmittal and receipt of health information and whose accountable actions are or should be ascribed therein, again, with a list of individual organizations and business units.
Privacy and confidentiality protections. The SIG has noted that various parties have inherent rights and expectations regarding privacy and confidentiality protections for the individual identifiable information. The SIG has agreed that these protections are a primary overriding objective for the SIG work plan.
Accountable parties. As noted above the SIG has drafted a description of accountable health care parties, individuals, organizations and business units and, also, accountable agents being software and medical devices.
The SIG has drafted a description of accountable actions that are significant to the SIG's domain of interest, specifically the provision for completion of health care services, the origination or amendment of data content, accuracy and completion of data content or verification thereof, translation of remapping of data content, access to use of data content, stewardship of data content, duplication, disclosure, transmission and receipt of data content, aggregation and summarization or derivation of data content. These are accountable actions that we have identified in our SIG activities so far.
Another key area is the area of data definition, data registration as the key foundation to the assurance of data quality and integrity. The registry should include both data element and data sets. For HL-7 version 2 is version 3 data and data sets. SIG is drafting a recommendation for HL-7 to become a registration authority in the US health information knowledge base, a data registry project now proceeding under auspices of the ANSI-HISBE(?) and underwritten by HCFA in the first year.
The SIG, also, intends to be proactive with other STOs, vocabulary developers, regulatory accreditation and reporting agencies to encourage broad industry participation in the US HIC(?).
Each organization can be granted its own standing, its registration authority for its own data and data sets. Data registration in the HL-7 version 3 message development framework MDF. The SIG is drafting a recommendation for the US HIC to be engaged in formal steps in the HL-7 version 3 message development process and is suggesting corresponding revisions to the MDF as follows: As new data elements and data sets are contemplated for inclusion in the HL-7 standards the HL-7 technical committees and special interest groups should consult the data registry for similar and existing data constructs and usage.
Any standing precedents should be seriously considered prior to creating new HL-7 data elements or data sets. As the valid process is completed for each successive version of HL-7 standards, newly introduced and revised data elements and data sets should be formerly registered in the US HIC.
Then I go into a description of the data registry in terms of data elements and, also, in terms of data sets looking at specific things that should be part of that registration process. HL-7 has something called observation data elements which as many of you know is a big hole where all kinds of sins may lurk. The SIG is drafting a recommendation regarding use of the open observation data construct known in HL-7 version 2 as the OBX segment. The observation data construct allows repeating data name, value pairs and interface message sequence.
As an open interchange construct, HL-7 has not defined specific data elements or data sets although this base is neatly filled by vocabulary developers such as LOINC. In terms of the observation construct it is the SIG's recommendation that interface implementers use common uniform data definitions from open public data registries such as the US HIC to the greatest extent possible and particularly in preference to creating their own new data elements, data sets and definitions.
Another area of work for the SIG is in what we call persistent context templates where the SIG has followed the lead of the HL-7 vocabulary technical committee in recommending a series of persistent context templates which are intended to track data and information flow from point of origin to ultimate point of use.
The first is the accountability context which provides evidence of the provision, performance and completion of health care services. The second is the evidence of data source or authorship, transcription, verification, translation, stewardship, access, use, duplication, disclosure, transmittal receipt.
The second context is data integrity and quality context which is evidence that specific data integrity and quality rules and measures are engaged to ensure data and data set accuracy, context, consistency, continuity, completeness and persistence as applicable.
The third is the clinical context, probably fairly obvious which is evidence of corresponding clinical context which may include data regarding rationale, clinical parameters, clinical context and conditions, rules and measures to ensure continuity and completeness of health care services, rules and measures to ensure compliance with standards of care or practice, measures and indicators for performance quality and outcomes.
The fourth is an operational context which is evidence of corresponding operational context surrounding data and may include allocations of deployments, assigned responsibility, resource utilization, such as staff time, facilities, equipment and supplies, measures and indicators of costs, productivity and so forth.
The SIG has, also, developed a series of conceptual diagrams in a white paper on trust and information flows. This exercise has staged information flow from point of origin which is the point of service in care in many cases to its ultimate point of use, from data source to data consumer, from clinical front end to back end repository to third party, traversing multiple points of interchange or interfaces, traversing multiple points of translation or remapping, including in on case at the point of use or point of report including in an alternate case at a point of convergence where data from multiple sources is aggregated, summarized or derived and then reported.
This exercise has included privacy and confidentiality protections for individual identifiable information. It has designed accountable health care parties and agents and accountable actions. It has demonstrated auditability including accountable actions by accountable parties or agents, data states from original through each amendment, forward, downstream and backward, upstream to audit trails.
It has ensured faithfulness, persistence and non-alterability of data and information. It has demonstrated assigned responsibility. It has demonstrated chain of custody. It has ensured measurable and verifiable data integrity and quality through measures of accuracy, consistency, context, comparability, continuity and completeness. It has demonstrated the persistent contexts that were described previously in the areas of accountability, data integrity and quality in clinical and operational context.
The SIG is, also, drafting a recommendation to HL-7 regarding end-to-end information flow models and integral to the suite of version 3 foundational constructs. HL-7's current version 3 repertoire includes the message development framework which describes the RIM(?) and the progression therefrom to interface messages vis use cases, stay for classes, state transition models, application interaction models appearing in each set of transmitters and receivers, dispute application profiles as a basis for performance claims, high-level message descriptions and message specifications and ultimately encoded XML messages, but curiously enough the result of all that is still a point-to-point interface. So, the current notion is that the SIG will recommend that the HL-7 messaging and modeling committee modify the MDF to include end-to-end information flow in addition to its point-to-point orientation as it currently stands.
We are, also, recommending to the HL-7 methods and modeling committee that various classes and subject areas be included in the RIM.
These include data definition, data registration. If you look at the RIM it is fairly involved. Nothing in there talks about data registration or data definition, accountability and in terms of provision and performance completion of health care services, accountability for aspects related to health information and the health record as the source of data, author ascribed verifier, translator, steward, user, transmitter or receiver, also, areas of auditability, chain of custody, assigned responsibility, the persistent context that I described earlier and data aggregation summaries and derivations.
The introduction of these classes of subject areas into the HL-7 RIM forces a substantive shift in the HL-7 modeling paradigm in that the proposed additions have legitimate relationships with virtually all existing RIM classes.
Think of how all or many RIM classes and their attributes may be subject to data definition, accountability, auditability, chain of custody, etc. They really all are, one way or the other.
Think about any and all RIM classes which may be subject to aggregation, summary or derivation. Again, it is virtually all RIM classes.
Let me see, the last area in terms of SIG activity relates to use cases where we are, also, looking at this end-to-end information flow and in one case for lab HEDIS reporting as chaired by Chuck Walker of West Diagnostics. There is an immunization information flow use case that we are working on that I have worked on along with Susan Abernathy of CDC. There is an information flow for performance measurement which the JCHO and various others are working on, and I have appointed her to the REL for HL-7 if you have interest in additional information on the SIG activity.
The second thing which will be much more brief is the activity in ISO Technical Committee 215 on Health Care Informatics, Working Group 2 on Messaging and Communication where I have collaborated with a number of international experts in drafting a new ISO work item proposal which is entitled Essential Characteristics Required to Enable Precise Messaging and Communications Standards.
This ISO technical report establishes a series of requirement statements to guide developers of messaging and communications standards and to guide implementers of such standards. As a forward guide post it establishes a bench mark of achievement well beyond the current state of the industry and the messaging and communications standards upon which we depend.
This report draws on many of the same principles and objectives focused by the HL-7 SIG but introduces them formally to the international standards arena.
In July this NWIP, new work item proposal was affirmed by Working Group 2 on a vote of 25, 0, 0, with eight countries participating.
In August it was affirmed by the US Technical Advisory Group by a vote of 19, 0, 0. It will go to Japan, Tokyo, next month and will be voted on there in the full TC as a new work item proposal.
The third thing I wanted to mention is that in the fall of 1996, I collaborated with Dr. Buck of the JCHO and John Quinn of Ernster and Young and, also, Chair of HL-7 Technical Steering Committee to declare the problem space slash domain of the HL-7 standard, essentially to describe what it is and what it isn't. This declaration appears in Chapter 1, Section 7 of the two most recent revisions of the HL-7 including the 1999 version 231 and includes many of the topics now on the SIG agenda.
This is another example of a requirement statement serving as a forward guide post for standards development efforts.
Question 2D, is the private sector making satisfactory progress to address these problems and limitations? I would say that progress is painfully slow. It is unclear whether the private sector has the appropriate incentive to act and/or commit the necessary resources.
Question 2E, is there a role that the government should play in this area that would yield results within the next 4 years? I would say that 4 years is optimistic, but anything is possible. Support for existing initiatives is crucial. Incentives will provide an excellent boost but should be reserved for those who are serious partners in this endeavor.
Is there a need to facilitate inclusion of data quality, accountability and integrity issues within the standards development activities? Yes, obviously as I previously described.
Can the private sector address this need satisfactorily? There is little reason to believe the private sector can shoulder this without government involvement and the inducement of substantial incentives.
Is there a role that the government should play to address this need? The government should champion a coalition of health industry organizations including key government regulatory and accreditation agencies, standards developing organizations, providers, payers, vendors, consumers, employers, etc.
Prime participants should include government regulatory agencies, US accreditation report card agencies such as JCHO, NCQA, informatics standards coordination and developing organizations, NCHSB, ASEX-12N, dicom(?) HL-7, NCPDP and others, vocabulary coding classification developers such as LOINC, SNOMED, READITE(?) CDCPT and others.
The government should offer support on the standards to those standards-based initiatives currently under way, especially those focused on accountability and data quality and integrity.
From our perspective there is substantial bias to follow the lead of the HL-7 SIG rather than plowing new ground, but we need as much support and interest as we can muster in that area to address these particular needs.
The government can engage its own agencies and offer incentives to non-government organizations. A basic strategy would be to characterize the problems base which is what I tried to do here to some degree, to establish objectives and rationale, to forge specific requirement statements, to set measurable milestones and bench marks for achievement and to develop implementable technical specifications as open consensus standards, and then I have a list of particular areas of focus which basically is reiterating many of the things that I have already described and then I will close with one paragraph here.
Open consensus industry standards have to be motivated by strong leadership driven to produce results. The HIPAA legislation has served to focus much energy around specific standards serving particular purposes. As an industry the HIPAA momentum needs to carry us forward into many new areas. Accountability and data integrity and quality are prime candidates for this continuing initiative and the long-term benefits of the strategy will prove to be enormous.
Thank you.
MR. BLAIR: Thank you very much, Gary.
We do have, I believe a good 30 minutes for questions now, and I think we may need all that time. Actually with the three of you we really have two different topics because Joan Kapusnik has talked to us about drug knowledge bases and the requirements for terminology standards in that area, and Floyd Eisenberg and Gary Dickinson have covered the area of the need for standards for data quality, accountability and integrity.
Rather than try to separate it because it is going to be hard to figure out how many questions are going to come in on each, let me just leave it open for people to question wherever they have a concern or interest.
Anyone?
Yes, Michael?
DR. FITZMAURICE: I will start with Gary Dickinson. You have given us a comprehensive list of things that ought to be done. So some of these will be judged according to these criteria. What is the role of government versus the private sector? Will the private sector generally use this or it doesn't use standards, participates or for the most part maybe doesn't participate in the development of standards? Do you see the role of implementing and oversight for this organization by HL-7, does it provide a certification of these things or the government should consider them in contracts when they purchase information systems? I think you said that there ought to be a law that people who use patient medical record information adopt systems that adhere to these criteria. How would you approach the implementation of them and the oversight of that?
MR. DICKINSON: I think obviously HIPAA did it with legislation and said, "You will use ANSI standards." It is just a question of which ones to meet these particular objectives, and I think that although I am not necessarily an advocate for government action and government, what is the right word, strong-arming these things through, I think the government has a very crucial role to play in terms of defining what the requirements are in terms of setting expectations both in terms of what the government agencies themselves might do and procure and, also, for the community at large.
The thing that I find fascinating or have found fascinating about HL-7 and a number of these other standards efforts is that they tend to gather the people who show up; they tend to say, "What is your interest?" Here is a choice of 8, 10 or 12 or in the case of HL-7, they have 28 different technical committees in SIG at this point. Go find a place to talk, and what has been lacking is that we have not come to a useful strategy in my opinion in terms of what the needs are, what the requirements are, what the objective should be before we go off and figure out what technical solutions might look like, and so that was one of the attempts that we did, that Dr. Buck and I did in 1996, was to say, "Hey, the HL-7 standard is great, but guess what, it doesn't do these things yet, and we should at least put them on the table as things that the industry should have an active interest in."
DR. FITZMAURICE: Do you think there is a need for national leadership that was mentioned earlier, holding a conference or two to identify what the gaps are, what things are not being done? I think you have identified some here and then to try to cause action, not strong-arm action but to see if there can be promoted in the private sector ways of addressing those gaps? Let me ask both you and then move to Floyd as well for answering that question. How do we get the identification of the things that have the highest priorities and then how do we encourage that they be done?
MR. DICKINSON: Obviously the more industry input we can get on that issue the better. I have struggled in my own efforts to establish objectives and requirements in the HL-7 domain. I have, also, now done that with the ISO TC215 activity and that will continue I think now that we are moving and transitioning from, not transitioning. That is not the right word, as I am continuing to focus on two different areas. One is Working Group 2 where we have a document that is in draft form. It is currently 75 pages including 25 pages of validation from the Germans and now we are looking at Working Group 1 which is modeling, coordination and health records, and in that particular environment we are looking, also, at functional requirements as a list of things that need to be done, objectives and things that have specific requirements attached to them.
DR. FITZMAURICE; Floyd, do you see the need for national leadership in identifying the gaps and in encouraging the private sector to take part in filling those gaps, and how might you see that being brought about from SMS's perspective?
DR. EISENBERG: I do see the need to identify the gaps among the various organizations and the way I would, I think seems to have worked well specifically with nursing terminology is using that as an example, bringing people together to identify the issues and the gaps to figure where it could work, they could work best together.
I think that would be a good model.
DR. FITZMAURICE: Let me move now to Joan. Joan, you talked about drugs and drug coding systems. There is something called ICH, the International Committee for Harmonization that is looking at terminology for things like adverse drug events and new drug applications. Does that have any relationship with the drug codes and the terminology that you use? Is there an integration there? Is that entirely separate from the coding and terminology that you use for drugs?
DR. KAPUSNIK-UNER: Some of the codes that you mentioned that are included there, the NDAs, COSTART(?) MEDRA(?) some of these other vocabularies would be helpful terms to be considered within our own terminologies, but they are created for separate purposes, but again need to be mapped in for example, to the UMLS. They have a distinct use.
DR. FITZMAURICE: But you say that they may use the same concepts but describe them differently?
DR. KAPUSNIK-UNER: They probably don't use the same concepts. In other words, their terms that describe a particular COSTART, for example, would be an adverse drug event in a very precoordinated way. It would have many terms describing a particular adverse drug reaction. NDAs are new drug applications. It may describe drugs at varying levels of granularity to be studied or given to patients and so, they are used for particular purposes other than to prescribe drugs, etc. So, they are at different levels of abstraction and granularity. It would need to be folded into whatever reference model we would initially come up with.
DR. FITZMAURICE: Do you see any gaps, any areas, does there need to be national leadership in the area of drug codes and drug terminology? Does there need to be mapping, and if so, what are some of the ways that you think the government role could help get this moving, and if you don't, let us know that, too.
DR. KAPUSNIK-UNER: The obvious issue that a lot of people point to is NDC codes because of the vast number of users of those codes to describe packaged drug information.
The FDA is responsible to oversee how manufacturers create and use and disseminate information on NDCs and it has been said that perhaps this is rather loose and this process could be improved. Many people do depend on NDCs for lots of decision support, financial decision support as well as clinical decision support applications, and so, the FDA definitely plays a role and they have been doing I think a fairly good job for the many views and users that they have to contend with. So, they are national leaders in that sense.
MR. BLAIR: Dr. Cohn?
DR. COHN: Actually following up with your last question, Mike. Joan, first of all even though I should be tremendously familiar with the First Data Bank I am unclear about what percentage of the total market you have in your company.
DR. KAPUSNIK-UNER: It depends on the market sector, I suppose that you are thinking of, sort of the old Legacy systems, the big companies which actually, for example, SMS, for example, they may have pharmacy systems. They now have EMR systems. They have these systems with versions of those systems. So, probably within SMS I don't know how many systems have some sort of First Data Bank database but probably a significant number. Some might not.
So, we probably cover most vendors in most sectors, at least in parts of their product lines, and I know that sounds like I am hedging, but it is kind of a big three-dimensional at least puzzle at this point in time, but it is a significant installed base especially in the pharmacy market which was our initial target area, if you will.
Our founding database was specifically for drug reimbursements. The clinical information grew later, and therefore our audience grew later.
DR. COHN: May I ask a follow-up on that?
MR. BLAIR: Sure.
DR. COHN: I sense that it is a large percentage of the market. Is that an appropriate way of describing that?
DR. KAPUSNIK-UNER: I would say, "Huge," yes.
DR. COHN: Huge, okay. Now, we heard back in our testimony back in May that there was an attempt going on through HL-7 having to do with some sort of work between your organization and I think some of the other drug terminology developers. I am unclear what has happened since then.
DR. KAPUSNIK-UNER: The status of HL-7?
DR. COHN: I know what the status is of HL-7, I mean that effort per se. I am curious from the First Data Bank view exactly what the activity was, what its purpose was, what has happened in the intervening time with that and I guess the other question is does this effort around trying to put all the terminologies into UMLS, is that part of the solution or is that something different?
DR. KAPUSNIK-UNER: Let me answer the last question because that is the easiest one. The UMLS I believe is perceived to be quite a solution especially with their promised enhancements, put it that way. In other words, they have a better view of the Internet and of what perhaps they are capable of doing and I personally was sold on their motivations that this is going to be an answer for many people. Specifically as an example of that at Stanford University there is an ongoing project where cuees(?) are used as a meta search engine strategy for the Internet for medical information, such that these cuees when they are selected by an internist for example, go out to the Internet, go out to the medical journal archives, go out to the full textbooks, etc., and pull in all the concepts and information linked as a meta search engine as you would see it, you know, what is a dog pile dot com on the Internet for other uses, so that the cuees, I think are coming to the point of care and that is a good example of how that might be done.
The HL-7 activities I have not been in attendance fully over the last 2 years. Remember I had a late midlife crisis. I have only been involved a few years, and a lot of that has been with the Orders and Results Committee, but I would say that it appeared to me that the 3.0 version of the RIM is the main goal and objective is to get that up to snuff so that the structure of what is to come is fairly solid and it seems as though perhaps the HL-7 committee efforts have been diverted somewhat to creating some of their own data sets to instantiate the model, and so, I am in the midst of sort of sorting out what our role should be. I mean it should be to participate, to help build consensus and part of my job is to sort out what has happened and work with Tim and others to make things progress, but I do see the UMLS as a viable broker of clinically viable point of care vocabularies.
MR. BLAIR: Actually I am following up on Simon's question, and, Joan I don't want to be coy or anything else like that, and I think I mentioned when we asked you to testify that it was our hope originally to be able to get each of the drug knowledge base vendors to testify at the same time. That didn't work out, but I did ask Tim McNamara of Multim be here at least as an observer. So, that is out on the table for anybody listening over the Internet or anything else. That is the preface to my question here because when Tim, I think it was Tim. It was somebody from Multim. I don't remember whether it was Tim or --
DR. KAPUSNIK-UNER: Harry Meredith, also, testified.
MR. BLAIR: Yes, when they testified back in May and this is at least my understanding of the gist of it, and Tim is here to correct me if I misunderstood, but it kind of led to a little bit of a quandary here in terms of myself and probably other members of the Committee trying to understand an issue and whether or not we should focus on it.
In essence, he indicated that there was an effort in HL-7 in the vocab SIG in particular to try to get some foundation, some methodology, some model for coordination of terminologies among drug knowledge base vendors and for a while there First Data Bank really was taking the lead on that, and there seemed to be good progress that was being made, and then it appeared as if First Data Bank has stepped back, and I sensed some frustration on Multim's part; for example, they are a new small vendor and many of the installations they go into already have First Data Bank installed which is as you said kind of huge in the marketplace, and at least the impression I have was that there was difficulty in being able to share comparable information. Multim was trying to step forward by putting its model and its terminologies on the web, and interestingly enough the initiative that was brought forward was relating it, also, to SNOMED RT in the same sense of the characteristics for a clinically specific terminology were embraced, and you, you know, new information to us right here indicated that you are, also, working SNOMED RT which sort of means that you are, also, embracing those characteristics.
So, now that I have given you this long preface, could you explain at least a little bit, you know, what plans you might have for being able to work with other drug knowledge base vendors, other developers of terminologies for drug knowledge bases to be able to move things forward to being able to share comparable terminology?
DR. KAPUSNIK-UNER: You weren't gentle.
MR. BLAIR: I am sorry.
DR. KAPUSNIK-UNER: I am actually not prepared to answer all of that because I don't know all of the history but I have a perception of what I think has been going on, and I have tried to share this with Tim, too, that I am kind of the new person, but I do believe that the model, the part of the HL-7 RIM version 3.0 which is being developed and which is so important for the future is something that we did significantly contribute to, in other words, identifying all the levels, important levels of granularity of what a drug is, what is a drug for all the relevant viewpoints for an electronic medical record so that that model actually needs to be decided upon, discussed intently, etc., and then perhaps the individual data sets, code sets can be mapped to those message segments and elements and in some way it seems like that might be fairly easy, that the individual vendors map their own vocabularies to the different coded elements and that they are provided to their customers so that they can interoperate.
Now, whether one vendor gives something away free and one doesn't give it away free, that is the difficult part, and I know that Keith Campbell has been here talking about the freeness issue.
When we think of freeness in pharmacy we think of sugar free and alcohol free, but this is in a different context. The freeness issue is a sticky one, and AMA and CAP are, also, very interested in the precedent set in this manner. There is a lot of intellectual property, but there must be some line where we can share and so, I guess it is HL-7's responsibility in my mind to make the cases for what is sharable and what is not. It is up to this Committee to decide what should be sharable, what is the minimum level? The government should set minimum standards and minimum levels of sharable information.
We have submitted to the UMLS perhaps that code set is the minimum sharable level and so I think it looks like it has just been fraught with problems and perhaps HL-7 has gone off and done some work things and said that they were going to do it on their own because nobody is cooperating and that perhaps set off a chain reaction of non-participation.
I cannot speak for Micromedics. Perhaps they need to be included in this discussion as well.
MR. BLAIR: Bob?
CAPT. MAYES: I just wanted to make a point. One of the problems with UMLS and why it is not a solution for a lot of people is that in fact you cannot use UMLS freely. You have to sign. It is not available for public use unrestricted. If you want to use UMLS, you do have to sign an agreement with the National Library of Medicine stating that you will, in fact, meet all licensing and other fee requirements of all contributing organizations and so in effect while from a research point of view and perhaps a developer's point of view it offers great utility and hope, that is actually a very major barrier for it becoming, and I don't think National Library of Medicine has any intention of having it become sort of a public domain, you know whatever you want to call it, commercial product that would be used as a basis for cross vocabulary mappings in a commercial sense.
DR. KAPUSNIK-UNER: But there may be a version of the UMLS that is something that the government would support license fees for at some minimal data set level across all of the vocabularies that have submitted so that you could identify the concepts in each vocabulary, the value set and those then would be in fact, in the public domain.
CAPT. MAYES: Absolutely. It is a model.
DR. COHN: Actually I am just sort of struck with the concept of minimal available data set for free and I am trying to think of how that would go over in a quality view of the country about physicians being able to access a minimal amount of data that then they could use. I am not sure that that would quite --
CAPT. MAYES: I didn't react to minimal in the same way, I guess.
DR. COHN: I don't know. It is an interesting question, but actually --
DR. KAPUSNIK-UNER: Not in a negative sense, minimal not in a --
DR. COHN: I know. I am being a little facetious in the afternoon. However, this does bring me to the question sort of that begins to address some things Dr. Eisenberg wrote and you, also, stated and it occurs to me that the two of you could have a little bit of a dialogue. I mean, Dr. Eisenberg you were commenting and recommending adopting this single vocabulary standard that integrates the many existing terminologies and then you are talking about putting that standard in the public domain.
DR. EISENBERG: Correct.
DR. COHN: Now, we are sitting here going, I mean how would that work; how would that impact Joan and First Data Bank? How would First Data Bank feel if something like this might happen? Would this even be a good thing?
Dr. Eisenberg, can you start out?
DR. EISENBERG: I think part of the problem of getting systems up and running at various institutions when we deal with customers is addressing the issue of what licenses do they want or have so that they can get their vocabulary in and what do we have to map to, and each one is individual and so each one being individual requires a lot of time and effort, and I think that given a standard it would be easier to have a starter set and available information to deliver and allow use of systems much quicker. The problem is one of a pricing structure for current vendors of knowledge, and we understand that.
I am not saying that that is a simple solution. There may be licensing structures, for example, through UMLS if the National Library of Medicine were interested in doing that as one solution to that, as the hierarchy of licensing, just as a thought. Some of this is personal. It is not all SMS speaking here.
DR. KAPUSNIK-UNER: All I can potentially say to that is I have the one slide that says, "Don't try this at home."
I mean we have a vast amount of knowledge. We have very well-educated content people which I know Tim's staff is, also, very well educated. You need a high level of expertise to even sort out and tease out the issues with drugs. I mean what is a drug? The biotechnology age is here and just sorting out, classifying what a drug is and then on top of that adding the knowledge of what the side effects, appropriate designations of those side effects, the precautions, the drug-drug interactions, sorting out the medical literature for that, I mean there is a lot of knowledge that is created, and it does cost a lot of money to be in business to employ people to create that knowledge.
So, I don't know what the answers are with giving away your intellectual property and what the government has to say about that to businesses in all realms.
DR. COHN: May I just respond to that? I am understanding. I meant to play a little bit the devil's advocate. I think that one of the things that the work group and full Committee is going to have to deal with is the issue of equitability and I don't think we are interested in taking valuable assets and giving them away for free to everyone without any sort of equitable balance there.
On the other hand, we have heard from many testifiers, including HL-7 and others that as we move from a world where, geez, all you have is a pharmacy system, and you just need a license for X, Y and Z for that pharmacy system into a complete complex intermingled set of systems where more data moves from one system to another, to another and then eventually as in John Kelly's description this morning into a data warehouse that the world becomes very complex as far as terminologies and domains are concerned, and the question is if you are HL-7 and you want a little bit of this vocabulary and a little bit of that vocabulary and a little bit of another terminology to use, you know, what is a person to do, and this isn't Simon Cohn making this comment. This is basically testimony from HL-7. So, it is really going to be on our plate over the next couple of months.
DR. KAPUSNIK-UNER: But if the messages, the HL-7 messages, for example, are clear enough and the data elements are described within those messages, then if a vendor wants to plug in a free set of codes that would be fine or if they would like one from another vendor, that would be fine and interoperating potentially between those two would be up to mappings that occur through HL-7, through UMLS. These mappings could occur.
MR. BLAIR: I think that is just it. In order to facilitate that mapping, and correct me if I don't understand the issue, the impression I have is that in order for those mappings to occur the drug knowledge base vendors have to sit down in some forum to be able to facilitate the mappings to occur, whether that is HL-7 as the forum or whether that is going to be the National Library of Medicine or you can go on and name any set of organizations. Am I wrong? Do I misunderstand? It is that something has to happen, initiatives on all sides to sit down together and work out those mappings to create a model that could be mapped.
DR. KAPUSNIK-UNER: The mappings would be to the model though, not vocabulary to vocabulary but vocabulary to the model so that each vocabulary would have an HL-7 mapping to the message segments so that we won't know what things Multim maps to, but we will know what elements within the model, what concepts and we will know what our different databases map to. If somebody is using that same message segment they would then perhaps --
MR. BLAIR: Okay. Could you tell me what would you suggest to this Committee as the best way, and it doesn't have to be that the government even plays a role in this. As a matter of fact, if the private sector could do this without the government playing a role that is probably better. What is your suggestion for the way this could occur?
DR. KAPUSNIK-UNER: Perhaps to have one of these think tank conferences as the nursing vocabularies did at Vanderbilt. This might facilitate action as it were. Obviously the chairs of HL-7 need to come to some agreement on finally what the goals of the Committee are, in fact, short-term and long-term goals so that it is clear to the vendors for action to occur, perhaps a consensus conference.
MR. BLAIR: Okay, we have Simon and then Bill Yasnoff.
DR. COHN: I want to apologize. I know you are new at the company, and we hate to barrage you with questions, but you were mentioning the Vanderbilt model and the way they dealt with proprietary systems was to agree that all of their systems were not the reference terminology and then proceeded forward to I think try --
DR. KAPUSNIK-UNER: To model, just like the RIM.
DR. COHN: But, no, you see the model is Phase I. I think they are developing a reference terminology. They are just figuring out what model to use for the reference terminology. So, doing a model won't solve their problem nor will it solve the national problem.
So, are you proposing from your side that what you think makes sense for pharmacy and drug terminologies is that we sort of suggest that the government develop a reference drug terminology?
DR. KAPUSNIK-UNER: That the government do it?
DR. COHN: Well, somebody do it, maybe groups meeting a la what the nurses have done.
DR. KAPUSNIK-UNER: Maybe perhaps I don't understand some of the subtleties of what they have done or are planning to do, but I mean it sounds to me as though they are doing something similar to what HL-7's vocabulary SIG Technical Committee has done over the last 3 years, 2-1/2 years and that is to make great strides to improve the model to define the message segments and the elements. Obviously there are lots of other activities going on in that committee a well, but that was sort of the goal was to define those things and then there was the sidetracking of some of these other, well, we are just going to make a code set for the terms to describe routes of administration or race or some of these other side things so that it seems like the activities are somewhat mixed and then at some point they were going to just create their own drug vocabulary and maintain it. So, again, if they better define their goals perhaps.
DR. COHN: Okay, and as I said, I have no specific knowledge of what HL-7 is doing in this.
Thank you.
MR. BLAIR: Bill Yasnoff?
DR. YASNOFF: I wanted to change directions a bit, and I have a question for Dr. Eisenberg about your third recommendation about encouraging nationally recognized sources of evidence-based clinical care recommendations to publish guidelines and protocols in a standard format such that they can be plugged into systems.
Do you have a specific standard format in mind or if you would not like to say or you don't have one, could you give a specific example of how you think that might work, and I have a follow-up question?
DR. EISENBERG: Sure. One of the issues of having national guidelines applicable at the point of care when someone is providing care to a patient to get the appropriate reminders and the appropriate next steps reminded to them requires often work at each individual institution depending on systems they have installed, and we have enterprise customers who have multiple systems not always their own in every portion of the enterprise.
What I was referring to is things like Arden(?) syntax and/or the GLAF to be able to provide evidence-based guideline recommendations deeper into that type of format so they can be more easily incorporated into a health care institution.
The issue with that is the vocabulary has to be standard enough so that it doesn't require a lot of work for Arden syntax to for instance fill in the curly brackets.
DR. YASNOFF: So, by implication the fact that you put this recommendation in because we are dealing here with potential recommendations for patient medical record information by implication you would say, and I am going to ask you specifically to make it explicit that these evidence-based clinical care recommendations are, also, part of patient medical record information. Is that what you mean to say?
DR. EISENBERG: Yes, it is what I mean to say. Clinical decision support at the point of care on recommendations is an important reason for creating a patient medical record, computerized patient record.
DR. YASNOFF: Thank you.
MR. BLAIR: Do we have other questions?
Kepa?
DR. ZUBELDIA: Yes, I have a question for Joan, and this is slightly off the topic. So, it may be a refresher. You said in one of your slides that you are the historian for drug-related HCPCs and that is a very interesting sentence. How is the mapping of, I am sorry, how is the relationship of the J codes to the NBC codes coming along and how is that going to work? That has been a question that has been asked of me many times when we talk about HIPAA adopting NBC instead of the J codes. Could you give us an update on how that is going?
DR. KAPUSNIK-UNER: I am not totally familiar with all of the levels of care that are described by HCPCs. I believe there are three levels. The J codes specifically are drugs and at a level of abstraction to describe drugs that are administered in an outpatient setting as a parenteral drug as part of a health service, so cancer chemotherapy, for example, and within the HCPC what is done now is that it is a level of abstraction. So, a physician might say and the HCPC might be chosen that a certain dosage of a drug be administered and be covered.
Now, that dosage of drug obviously can come from different packages that can be pulled of a shelf and so what is going to have to happen is that a different level of granularity is going to need to be described within the patient record, the NDC level, what actually was pulled from the shelf as opposed to what did I order, and so it is a different level, quote, of abstraction of the drug description, and it may require more work in the physician, nursing area where the drug is administered, perhaps with bar coding of things. This is an easy fix actually. It is easy to scan something and then you know the NDC code.
It is perhaps a more exact way of saying exactly what did the patient get with the lot number, and so there are good things and there are bad things about it, but the NDC level of information is a good clinical level of information. So, I don't think we are compromising patient care by switching. It is just something different, and we have been lumping things before, and now we are going to have to split them out, but it is not an unfeasible thing especially with the bar coding and scanning.
DR. ZUBELDIA: Let me follow up on that because I thought the NBC codes coded not only the drug but the administration of the drug and, also, the NBC codes at some point need to be mapped to HCPCs codes, I am sorry, the HCPC codes cover the administration of the drug, and the NBC code is the drug only, and they need to be at some point mapped one to another for the adjudication systems to work.
DR. KAPUSNIK-UNER: We do that mapping now.
DR. ZUBELDIA: Are you aware of anybody else doing that mapping?
DR. KAPUSNIK-UNER: I actually don't know.
MR. BLAIR: It is about three-fifteen. I think we could take one more question if there is one.
DR. FITZMAURICE: Just a comment, Jeff. Did the shrug of the shoulders mean that not only does First Data Bank do the mapping, but, also, Multim does the mapping as well or MedicaLogic?
PARTICIPANT: Yes.
DR. FITZMAURICE: Okay, the answer is yes.
MR. BLAIR: A correct interpretation of shrugs, that is important here for interoperability.
DR. FITZMAURICE: If I were on the Internet I couldn't see a shrug, and that is, also, useful information as well.
MR. BLAIR: Thank you.
Okay, let us take a 15-minute break. Thank you very much for excellent testimony.
(Brief recess.)
MR. BLAIR: Michael, you are taking notes, your general notes on your computer, and Margaret is able to do any updates?
DR. FITZMAURICE: We will make the official changes.
MR. BLAIR: Fantastic, okay.
You have got this mile high stack of papers that we just handed out. So, let me help you kind of sequence them the way we will be stepping through it, and Simon, if you are listening on the Internet this is the sequence of activities that we will be going through here.
The first thing I am going to cover just real quick is going to be the updates to the work plan based on our last meeting and other feedback that I received. That should be followed in sequence by Appendix A which is the detailed schedule for the next 3 months or first draft of that and Appendix B which I think we refer to it as a framework for the report to the Secretary of DHHS. I believe that that is followed by the agenda for December 9, suggested agenda for the ninth and then followed by the suggested agenda for January 31 and February 1, and then the consensus documents and the reason that you have extra copies of the consensus documents is because that is followed by some ideas that Margaret has pulled together in terms of trying to converge somewhat further some of the issues, assumptions and maybe some recommendations we can start to look at for the message format standards and medical terminologies.
So, let me hit first of all --
PARTICIPANT: I am sorry, Jeff. My battery was out, and the electrical outlet here is not seeming to be functional or something at the moment.
MR. BLAIR: Do you want me to wait a little bit?
PARTICIPANT: Yes, one moment. We are going to try duct tape on it.
Okay, Jeff, sorry.
MR. BLAIR: All right. You may notice that the work plan now says, "Version 11," and the only thing I would call your attention to there is the changes that were made in this particular version. If you look at the section that has the focus areas, and I will let you turn to that. I think that is Section 3 or 4 or something like that.
We had agreed at the full Committee hearing of the NCVHS which I believe was September 27, John Lumpkin indicated that he really wanted us -- let me back up. When we were discussing the progress letter to the Secretary on our work group activities we restored the privacy, confidentiality and security focus are.
So, at the bottom you will notice that that focus area has been restored and then the only other changes were at the back of the work plan where it has the schedules that there was the correction that the next meeting is December 9. Actually it is the ninth and the tenth, but the tenth will be activities that Simon will schedule for the full Subcommittee on Standards and Security, and then we, also, had determined in our last meeting, we agreed that January 31, and February 1, would be the meeting when we would pull together our recommendations to present to the full Committee.
That is all I have on the work plan. Does anybody have any questions on that or concerns?
DR. FITZMAURICE: Jeff, I am missing the reference to the privacy and security on here.
MR. BLAIR: I think there are some pages missing from these handouts.
DR. FITZMAURICE: I have Page 2, and then it starts in with tables.
PARTICIPANT: Yes, I think 3, 4, 5 and 6, Roman numeral are missing, and it may because every copying machine in the building is now broken. So, that might be the problem.
DR. FITZMAURICE: Okay, if it is critical that we go through that, I can find a working copying machine and get it done.
MR. BLAIR: I don't think it really is. Aside from what I told you they were just sort of minor updates, and I will make sure here, and let me go ahead and record it so that when I get back I will send you electronically the update that has it. Okay, to do this for when I get back and I need to resend to everyone a copy of the work plan Version 11. There is a copy incidentally on the diskette and maybe that could be run off tomorrow and distributed. We will just see if they can do that.
The next thing is hopefully you have Appendix A and Appendix B? That is separately.
PARTICIPANT: Yes, dated October 15 at the top, I believe.
MR. BLAIR: Yes, the detailed schedule.
PARTICIPANT: Yes, we do have those.
MR. BLAIR: I feel frustrated that Simon isn't here.
Let me step through this with you all and you folks indicate whether you feel we need to change this or correct it or enhance it in any way. This is kind of a subset of our total schedule to produce the final report to the Secretary by August of next year, and what this piece is doing, this detailed schedule is to say, "What do we need to do to at least get that draft in place for approval by the full Committee?" So, we want to have as much done as possible by that February 23, 24, full Committee meeting, and in order to do that we laid it out in the following way where we essentially are figuring that today and tomorrow are the end of the information gathering stage and that from this point on -- did I hear a door open?
DR. YASNOFF: No. We will tell you if Simon is seen. We have an APB out.
MR. BLAIR: All points bulletin, yes. We kind of broke it down into two sections. We felt as if, and I say, we, Margaret and I kind of worked on this together. We felt as if we wanted to get the issues in place as much as possible. We have already got them somewhat identified in the convergence documents for the message format starters and the medical terminologies. So, that is the next section that we are hitting there and Margaret has taken a look and kind of pored through past testimony and also, looked through the convergence documents and started to see what some of the major issues are that we could begin to look at, issues, assumptions and some suggested recommendations, with the understanding that as we discuss this and update it by the end of October we will wind up coming out with a different update, reviewing it with you again in a conference call. We picked November 9. That was an arbitrary date that looks good from a time standpoint, but if you can just glance at your calendars, is that a date that is good for most people or not or do we need to move that forward or back by a day or two or three?
DR. YASNOFF: Jeff, Bill Yasnoff, that is the middle of the AMIA meeting.
MR. BLAIR: So, the AMIA meeting is that whole week?
DR. YASNOFF: It is through Wednesday or Thursday, but does it really go through all of Thursday; doesn't it end like noon on Thursday?
DR. FITZMAURICE: I think it ends at noon on Thursday.
DR. YASNOFF: So, Thursday afternoon might be okay, but people would be traveling home. So, maybe the twelfth. That would be Friday or the fifteenth, the following Monday would be better or sooner, before the AMIA meeting which would be the week of the first?
DR. ZUBELDIA: We have a meeting on the third in Georgetown.
DR. YASNOFF: That is the full NCVHS meeting.
MR. BLAIR: That is the third and fourth. So, you were trying to do it after that?
Simon has arrived. We sent out a posse to get you, Simon.
DR. COHN: My apologies, everyone.
MR. BLAIR: Simon, let me quickly bring you up to date. You should have handouts in front of you. It should include the work plan, and it should include an Appendix A which is a detailed schedule for the next 3 or 4 months and Appendix B which is a little bit of elaboration on what the report to the Secretary would be. That would be followed by a tentative agenda for December 9, followed by tentative agendas for January 31 and February 1, and that should be followed by the convergence documents for reference and then by the work that Margaret has done to pull together some suggested issues and assumptions and recommendations based on derivatives from the convergence documents. So, you have everything?
DR. COHN: Not in order, but I have everything.
MR. BLAIR: I was just mentioning it because that is the order we would be going through.
Okay, it turns out that apparently the copy of the work plan is missing the pages that I updated. As you had indicated I made sure that the phraseology for restoring the focus area for privacy, confidentiality and security was added with that reference, but apparently I guess in the copy that seems to be missing here. Actually it is on the diskette, and we may be able to get you the updated copy tomorrow. If not, then I will send it electronically when I get back on Monday.
Okay, so, the next item that were going to was Appendix A, and with Appendix A that is the detailed schedule to try to make sure that we get as much as possible to that first NCVHS committee meeting at the end of February.
Okay, did you locate that?
And this is kind of a little bit of a mixture here because we pretty much figured that today and tomorrow if not completely then at least the last time we are all together to do the information gathering in a formal manner and that we wanted to begin to draw down the issues, assumptions and recommendations as far as possible starting with the convergence documents for message format and medical terminologies, and I think that is Item 3, and in that what we were looking at doing was trying to see how much progress we could make this afternoon and tomorrow morning up until one-forty-five tomorrow. We will wind up then getting that out by November 2, as an update, and we were talking about a conference call.
We thought we would schedule it for November 9, that is the piece that is on that detailed schedule. That turns out to be the middle of AMIA. So, we were looking for a different data for when we could do that conference call, and the suggestion was that it either be the week after or the week before.
If it is the week after, what is that?
DR. YASNOFF: The fifteenth.
DR. FITZMAURICE: I think we could do it on the twelfth. That is Friday, November 12.
PARTICIPANT: That is the day after. People will be taking that off.
DR. FITZMAURICE: Oh, to make a long weekend? Okay.
MR. BLAIR: The thirteenth, fourteenth, just scratch that, the week of the fifteenth.
(Administrative discussion.)
MR. BLAIR: What do you think? Should we go back to --
DR. COHN: Is there a reason we don't want to do it earlier, the week of November 1?
MR. BLAIR: We figured that it would take -- this is kind of keyed with a whole lot of other issues for all the other work groups.
DR. YASNOFF: Our writer is giving a thumbs down to that. I am getting all sorts of bad vibes over here.
PARTICIPANT: That whole week is booked for me.
MR. BLAIR: Margaret, as --
DR. COHN: Jeff, could I make a suggestion? I think that your idea of a conference call is fine rather than take the Committee time, especially since we have barely a quorum, it might be a useful thing for us to send around an e-mail, and I think what I have heard from you is sometime during the week of the fifteenth of November.
MR. BLAIR: Simon, on this one to be honest with you at this stage I really want to get it pinned down as best as we can because --
DR. COHN: You are finding it logistically difficult?
MR. BLAIR: Yes. I am kind of running out of time and schedules and getting folks coordinated. So, at least we have the people here today. If we come out with the best date that we can, you know, with the folks we have now --
DR. COHN: How about the seventeenth then? I think, Mike you will be back from --
PARTICIPANT: What was wrong with November 12?
PARTICIPANT: The eleventh is a federal holiday, and I, for one, will be taking off the twelfth to make it a four-day weekend.
MR. BLAIR: And one or two other people may also.
PARTICIPANT: I would be willing to call in from wherever I am.
PARTICIPANT: That is a bench mark right there. We should all follow that.
DR. FITZMAURICE: The afternoon of the tenth people would be flying back from AMIA. Would you be one of them, Bill?
DR. YASNOFF: I am actually not available on the tenth.
PARTICIPANT: Maybe November 9, is better because at least you will be in one spot. You could take a call.
DR. YASNOFF: I don't want to try to take time out from AMIA for a conference call. I mean the whole reason I am there is to talk to people that I don't get to talk to.
MR. BLAIR: What about in the evening, the ninth in the evening?
DR. YASNOFF: Same issue. I mean every minute I am at AMIA I am booked. That is why I go.
What is wrong with the fifth, the week before? Oh, you are booked that week. Okay. So, we are back to the fifteenth.
How many people are going to be at AMIA? I don't want to be the -- Mike is going to be at AMIA, also. I can tell you Clem McDonald will be at AMIA and probably a number of other folks. I just don't think that is a good time for it. What about earlier than the week of November 1?
MR. BLAIR: The activities that we have on this work plan, you know there is going to be a tremendous amount of work that Margaret and I are going to have to do for this meeting to pull together all the stuff that we are going to be reviewing in that call, and we wanted to get that stuff out to you a good 3 or 4 days prior to that call so you could review it. In a sense it is all of the consolidation of the issues for all of the focus areas for you to start to look at.
DR. YASNOFF: But October 29, if that is a possibility is 2 weeks from tomorrow. So, that would give you a week or a little over a week to work on the material you could distribute on that Monday or Tuesday, the twenty-fifth or twenty-sixth, and then we could have the call the twenty-ninth, and then we would be a little bit ahead of the schedule that you projected which --
MR. BLAIR: I don't think I am capable of getting that much work done that fast.
Margaret?
PARTICIPANT: Why don't we say, "November 15" and if Mike and I are someplace else, we call in? I mean we are going to be jet lagged anyway if we go someplace. An hour won't make any difference what time it is.
MR. BLAIR: Is that Monday, the fifteenth?
PARTICIPANT: Yes, Monday, the fifteenth.
MR. BLAIR: Okay, what time during the day?
DR. COHN: Can I just throw in something here? I think many of you know I actually still do some clinical practice, and I have no idea whether I am going to have a clinical practice day on the fifteenth or sixteenth, and I can tell you on the seventeenth I am available.
PARTICIPANT: The seventeenth is good.
DR. COHN: And I may very well be available on the fifteenth or sixteenth, but since we are pushing to actually get this scheduled today I just have to tell you my answer.
DR. YASNOFF: How about if we set up a time on the fifteenth and a time on the seventeenth, and if you are not not available on the fifteenth, we will take the second choice?
DR. COHN: That is fine.
DR. YASNOFF: Because I think we are pushing the time a little bit back. I don't know how you feel, Jeff.
MR. BLAIR: Yes, it is pushing it back and then after that conference call there will be updates that will come out of that. What I would like to do in that is to essentially have a 2-hour conference call to go through all those things. It is going to be a lot of stuff to go through, a lot of corrections and all.
DR. YASNOFF: I assume we would like to have that in the afternoon, Eastern time so as not to destroy the day of the West Coast people?
MR. BLAIR: I think that makes sense. Okay, Margaret, would you like to suggest a time?
PARTICIPANT: One o'clock.
MR. BLAIR: One o'clock on -- what time zone were you thinking of when you say, "One"?
PARTICIPANT: One p.m., Eastern Standard time.
MR. BLAIR: Okay, 1 p.m., Eastern Standard time on Monday the fifteenth or alternatively the seventeenth.
PARTICIPANT: What was the alternative,November 17?
MR. BLAIR: Yes, same time. Okay, let me continue to take you a little bit through this detailed schedule because what you noticed is we carved up Items 3 and 4. Item 3 is the activities to pull together essentially most of the issues, but there we can go a little bit further and we may be able to get some of the initial recommendations done during that time piece, and those activities are really leading to having something for us to dig our teeth into on December 9, when we all get together, and Item 4 is with respect to the focus areas other than message formats and terminology, and that really has Margaret and I pulling together that stuff for you to start to review on November 15 or 17, and again that is going to be for the most part issues. I don't think we are going to get down to recommendations on those.
Those other the focus areas just to help you remember include the quality, accountability and integrity focus area, the one on the state laws, the different state laws, and the thing that will feed us to get that done, and that is why we couldn't move it earlier than October is that that document will be given to us by Kathleen Frawley by the end of October. So, that feeds into preparing this, and the interfaces to the NHII activities and the interface to the privacy, confidentiality and security. So, that is what we will be pulling together so that you could review it by the fifteenth, and if we are going to have AMIA then, Margaret I am just assuming that before we go to AMIA we would get that distributed so that people would have the documents for a week before the meeting.
PARTICIPANT: Yes, whatever was on the schedule is fine.
MR. BLAIR: November 2, is what we were shooting for, and then you can see that on December 9, we would really start to dig our teeth into the issues, the assumptions and the recommendations and make as much progress on those as we can and then Margaret and I would attempt to pull together the -- oh, also, on the ninth would be a much more detailed outline of the final report so that Margaret and I could pull that together by the end of December, and we could wind up reviewing that in a conference call the middle of January, and what we would be reviewing in the middle of January would be what we would call the first draft of the final report including those recommendations, okay, and we would get those critiqued or excuse me, we would get, yes, we would wind up looking over those in that conference call the middle of January, and we need to pick a date for that. I will come back to that. Then we would update that, and then we would have our 2-day meeting on January 31 and February 1. That would enable us to come up with a second draft which we could then have ready to get approved by our work group here and critiqued and then move it on to get reviewed by the full committee at the end of February.
So, are there any difficulties or problems or discomforts people see in this schedule?
DR. COHN: Actually I would comment on our December 9, meeting that we are, actually, also, meeting the tenth, and it is likely that there will be a couple -- I mean we are going to need on the tenth time to deal with some subcommittee business related to, for example, the claim attachments, probably preparing our letter on claims attachments. Otherwise my hope would be that we would have some time into the tenth, also, to discuss some of this.
MR. BLAIR: Right. Okay?
DR. YASNOFF: Simon, you are saying that we should plan to be here on the tenth, as well?
DR. COHN: Yes, because the schedule doesn't say anything.
MR. BLAIR: Actually the schedule and the work plan does, and up until now I was just only focusing on our work group here when I said, "The ninth," but all along we have been figuring on the ninth and the tenth for the Subcommittee on Security.
DR. COHN: And just as we are looking at things I think there is going to be some time on the tenth for this.
You know, I think the only question I had on all of this is just having to do with the ordering of things, and a sort of conceptual view that it seems to me that the most important thing has to do with the business case.
MR. BLAIR: I am sorry, yes, that is listed.
DR. COHN: Sort of like as a fourth or fifth focus area, and I am just wondering if almost any discussion we have about this needs to start from agreements and grounding on what we think is the overall -- once again, I mean the business case the way I mean it as opposed to, I think, the way you mean it on this one which is that it is not the business case that people in small groups cannot make it to standards meetings but more a case of like what are the compelling issues that we would be, that require these recommendations, and so, I just want to make sure that in any sort of process that would go on in December that we have a chance to review that one early on.
MR. BLAIR: Let me just capture this if I can? Simon just pointed out that when he was thinking of business cases he was thinking of what are the compelling reasons that are driving or the need for these standards. Is that right?
DR. COHN: Right.
MR. BLAIR: Okay, and incidentally did you get the feeling that when Blackford Middleton gave us his testimony he was saying very much the same thing, that we have to look at the driving forces as we prioritize down? I sensed that it was similar to what you just said.
DR. COHN: I think there have been a number of speakers who have made comments similar to that. We need to make sure to be extracting some of their views of what those main drivers are because they really help key us into the issues and actions on everything else.
MR. BLAIR: Good.
DR. COHN: Margaret, I see you nodding your head. Is that --
PARTICIPANT: Yes, I think that actually I have already begun to identify some of those that even were included in the convergence documents for medical terminologies and for message formats and we just said, "That is business case. We will kind of reserve that for that area."
It may be appropriate to try to develop a convergence document type of working document just on business cases.
DR. COHN: That would be great, and I think speaking for Kathleen Fyffe, I think she would say, "Thank you."
MR. BLAIR: Could we try to make maybe one or two dates in the middle of January for that conference call, identify some suggested dates that are goof for you folks?
DR. ZUBELDIA: The week of the tenth?
MR. BLAIR: Good, the week of the tenth.
DR. YASNOFF: Early part of the week of the tenth.
MR. BLAIR: Early part of the week, I am hearing, either the tenth or the eleventh.
DR. COHN: I know I am not available on the eleventh.
MR. BLAIR: So, we are back to the tenth.
Sold on the tenth? Okay, January 10, also, at 1 o'clock for 2 hours Eastern Standard time?
Okay. Any other concerns or observations or suggestions with respect to this detailed schedule?
All right. That is Appendix A.
Let us go on to Appendix B. On Appendix B, and again we are kind of doing this in iterations. Each time we try to go a little bit deeper, but take a glance at this. Do you folks feel that this is a good way for us to begin to look at that framework or outline for the final report? Did we leave some things out?
DR. COHN: I would ditto my comment on the business case.
MR. BLAIR: How would we reflect it? What would we change in terms of the framework?
DR. COHN: I think the business case is the overarching piece of which all the other pieces fall from that, and so, it is a different sort of focus area and I think it needs to be sort of the first. It needs to be after the Executive Summary, but it sets the context for everything else.
Mike is raising his hand. So, maybe we should let him comment.
MR. BLAIR: Let me just before I lose my thought, is essentially what you are saying that while we still have the focus areas the way we have defined them, preceding that we would have what you are calling business case? Could we call that the driving factors or driving forces? Is that the same thing, driving forces for standards or is that different?
DR. COHN: It is very close to the same thing.
MR. BLAIR: Okay, let me just add that we would add in a section prior to the focus areas that would include the business cases slash driving forces for standards.
DR. COHN: I sense that Mike has maybe an improvement on this.
DR. FITZMAURICE: Not an improvement. Jeff took the thought right out of my head. Actually it probably was in his head all the time of having an overarching or cross-cutting section called like driving forces, incentives for standards which could be the need for business profits, improve revenue, reduce costs. It could, also, be a social need as well, I mean to improve efficiency in the health system even if it doesn't improve somebody's profits moving public health data around, for example.
It could be driving forces. It could be incentives, but it is places where standards should matter.
MR. BLAIR: Do you think you would like to volunteer to write the paragraph?
DR. COHN: It is the why in all of these.
DR. FITZMAURICE: Yes, why is it important and to whom; who will do something about it, and so the government is, also, another driving force in there, too, because sometimes the benefits are so diffuse that it takes a central authority to sum up the benefits and say, "Yes, it is worthwhile."
MR. BLAIR: Good.
DR. YASNOFF: Another word you may want to use to title that section is rationale.
MR. BLAIR: Another phrase to title that section might be rationale.
DR. YASNOFF: And obviously you want to have that right up front because you want to explain why this is important and the business case is not the only reason why this is important.
MR. BLAIR: Is this all consistent with your thoughts on this?
DR. COHN: Yes, I can think of the business case as being both tangible and non-tangible reasons.
DR. YASNOFF: But for example, the issue, the benefits to public health are not part of the business case but yet I think are one of the compelling reasons why this is important.
MR. BLAIR: Compelling reasons. I love that word.
Okay, any other observations or suggestions related to our framework for the final report?
PARTICIPANT: May I ask Simon a question then? Do you see that replacing the focus area called business case issues or do you see that still as a separate issue, a separate focus area?
DR. COHN: I, personally, think it replaces it, though I would defer to the overall set of recommendations, and there may be some things that have to do with, as I think I commented that there was another piece that was somehow captured as, I am trying to think of how to describe this, as there are certain groups that need funding to fully participate. I am not sure in my mind I would even consider it a business case, but more of like barriers to participation, but that would be the only thing left out of that.
DR. FITZMAURICE: I am thinking of the same thing as Simon. The driving force is an overarching list of incentives or rationales, but there still may be a business case issue in that why isn't the private sector doing this or what does it take to get the private sector to do it.
DR. ZUBELDIA: In the summary there is the background and purpose, and maybe besides having the summary, having that as a section before the body of the report and a detailed description of the background business case and the purpose of the effort, what is the motivation behind and why.
MR. BLAIR: Now, you are figuring that this would then be between the background and the purpose and the Executive Summary as well as Section 2 of the document as a whole?
DR. ZUBELDIA: Section 1 is the summary. Section 2 is the body of the report, and I think that the business case needs to be more than just a summary, but it is before the body of the report.
MR. BLAIR: I think I understand. The first part is the body of the report but the Executive Summary is, also, going to have a reference to that. So, that will probably be a paragraph within the Executive Summary as well.
DR. ZUBELDIA: Yes.
DR. YASNOFF: Jeff, if the Executive Summary is going to present this rationale, if you will, why this is so important has all these benefits and so on, doesn't it, also, have to address what the barriers are? I mean if this is so important and so compelling, how come it is not being done or am I trying to put the whole report into the Executive Summary?
MR. BLAIR: I think the Executive Summary really has to include all of the important things for, quote, the executives that are not going to read through the details.
DR. YASNOFF: Which is almost everyone.
DR. COHN: Maybe I might just make an observation. At least in my experience I typically write the Executive Summary after I write my report, and it becomes a summary of it. So, probably we just need to be aware that whatever we are putting up there we know there is going to be an Executive Summary, but this all had better be in the report.
MR. BLAIR: I agree completely. Any other thoughts or ideas? Margaret, I think the answer to your question is we still have business case as a focus area, the topic that we were talking about related to whether we call it business case, rationale, compelling reasons, whatever the name is that would be an overarching section that would precede our discussion of the focus areas.
PARTICIPANT: Right.
DR. ZUBELDIA: I think that everything that we have in the summary now including the definitions should be in that overarching section rather than trying to put the definitions in the summary. What we have here in the summary actually should be part of the body of the report, and then the summary may have a very brief extract of the body of the report, but all these items need to be touched more than just in the summary.
MR. BLAIR: Okay, so, Kepa is mentioning that if the summary is a derivation of the body, then all the items that are in the Executive Summary, also, have to be in the body.
Anything else?
DR. YASNOFF: May I follow up on that? What we are essentially saying is the Executive Summary is a summary of the whatever we write as a report, but the report is going to have an introduction in essence which says the purpose of this, the compelling reasons or rationale why it is important, the important, the barriers we are trying to address and as a way to lead in to the specific focus areas. Is that essentially what we are saying, so that this should be titled introduction rather than Executive Summary.
DR. COHN: Yes, I think one is whatever we called the first part of the report rather than -- I see what is going on here is that, and Jeff, unfortunately, we are getting a lot of cutting and pasting here, and I just don't know why we are not just taking what is in the Executive Summary and renaming it as the first part of the report or introduction or whatever you want to call it.
MR. BLAIR: I think that there is a difference between an introduction and an Executive Summary.
DR. FITZMAURICE: I think we would not put the general recommendations in the introductory chapter.
MR. BLAIR: Yes, so, maybe I misunderstood you. You are not saying that we shouldn't have an Executive Summary. What you are saying is that once we get to the body, the body begins with the introduction which covers most of these items; is that right?
DR. YASNOFF: Right, and I am agreeing further with Simon.
MR. BLAIR: Once we get into the body we have an introduction and an elaboration of the --
DR. YASNOFF: The Executive Summary will be defined afterwards, but the body of the report has to have this introduction that is not related to the focus areas which include this rationale and barriers and maybe the definitions if we choose to put them in.
CAPT. MAYES: Maybe at this point all there should be is a single line saying, "Executive Summary," without any of those bullets underneath it.
DR. YASNOFF: Exactly.
CAPT. MAYES: Since you have already copied them down.
PARTICIPANT: Except I didn't copy the general recommendations.
CAPT. MAYES: At the bottom of the list is the --
DR. COHN: That is all right. You can get rid of that. So, now, the Executive Summary is one line.
DR. ZUBELDIA: Margaret, if you call that Executive Summary and recommendations, then you have both.
DR. COHN: To remind us to put those in.
MR. BLAIR: I still think that the Executive Summary is going to include a summary of the recommendations.
DR. ZUBELDIA: It is just to remind us because she took it off the screen, and it just disappeared.
DR. YASNOFF: Just as a reminder, I don't think there is any chance we are going to forget our recommendations in the Executive Summary, but it doesn't hurt to remind us.
MR. BLAIR: Okay, anything else on the outline or should we move on?
Okay, the other pieces here, to be honest with you, I sort of feel like they may -- it is the agendas for the ninth, January 31 and February 1, and I don't really feel like we need to wash through this in any great detail, just to give you a feeling for how we might lay out the day; the times for each of those items alter somewhat. The sequence might alter, but essentially it gives you a feeling of what we would do.
Does anybody have any thoughts, concerns or changes on like December 9, for example?
DR. ZUBELDIA: Jeff, may I go back to the outline for a second?
MR. BLAIR: Oh, sure.
DR. ZUBELDIA: On the appendices we have the work plan, the questionnaires, the written testimony given to this work group. Maybe we ought to include some of the testimony given to the privacy work group because we have a section in the outline that talks about privacy, confidentiality and security.
MR. BLAIR: Okay, I don't have any objection to that. Is that all right?
DR. ZUBELDIA: Some of the testimony given to privacy was very relevant to the clinical record.
MR. BLAIR: Yes, and it may not be everything, but it may be at least some -- I don't know if it would all be bodies of testimony but maybe it would be some input or contributions from that work group.
DR. COHN: Maybe it is our recommendations on security, privacy and confidentiality that we made to the Secretary a couple of years ago, unless we have something new to say.
DR. ZUBELDIA: And some coordination.
MR. BLAIR: Margaret, do you have that? In appendices we are going to add the privacy, confidentiality and security recommendations to the appendix.
DR. ZUBELDIA: And some coordination with the other work groups.
MR. BLAIR: You know, since you made that point we probably would add the proposal for the NHII as well in the appendix as well in the appendix as well.
DR. YASNOFF: Well, a reference to any recommendations that they make because obviously the structure is going to have a great deal of bearing on some of these standards.
DR. ZUBELDIA: Sorry about that.
MR. BLAIR: That is all right. You are allowed. All right, this is interesting. The blind guy turns the paper as if he could see what is on the page, you know. You know, for years after I lost my vision when I would do a presentation I would automatically turn around as if I could see what is on the projection thing, just habit.
Okay, December 9, any concerns or discomfort about at least this conceptual outline for December 9?
DR. ZUBELDIA: Do you have an idea of the location?
MR. BLAIR: Here because it is most convenient for people in Washington to attend, and you will notice that if we go to January 31, and February 1, it is similar. I think all we did was we changed the word to updating each of those sections, and I think on February 1, we figured that there would be a whole morning going over sections of the report itself, a little bit more than a morning, I guess, about 4 or 5 hours.
Is that okay? Do you need more time to look at it, to get a feeling for it? Should we move on?
Okay, that I think tends to put things in perspective for you in terms of where we are going so that now as Margaret begins to introduce some of the issues, assumptions and recommendations for message format standards and for terminology you can put that in context. As a reference since we derive most of this stuff from the convergence documents as well as the testimonies copies of those convergence documents are here, and I think at this point, Margaret I will turn this over to you.
PARTICIPANT: Okay, what Jeff asked me to do was to come up with key issues, the most key, what are the most important issues in the areas of medical terminology and message format standards as those two focus areas to start on, and I didn't have an opportunity to go through every last word of every element of testimony, but I kind of scanned through it all and then looked at the two convergence documents that existed, and I felt that those were really excellent summaries of the issues for the most part.
What I did was I started with the convergence documents to really go through those with a fine-tooth comb you might say, and for medical terminologies I felt that instead of coming up with key issues that were really the same as what you already had in the convergence document what I ended up coming up with was what we decided to call basic assumptions and issues. There was a couple of basic assumptions that we felt there seemed to be a lot of consensus about. Let us put them on the table and see if that is really so. If not, we will change them, but it seemed to be there was a fair amount of consensus, and then there were still some open issues, and then we, also, felt like we could get to even a few recommendations, that there seemed to be consistent themes to do so.
When we got to the message format convergence document it seemed that although the issues were fairly well laid out there, the issues remained as open issues and we couldn't really begin to identify consensus for even assumptions or recommendations. So, those are perhaps, it appeared to me that there was less consensus in that area as to kind of moving forward.
So, I developed some verbiage and then Jeff said, "Why don't you take the group through the convergence documents first to show how you arrived at what you did?" So, that is what I am going to do.
DR. COHN: So, you are actually going to walk us through the --
PARTICIPANT: So, you should really be looking at the convergence documents, and let us start with the medical terminology one that is the May 17 and 18.
DR. COHN: Just to make sure I understand, these haven't been in any way updated with our September hearings?
MR. BLAIR: The only thing that I did was I made sure that I updated any references. Marjorie Greenberg had expressed concerns about the way we had referenced ICD and CPT codes as reimbursement codes, and I corrected those.
DR. COHN: Okay, I wanted to make sure. So, basically these things have no input from any of our hearings related to users or anything like this?
PARTICIPANT: No, no. The document physically has not been updated, but as we reviewed them and tried to develop our issue list we included the testimony from September in our thinking process.
DR. COHN: Okay, but not in any of the documents we are looking at?
PARTICIPANT: We didn't change these documents. We moved it over to this new document.
DR. COHN: And the new document is the one-page document?
PARTICIPANT: Right.
So, what we did with respect to the convergence on medical terminologies was first of all the first slide is the title slide. The second slide is an outline.
If you look at the third slide which is purpose and scope it appeared that there needed to be some overarching sort of principle or basic assumption or statement and the suggestion was that there needs to be convergence and interoperability among health care terminologies in order for them to be used as components for uniform data standards for patient medical record information. So, although we word smithed that a little bit in the final document that we put together for you that was sort of the basic sense, and I think perhaps it would be best if I went through and just sort of gave you a basic general direction, and then we will go back to the actual items individually.
I think it will set a context for you. The next slide in the medical terminology convergence document is called terminology characteristics, and I looked at terminology characteristics as well as the next slide on strategic imperatives, and it appeared to me that instead of dealing at the level of all of the detail that was in there if we wanted to get agreement on is this a basic assumption or an issue or a recommendation, we would assume that this document because it was a convergence of a lot of the testimony that we could say something to the effect of there are key characteristics and attributes and imperatives and maybe we could come up with a different term than imperative, but there are key characteristics, attributes and imperatives that are necessary to facilitate convergence and interoperability among medical terminologies for them to be considered national standards as a high level issue statement.
I think looked at the fourth slide which is key observations, and I began to find that some of these key observations had already been stated as key characteristics or imperatives. For example, scalability and maintenance of medical terminology such as LOINC and NDC as a problem, we have already identified that a key characteristic, attribute and imperative is scalable infrastructure.
So, the key element or key issue that came out of that key observation was really what was new there on that slide with something to the effect that all reimbursement research and other uses of patient medical record information should be derived from health care data, that should be collected once at its point of origin or something to that effect, and that is basically the issue that Jim Simino talked to in that slide.
The next thing I looked at was the key observations continue which is on the next two slides, well, actually next five slides and again there were a number of items identified in here that basically represented the characteristics and imperatives that we had already seen in the previous slide.
What was new in these slides represented things the government ought to do and so, we came up actually with a set of statements relative to what the government should do and what we thought we would do is put them out there for you to say, "Yes, I agree" or "No, we should turn that around. That should be completely opposite." But at least it is like a straw dog to help you say that yes, that is a point.
The last set of slides starting with the diagram called medical terminology domain areas and the remainder of the five slides basically was a discussion of each of the individual terminologies or code sets, and obviously should be included in the focus area for discussion purposes in the body of a report but again, were not specific to an issue that hadn't been addressed in the earlier slides.
So, if we could then go to the one-page document we came up with five basic assumptions and two recommendations relative to medical terminologies, and it might be helpful to read them all together as a set and then take them individually.
First of all there needs to be convergence and interoperability among medical terminologies in order for them to be used as components of uniform data standards for patient medical record information. This will ultimately improve the quality of patient care.
Two, there are key characteristics, attributes and imperatives that should be adopted by medical terminology developers in order for their terminologies to become accepted as national standards.
Three, standard medical terminology should support collection of health care data once at its point of origin and all reimbursement research and other uses of patient medical record information should be derived therefrom.
Four, medical terminology standards should relate directly to health care message format standards.
Five, what role should the government play if any to resolve the disparity of usage fees charged by different medical terminology developers, and then the recommendations were the government should promote greater vendor and user acceptance of standard medical terminologies by officially adopting them within government agencies such as for the GCPR project through requiring their use and complying with minimum data sets, encouraging their adoption for use in performance measurement by accrediting agencies and other organizations. We need a period there.
The government should develop policies and mechanisms to assist medical terminology developers develop, maintain, coordinate and map nationally and internationally medical terminologies in an open process.
DR. FITZMAURICE: Now on the first basic assumption, does that include mapping? I guess not convergence, but the interoperability portion of it. Does that include that there needs to be mapping? Is that part of interoperability, or are we really meaning convergence?
MS. AMATAYAKUL: Well, if it's not clear, I think we should make it clear. Or we could, in our definition of terms in the body of the report, define convergence and define interoperability, and define whichever one of those terms is appropriate to say it includes mapping.
DR. FITZMAURICE: I would think mapping is a way to get interoperability.
DR. COHN: Wasn't that in the general recommendation part though? Do you think that needs to be specified as an assumption?
DR. FITZMAURICE: No.
DR. YASNOFF: What do you mean by convergence? What is convergence with medical terminologies?
MS. AMATAYAKUL: I saw it as a level above our present coordination, but bringing each one of the terminologies to a reference terminology.
DR. YASNOFF: Well, can we say that then? Because I think if you say something like medical terminologies all need to map directly to a reference terminology, then you have said something where you can say, this one does map, this one doesn't map. If HL7 meets weekly, is that more convergent? I don't know. I'd like to say it very explicitly. I don't know if this is where it should be said, but I would like to say it very clearly. Maybe we could just define it.
MS. AMATAYAKUL: Would it be necessary to identify a set of reference terminologies, or are you suggesting a single reference terminology?
DR. FITZMAURICE: I would say as an assumption or an issue I would go with the single. The reference terminology would be a set of concepts that everything should map to, all the other terminologies should map to. Convergence would be the process of getting everybody to map to that.
DR. YASNOFF: Is there such as thing?
DR. FITZMAURICE: As a single reference terminology?
MR. BLAIR: No.
DR. ZUBELDIA: No, but from what we heard today, it could be mapped onto the model, onto a higher level.
DR. YASNOFF: But I guess the reason I'm asking that question, for example what Judy Ozbolt said today, that they are working on developing a reference terminology for nursing. That doesn't exist now.
DR. FITZMAURICE: So there should be one.
DR. YASNOFF: There should be one, but there may be a set of reference terminologies, but within each discipline there is only one reference technology.
MR. BLAIR: These questions I think are really good, because I found myself changing my thoughts here about three or four times while I was listening. I tend to go back to I guess it was Blackford Middleton's observations where what level of comparability are you talking about.
Are you talking about comparability for the use in claims? Or are we talking about level of comparability for patient care? Or are we talking maybe even at a more disciplined and higher level of comparability, where it has to be able to support clinic decision support, where it is even more demanding.
I think the same thing is going to apply when we talk about mapping, or when we talk about reference terminologies is it's interoperable within the context of how or what it's going to be used for. That could change, whether it is interoperable or not, or whether it is comparable data or not.
DR. YASNOFF: You are getting into the question of what is interoperability.
DR. COHN: I think we're doing a pretty good job of confusing ourselves. My own view on this one is that we need to be very careful with the wordsmithing. You do get into this issue, there are papers that have been written talking about the fact that there is no single reference terminology.
We already know that even for example with SNOMED-RT that doesn't cover the drug domain, even if you don't talk about the nursing issue. So we're already sort of talking about how do we interlink and interconnect potentially important reference terminologies, which becomes an important sort of conceptualization of how do you do that. How do you keep them in sync while leveraging what exists out there, just is sort of the view that I've had on this one.
Although how you describe it in a way becomes a difficult issue. Of course Dr. Eisenberg in his recommendations talked about adopting a standard that integrates the many existing terminologies. While I'm not suggesting that that's the wording we want to use, I think that's sort of the concept that we're trying to move forward on, I think. I'm at least throwing it out for discussion.
DR. YASNOFF: I guess I'm confused as to whether -- this all seems to be recommendations, as opposed to issues. An issue would be that currently there is a lack of interoperability, which is a big problem. That's an issue. What we are talking about is what we should do about that issue, which I think obviously we need to talk about. Because there are a whole series of things that are possible recommendations, and I guess is there is a list in the presentations -- is that captured?
In all of the testimony we have had, there have been a large number and a wide variety of recommendations. Do we have those captured here?
MR. BLAIR: No, we don't have them summarized and pulled together at this point.
DR. YASNOFF: Should we not create at least a list of what we have heard people recommend?
MR. BLAIR: Well, that's what we're hoping to have by December 9th.
DR. YASNOFF: Oh, I see. I'm sorry.
MR. BLAIR: That was the detailed plan, is how do we get there. We thought what we would do to get there is agree on what the issues are. Because in a lot of cases people either didn't make a recommendation, or they made it in a very ambiguous way, or there were gaps and holes in the recommendations. So we thought to pull them together if we identified the issues, and then said what recommendations do we have to address those issues. Then we know that we have tied together the loose ends.
DR. YASNOFF: For example, the thing that is in recommendation 2, the government should develop policies and mechanisms to assist developers, et cetera to develop, maintain, coordinate, and map medical terminologies. That's great. But now I'm the secretary and I look at that and I say, well, what does that mean I'm supposed to do? Or I'm Congress and I say, wow, what exactly are we talking about? This sounds like motherhood and apple pie. Yes, this is great.
DR. FITZMAURICE: You're saying it's not actionable.
DR. YASNOFF: No, it's not actionable. And then I want to add to this that essentially I think that our testifiers have all, in one way or another, said this. Haven't our testifiers essentially said this, and then some of them have said nothing in further detail. But some of them have said more in terms of detail as to exactly what they think should be done about this, like the government should purchase SNOMED and put it in the public domain.
I think we need a list of those actionable things so that we can decide which of those actionable things we think, based on what we have heard and know, are likely to push this forward.
MR. BLAIR: I think we'll have to pull that together. The bottom part of the testimony winds up saying what's the role of the government should be, and those are saying what the government should do. Those are the recommendations. So I'm afraid it means that we have to cull through the testimonies.
DR. COHN: I think there is also perhaps some opportunities in things that aren't just government that we should be capturing also. If there are public/private partnerships or just public activities. I think if we are going to go to the trouble of putting together a list of recommendations, we probably shouldn't miss those areas where private activity needs to occur.
DR. YASNOFF: Well, maybe what we should say here then is that the sense of the testimony was that we need to achieve this goal. And that the government may have a role in that, or it may be private sector things that need to be done. There may be a number of ways in which it would be addressed.
I think the issue that is important, the reason this is here, the reason it should be here is because this was the sense of almost all the testimony we have, is that this is a problem that needs to be addressed through some coordinated action. There was not a consensus on what that action should be that I heard.
MR. BLAIR: Margaret, your thoughts?
MS. AMATAYAKUL: I think what we tried to here was to raise up to a very high level what were the major issues, assumptions, recommendations that were heard throughout, and not really to get into fine grain detail at this point, but to get a sense from you are these the big buckets if you will that you heard.
That seemed to be something that Jeff wanted, Mike wanted. So that's kind of how we approached it, was from a very high level. But obviously for the December 9, we need to get into much greater detail.
DR. COHN: Margaret, I was going to comment I think that's exactly right. You were talking about the highest level, and then if they seem right, we begin to draw down. So I think that nothing is actionable here yet, and probably some of us are action oriented, we want to have them here right now, but we can also wait.
I guess I fundamentally agreed with number one until you were sort of wordsmithing, and I'm not sure I agree with it any longer. I do want to specifically what number four means, which is that medical terminology standards should relate directly to health care message format standards. Now I think I sort of understand that, but not in this.
MS. AMATAYAKUL: Well, you know actually what happened is I identified a particular one -- I did identify it from the medical terminology convergence document. But we also then went on to the message format, which I haven't covered yet, and we identified this same point that the terminology in the message format needs to be coordinated. We stuck it up here instead of down under message format. It maybe is more appropriate in the other, I don't know.
DR. FITZMAURICE: Is another way to say this is that they should service the same clinical function, that they should support a given clinical function? You have to have the message, and you have to have its terminology and content.
DR. YASNOFF: This doesn't mean anything to me the way it is stated, but if you say medical terminology standards are the basis for health care message format standards, or form the elements that make up, then that makes sense to me and that's an issue. And the reason it's an issue is because you can't have good message format standards unless you have good medical terminology and vocabulary. This is essentially the domain from which those standards are drawn.
DR. COHN: Well, I think though that that was not the point that was being made in the testimony. This is testimony that we heard from message format standard developers was not that there was necessarily bad terminologies, but it was like these things were sort of being done in different orbs of development. There was not a close connection between the information model and the terminology model, at least that's how I would best describe it. I think there is an issue here, but I guess I thought we hadn't quite gotten the issue right.
MR. BLAIR: Can I just in a second and explain a little bit on derivation, or at least my understanding of it? A lot of folks that were testifying were struggling with moving interoperability to the ultimate ideal of plug and play. And they were describing why they were falling short.
Among the things that they were saying is that there are some problems with message format standards, where we don't have plug and play, where you still have Z fields and you still have ambiguities in the fields of a message format standard.
But the point that they were making is that the code set, the terminologies that you would fit into the fields were not necessarily ready or complete or consistent or convergent. And so at least my understanding is that this was trying to get to that point, is that in order to get to ultimate interoperability, the message format standards have to work with the medical terminologies to get to real interoperability.
Margaret, was that your thought?
MS. AMATAYAKUL: Yes, actually the observation we took this from was medical terminologies must also be able to work with health care information standards such as HL7.
DR. YASNOFF: But isn't what you're saying, Jeff, that medical terminology standards are the basis of health care message format standards? Are you saying more than that?
MR. BLAIR: I don't think as a basis. I hope it's not saying my view. I'm trying to understand what they were telling us. My understanding of what they were telling us was that the goal was put in play. Interoperability is leading towards plug and play. We get there with message format standards. Among the things that we need from message format standards -- we need many things from it -- but one of the things that we need is terminologies that will fit into it. I wouldn't necessarily say it's the basis, because there are other things that are needed.
DR. YASNOFF: How about is a key element in? Because the statement as it stands, medical terminology standards should relate directly doesn't communicate anything to me. If you say medical terminology standards are a key element of health care message format standards, I agree. That's what we heard in the testimony. That makes sense.
DR. ZUBELDIA: On the other hand, the message format standards needs to be somewhat independent of the terminology. So when the terminology evolves or is redefined, you don't need to be changing the message format.
DR. YASNOFF: No, but in order for the message format to work, you have to have good terminology.
DR. ZUBELDIA: Well, define it in the first place. But they also need to be defined somewhat independent of the terminology.
MR. BLAIR: Can you reconcile this by instead of saying a key element, you said key elements? Make it plural, because you could have different terminologies that fit into the fields of a message format standard. Does that reconcile your point?
DR. YASNOFF: That's fine with me.
MR. BLAIR: So make it plural. Our key elements.
DR. FITZMAURICE: And they are key elements for the contents of message format standards?
DR. YASNOFF: That, I agree, is a key issue.
DR. COHN: Is that an issue or is that an assumption?
MR. BLAIR: Assumption or observation?
DR. YASNOFF: The way that section is defined, we don't have to determine which it is.
DR. COHN: I guess I had a question. This is more of how my mind processes things. I find I do much better if I understand what the issue is. And I think we have done a good job of laying out a bunch of things that we heard. This is not for today, because we're not going to fix this on the fly, but probably for another discussion, having this presented to us in a way where the issue is maybe a business issue that is underlying some of these things.
Then we can sort of go from there. But we have sort of mixed up the reasons and what we think about things together into the issues/assumptions area, which makes it hard for me to think through things.
DR. YASNOFF: I agree with that. I would like to separate the assumptions from the issues. Because to me, number five is an issue, and the issue is the perceived cost of medical terminology is too high. That's the issue. That's what people are telling us. I used the word 'perceived' on purpose. I don't know if it really is. But they are telling us the cost of this is too high and it's a barrier. That's an issue.
But what we said for number four now, wherever we are, medical terminology standards are key elements of health care message format standards, that's almost an assumption.
MS. AMATAYAKUL: Actually, we did initially have basic assumptions, and then added the fifth one. Since that was more of an issue, we added them together.
DR. YASNOFF: I would like to separate those, because I think those are vastly different. Because how you analyze your assumptions is totally different than how you deal with issues.
DR. FERRANS: I would suggest from the assumptions piece that perhaps what might be appropriate is that from the standpoint of these is that the basic assumption is that medical terminologies need to be available at a reasonable cost. I think that's the assumption. We need to operate on that assumption, and see how we get there.
MR. BLAIR: Can we capture that statement? That's a simple, direct statement that is understandable.
MS. AMATAYAKUL: I'm copying it, Jeff.
DR. FERRANS: If I might add another one. I think I have heard a lot of testimony about people saying that users need to be incentivized to use the terminologies. I don't know if that was unanimous or anything, but that was certainly -- because the flip side is if we do make them available, will people indeed use them, or is there some incentivizing needed?
DR. YASNOFF: But are those assumptions?
DR. FERRANS: I think the first one is an assumption.
DR. YASNOFF: The second one is an issue.
DR. FERRANS: Yes.
DR. YASNOFF: See to me an assumption -- well, I think what you are saying, health care terminologies should be available at reasonable cost, that's a goal. I don't know if that's different than an assumption, but that's a goal. But the issue -- I still would maintain that the issue that we heard, that overwhelmingly that people are saying that the perceive the cost as not reasonable.
MR. BLAIR: Well, it depends. They do have that view with respect to certain situations.
DR. YASNOFF: Some of them, right.
DR. FERRANS: This one at least falls into the should category, which is the way the other four are formatted. So whether they are imperative assumptions or issues, they seem to sort of flow together I guess.
DR. FITZMAURICE: Perhaps the issue is that common medical terminologies are not being used where we see that they might improve quality of care and reduce costs. The reasons for that are the cost of developing medical terminologies, the cost of maintaining them, the burden on users.
So the issue is that they are not being used where we see there are advantages. What are the barriers? And we have at least three of them. So then is the marketplace taking care of it? Should the government step in? What should the government do?
MS. AMATAYAKUL: Mike, what were your other two issues besides cost?
DR. FITZMAURICE: The cost of developing, the cost of maintaining the standards. The burden on the users, or you have to say the cost of implementing them. The time that it takes, as well as what you have to pay for the licensing fee.
DR. YASNOFF: Would you be willing to add the risk of implementing them, since you have to take a risk in picking one?
DR. FITZMAURICE: The risk of -- I'm not sure what the risk is.
DR. ZUBELDIA: That's probably the single most important factor, because if you adopt a terminology that in three years is going to become obsolete, the cost of switching is going to be tremendous. Some people are just saying I won't adopt anything until there is a standard.
DR. YASNOFF: That's a significant barrier.
DR. FITZMAURICE: The risk of becoming obsolete.
MR. BLAIR: I'd like to suggest we take a look at lumping these under the ideas of assumptions. I think to some people assumptions would imply that these are things the committee is assuming. But really they are more the observations that we have gotten from the testimony. And I think observations might be a better word than assumptions.
Do you agree with that?
DR. FERRANS: Are they guiding principles?
MR. BLAIR: Or principles that we have observed, something like that.
DR. COHN: I think I speak against these things as being guiding principles. These are probably early observations.
DR. YASNOFF: I think it's helpful in this to distinguish what we have been told, from what we concluded.
MR. BLAIR: Margaret, do you feel comfortable with that type of a change?
MS. AMATAYAKUL: I have already made it.
DR. ZUBELDIA: She said, 'early observations from testimony.'
DR. FERRANS: That's exactly what they are.
DR. ZUBELDIA: You need to put the word 'cost' at the end of number one.
DR. YASNOFF: Why are they early -- we don't have any late observations?
MS. AMATAYAKUL: Somebody said early.
DR. YASNOFF: I'm sorry, I don't mean to be wordsmithing.
MS. AMATAYAKUL: We'll leave it as observations, how about that?
DR. YASNOFF: Thank you, but I guess I am.
MS. AMATAYAKUL: Well, they were early in the process of collecting observations.
DR. YASNOFF: Yes, but it was only early because it happened to be the first focus area.
DR. FERRANS: Should there be an observation from the testimony -- there seemed to be unanimous agreement that if there was a standard, and if people were using terminologies, that there would be great benefit from it. Or is this just sort of stating the obvious and we already said it?
DR. ZUBELDIA: I think it needs to be stated.
DR. YASNOFF: I agree, I think it needs to be stated.
MS. AMATAYAKUL: Is that a business case issue, or is that a terminology issue?
DR. FERRANS: I'm saying an observation from the testimony. Everyone says, boy, if we had standards for terminology, that would be a great thing.
DR. YASNOFF: Right, that's what people seem to be saying.
DR. ZUBELDIA: And one of the observations that was made this morning was that if there is a standard, industry would adopt it. As long as there is not a standard, then everybody is trying to put their own, to see if they become the top of the heap. So I think the observation today from the vendors was they would be willing to adopt whatever the standard is.
MR. BLAIR: But they said to us they are ready to accept standards if they exist.
DR. YASNOFF: But I think you need to say a little more about that. Of course there are lots of standards out there that could be adopted. I think what you are wanting to say is if there was a clearly defined, acceptable, no risk, government-endorsed, however you want to put it standard, if there were a clear -- I'm not sure how to say it. Mike, you're good at this. You know what I'm trying to get at.
DR. FITZMAURICE: It's alluding me.
DR. YASNOFF: It's not if there were standards.
DR. FERRANS: The set of reference terminologies, since we have used that?
DR. YASNOFF: It's not that. It's that people want to be assured it's the right standard, that their investment is going to not be lost.
DR. ZUBELDIA: Probably if there is a standard backed by the government, that the government is going to put their money behind it, adopted by the government, people will see that as a risk reducing factor.
DR. FITZMAURICE: Authority, and it's not going to become obsolete.
DR. YASNOFF: But I'm a little uncomfortable about saying if there was a government-endorsed standard, people would adopt it. Maybe we should say if there was a universally endorsed standard, people would adopt it or something like that.
MR. BLAIR: Can I try to help to see if I'm keying into your thoughts? I think what you are trying to say is that the vendors are saying that they are ready to accept standards that support their business models. In other words, that help them meet their customer needs, and help them do it in a cost effective way.
They don't want to be forced into a standard that is burdensome. They don't want to be forced into a standard that is costly, but in short they are ready to accept standards that support their business models. Is that what you were saying?
DR. YASNOFF: I agree with what you said, but I don't think that's exactly it.
DR. FITZMAURICE: Bill was down to an action item, what should the government do? The government should announce and adopt a standard to set the pace for the industry.
MR. BLAIR: Well, it would be a catalyst to move it forward.
DR. FITZMAURICE: More than a catalyst at that point. We should make a choice and move with it.
DR. YASNOFF: I was trying to capture Kepa's point, which I think is exactly on target, which is that people want to adopt standards, but they want to know that they are adopting the right standard. But I don't want to say that in a way that implies a recommendation that government should say what that right standard is, because we haven't agreed to that. We could put it in just as a place holder.
MS. AMATAYAKUL: I'm just taking a few notes without regard to whether this is the final wording. I just wanted to capture as much of your statements as I could, so we could go back and wordsmith it.
DR. FITZMAURICE: This might be part of incentives or guiding forces. That government adoption can reduce the risk and create a market for a given standard. It doesn't say how you choose the right standard. It says here's an incentive. The government can provide an incentive by stabilizing a fluctuating field.
DR. YASNOFF: Well, for example long before my time the government adopted a standard for the delivery of electricity, and this promoted the development of all kinds of nice electric devices. And this is a similar kind of thing in that before that standard was adopted there was tremendous chaos in the marketplace with some alternating current, direct current, different types of devices and so on, and it was a mess.
DR. ZUBELDIA: The electric company would give you light bulbs that would work with their system.
DR. YASNOFF: That's exactly right. That was the incentive. They would give you free light bulbs.
DR. ZUBELDIA: But I think we have a reference with the administrative simplification transactions. At the beginning of the process there was big debate over which is the right standard. Is it the NSF UB92 or is it X12? Once it was settled that it is X12, and that's what would be adopted by the secretary, there was no more debate about that. Everybody is getting ready to implement the standard. I think the same thing would happen here.
MR. BLAIR: But I do think that tying that all together -- you used the word the right standard. And I was trying to wind up saying what does a vendor think is right. That's where I used the phrase 'business model,' and to me I expanded business model to mean that it helped them to meet customer's needs. It helped the to provide things at low cost, and be probably interoperable with other standards.
So I do think -- and in a sense we had some of those things in the guiding principles when we went through this process before, Michael, that you developed. So they were guiding principles for good standards, for right standards, for guiding principles?
DR. FITZMAURICE: They were guiding principles for making standards choices for the secretary's administrative simplification. We then made minor changes to say they were getting principles for making choices among the patient medical record information standards.
MR. BLAIR: So in short, those were used as a criterion for the selection process.
DR. FITZMAURICE: Maybe for making the recommendations on legislative proposals.
MR. BLAIR: It seems like we might need a criterion for terminologies, for choosing them. Margaret has already alluded to those. It seems like the folks that have testified to us have already articulated the characteristics that we would need. We may need to add some more though. But we may need one for message format standards for PMRI. That would probably be similar to the ones that you developed.
DR. FERRANS: We seem to be dancing around the word 'national' standards, and not being able to say it. I think one thing people said is that they would readily adopt national standards, assuming they were good. What people didn't say is that the federal government should establish the national standards.
So certainly the process by which -- everyone has said essentially, you know I really wish everyone would come together and we'd agree, much like the nursing terminologies appear to have done successfully, now at least from the testimony this morning. So if there could be harmonization or reference terminologies, wouldn't that be great?
So my take on it is that people have said that the vendors and users would embrace a national standard if it were of such quality that it met their needs.
DR. COHN: Richard, can I ask you what you mean by a national standard?
DR. FERRANS: Or standards. I think it gets to reference terminology sets.
DR. COHN: I think it's the history of a lot of voluntarily developed, ANSI approved, American national standards. The reason behind HIPAA administrative simplification was the realization that in the chaotic marketplace, that we couldn't bring everyone together, seemingly get them implemented very well. So I think there was a belief that the federal government needed to help identify what those standards are.
So I mean if what we are going to do is to again have another round of just voluntary national standards, I guess I would have a question.
DR. FERRANS: I guess what I'm trying to say, and it's sort of a delicate dance, but what I'm trying to say is that under the category of observations from testimony, everyone wants that end piece. Now if should be so that there should be a rulemaking process or legislation or a voluntary effort, but at the end of it everyone agrees that there is going to be universal adoption, I don't think that should fall in the observations from testimony. That should fall under the conclusions, the discussions, the recommendations.
DR. COHN: Agreed.
DR. FERRANS: But the end result I think everyone agrees to. If such a thing were to exist, that would be a great thing.
DR. ZUBELDIA: I think that the charge the NCVHS is not to create national standards by any means. I see it more like what we did in 1993. We proposed some parameters for the adoption of administrative simplification type of EDI standards. These are the parameters that the standards have to have. Then we just said the industry has five years to adopt standards voluntarily according to these guidelines. If they don't, then the government will regulate it. So the five years passed, the government regulates it.
I think that with the CPR maybe we ought to play that same role and say these are the parameters by which the industry should adopt voluntary standards. And give them some guidelines and things that they should follow. And if they don't, set a time frame by which it would be regulated. I think that with the experience on the administrative side, they would very quickly adopt something voluntarily.
MR. BLAIR: Could I support at least conceptually what you said, Kepa. I would also like to suggest that it is restrictive and maybe not useful for us to refer to things as national standards, because the testimony that we have received from many sources -- from Judy Ozbolt today were she indicated even in the development of nursing codes, they are going international. SNOMED has made an alliance with the NHS, and they are coming up with international standards, and it is being renamed to be an international standard.
And you hear more and more than when it gets to terminology and message format that relate to the clinical area, to patient medical record information, those are international in terms of how they are used. Now that isn't to say that national government action would not be helpful to move things forward faster in the United States, but I don't think we should refer to them as US national standards. Does that make sense? I don't see anybody's heads shaking.
DR. YASNOFF: Yes, that makes sense. I the general recommendations area did we capture -- a number of people have said in various ways that money needs to be spent by the government. There have been at least three or four different ways people have suggested. We just heard today travel. People have suggested sponsoring research, sponsoring conferences. I don't think we have captured that. Maybe that's an observation.
I don't know where that should go, but there were a number of different folks who said the government -- the issue of buying terminologies.
DR. FITZMAURICE: Those would be actual recommendations.
DR. YASNOFF: But I mean if we are trying to outline the general areas that we then have to delve into, maybe it should be a question what government expenditures should be recommended to facilitate this process or something like that.
DR. FITZMAURICE: I think when we get down that point it should be what actions should the government take. What entity within the government? Should there be a creation of an entity within the government? Should there be a private institute? Will existing organizations do just fine?
DR. YASNOFF: But I guess I'm arguing that in our list of observations to just say that there have been many different recommendations for how the government should spend money to improve this problem.
DR. FERRANS: I agree with you, and in the balanced budget type environment we better separate out the government should help, facilitate, encourage, and spend. And that should be a separate item if such a thing is going to be a recommendation, because it needs to be transmitted clearly, because funds are going to have to be identified to support the effort.
DR. YASNOFF: Right. I guess you could say item two says that, because mechanisms might include money, but I think we better be pretty specific if we are going to recommend actual expenditures.
MS. AMATAYAKUL: Would you look at the basic assumptions issues under message standards 1 and 2? I think there we are little bit more specific than we in medical terminologies.
DR. YASNOFF: I think that seems reasonable.
MR. BLAIR: Now we're at about 5:25 p.m. by my watch. By the way, am I off on my time. Is that the time that everybody has?
DR. FITZMAURICE: Yes, it is.
MR. BLAIR: So we're drawing to a close. I'd like to get your feedback. What Margaret has done was an attempt to kick start and accelerate and be a catalyst to help move forward, to discuss these observations and issues. Is this a good way for us to proceed for tomorrow morning? Is this helpful?
DR. FITZMAURICE: I think this has been very helpful. I would suggest perhaps trying to frame it instead of basic assumptions issues and general recommendations, try to have more specific components. Maybe issue, barrier, general recommendation, specific recommendation. Try to be more specific about what we see, what we think, what we have heard, and what we think should be done.
MR. BLAIR: Okay. Then, Margaret, do you have any other thoughts before we adjourn for today?
MS. AMATAYAKUL: No.
DR. FITZMAURICE: I would suggest doing that for each focus area. That could move us forward with a good agenda for action tomorrow.
DR. YASNOFF: I have, if you will forgive me, one little wordsmithing in number six. Could we explicitly say public health, instead of relegating that to other uses of patient medical record. And put it before research, please? Thank you. I was paid to say that. I have now justified my attendance for today. Thank you.
MR. BLAIR: Well, this has been an extraordinarily productive day. The testimony we received today was tremendous. I think we've got a running start on the next three months. Margaret, thank you so much for helping us really dig into this and get going.
MS. AMATAYAKUL: You're welcome, Jeff.
DR. FITZMAURICE: It was extremely helpful to have this framework, not only pulling together the consensus documents, the converging documents, as did Jeff, but also to have a straw page to begin quaking away and saying how do we want to think about this, and how do we want to present it to the national committee. This is a good step forward. We are not there by any means, but I'm feeling more comfortable than I did at the last meeting that we're making good progress.
MR. BLAIR: Mañana.
[Whereupon, the meeting was recessed at 5:30 p.m., to reconvene the following, Friday, October 15, 1999, at 8:30 a.m.]