[This Transcript is Unedited]
Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, SW
Washington, DC
Call to Order, Welcome and Introductions, Review of Agenda ( Dr. Lumpkin)
Update from Department Data Council (James Scanlon, ASPE)
Data Standards Component (John Fanning, ASPE)
Annual HIPAA Implementation Report to Congress Action Item 2/24 ( Dr. Cohn, Mr. Scanlon)
Briefing on Draft Report on Standards for Patient Medical Record Information ( Mr. Blair, Dr. Cohn)
Briefing from NHII Workgroup (Dr. Lumpkin)
DR. LUMPKIN: We are broadcasting live over the internet, so it would be very important for people to speak into the microphone. We have a microphone in the back if there are individuals who will be presenting or making comments. We will be asking individuals to use the microphone.
My name is John Lumpkin, and I am the Chair of the committee. Why don't we start off with some introductions. We will proceed to my left and go around the room to introduce the members of the committee. Then we will go to the members of the audience.
DR. SCANLON: I am Jim Scanlon. I am the HHS Executive Staff Director for the National Committee, and I am in the Office of the Assistant Secretary for Planning and Evaluation at HHS.
DR. STARFIELD: I am Barbara Starfield from the Johns Hopkins University and member of the committee.
DR. COHN: I am Simon Cohn from Kaiser Permanente and a member of the committee.
DR. FITZMAURICE: I am Michael Fitzmaurice, and I would like to marry a millionaire.
[Laughter.]
I am with the Agency for Health Research and Quality, although I hesitate to say that now. I am liaison to the committee and co-lead staff to the Committee on Computer-Based Patient Records Working Group preparing the report that was mandated by Congress.
DR. GELLMAN: I am Bob Gellman. I am a privacy and information policy consultant in Washington and a member of the committee.
DR. ROTHSTEIN: I am Mark Rothstein from the University of Houston and a member of the committee.
DR. FYFFE: Kathleen Fyffe. I work for the Health Insurance Association of America, and I am a member of the committee.
DR. BLAIR: I am Jeff Blair. I am with the Medical Records Institute, and I am a member of the committee.
DR. FANNING: I am John Fanning. I work in the Office of the Assistant Secretary for Planning and Evaluation of HHS, and I serve as privacy advocate of the department.
DR. BRAITHWAITE: I am Bill Braithwaite. I work for HHS and staff the committee.
DR. ZUBELDIA: Kepa Zubeldia. I work for Envoy Corporation. I am a member of the committee.
DR. NEWACHECK: Paul Newacheck with the University of California and a member of the committee.
DR. TRUDEL: Karen Trudel, Health Care Financing Administration, staff to the committee.
DR. FRIEDMAN: Dan Friedman, Massachusetts Department of Public Health, a member of the committee.
DR. FRAWLEY: Kathleen Frawley, a member of the committee.
DR. COLTIN: Katheryn Coltin for Harvard Pilgrim Healthcare. I am a member of the committee.
DR. GREENBERG: I am Marjorie Greenberg from the National Center for Health Statistics, CDC, and executive Secretary to the committee.
DR. LUMPKIN: If we can start over there.
[Introduction of observers and guests.]
DR. LUMPKIN: I think this is our first meeting of this millennium, so we have an opportunity now to not only meet the challenge of what we have done in the past but to move forward to the implementation. We have seen a lot of progress to that. We sent quite a detailed letter of comment related to the privacy regulations, and I just wanted to thank all of those who worked very hard on the Privacy Committee. There was a lot of hard work that was done in a very short period of time, and for all of those of you who participated on a conference call.
We are going to start off with some updates from the department. Jim.
DR. SCANLON: Thank you, John. I was going to say that Gary Christoph will be here shortly, but he is dealing with the February 29th date change.
You will hear reports this morning from Bill and where the HIPAA Standards stand, and from John Fanning on some privacy issues as well. I wanted to update the National Committee on three or so items that have occurred since the last full committee meeting. One of them is a budget initiative that HHS proposed for the year 2001 budget. It is a health informatics initiative which I will describe in a few minutes.
Secondly, I want to describe some updates in the area of race/ethnicity data. Third, I wanted to talk a little bit about a report from the National Research Council that I think will be released today dealing with health requirements for the second generation internet. This is the report of an expert panel chaired by Ted Shortliff(?), and that study was funded by NLM.
Let me begin first with the budget initiative. Our Fiscal Year 2001 budget that the President sent to Congress earlier this month includes what is called a Health Informatics Initiative, Improving Information for Decision Making. You all have a copy of that at your place. The initiative was developed here within HHS by a working group of our data council.
Let me tell you a little bit about its evolution because I think it is instructive. Clearly, it ended up with the focus on health informatics, but it started out, actually, with somewhat broader themes. There were three themes, actually, that we initially focused on. What we wanted to pull together agency investments as well as cross-cutting investments that would be needed for three broad purposes. One was closing critical data gaps, which this committee is very aware of. The second goal was investments that would contribute to building the next generation of health information systems. The third goal was to make improvements in delivering useful and accessible information to decisionmakers and other customers for decisionmaking and action in health.
The initial request to OMB totaled about $200 million. This includes both the agency side and the cross-cutting side. The agency component was about $175 million of that total. The cross-cutting investments were about $25 million. HHS proposes, and then OMB disposes. When OMB reacted to our initiative, and actually they were quite positive about it all, but they asked that we focus primarily on the second goal, building health information systems for the future. They asked that we emphasize the role of informatics in that. Instead of $25 million in cross-cutting investments, they approved $20 million, which is actually quite reasonable. That is actually quite good.
They further indicated that the meeting data gaps kind of an issue was largely an agency focus, which is to some extent true, the data collection agencies, and that that would be met through the agency parts of the budget. Also, the issue of access and delivery of information was also an agency primary responsibility, and that should be dealt with in the agency proposals as well. Many of the agencies did quite well, agency by agency, in the budget process.
On the data gap side, again, I think we all feel that we fell a little short. Most of the data gaps kinds of initiatives would have been in the NCHS budget, state data, race/ethnicity data improvements, and unfortunately, there was less of an increase there than there were for other agencies. At any rate, we ended up with a cross-cutting initiative of about $20 million that focuses on the kinds of things this committee is quite familiar with, the data standards and so on, characterized largely under the rubric of health informatics.
Let me just briefly go through each of the areas that are included in the initiative, and I think we will be looking for -- some of these you will see are largely placeholders. I think we know the direction that we want to go in, but depending on the amount we get and what transpires between now and the budget for 2001, we would probably have to be specifying what exactly we would want, where we would want to provide some of these investments.
Let me just go through what you have, briefly, at your place. I am not going to read line by line, but I am going to describe the nine cross-cutting investments. The first is some funding that we would put largely into coordination and planning and design. It would be largely coordination support, probably some funding for consultation and some planning activities here at HHS to bring all of these areas/pieces, together.
The second area focuses on strengthening health information confidentiality and security. Here, we earmarked about $2 million out of the $20 million for some leadership and convening activities in the area of confidentiality and security. I think we could plan on supporting some research and development, some evaluation, and some dissemination of some cross-cutting approaches, here within HHS and working in partnership with the industry and the public health and research communities as well. Examples might include, though again, these are largely placeholders, standards and tools for disclosure avoidance, work on other privacy-enhancing technologies, and research on methods of encryption and deidentification.
The third area deals with the concept of bringing about some sort of unified electronic access to the many sources within HHS of data and information. Here, what we -- again, here we would take the point of view of the user of information. We have a number of directories and webpages and other sources of information for individual agencies or individual topics, but from the point of view of the user, it is difficult to navigate these areas, certainly on the HHS website and certainly if you have to deal with these in some other fashion. Here, we would look at approaches to bring together, from the user perspective, how would you go about approaching the HHS website or other websites, how would you search, and how could we organize our data sources so that we could lead you to those from the point of view of the user and the point of view of the topic. We will always have the high end users who know exactly where they want to go, and we want to accommodate those as well. For those who do not know the data source as well and so on, we would invest some money into how could we make that better.
The fourth area focuses on improving health information systems through more work in data standards. This would build on the HIPAA effort and the HIPAA successes. It would go further in terms of new potential standards. It would look at potential standards within HHS as well as industrywide, and it would provide funding for leadership, convening activities. It would provide some funding for assuring that the public health and the research communities can participate in the standards development process as well. There, we earmarked about $4 million.
I should mention also that we have included in here some work on maintenance of clinical vocabularies that would be needed for PMRI information and so on. NLM will be helping us to develop that proposal further.
I will go through the others quickly. Number five was the idea of states as laboratories. Here, we would, with sufficient funding, would fund some demonstrations of state level efforts that apply informatics and integrated information systems approaches to link and analytically integrate data from multiple sources -- public health, welfare, health care delivery system and so on, as well as administrative data and population-based data. We will have to see how many demonstration projects we could actually fund, but at any rate, this would look at the states where there has been some good work in this area as laboratories and what can we learn from them and how could we support that further.
The sixth area would be the whole issue of integrating Health and Human Services information. Here, a number of the programs and issues in health, as you all know, are both health issues, income maintenance and social issues as well. In fact, we in this department have programs that are highly interrelated. The data systems, unfortunately, have developed somewhat separately. We have a very good array of surveys in the public health area and the health area. We do not have as much in the human services side; there is a reliance largely upon one of the Census Bureau surveys. I think here, we would like to see the extent to which we can integrate some of the content, at least, in the human services and the health area.
Number seven, as you know, we have had a group under the Data Council looking at what kinds of data are needed currently and in the future on the health system, health providers and on health plans. We have been working with a number of the groups represented in the audience today to see if we could develop partnerships in terms of meeting some of these needs in the future. I think here we would -- those recommendations, our working group is more or less finishing its recommendations. They will present those to our Data Council probably in March. This part of the initiative would provide some funding to go forward on some of those initiatives.
Let me quickly finish eight and nine. Number eight I have talked to you previously about. This involves HHS participating in a White House initiative to improve the measurement and tracking of race discrimination in health care. HHS is responsible for the health care sector of the economy. There are four other sectors that other departments are asked to look at including housing, education, criminal justice, and so on.
We currently have underway a literature review by Tom Lovice(?), a former member of this committee, who is looking at what have people looked at previously in the literature in terms of identifying and measuring race discrimination in health care, what are the sources of data. We should be coming forward with a report probably in May or June that will provide kind of a state of the art of what the measurement is here now. Based on that and based on other deliberations, we have reserved some money, about half a million dollars in 2001 to begin to implement some of those ideas.
Finally, number nine, this whole initiative started out with a concept of -- at least partially with the idea of is there a way that we could take all of the various surveillance systems that we have and begin to unify them or at least integrate them or at least coordinate them and building upon the capabilities of the internet. That manifested itself as both -- CDC has a major component dealing with the National Electronic Surveillance System, which is their part of the initiative and their agency budget. Here, we were trying to look at some seed money and planning money so that we could look at the surveillance activities, look at the extent to which they could be make electronic, web-based, and unify them in terms of analysis and availability of data for risk assessment, including FDA, CDC and HRSA.
At any rate, those are the nine cross-cutting components of the initiative. We keep our fingers crossed now in terms of what will happen with the 2001 budget. There was a lot of support in OMB and the leadership here in HHS for moving forward on this. I think we actually did reasonably well in terms of getting $20 million for cross-cutting investments. Most agencies, actually, did quite well as well.
Let me say a few quick words about race/ethnicity. The second document you have at your place is the report of our HHS working group on race/ethnicity data. This is a working group of the Data Council. You have had a briefing by Tony DeAngelo, I believe, in December, a preview, basically, of what the recommendations might look like. The work group provided its recommendations to the Data Council last week. There are about three dozen individual recommendations, but there are about ten that are viewed as priority in the executive summary. We are now having the members of the Data Council look through the various recommendations and see which ones we might focus on in terms of three to five that we could focus on this year to actually push forward. That process of prioritization is underway right now, but we would appreciate the views of the full committee, obviously, on some of the directions as well. They range everywhere from kind of a ten-year, specific plan about what each survey in our portfolio -- what information it would collect on what race/ethnicity groups over a five- to ten-year period, to investments in training and data availability and so on. We would appreciate any feedback from the full committee on that as well.
One more thing. I will just announce today that I think later today, the National Research Council will be releasing its report dealing with the next generation internet and what the requirements are for health. Ted Shortliff(?), I mentioned, was the chair of this panel. They finished their work, and we probably will want to have the NRC come over here and brief the full committee at a later meeting. Ted Shortliff gave us a preview of what the NRC was thinking about and some roles for HHS as well as some of the technical and policy requirements if the health area is to achieve the full benefits of the internet and the global information infrastructure. Ted's preview was actually quite helpful. They will be releasing that report today. Again, as I say, we will probably want to have them come to the full committee and brief us on that. The report will be available, I understand, later this afternoon, so we will try to get copies for everyone.
I think I will stop there.
DR. LUMPKIN: Any questions? Dan?
DR. FRIEDMAN: Jim, just a couple of comments on the informatics initiative, which I think overall is really excellent. It is terrific to see HHS going in this direction. First of all, it strikes me that different countries have really taken the leadership in different areas around health informatics. Clearly, Australia is way ahead of us in terms of the national health information model. The Canadians and particularly Manitoba have put together a really good dictionary that sort of drills down from concept to operation to even SASS(?) code. I think that we, and certainly a lot of the states, have done very good work in internet-based interactive health information services.
I think one area that would be extremely helpful for us to go in, both for this country and also internationally, would really be to try to integrate those three schemes that really have not been done -- the internet-based, interactive information services, the health information model, and the dictionaries. If we could put those together, that would really be very powerful.
Second, it also strikes me that this would be -- this kind of a rubric would be really helpful for starting to think in terms of funding some components of a National Health Information Infrastructure pilots and trying to think perhaps explicitly in those terms, and particularly around, for example, the community health dimension. Third, and you probably know this, but just in case you do not. Maternal and Child Health Bureau have just led an RFP to fund porting some existing internet -- state-based internet interactive information systems to other states.
DR. SCANLON: That is what we will be looking for, I think, any good models from the states, for example, actually your state as well, Missouri, Illinois and other states. We have set aside some of the money. Again, we are crossing our fingers that we will get some of this funding because it provides room for growth where we can actually move in these areas. Otherwise, it is very difficult. I think we can certainly move in that direction.
DR. COHN: Jim, thank you very much for the briefing. I just want to compliment you and the Secretary on what I think is a very important initiative, this health care informatics activity.
I think my one question or at least area of concern is, given what is really a very large scope of activity, I am concerned with the amount of money that you are appropriating or requesting seems to be very small. I say it nicely. Is this intended to be the first year of a multi-year effort where you will be requesting significant additional funding in future years? Or do you intend to make significant progress on all of these fronts with $20 million in the first year?
DR. SCANLON: Good questions. Good questions. I think the chances are -- again, this is the first time that we have tried this. As I guess I should have mentioned, the $20 million, I guess where we ended up is probably about $120 million total. If you count the NLM investments, the CDC investments, the OCK-FER(?) investments. ARC(?), for example, has a proposal for informatics. I am forgetting what the amount is, but I think it is around $10 million in the same budget. If you look at what the agency parts of the contribution is as well as the total, I am guessing it would -- we did not do the final tally as to how things ended up, but it is probably a little over $100 million. That is the totality of the initiative, although obviously, I am going to be on focusing on the $20 million cross-cutting.
In terms of years out, we would clearly like to get this established, and then we could look at what we -- part of the work in this first year, I think, would be looking at sort of what the alternatives are, what the design alternatives are, and to sort of make estimates of what it would take to really make an impact here. That would help us, I think, Simon, for the second year and the third year.
In terms of budget strategy, when we get to the out years, we could ask agencies such as HOM or OCK-FER to include in their budgets some of the work to proceed, or we could continue the cross-cutting part of it as well. This $20 million initially would be housed in the Office of the Secretary. In our office, ASPE, we would work closely with our Chief Information Officer and a lot of other folks in actually awarding the money or moving the money around and so on. It is really kind of experimental, and we have not done any -- we have had data initiatives in the past where we got together as a group at HHS and decided what we would like to make some headway in. Often, those dealt with data gaps, for example.
We have had a $40 million initiative about two years ago. We have had other initiatives as well. Typically, they have received a lot of support at the HHS level and the OMB level but at the Congressional level, it is not that there is not interest, it is just that they are dealing there with overall amounts. When targets are given, some things fall out just because they are new. The preference is usually given to those things that are continuations. Again, we have gone as far now as an actual proposal in the President's budget. Hopefully, it will be positively received, and then we will go from there.
DR. LUMPKIN: Jim, I have a couple kind of rounded into questions and concerns. My experience with the budgetary process is usually the further you are away from an actual program, the less likely you are to get -- for people to understand it. Your comment that really you are looking at an initiative in excess of $100 million when you are looking at what is happening in the various components of HHS.
A lot of my concern and others' has been that there is all of this stuff going out in all of these sort of directions, and to what extent can the Data Council play a role in trying to coordinate these initiatives so that it actually is over $100 million worth of impact? That is just one of the concerns, and I think this committee would be very interested in participating in monitoring that process.
The second concern I have is how will we know that process has been successful? The ability to fund in the out years is going to be dependent upon whether or not Congress, OMB and the new administration that comes in will say, "We spent this money. What did we get from it?" I think that we have to look very closely and very carefully at the metrics of this particular endeavor. I suspect that it would be very useful for this committee to have, at each of our meetings, an update of how the project is going, some of the metrics, so that we can use this as a forum to get some visibility of what I expect and hope will be the successes of this program.
DR. SCANLON: Under the Data Council, we are pulling together again the work group that pretty much included all of the agencies to begin moving on this. They will be updating the Data Council periodically and bringing issues there in terms of what are their choices of direction. We will at least have a structure to begin with in terms of a working group of all of the agencies involved under the Data Council. You are right in terms of success, how would we know, what are the specifics, how would we actually measure whether we have been successful. We could use your help.
DR. NEWACHECK: Jim, can you comment briefly on how the National Center for Health Statistics has fared so far in the budget process and whether there are any new major data initiatives?
DR. SCANLON: In the addressing data gaps area, when we started out on the initiative, the NCHS really was the bulk of that aspect of the initiative. I know initiatives were planned on race/ethnicity data on a special, what is called Defined Population HANES, which I will tell you a little more about. Looking at addressing data gaps in terms of special populations, geographic data, and the other area was provider data, we really need to relook at what we are collecting, and how we are collecting it, and where we are all heading there. There were a couple of other areas as well.
The NCHS -- Marjorie, you may remember better than I do, but they did not get -- NCHS did not end up with a very large increase in the 2001 budget. It is roughly $5 million to $8 million. That is clearly very positive, but in terms of the need, I think we were all a little disappointed in terms of really making some headway in some of these areas of data gaps. We can use some of this initiative for some of these areas, particularly the health care system data. For some of the others, we were really relying on NCHS as the designated statistics agency to be able to make some headway. There is some increase, but it was not nearly as big as we were hoping. Marjorie, you probably know more about the budget, the details of the budget, but I think that is the one area where we all feel a little -- we were not able to make as much progress as we wanted.
DR. LUMPKIN: Thank you. John.
DR. FANNING: Good morning. I am not going to cover the Privacy NPRM. Dr. Braithwaite will cover that.
[Laughter.]
I wanted to call to the attention of the committee, though, a study that the Agency for Healthcare Research and Quality and our office have funded. We have asked the Institute of Medicine to do a study of current practices followed by IRBs in safeguarding the confidentiality of identifiable information used for health services research purposes. It is focused principally on the use of existing data for research.
As we know, there is no shortage of principles for the protection of information, but we need constant attention to the practices and everyday practicalities of protecting information. This study is intended to find out what is going on, do some evaluation of what is going on, and possibly identify some of the best practices. Their committee includes Lisa Iezonni of our committee here. They have asked, they have put out a notice on their website which Dr. Fitzmaurice will describe, which asks people to feed in information on what is in fact going on. The website has a very long address, but you can find out about this project if you go to www4.NAS.edu and then look in their project system for project HCSX-H-99-07-A. Dr. Fitzmaurice, I think, will talk a little bit about the paper that he has just circulated in which the project asks for input from whoever cares to give input.
DR. FITZMAURICE: I will just take a brief minute, hopefully less than a minute. What has passed around is an exchange between Lee Zwanziger(?), the principle investigator there, and myself and John Fanning. Lee sent around a public call for information. You see in front of you the nine questions she wants the public to respond to. As soon as we received this, John beat me to her by one minute and said, "Can you tell me about the public dissemination? We want the public to know about this as much as possible. Can we also present this to the national committee?" She said yes, so you have here the call for information. You can dial up their web number and put in answers to those questions.
On the back of the page that I handed out, you see the web address. As John said, it is very long. It is complicated, but it is there so that you can key it in or start keying it in and make choices once you get to the website. There will be a -- not a working meeting, a workshop to be held in March. This is moving very rapidly.
The intention of the Office of the Secretary and the Agency for Healthcare Research and Quality is to find out what the best practices are, get some of the best thinking on this, and get a report out to help guide IRBs, to help guide researchers both federally funded and privately funded, to do the best thing in protecting individually-identifiable healthcare information when used for research. So, there is a lot of speed on this. We expect it out before the end of the summer. That should be good timing whether there is a privacy law passed, whether there is a privacy regulation out in final form, or whether it serves to help inform the debate about researchers and the use of information.
DR. LUMPKIN: Is that group meeting today?
DR. FITZMAURICE: I beg your pardon?
DR. LUMPKIN: Is that IOM group meeting today? This work group?
DR. FITZMAURICE: Oh, no. That meeting will be scheduled sometime in the middle of March, the 13th, 14th or 15th.
DR. FANNING: I think it is scheduled for the 13th and 14th. The website will tell you who to call to come get admitted to the meeting.
DR. LUMPKIN: Any other questions? John?
DR. FANNING: That is all I have.
DR. LUMPKIN: Okay. Bill.
DR. BRAITHWAITE: Okay, I am going to get you up to date on the administrative simplification transactions and the regulatory process for putting those into effect.
As you know, we have issued five NPRMs at this point. We have a few of those where we have had a chance to respond to the comments that we received and we have final regulations that are in the clearance process. By the time this committee meets again, hopefully, we will have several of those published and in effect.
The transaction and coats-head(?) regulation, as I have told you before, is the one that we are putting our resources into to get out first. That is in the clearance process, and I am hoping to get that out and published in the next couple of months.
The development that some of you may not know about in that area is that one of the difficulties of adopting private sector regulations or private sector standards, rather, in regulation is that we do not have a control over or sort of oversight over the process of maintaining those standards. If we mandate that those people in the industry who are going to do electronic transactions of this type use these standards, we were instructed to insure that was a sort of consistent, public, open process for maintaining those standards over time.
After a lot of false starts, we ended up helping to negotiate a memorandum of understanding between the six standard maintenance organizations, the data content committees as they are called, the National Uniform Billing Committee, the National Uniform Claims Committee, the NCPDP and the American Dental Association, and the standards developing organizations, and some of these are mentioned twice because they are crossovers. They do both: HL-7, X-12, NCPDP and the American Dental Association.
We end up with six different organizations who have all agreed to, either have signed or will have agreed to sign in principle a memorandum of understanding where they all cooperate together, they work together, they produce a consistent, single website as the way they present to the public what is going on in standards development in support of these HIPAA standards that we have adopted a single place for the public to put data maintenance requests into the hopper. I am very pleased with that development, and I am hoping to celebrate it at the end of March meeting of the Standards Committee by having a signing celebration. We will bring in each of the groups to tell us about their part in it, and we will get them all to sign the MOU in public and sort of make it an event because it really is an event. Although they have cooperated in the sense informally before in coming up with the standards that we have adopted, this is really the first formal arrangement for this set of voluntary organizations to come together and come up with a consistent mechanism for maintaining the standards that the industry is going to become very dependent upon.
We have -- the employer identifier rule is also in clearance, and presumably we will come out at the same time or shortly thereafter with the transaction standard. The privacy rule, as you know, the NPRM went out in November. The comment period for the privacy proposed rule closed on February 17th at midnight, even though we still ended up getting a few comments that were dated after that time. As you know, those comments will not be opened, which is too bad that those did not get to the post office on or before the 17th. We did get about 10,000 comments over the web and over 40,000 pieces of paper. I distinguish those because on the web, you cannot tell how many comments each person made. On paper, we know how many pieces of paper we got approximately, but each piece of paper may make one comment or 100 comments. We got one comment, I think, that was 450 pages long, including the attachments, several others in the 100 page range.
It is going to be quite a job. We, in fact, have set up teams of people who are going through those comments one by one, reading every one. We will be organizing them, summarizing them, and responding to them before we come out with a privacy final rule. No target date for the final rule has been set at this point. That date is unknown, but we are going to work through the process as quickly as we can without lowering the quality of our interpretation and analysis of the comments.
We have a couple of other NPRMs in process. The claims attachment one is in the clearance process and that, too, will follow the transaction rule as soon as we can get it out. There is quite a backup of things to do in this area, and we are working very hard to put them forward.
I will mention once again, just because we had some comments to this effect that came in as part of a privacy comment period, that the Congressional mandate that we set a standard for individual identifiers is on hold. It has been on hold since the Vice President said we were not going to do it. I think it was in July of 1988. Congress has once again put in our budget for this year a statement that says we cannot use any of our budget to adopt a final rule in that area unless they approve one, which is pretty unlikely until we sort of get privacy final rules out and protections in place.
All of the other transactions, all of the other standards that we have talked about are still moving along in the process, and we are making progress. Questions?
DR. BLAIR: Dr. Braithwaite, would you be able to bring us up to date on the status of the electronic signature piece? I think that you had mentioned to us in a previous standard subcommittee meeting that that may be separated and may not be included with the final regulations? I was wondering if you could give us an update on that and help us understand what the thinking was behind that.
DR. BRAITHWAITE: We had included some basic criteria for an electronic signature standard in our NPRM on security and electronic signatures but were unable to propose a specific electronic signature standard. The field was moving very quickly. We were instructed to cooperate with the Commerce Department on that in coming up with a standard of sorts. Our interactions with the Commerce Department and with this rapidly-changing field led us to believe that it would be better to wait a little bit in coming up with a final standard for electronic signatures until the industry had matured a bit further and the Commerce Department had had a chance to do a little more work on setting standards for commerce in general.
There is no reason why healthcare should have something different from other areas that require electronic signatures. We were hoping by setting sort of general criteria that needed to be met so that it would meet the needs of health care that it would stimulate the development in general of electronic signature standards along the lines that we could then adopt as a health care standard without having to do anything special for health care. That seems to be happening, but it is not ready, in our opinion, for adoption as a final rule, a final standard for healthcare. I do not know when that will happen, but I will certainly let you know, and we will publish it when it is ready.
DR. GELLMAN: I want to try to nail down this issue of how many comments you got on the privacy regs. Could you be more specific? I have heard various numbers bandied about. Could you help?
DR. BLAIR: No.
DR. GELLMAN: No?
DR. BLAIR: I can tell you that we are still opening envelopes and serial stamping every piece of paper that comes into the mailroom, so we are not finished counting yet. I cannot be much more specific than that. We have a little stamping machine, and every comment that comes in on a piece of paper gets a serial number, gets registered in the database, and then analysts have to look at each piece of paper to figure out how many different areas are commented on by each of those pieces of paper, and that is going to take some time.
DR. GELLMAN: What is the number on the stamper?
DR. BLAIR: The number on the stamper at the moment I do not know exactly because they are stamping as we speak.
DR. GELLMAN: What was the last number you saw?
DR. BLAIR: The last number I saw was 200,000 -- I do not remember, Bob, exactly. We started at 200,000, so I know it is above that.
DR. GELLMAN: All right.
DR. LUMPKIN: Just a question. When you give us a count, it is going to be the number of -- let's say I send a letter or we sent a letter, and there were a lot of individual comments. That would not count as one comment when all of the process is done? That would be as many sections as commented on? I am trying to get a feel for it, and I do not think it matters; it just helps us understand the numbers that we get.
DR. BLAIR: Typically, the way that it has been done in the past, is that we give a count of the -- where we can, the number of people who have commented and the number of comments that were made, where a comment refers to a specific suggestion or comment on a specific area of the NPRM that we sort of isolate and then gather together and summarize for purposes of publishing the final rule. Just guessing from my scanning of the input that we have seen, the majority of them have three. I can tell you that.
DR. FYFFE: When you say "pieces of paper," you are not being literal? You are talking about pieces of correspondence?
DR. BRAITHWAITE: Pieces of correspondence, yes. Some of them have 100 pages, but most of them only have one.
DR. FYFFE: There are at least 40,000.
DR. BRAITHWAITE: At least 40,000 pieces of correspondence.
DR. FYFFE: Correspondence on hard copy.
DR. BRAITHWAITE: On hard copy.
DR. FYFFE: It is unknown. It is several thousand via the web, 10,000 I think you said.
DR. BRAITHWAITE: It is slightly -- my best understanding is that it is somewhere between 8,000 and 10,000 on the web, and we will get a final count in the next day or two.
DR. FYFFE: Thank you, Bill.
DR. BRAITHWAITE: There are some test comments and some other reasons why I do not have an exact number on that yet.
DR. NEWACHECK: Just a question. Once you have categorized all of these comments and summarized them, can you tell us a little bit more about the process that you will use to address those comments or how they will be -- that is which ones will be accepted, which ones will be rejected, and how you will deal with that process?
DR. BRAITHWAITE: We do not reject any comments unless they come in after the close of the comment period. We accept every single comment that comes in to the appropriate address. As we said in the NPRM, we did not accept fax comments. We did not accept telephone calls. We needed documentation that we could rely on for those comments. Anything that came in that was addressed to the address or one of the addresses in the NPRM was accepted, will be read and analyzed by the analysts.
DR. NEWACHECK: I guess my question is what happens next after they are read and analyzed by the analysts?
DR. BRAITHWAITE: Then we start gathering them together so that we put like comments together. If there were 300 people who commented on a particular aspect of the NPRM, then we gather those together, and we have an analyst who then writes a summary of what that comment was. We include that summary and a response to that summary in the final rule.
DR. LUMPKIN: That response can be, "Yeah, that is a great idea, we should have put it in," or "Gee, it is a thoughtful thing, but we disagree, and so we are going to..."
DR. BRAITHWAITE: It is more than that, John. It is not just that we do not like it or something like that. We look at the rationale of the comment, what the impact of what they are proposing as opposed to what we proposed, and we come up with a rationale for why we either accept the comment and change the final rule or reject the comment conceptually and say here is the rationale why we chose to keep what we originally decided, or some other compromise which allows us to meet our expectations for the final rule and meet the needs or the complaints of the commenter.
DR. LUMPKIN: Kathy?
DR. FYFFE: I do not remember the inventory number, but in the preamble to the proposed rules for privacy, there were many, many requests for comment from the public on a number of issues. Were there about 50 or 70 or 100 of those questions?
DR. BRAITHWAITE: Well over 100 questions.
DR. FYFFE: Well over 100, okay. I would imagine that in the final rules that you will have to say something about each one of those, would you not?
DR. BRAITHWAITE: Certainly every one of those where we received any comment. There will be a summary of the comments that we got and what we decided to do with them and why.
DR. FYFFE: Okay, thank you.
DR. LUMPKIN: Simon.
DR. COHN: I think the amount of comment that you received sounds overwhelming, and I hope that you have a large staff to help assist you with this task of going through them. I had perhaps a little more mundane question which is that I think we all recognize that the privacy final rule and the security final rule need to be in sync, and I think we have all observed that. I was just curious on how the massive amount of public comment that you have received on the privacy NPRM is going to affect the publication of the security NPRM.
DR. BRAITHWAITE: I do not know yet, Simon. People are looking at that right now. There are three levels of interaction that I can see between privacy and security. Conceptually, they are very different. One is the implementation of usually technology, which enables you to enact, in an organization, a policy based on the privacy. So, privacy is the basis for decisions made by the organization, and security is the mechanisms by which you implement those decisions.
Now, it would be easy to say, you know, there is a line between them, and we can put out the mechanisms without knowing what policies you are going to implement, and vice-versa. It is not quite so simple because there is overlap in terms of requirements. For example, the security rule requires that you identify someone who is going to be in charge of security. In a one-person shop, it is clear who that is going to be. In a large organization, it might be a committee of people. The security proposal is that there also be someone identified who takes charge of the privacy policies. The privacy rule deals with a person with that responsibility. The questions arise, can this be the same person? or the same committee? or what is the relationship between the two? There is some interaction like that that we have to at least consider.
The answers do not have to be in the security final rule. We could put out a security final rule that left room for whatever answer we come up with in the privacy final rule. We just do not want to put something out in the security final rule that is contrary to either the privacy proposal or some basic expectation for what the variation on that might be when it comes out in final.
Also, there was some additional thinking done by the Office of General Council between the time the security NPRM was published and the time the privacy NPRM was published. There are some minor -- well, some might not think they are minor, but there are some differences in the proposed interpretation of the law, the definitions, that sort of thing, that have to be harmonized between those two. It would not make any sense for us to come out with an NPRM and then come out with a final rule that contradicts even what we have proposed for ourselves. So, we are in the process of harmonizing those. Whether or not we have to wait for more comment analysis or wait for a final rule on privacy before security can be pushed forward has not been made. I do not know where that is going to turn out.
DR. LUMPKIN: Kepa, and then we will have to move on.
DR. ZUBELDIA: Following up on Simon's question on the harmonization between security and privacy, I am concerned that the delaying of the security final rule until there is this harmonization with privacy could be detrimental to the actual implementation of the transaction final rule because we will end up with a period of time where we have a standard for the transactions, and there is no standard for privacy, for security yet. Would it be possible to come out with a security final rule even if some parts are not harmonized, and when the privacy final rule comes up, replace those paragraphs or sections that came out in the security final rule that were maybe incorrect or incomplete, and just overlay additional information on those sections based on the privacy final rule?
DR. BRAITHWAITE: There is no legal reason why that cannot be done. One final rule is constantly going back and fixing up what was put in the CFR in a previous final rule, so there is nothing that prevents us from doing that. I do not get to make the decisions.
DR. ZUBELDIA: I have another question, and that is why I raised my hand first. Out of the 40,000 paper comments that developed, do you have an idea how many of them are a form letter of some sort?
DR. BRAITHWAITE: A large majority of them are form letters. I do not know exactly how many yet. I know there was one form letter that had tens of thousands of copies of it from different individuals, but there were many other form letters as well that were not as easily identifiable. I am not sure yet.
DR. LUMPKIN: Okay, go ahead, Mike.
DR. FITZMAURICE: One last question, and that is, in doing the transaction standards, the privacy standards, security standards and the enforcement standards, there is a lot of activity within the government. A lot of talented and expert people are getting around the panels to put out the NPRMs and then to put out the final rules. Then once the final rules are put out, in many cases, the government has to do something like to support production of identifier, the enumeration of identifier. In the past, it has been reported to this committee that this has been done without any additional resources being given to HHS in support of HIPAA. To the best of your knowledge, is that still the case? Have there been any appropriated funds to help support HIPAA, or is it likely to -- one, and secondly, is this likely to present a constraint either on the timing or the quality of what is produced in response to HIPAA for administrative simplification?
DR. BRAITHWAITE: It is true, Mike, that we did not receive any appropriation for this effort, and that is still true. I think it is more complicated than, "well, we did not get any money." We did not get any money to produce the rules. We also did not get any money to implement either the rules or the results of the rules. That is, the rule for transactions, for example, sets standards for the health care industry for the exchange of administrative information between health plans and providers and clearing houses, but the government, HHS in particular, has an organization called HCFA that is listed as a health plan in that case of legislation. So, not only do we produce the rules but then an element of our organization has to implement them. They do not get any additional funds for that either.
We have been telling the people in the private sector, at least, that yes, we are not paying you to implement these standards. You asked for them. Here they are. Be careful what you ask for, but you got it, so now implement it, with the expectation that when they came to us and said that they would save multiple billions of dollars per year by implementing these standards that they were correct. We expect that implementing these same standards within the government programs will save them money in the long run as well. So, they are not getting appropriations just like the private sector is not getting appropriations for implementing these things.
Now, for those elements like identifiers where the government is expected to either produce or arrange for or contract for or something, provide the resources in some way for a system that would assign identifiers to providers and plans so that they can participate in this, that is kind of still partially up in the air. Exactly what funds are going to be used for that and how we can manage it is a major legal and resource question that we have not answered yet, which is part of the explanation for the delay in getting those rules out.
DR. LUMPKIN: Thank you. We are really behind. Karen, you might want to just mention that -- you probably want to make a comment about why you are sitting at the table. No? Okay.
DR. TRUDEL: No, actually, I just wanted to clarify Bill's statement about budget and appropriations. It is absolutely correct that we got no additional administrative resources or personnel to implement these provisions, but we have been requesting budget funding so that our carriers and fiscal intermediaries can implement these provisions.
DR. LUMPKIN: Okay, great. Gary is not here. For those of you who do not know, people who are in administrative positions within agencies generally expect all information technology problems to be resolved, and those who have the lead responsibility for those may not make it to our meeting if they have other conflicting requirements by people higher up than them in their organizations, so Gary could not make it, and we are pleased to have Karen here today.
While I am explaining that, we are going to move on to the next item on the agenda. Lisa will be in and out. She has, I think, an Institute of Medicine meeting on the other side of town. She is going to try to be in two places at once, so she asked me to convey that.
The next item on our agenda is our annual HIPAA report. Simon.
DR. COHN: John, thank you. I wanted to give sort of an introduction to the third annual report to Congress, and hopefully we have Jim Scanlon here. He came back, good, because I understand we look forward to your great assistance with this document.
First of all, I think I do want to apologize to the committee. I think we have strived very hard to get this out in advance so that everyone could take a look at this. Unfortunately, because of the timing and the need to produce the packets, I think most of you probably saw this on your desks on Friday, at least I did. I think I want to apologize for our subcommittee in that we have produced 40 pages of annual report plus another 50 pages of CPRR(?) work group recommendations, all for you to look over the weekend and Monday before you came here. We do understand if you have not thoroughly digested every aspect of the annual report.
Just to remind you, last year, we started -- we produced the annual report in February. There was a desire to have additional comments, and therefore, the final report was delayed until June. What we are trying to do is to get back on the February schedule though the committee does have a choice based on our comments and input from all of you, which we will decide tomorrow about whether we approve the document without change or minor modifications, approve it with modifications going to the executive committee, or go back and revise it and bring it back in June. The committee once again, I think, would open this to additional comments as was the case last year.
I want to just walk through sort of the table of contents for a second and then sort of open it up for comments, questions, additions, changes or otherwise. If you have comments about wordsmithing, which actually I also have a couple of comments about wordsmithing, we would ask that you keep them relatively high level, and we will certainly in the executive summary area attempt to tighten things up. What I would, however, direct your attention to is the table of contents. This is pretty much in keeping with previous annual reports in the sense that we start with an introduction, the background, the purpose and content of the report, and the statutory requirements. Then we are commenting on the implementation process which includes the overall implementation strategy; guiding principles; private sector consultations; the hearings that we have held over the last year which we are -- because privacy is a notice of proposed rule making, we are obviously including privacy related hearings in that; outreach to public health and health services research; just a comment about our comments on various NPRMs; and then our liaison role with HHS.
We are also obviously observing progress to date on the various notices of proposed rule. Recognize that we do not have the final rules yet. We are also obviously commenting at least on the proposed dates from the Secretary for the publication of the final rules.
Finally, Section 4, which is implementation issues, we sort of took this as sort of the center of the report or sort of, at least in our view, what sort of needed to be communicated this year. As we prepare for implementation, that there are obviously a whole lot of issues regarding assessing industry readiness, monitoring implementation, issues of security and how we will follow that, how we go about identifying and resolving standards implementation issues, enforcement issues, learning from early implementers and identifying the need for new and revised standards.
I think I will open it at this point. This is effectively the report, and at least the slant that Jim Scanlon and I and the subcommittee took and present for your consideration. Now, I do want comments on this. There are a couple of other issues that we did not address that I do want to bring up to see what the wishes of the committee are in terms of additional comments on a couple of things, but I think it makes sense first of all just to open it up for any comments or discussion.
Has anybody read it?
PARTICIPANT: [Comment off microphone.]
DR. COHN: Well, I think we want a decision tomorrow. As I said, there are three choices: approval, approval with modifications to be handled by the executive committee, or go back and revise and bring back in June. I think we have three choices. We will make some decision tomorrow based upon input and sense of the committee on this.
DR. LUMPKIN: Are there any?
DR. COHN: This was an exciting report, was it not?
DR. SCANLON: Simon, we might -- there are different components of the report, as all of you remember. Part of it is just simply restating for the record what the actual requirements are of HIPAA and of the law. Secondly, there is a requirement to report on the actual status of the implementation of the standard, so part of the report takes you up to I guess the end of December in terms of where each of the proposed rules stands and some projected dates as well. These are the dates that are on the website as well. Then, as Simon said, there is a look ahead to thinking about the implementation.
Remember, now, there is still a 24-month wrap-up period after the publication of any of the final rules where full compliance would have to be shown. So again, we are at the stage where we are preparing for implementation though everyone is clearly seeing what the standards are going to be, but the committee then looks ahead to about seven issues relating to the process up to now and what issues maybe the committee would want to focus on in the 12 months ahead, preparing for implementation, readiness and so on. That is the basic structure. There is a seven-page executive summary where that is capsulized, and then there is a full 25 pages where the detail is provided.
This would be accompanied by a transmittal letter from the chairman which would be largely a simple transmittal letter, no editorial or commentary most likely unless the committee wanted it. You would have to vote on that as well.
DR. COHN: I have some issues that I want to bring up, but I wanted a sense from the committee of any thoughts they have had so far.
DR. GELLMAN: I just have a procedural question. What is the statutory reporting requirement? What does it say? Are you supposed to report every year on this subject?
DR. SCANLON: Yes, it says not later than one year after enactment of HIPAA and annually thereafter the committee shall submit to the Congress.
DR. GELLMAN: Is this reporting requirement subject to the Reports Elimination Act, and will it terminate at some point?
DR. SCANLON: Since it is in here, it would have to be specifically deleted. You would need a change to remove it, I suppose.
DR. GELLMAN: I thought the -- I am not really sure of this, but I thought the Reports Elimination Act worked that if it was not reenacted after a certain point, the requirement terminated.
DR. SCANLON: I do not know. We usually have to seek -- at NHHS, we usually have to seek authority to end the requirement.
DR. GELLMAN: This was an across the board attempt to end all of this. Anyway, I am just curious about it. We do not need to go into it here. I think it is probably worth a look at this requirement. If my understanding of the law is right, and I would not put a whole lot of stock in it because I have not looked at it lately, this reporting requirement may terminate at some point in the near future.
DR. COHN: Can I make a comment. Actually, obviously not being a lawyer, I cannot comment on that particular law, but I would observe that since we have not even gotten into implementation yet, it probably is premature to terminate the annual reports on implementation.
DR. LUMPKIN: So we would probably want to do this anyway.
DR. COHN: Yes, I would think that this would be part of our charge in terms of helping to shepherd the HIPAA administrative simplification transactions and standards, move those forward.
Other comments before I move on?
DR. LUMPKIN: I see none.
` DR. COHN: Let me bring up a couple of issues. I think Jim Scanlon really took the lead in terms of helping us prepare this. It obviously has been prepared by the subcommittee. There were a couple of -- well, as I am looking at this, I would observe first of all that there is relatively large elephant that sits sort of in the middle of this report that we are not commenting on. I am curious about whether we as a committee want to make any comments about this. That is, quite frankly, that the publication of the final rules has been delayed for two years and whether there is a need to respectively call on the Secretary to help expedite the implementation of the final -- publication and implementation of the final rules.
I bring that up as an issue. It is not covered currently in the report. This is not a funding issue, though. A funding issue will be another issue that I will bring up in terms of how we may want to handle that. Is it appropriate at this point for us to respectfully call on the Secretary for prompt publication of these. Do not all raise your hands at once.
DR. GELLMAN: I will offer a comment on that.
DR. COHN: Please.
DR. GELLMAN: I have not detected any evidence that the Secretary or that the department is dragging its feet in this process. It is just taking a lot longer. So, I do not see any reason to criticize anybody. I do not know what they could do that would shorten the process. They have all of the comments to review. I think they have gone about it in a perfectly legitimate way. It is just time estimates, as always, were way off and how much effort would be involved in doing this stuff. So, I do not see any reason to criticize anybody here.
DR. LUMPKIN: I think further, at least it has been my experience, that this has been a very open process. I think it is one of the most open rule making processes that I have seen in a long time. I think that adds to the length.
DR. COHN: Yes. No, I have no complaints, and I do not think that anyone has any complaints about the open or collaborative process. I think it is just concern as increasing pressures on HHS mount, which most recently the privacy notice of proposed rule that there is obviously always the risk of further delays.
DR. ZUBELDIA: I think the whole HIPAA process is losing steam in the face of the industry. I would like to see at least the standards final rule out immediately. From the feedback that I have been getting from the insurance companies, they are saying, well, they have not passed the final rules yet, so we are not going to do anything until there is a final rule, if there is a final rule. Now the "if" question is starting to come up again. It came up a couple of years ago. There are some people who believe that the whole thing will be delayed until privacy is in place. That may be a couple of years. I think that is the wrong message, and I would like to see at least the standards final rule for standards and causes out as soon as possible.
DR. COLTIN: I just have one comment. I noticed as I was going through it, I had an expectation that I would find more detail in the full part of the report than I did in the executive summary. In some areas, there was actually more information in the executive summary than there was in the full report. In particular, just one example is around identifying the need for new and revised standards. In the implementation section, I wonder if you want to at least include in the full report as much information as you had in the executive summary.
DR. COHN: Thank you.
DR. GELLMAN: That is what most people read.
DR. LUMPKIN: Yes, Barbara.
DR. STARFIELD: Can we have a sense of the committee on what Kepa said because I think that is sort of a major issue. We want to make some suggestions, if there are any, by tomorrow. That would be useful to know. I personally think that Kepa is right.
DR. LUMPKIN: Other comments? I suspect the issue, it is certainly the fact that there is that discussion that is real. The question is what should we as a committee do to respond, whether or not there is a role or a utility for us commenting on the importance of maintaining the momentum. I guess that is the issue. I would suspect that it would not be in the letter to Congress. I mean in a report to Congress. If we are concerned about that, since we are advisory to the Secretary, it would seem to me that in all fairness, we would advise the Secretary that we are concerned before we put it in a report to Congress.
DR. STARFIELD: I guess I do not see the rationale because the pressure works both ways.
DR. ZUBELDIA: Let me give my view on that. If the report to Congress goes out now, in February, I think it would be effective to say that in the report to Congress. We need their help in pushing this through other departments. The clearance process is not just the Secretary domain. There are other departments that are involved that can drag it for a long time. It need to be expedited, and Congress has certain ways of expediting things in that area. If the report goes out in June, there is probably no need to put anything because I hope there would be some action before then.
DR. LUMPKIN: I think that is a good point. Let me just sort of follow up on my comment. I can just tell you, because in Illinois, we have about 50 advisory committees to our agency. I know that I would consider it courtesy if the various committees that reported to -- that are advisory to me would let me know that there is an issue before they went to the legislature because nothing is worse than going before a hearing and having a totally unrelated issue that I have not heard about get raised by a legislative committee. Usually, that leads to the chief executive of that agency coming back and saying, "Who is this committee, and what are they doing?" I am not sure that we want to have that sort of relationship with the Secretary.
DR. STARFIELD: Are there any barriers to telling the Secretary?
DR. LUMPKIN: No. I think if there is concern, it would be appropriate for us to send a letter to the Secretary saying we are concerned. I think that would be the first step. That was my only comment.
DR. COHN: Sure.
DR. LUMPKIN: That we should send it to the Secretary first. Jeff?
DR. BLAIR: Thank you. I have a question for Kepa also helping to understand better the feedback that he has been getting. I am assuming that much of this feedback occurred in the Workgroup for Electronic Data Interchange meeting a week ago in Chicago. So, let me ask my question just a little differently. Apparently you did hear concern on the part of a number of people as to whether or not the Department of Health and Human Services would be able to move the NPRMs to the regulation. Maybe it would be helpful for us to understand -- since Bill, Dr. Braithwaite, indicated that the original impetus for the administrative simplifications provisions was because the health care industry asked for these standards. Are you still hearing from your experience that different constituencies are impatient, or are you hearing that they would prefer a delay? What are you hearing?
DR. ZUBELDIA: Jeff, I am hearing different things from different sides. On the vendor and the clearinghouse side, everybody is for the administrative simplification. Everybody wants to do it as soon as possible. Although people are not willing to commit resources until there are final rules, thinking that they may be able to do it within two years, but if the final rules are delayed, they have other things to do with their time than to do this.
Some of this is anecdotal, but on the payer side, I think the report from the association on the cost of implementing HIPAA, meaning the many billions of dollars, has people scared. They are thinking that this is not what we were promised, this is a lot more expensive than we thought, and maybe we should wait, and it may not happen. I think that is probably the wrong message, but that is what I am getting.
DR. BLAIR: Is there a certain constituency that is feeling that way, or is that across the board?
DR. ZUBELDIA: I could not say that it is across the board. I have had conversations with TPAs and small payers in general, and they are saying they are very concerned, this is very expensive, and we do not think Congress is going to let this happen. I know these same issues came up two years ago, and they were resolved. The concern that I have is that they are coming up again and maybe because there are no final rules yet. The message coming across is the wrong message.
DR. BLAIR: If I am hearing correctly, it sounds like this is a valid issue which we need to understand better, but maybe it is not something that is appropriate to include in the report at this time. Dr. Cohn, is that your sense?
DR. COHN: Yes, I am actually raising my hand because I think I have a comment based on the input.
DR. LUMPKIN: Actually, Kathleen had her hand up first.
DR. FYFFE: To make two points. If I recall correctly, I think that in early January, there was an article in the Wall Street Journal about the American Hospital Association expressing concern about the expense of implementing administrative simplification. So, if you are asking about which constituencies seem to be concerned about this, I think the institutional provider community is one.
The other question I have is a point of clarification. For practical purposes, the implementation of admin simp by HCFA is very, very important because the bulk -- I mean, they represent a very large bulk of the transactions. They are a critical mass. If they are going to be able to implement, this means the hospitals will have to implement, and this means that all of the other smaller payers will fall in line after HCFA. I am confused because I am not convinced that HCFA is going to have the money to be able to meet the deadlines. There are a lot of interdependencies here.
Perhaps Karen can shed some more light on that. I mean literally, if the final rules are implemented, what sort of chance do we have two years later of HCFA being able to comply? Does anybody know the answer to that? You will be in violation. But then I worry that someone will come along and pass another law or there will be some exception and the whole thing will just lose further momentum.
DR. SCANLON: I do not think that HCFA plans not to be in compliance. Karen?
DR. TRUDEL: No. We plan to comply. On time.
DR. LUMPKIN: Simon.
DR. COHN: I actually really appreciate the feedback from everyone on the committee on this particular issue. I do think that actually annual reports, even though they tend to be dry, provide really an opportunity to reflect on where we are in various stages. Obviously, I think what you have heard is I think a little bit of frustration that things have not been moving a little faster. I think you have to excuse me. I am an emergency physician when I practice medicine, and time does have some meaning. So, I do get to be a little impatient at times.
I think what I am going to suggest is the following on this one, just as Lisa's proposal to the committee. This may not be an issue, and it certainly by June may not be an issue if the dates work as they plan. It probably is premature for us to be making comments if indeed, as has been at least in a draft mode proposed by HHS, that these final rules will be out over the next three or four months.
I think that probably assuming that we pass this tomorrow, I am going to suggest that we not include it in the annual report but that we direct the Subcommittee on Standards and Security, which as you know I happen to chair, to prepare a letter to the Secretary for consideration at our June meeting that if things have not progressed by that point, or not sufficiently progressed, that we consider that as a letter to the Secretary expressing our concern. Is that a reasonable resolution of this particular issue? I mean, based upon what I am hearing as feedback?
DR. LUMPKIN: I am actually assuming -- that sounds good, and whether or not we have any disagreement with that, I do not see any --
DR. ZUBELDIA: I would express the concern now to the Secretary and if necessary by June then move it forward. I think the concern exists now. I do not know what can be done about it.
DR. LUMPKIN: Mike?
DR. FITZMAURICE: John, I think you sit on the Data Council, is that right? It may be that you could make mention of a discussion without waiving a lot of red flags, but that there is a discussion about whatever the committee discusses. That could be an alert that you may be working on a letter for consideration. There are steps that you take. As you mentioned before, the main role of the committee is to advise the Secretary. You also determine how you advise the Secretary. So, one way is -- it is a story, and I will not go into the story, but a fellow says, "How could you tell me my mother has just passed away? You do it gradually. You say, 'Well, she was fixing something in the kitchen, something fell, it caught on fire,' and so forth." He says, "Well, your dog was fixing something in the kitchen, too." You can ease into it. The Data Council is one way to ease into it. Another step is a letter of your choosing to go to the Secretary and maybe next year's final report. Some things are beyond the control of the Secretary, so you want to make some allowances for where is the responsibility and offer suggestions that will be supportive but express also any concern that you might have.
DR. LUMPKIN: I think that what we are outlining is sort of the informal route. I think that there are plenty of ways that the message can be forwarded that we are concerned about this. Then in June, we would then take a formal route which would be a letter.
DR. COHN: If necessary.
DR. LUMPKIN: If necessary.
DR. SCANLON: A related point. WEDI(?) has already written into our deputy Secretary asking that -- focusing on the transaction standards specifically, which we have always projected as the first of the final standards to be issued, expressing a concern that it not be delayed. The issue is clearly on everyone's radar scope already. I think WEDI will be meeting with the deputy Secretary next week just to emphasize the need to move along. They do not point out the fear of losing momentum, but they do point out the need to move forward with what was the correct initiative to begin with.
DR. GELLMAN: I just offer an alternate suggestion to think about. I think writing a letter to the Secretary saying that you are not moving fast enough is pointless. The department seems to be pedaling as fast as it can in this area. If there is concern in the industry about the viability of the HIPAA process, then maybe what needs to be said is something to the industry to reaffirm the importance of the HIPAA process and the importance that it go forward and be implemented as promptly as possible. Maybe the focus here is not on the Secretary needs to do better but the industry maybe needs to hear the message that this is still important from us, maybe from the Secretary, too, and that they will just have to wait until this gets done. If the concern is that the industry does not think that the process is credible anymore, then that is what needs to be addressed.
DR. STARFIELD: That sounds fine to me, but how do you do that?
DR. LUMPKIN: I think we can, as part of the executive summary, perhaps in the overview, the first section, we should start off with a note, a couple of sentences saying how important the committee feels this process is and that it is moving forward. I think that if we get to the point where we want to send a letter to the Secretary, what we should do is to encourage the Secretary or some unit of HHS to say yes, this is still important, and our intent is to move forward in the process as expeditiously as possible. One of the issues that Kepa raised was a concern about the linking between the privacy rule and the transaction rule. I think the clear statement that there is not an intent to link those would be very useful. It may not be that our letter would be specifically to say that the process is too slow as much as to say that there is concern, uncertainty about the future, and it would be useful to make it fairly clear what the intent is despite the fact that it is a process that does take some time. Jeff?
DR. BLAIR: I was part of the process of a comprehensive survey of trends for health care information systems during these next few years and polling in particular the provider community, all the way from ambulatory care to acute care to managed care and integrated delivery networks, just to get a feeling for the things that they plan to do. A lot of the things that they hope to do over the next two years would be significantly impaired if the standards for data security, for financial transactions, for electronic signatures, are not available to the vendors to make cost-effective systems. I am adding that to Kepa's comment, not that we should change direction in terms of what we do, but as we begin to pull together our thoughts maybe for June and July as we express our concerns, I think there is a substantial amount of data, quantifiable data, indicating the impact on the industry if we are not able to get the standards in place to help the industry.
DR. STARFIELD: The committee is supposed to be the eyes and the ears of the outside, so I think it is really quite appropriate that we say something. We can do it, as you mentioned, in the preamble or something of this report plus a letter to the Secretary indicating that we think there is a need to reassure everybody that things are moving ahead and that there is still momentum.
DR. ZUBELDIA: Privacy and security are tightly linked to each other. We are seeing already that security is being delayed at least a little bit to somehow harmonize it with privacy. There is a substantial number of people who say that security and standards are also linked. In fact, there were some requests last year that -- some people were saying that you cannot implement the transaction standards if you do not have adequate security. You can see a linkage there. Also, standards and identifiers are linked, and some people will say we need to have the identifiers because we cannot really implement the standards without the identifiers. So, you can see the linkage of all of them. If we start seeing the precedent of delaying one to get in sync with the other, the whole thing could cascade and be delayed until privacy is ready. I think that is not a good message to send.
DR. LUMPKIN: I think that we are all in agreement on that. It is clear, the impact upon anyone who is developing an information system over the last two years is let's kind of wait on developing our system until we know what the rules are going to be. I think that there are a lot of missed opportunity costs throughout the industry being based upon the uncertainty. I think our desire as a committee to move this forward is to put the rules out as soon as we can so that the industry can move forward.
DR. COHN: Are we done? Kathleen, did you want to raise an issue on this one?
DR. FRAWLEY: No.
DR. COHN: Okay. I know we are getting into the break time in fact past. I just wanted to bring up one other piece that I think I was going to have Jim and I see if we can insinuate a section under implementation which has to do with, I think, a thing that we have been discussing which has to do with resources. I think that probably a sentence or two supporting the health informatics initiative, specifically the area around improving health information systems through data standards and supporting that piece as well as probably acknowledging what I consider to be sort of the yeoman's work with HHS to try to make this happen without additional appropriations and suggesting that as we move into the implementation that maybe there needs to be additional funding available. Once again, not in any way to be disrespectful to anyone but more the state that it is hard to do things without any funding at all. I think it might be appropriate as potentially a final implementation issue or somehow insinuated in there. I think maybe Jim and I, if we have time, may try to wordsmith some of that and bring it back to the group tomorrow or even discuss it at the subcommittees. Is everyone okay with that as an additional item?
Am I seeing heads nod? Okay, we will work on it and bring it back tomorrow morning. I want to thank everyone for this discussion. I think it has been very useful.
DR. LUMPKIN: We are scheduled to have a break until 11:00, at which time we will have discussions on the patient medical record information.
[Break.]
We are going to get started on the draft report for standards for patient medical record information. I am just going to apologize ahead of time. I have to go out and take a conference call around noon, so I will be leaving. Between Simon and Jeff, they will be able to chair the rest of the session for that. We will come back, we will have lunch at 12:45, and then at 1:30, we will proceed with a further discussion and continue on with the schedule.
At this point, take it away, Jeff.
DR. BLAIR: Thank you. To my left, for those of the committee members who have not been part of the CPR work group activities, it is possible this is the first time that you have seen Margaret Amatiokan(?). Margaret has done a fantastic job helping us pull together this report that you hopefully had a chance to glance at. It is in your briefing book. We are going to be stepping through that.
Let me start first. I am only going to take about ten minutes or less to try to give you a perspective so that you understand what we are about to head through. I know that in reality, not all of you may have had a chance to look through the document. This is going to kind of be the overview that may help you at least get on board if you have not had a chance to read it and maybe to put it into perspective if you have.
There is a separate piece of paper that Jackie was able to distribute to all of you which basically is the time line for us to produce this report. Do you all have a copy of that? It refers to the milestones and the dates for the report to the Secretary for PMRI standards. If you take a look at that, you will wind up seeing -- we did not end up going all the way back to the beginning a year ago but just to this last October as we begin to try to manage the project, so to speak. We are now at item six, which is that you are looking at now the third draft that the work group which is in the -- and again, for those of you who are not familiar, the CPR work group is a portion of the Subcommittee on Data Standards and Security that Simon is chair of.
On those milestones there, you can see that we are heading toward presenting the report to the Secretary in August of this year, that is as defined by the administration simplification provisions of HIPAA. This is not the final draft, but we wanted to try to get as far along as possible so that we could get everyone's feedback on this thing because our next chance to meet will be June. By that time, we really have to have it in pretty good final shape or close to final shape.
You will notice that on the time line there, whatever comments and suggestions and modifications you all recommend. we will come up with an additional draft, and then our CPR work group will meet again at the end of March. We will wind up then revising it again. When we revise it again, that would become the fifth draft. The fifth draft we would wind up reviewing with different agencies, committees and interested parties within the Federal Government, make sure we get all of that feedback and comments included. We will then meet as a CPR work group June 1 and 2 to include all of that feedback and then have what we hope would be a draft final report to the full committee. I think it is the week of June 20-23. We trust that it will be in pretty good shape then.
The next piece that I might mention is that as we work together on our work group to pull together this report to the Secretary, we are very much aware of the fact that when we start talking about uniform data standards for patient medical record information, there is a lot of folks who do not connect to that in terms of why is that important. We took a great deal of effort to try to construct the report in a manner where the beginning part of the report begins to show its relationships to national health care issues. Okay? Then we try to educate people as we go through the report. By the time they get to the recommendations, they are able to put these things into perspective.
If you could now turn to the report, I am just going to very briefly give you a highlight of how we did that. Then we would really like to get your feedback as to whether or not we were successful in doing this or not. If you look at the table of contents to the report, you will see that it, of course, begins with an executive summary. We did not attempt to write an executive summary for this particular meeting because we still feel like this report is in transition. It will still go through several other drafts.
We did put a good deal of attention on the next section which is the introduction. The purpose is there. After the purpose, you then have a background and general rationale piece. Here is where the education pretty much begins. We immediately try to help the readers begin to relate this to national health care issues, those being in particular that this would help to address. There is going to be cost and accountability for quality. We wind up bringing that thought train down into what has health care already been doing to address cost and quality. Standards for PMRI are not the only thing that will help that. We then wind up taking a look at how other sectors of our economy have made significant progress in the last ten years to address cost and quality. That is one of the reasons that our economy is doing so well and one of the reasons many of them have been able to do that is that they have moved to an information infrastructure. It is part of moving into the information age.
We then point out that health care, in many ways, has not been as successful in being able to develop a health care information infrastructure. We take a look at some of the reasons why we have been slower than other sectors of the economy to create and information infrastructure for health care that could help address cost and quality. We then begin to take it down into how does the idea of standards for PMRI fit into a health care information infrastructure. We look at the consequences of not having those standards. We look at the reasons why it has been difficult to develop those PMRI standards. We then wind up looking at the benefits that would be achieved once those standards are in place and an information infrastructure is in place. That pretty much is the end of this education piece.
We then wind up stepping through the process that we used to gather information for the report. We wind up showing how we attempted to divide the subject area into different focus areas. We move on to the second major section. The second major section is the next point of departure which is an overview of PMRI standards. There are two major sections in there. First, we discuss general, basic issues. We realize, as you wind up seeing there, those issues are interoperability, comparability, data quality, and those terms may not be comfortable to many people who are not clinicians or information systems people. So, we try to address that next. Then given that we have taken the reader that far, hopefully, we could then begin to say, well, what is the status of the standards that exist in the industry today and the standards in medical terminologies.
The next major section then begins to go into the issues, observations and assumptions, and most importantly, our assumptions. We start off with some of those recommendations that are overall. They go across the board. Generic, overall recommendations. Then we go into recommendations divided into each of the focus areas.
Excuse me. Let me back up a second. In each of those focus areas, we discuss the issues, observations, assumptions and recommendations for each focus area. There is a conclusion and then the appendix is there. I do not think I will elaborate on the appendix as this particular point. As Margaret takes us through those things, she will help you understand when to refer to that.
Are there any questions on this brief introduction that I have just given you? If not, then I would like to turn it over to -- oh, there is a question.
DR. HANDLER: Aaron Handler from the Statistics Office of Indian Health Service. I just have an observation. I was in Boca Raton, Florida, for a week visiting my in-laws. They had a special newspaper segment down there about all of the snowbirds that fly down to Florida. They exert themselves, they eat a lot, they drink a lot, they perform all kinds of activities, and then they get sick, and they hurt themselves, they have illnesses, and they flood the emergency rooms because they have no doctors down there. They are only there for a month or less. With elderly people, that is one strike against them as well. Then the crisis comes when the doctors in the emergency room are trying to figure out what conditions does this person have, how should I treat this person, what medicines are they taking. Half of the time, they are unconscious.
The medical records and electronic transmission would help the process if they had a unique identifier and their home state would refer their history electronically. That basically puts all of this in perspective. It is not just an exercise but what do the people do who are administering those emergency rooms when there is no rooms to treat the people living down there because all of the people are clogging the emergency rooms. That puts everything into perspective a bit.
DR. BLAIR: Thank you for your comment. Let me add just one other last -- are there any other comments? Okay.
Margaret and I have gone through this process several times with our CPO work group. We had a little bit more latitude there, and right now, I think we have two hours and 45 minutes available to us. While we will not be absolutely strict, let me just give you a feeling for the guidelines that, if possible, we would like to target as a goal. It is, out of that two and a half hours, if we could sort of target maybe 30 minutes on that introduction piece, 30 minutes on the overview of health care information standards, so that we would have an hour and a half to focus on the issues, observations and recommendations for each of the focus areas. We do not have to stick to that strictly but conceptually that at least is a goal that Margaret and I think might be helpful in terms of prioritizing. Let me turn this over to Margaret.
DR. COHN: Margaret, could I also make a comment on this one. I actually want to acknowledge Jeff for tremendous efforts and a very good job. Jeff, you have really done a super job in terms of moving this forward. I know Margaret has been very, very helpful and supportive of all of this.
Having lived through this effort, and many of you around the table have also been sort of participating on the work group, I actually have to say that I think the first parts are very good. I think from my view, what I want to make sure in the early section is that it is understandable and compelling. I mean, we may wordsmith a little bit, but any recommendations are based on there being a compellingly demonstrated need and issue. I want all of you who look through these beginning sessions, I mean, it is not the wordsmithing that we are concerned about. Really, the issue is, are we making the case?
DR. BLAIR: Thank you, Simon.
DR. AMATIOKAN: In the introduction, we take you through the purpose and scope, which is a reiteration of the provisions that were directed to NCVHS. We then go into the background and general rationale. What I will do is I will highlight a couple of the most important parts of each of these sections and then pause for your comments if that will work for you.
We begin with a story that is outside of the health care arena with respect to standards to try to get the attention of particularly the lay reader or somebody who is unfamiliar with the details of the standards that we are focusing on. We then talk about the fact that health care has similar problems as was faced in this other industry but even more so, and we cite three very specific real life examples of where harm was done to a patient because of lack of standards.
On the next page, we start to ask the questions that build from the beginning. How does this report help to address national health care issues. We talk about the state of health care delivery system in the United States, the fact that it is the best in the world but we still have room for improvement.
In the section, What has already been done to control rising health care costs and improve quality?, we outline some of the measures that have been taken such as expansion of managed care organizations and other things. On the next page, the question, "How have other sectors of the economy been able to control costs and improve quality?" We highlight here that other industries such as financial services and telecommunications and so forth have an information infrastructure and provide some specific examples of what those information infrastructures do for those industries.
Why has health care been slower than other industries to implement an information infrastructure to control costs and improve quality? Here, we talk a little bit about expenditures in comparison to other industries. In health care, our expenditures are quite low. Although we have been able to get information systems that will address financial and administrative processes, I think what the gentleman was just referring to earlier is that we have really not been able to get to the core data of our business which is the clinical data. Physicians are still continuing to write orders that are transcribed into order communications systems. Our medical records are still basically paper even if the paper is generated from a computer.
How do standards for patient and medical record information, PMRI, fit within the health care information infrastructure? Here, we describe and hopefully coordinate with the work group on health information infrastructure, that it includes standards, laws, regulations, business practices and technology.
What are the consequences of not having complete and comprehensive standards for PMRI? In particular, it limits the ability of different health care information systems to communicate with one another and to capture clinically-specific information. From a vendor and user perspective, there are a number of impairments that we identify there.
On the next page, Why is it taking so long to develop and implement complete and comprehensive standards for PMRI? The standards are much more complex than in other industries. There are many diverse sectors in health care. We have been fairly regulated and competitive pricing has made it difficult to identify standards development as a reimbursable cost to providers and vendors. Perhaps the health care delivery system has placed a higher priority on standards that have facilitated reimbursement than those that are directed to data and then quality of care.
What other issues need to be considered? We identify the fact that the marketplace will evaluate the extent to which it invests in solutions like data warehouses and advanced data mining tools and so forth.
What benefits can we expect when standards for PMRI facilitate a health information infrastructure? We listed a large number of those. Then to bring it to more specific examples, at the bottom of page eight, we indicate that although it is difficult to measure the full benefit of these functions and a threshold level of activity within the health care information infrastructure is needed before we can truly identify benefits across the board, there are some very specific examples. We have identified four that are kind of examples from different kinds of sources.
Then we have our summary. I am going to stop at that point and take your comments.
DR. STARFIELD: I have a comment about the justification early on. The justification, the examples, the vignettes, really focus very heavily on medical errors, but there is a lot of harm done that make things unsafe for patients that are not errors but are adverse effects that are not anticipatable in the sense that errors are anticipatable and preventable. I think that a record such as you are envisioning could do a lot in terms of, I guess you might call it post-marketing surveillance, to point out the dangers of technologies, medications that there is not now any way to recognize.
The Institute of Medicine report focused only on errors even though the subtitle said safer, there is a whole category of safer that does not have to do with errors. I think that you could do a lot more and make the application of the electronic record in a more pointed way by also including the anticipated adverse effects whereby a surveillance monitoring system based on this record could go a long way to make it a safer environment for patients.
If I look at the data, the evidence in the literature, the non-error adverse effects probably account for at least as many deaths as the error ones. If you include both of them together, it is the third leading cause of death.
DR. GELLMAN: I want to jump to the end of the report. I am going to have to leave in a few minutes, and I will not be able to come back this afternoon. I cannot wait. I did read over this report, and I actually think that in a lot of ways, it meets your criteria, Simon, in terms of trying to explain the issue. I think it does a pretty good job.
I do have a couple of comments about the privacy section at the end. First of all, I know it is an NCVHS report because privacy is the last issue discussed. I would like to see somebody show some variety once and make privacy the next to last issue rather than the last issue.
I think that the privacy section calls for privacy protections without specifying any details. What are the privacy requirements that ought to go along with electronic PMRI. This is not really discussed at all, and I do not think that is a bad idea.
There is a mention in here of off-shore(?) transcription of medical stuff, and I think that is a very important issue. I do not know what that has to do with electronic PMRI. I think that is an issue that cuts across the board for any kind of off-shore transcription. I think it is a general concern and one that has gotten very little attention.
The report mentions concern about the reuse of data without really talking about it. I think that is something that could be discussed.
In terms of the recommendations, there are three recommendations. I am on page 31 if anyone is interested. The first recommendation talks about insuring that standards for privacy and security are not violated, and it talks about the Secretary should encourage the public and private sectors to incorporate strict provisions to protect confidentiality and data integrity in their business partner agreements. This is an issue that is addressed in the privacy rules. It is a very controversial issue in the privacy rules. I hesitate to predict what is going to happen. At the moment, at least, the privacy rules are much stronger in terms of imposing requirements.
I think this needs to be refit. The issue was a good one, but I think the recommendation itself needs to be recast. This may be difficult given the timing of everything to try to be consistent with whatever is likely to come out of the process given the uncertainty right now. It is a good issue but to say the Secretary should encourage when there is a good chance the Secretary will require something is too weak, and to do it the other way around may or may not be something you might want to do. I do not know, but think about it.
Recommendation 22 talks about insuring consistency with the European Director for Data Security. I am not familiar with that in any detail, but it seems to me that there is an issue here. We do have security rules that are floating around. They are not final either, although they are further down in the process. I do not know to what extent the HIPAA security requirements are different than the European requirements, whether they are stronger or weaker, which is my guess, but I do not really know. I think the notion of just being consistent may again be a recommendation that at one level is perfectly reasonable and another level is somewhat inconsistent with positions that the department has taken in other areas. I think that needs to be thought about. I would be delighted to see you say that there are other ways that the recommendations -- that privacy rules ought to be consistent with the EU directive on data protection. It is much stronger than anything proposed here either legislatively or in the rules. I am not really proposing that you do that because it raises the same problems here. Security rules are sometimes easier to coordinate than privacy rules because a lot of what you are dealing with is technical.
Finally, on the last recommendation, which is to establish a center for health care privacy, I actually kind of like that idea but I suggest again that it needs to be reconsidered in the light of what the HIPAA privacy regs are proposing. I am not suggesting that it be removed. I just think it needs to be thought about a bit more. The HIPAA privacy regs suggest that there will be enforcement of the regs coming out of the office of civil rights. The function that is recommended here is a different function, but I think it needs to be coordinated and thought through. I think there is in fact probably a need for some kind office of privacy policy in the department. All we have now is John Fanning, who is a one-man band. There is an idea here, but I think it just needs to be coordinated a little bit better with what has already been proposed. Whether this should plug directly into the HIPAA privacy process or will be something independent of that I am not sure myself. Anyway, I think some revisions here will make this a better product.
DR. BLAIR: Thank you, Bob.
DR. AMATIOKAN: May I ask a question in relation to that? We struggled in this section and a couple of others where we knew that there was already an NPRM out. What do we do, do we just say we support that, or here were our comments in the latter, or do we make some specific recommendations relative to some of the areas that we felt were extremely important. It was difficult, I think, for the group to try to come to some resolution about that. Any suggestions along those lines would be helpful.
DR. GELLMAN: I will make a couple. One is, these kinds of conflicts, maybe that is too strong a word, but these kinds of overlaps require artful drafting so that you do not make things worse. On the other hand, where the committee has taken a position on something, even if the Secretary has not adopted it or has not yet adopted it, I do not see any problem with reiterating the recommendation and saying that the committee has supported this and continues to support it. If the secretary does not agree, so be it. That has certainly happened before. I just think this is clearly a delicate area. You are struggling with it because it is hard.
DR. LUMPKIN: I think in response to that, we should be careful that we do not feel too restricted. For instance, our comments noted that we thought there should be universal applicability of privacy regulations whether or not it was the written record or the electronic record. So, there are some areas where we may want to see what will come out of the privacy regulation more comprehensive, but HHS may feel that they are restricted by current legislation.
I think it would be appropriate for us to take the position that we are the most comfortable for and just note that the NPRM makes a step in that direction but additional protections may be required. I would be comfortable with that kind of position.
DR. GELLMAN: I think that is perfectly fair, and sort of further along those lines, this is a report to the Secretary, but you may want to include recommendations to other people or reiterate recommendations that you may have made to the Congress saying that the Secretary cannot solve this problem but we are still in favor of it. If the Congress or the other parts of the policy structure or the industry that can respond, I do not see any problem with including that either.
DR. LUMPKIN: Thank you. I guess we will jump back to the introduction. Thanks, Bob.
DR. FRIEDMAN: I just wanted to briefly return to Barbara's comment and to Aaron Handler's snowbirds. Even though it is a report to the Secretary, I do think there would be something gained by being -- trying to be even more persuasive about what some of the future might look like in terms of not so much the specific benefits that you lay out in terms of each individual benefit but broader scripts, broader scenarios of what this could bring. I think spinning out two or three of those could be helpful and could be persuasive.
DR. BLAIR: [Commenting off microphone initially.] Could I just ask, are you thinking that like we sort of had a list of those benefits, and we kept them concise, are you saying that we should elaborate a little bit more on each one or what is it that you are thinking of when you say "go into more depth"?
DR. FRIEDMAN: Jeff, I am thinking both of elaborating a little bit more on each one but also trying to -- I hate the phrases but sort of paint two or three pictures, broader pictures of what some of the benefits could be and what the future might look like in a health system where this becomes the norm.
DR. LUMPKIN: Mark?
DR. ROTHSTEIN: On page eight, picking up on this same issue, there is a section called, "What benefits can we expect?" There is no comparable section about what are the possible risks of adopting a system that is advocated here. I think in fairness, we ought to include, in terms of comprehensiveness, some of the risks. I think the main risk is in the privacy area. When you have a more comprehensive medical record that is available, you do pay some price in terms of individual privacy. I am not saying that it is not an acceptable price; I am just saying that there are tradeoffs. It will, in some instances, conceivably limit the autonomy of patients to disclose information selectively to providers. If you go to ten different doctors, you may decide, rightly or wrongly, that you do not feel like telling your whole story to all ten doctors. Whereas, if they can quickly access your information sort of automatically, then all of the information presumably might be available to all of your treating physicians, which may or may not be to the interest of the patient.
It would facilitate the transfer of more complete sets of medical information to third parties via release. In other words, if you want a job, if you want life insurance, if you want whatever, now once your medical information is accumulated in one source, it is much easier to release the entire file to any individual third party, a mortgage company or anybody who can require a release as a condition. Those are downsides to a comprehensive patient medical record system. I think they are offset in many respects by the gains in public health and clinical care and so forth, but I think we need to include those and then to address those issues in some detail in our discussion of what we intend to do in terms of privacy.
DR. LUMPKIN: Can I sort of clarify your comments because I think they are all legitimate issues yet there are design features that could mitigate those. So, in one sense, we talk about benefits. I am not sure if risks is the right term. Concerns, areas where electronic medical records requires heightened design features or something. Would that sit as comfortable.
DR. ROTHSTEIN: I do not care about the terms if you want to call it concerns or issues or something. What I am concerned about is that the document recognize that this is not without some areas that could be of concern to individuals, the centralization of their medical information. We need to think about what steps we want to take to mitigate some of those problems.
DR. LUMPKIN: Could I encourage you -- I am sure that Simon and Jeff would also appreciate it. If you have a few minutes, if you could just jot down that list of what you think are risk concerns, whatever areas, that would be helpful for the next draft of this report.
DR. ROTHSTEIN: Sure. Let me just give you an example, and I will deal with a personal example. I have had back problems for years and years and years. I have gone to many pain clinics. The first thing that they want to know is whether you are depressed because there is a cofactor. I understand that, but I do not feel like necessarily telling every ninth, tenth, eleventh and twelfth pain doctor that I go to whether I like my kids, whether I like my job, whether I like my wife and all of these things. Maybe at some point, that information is valuable if I am feeling depressed. Mostly when I go, I am feeling pain. I am willing to take the risk that the doctor is going to miss something because I do not report that. Now, if my records are all cumulated, that may be a good in a certain sense, but I am giving up something by having every doctor know everything about me.
Now, the question is should we build in some way of allowing the patient to select. Are we undermining clinical care where the physicians say wait a minute, I cannot treat somebody if I do not know what all is being done, what medications they are taking, what they have been treated for in the past. What I am suggesting is that it is perhaps a more complicated problem in terms of health care delivery and privacy than simply getting everybody on a single, centralized, uniform, electronic system.
DR. LUMPKIN: Let me just clarify one issue because I think you raise some important points. There is always a negotiation that occurs in the paper world when you see a new clinician of how much information you are going to share. You made a comment, and I just want to clarify. The conceptual model is not that there is going to be one centralized database. I mean, we have not -- so I think that we would need to, if it is not clear in this document, we need to go back to this because we have addressed that in the NHII, and I do not think that we, as a committee, want anything -- this is conceptualized really as decentralized recordkeeping primarily where it is kept now.
DR. ROTHSTEIN: You see, then we need to -- because one of the last benefits is to facilitate the ability to construct a comprehensive, lifelong healthcare record that enables continuity of care. That seems to run counter --
DR. LUMPKIN: Unless the patient controls it --
PARTICIPANT: Patient control.
DR. LUMPKIN: Exactly. I think that is a very good point. That line needs to be clarified.
DR. COHN: I was going to comment that this is a very slippery slope the work group has had to deal with because we are really talking about standards for comparable patient medical record information. We are not talking about developing a case with a computer-based patient record.
DR. ROTHSTEIN: Right.
DR. COHN: One enables the other, but really our focus is on the comparability of data so it is -- and I think what you are saying, as I say that, I think you are saying that it probably needs to be somehow referenced as we look at the recommendations. Clearly, there needs to be more work. As this is made more available, as it becomes more accessible, which I think is the case that you are making, be it a computer-based patient record or be it just on databases, centralized or distributed, it brings up new privacy issues that need to be addressed. It may not even be contemplated when you look at the privacy NPRM or final rules, which is I think what you are sort of saying.
DR. ROTHSTEIN: What I am suggesting is that we need to have in here a recognition of the tradeoffs that are inherent in any sort of system and that we understand that and are trying to take that into account in whatever our recommendations are.
DR. LUMPKIN: Dan?
DR. FRIEDMAN: You and Simon have already made the points. When I read this, it was just interesting to me because I had a completely different sort of lens when I read it than Mark did. Like you, I did not assume that we were talking necessarily about a centralized record. Clearly, that needs to be clarified and emphasized.
DR. LUMPKIN: Other comments on the introduction?
DR. BLAIR: If there are no other comments on specific things, can we just get back to Simon's point in terms of just general feelings. Did the introduction accomplish the purpose of providing a foundation, introduction and education for individuals who might not be involved with the information systems or maybe not even be clinicians? Did it accomplish that purpose? Is it -- Simon's word was compelling. Is it compelling?
DR. COHN: Can I make a comment? I actually think it needs to be about two times more compelling than it is. That is just with my hat on as a person who is trying to read this and trying to be convinced. I actually think that many of the recommendations in terms of increasing sort of the -- making the scenarios more vibrant and all of that may do a lot to help with that. I was once again reminded that this beginning part, the background and general rationale is really sort of the critical foundation to the whole document. I am seeing some heads nodding from that.
DR. LUMPKIN: We need to make sure that we can cross-index, cross-reference a benefit. If we make an allegation that there is a potential benefit, then we need to have somewhere in the text of the document that actually explains how that benefit would come about.
DR. COHN: John, if I can also add, I actually think when we are talking about benefits and the scenarios, there probably needs to be some reference to the cost issue since in the background we are already talking about cost issues and then we just move to basically patient care issues predominantly. There probably are some examples of environments that are spending lots of money and not getting very much benefit. That might be an equation that might be changed if there were more uniform standards.
DR. LUMPKIN: Barbara.
DR. STARFIELD: I think John's point about providing the documentation about how the benefit would come about is really important. I am looking at the four examples that are given on pages eight and nine. At least for three of the four, I cannot see how what we are proposing would do anything to facilitate those and maybe even for all four. Why you would need the computerized patient record to do what you want to do there. It is just not compelling to me. There are other ways you could do it.
DR. LUMPKIN: Where?
DR. STARFIELD: On pages eight and nine, the bottom of pages eight and nine.
DR. LUMPKIN: Perhaps the missing piece, and we will get into this this afternoon, is the NHII concept. We may want to, even though they are being developed on slightly different time tracks, discuss those. Several of the benefits really, you know, what we are going to talk about this afternoon with the NHI. The goal of the NHI is to push knowledge to the point of service. That is really where a lot of the benefits occur, but you cannot do that without the standards for patient medical records. It becomes an enabling standard for the kinds of things that we want to see develop. That may be how we need to address some of these pieces.
DR. FITZMAURICE: I think maybe it would be useful to have a couple of sentences just like what you said, that these benefits could not have come about if you did not have a common understanding of the concept across the physicians who are using these systems and get into the standards for vocabularies and data definitions. I do not think that you have to go through each one of the examples and point that out.
DR. COHN: If I can also make a point here. What is interesting about standards is that standards -- and probably each of these examples can be done without standards. The problem gets to be when you try to move something from place to place or make it more generally useful. You hear, for example, not to make an example, Kaiser Permanente of Ohio did something very good. The problem gets to be that without this sort of view of standards, it becomes very difficult to move that best practice to anyplace else.
DR. LUMPKIN: Other comments? So, more convincing links to other projects. Next section.
DR. AMATIOKAN: The next section, there is one very brief section on page ten which is just describing the process that the work group used to study the issues and make recommendations. The work group heard from 92 testifiers, and it seemed that the consensus of the testimony was pretty consistent, and the recommendations reflect that consensus.
The recommendations also considered how the government could support adoption of standards. We did go through an exercise in identifying four incremental levels used within agencies for government business, that plus all health plans that cover government employees, all of that plus health plans that are paid for by the government, and then for universal use. You will see in some of the recommendations later where we offered different levels of adoption depending upon the maturity of the standard.
Questions about that?
DR. LUMPKIN: Okay.
DR. AMATIOKAN: Going on to the overview of standards for patient medical record information, there are two connections. The first section is the overview of data standards issues. This really was intended for people who were unfamiliar with uniform data standards for PMRI. One of the issues is interoperability which is primarily achieved through message format standards. There are three levels of interoperability, and we define each of those levels. Then we address some of the other issues associated with the interoperability that implementation guides improve interoperability because often the standards are fairly general and the implementation guides, as you have seen from other standards such as the transaction standards, are really required to get them implemented.
Conformance testing is another issue that is very important and has not been done a lot in the area of patient medical record information. Again, I think you can see that from some of the work that you have been doing in testing the transaction standards.
Greater semantic precision to improve interoperability. This really gets at what level the standards currently are at. On the previous page, we talked about there is basic, there is functional and there is semantic. For the most part, we have really got functional message format standards rather than semantic standards at this point, so we really need to look at greater semantic precision.
There are gaps, and there are inconsistencies. There are areas where we do not have message format standards. Then there are areas where there may be multiple standards. That relates really to the issues of interoperability.
Another issue is comparability which refers to the ability of different parties to share the same meaning for data. Terminology is the area that we are looking at here. In order to make sure that we use these terms very, very precisely, on pages 12 and 13, we defined terminology, code set, classification and nomenclature or vocabulary and then within vocabulary defined controlled vocabulary and structured vocabulary. When we are talking about terminology as a whole, encompassing all of those things, we tried to use that term "terminology." If we are referring specifically to classification systems, we use that term. If we are referring to something that is much more precise and granular, then we use the term "controlled vocabulary" or "structured vocabulary" as applicable.
There are a number of scholarly works that have identified characteristics and attributes that are necessary for terminologies to have confidence in the meaning of the data. We cite those, and we actually included those in a revision to the guiding principles for selection of PMRI standards which is in appendix C.
We talk about that ideally data should be captured once for patient care purposes at the most granular or precise level, and all information required for other purposes such as reimbursement, public health research and other uses should be derived there from. That is a challenge, and there are actually a number of challenges. You have to balance usability of the system with the ability to capture information. You need to have a close matching structured data element being able to be found in the terminology and so forth. Then we talk a little bit about a solution in the form of text processing although that is not the only solution.
Finally, the central problem in creating a vocabulary for clinical language is indexing, organizing, storing and retrieving information objects to maximize their use.
Then we go into data quality and note that it is very difficult to measure the quality of health care data. There are a number of properties of data quality, and that many users of health care data can point to examples where the quality of data was suspect or could not be validated for one reason or another. There are impairments of data quality that can be attributed to the fact that there are different systems and data must traverse from one point to another between different systems. Common and uniform data definitions are often lacking. Code set assignments and codes assigned are often inaccurate. Data often are imbedded in text strings. Data are often reported in inconsistent units of analysis.
We also address accountability, referring to identifying the health care party that is responsible for the data activities and then the integrity of the data referring to the property that data have not been altered or destroyed in an unauthorized manner. Then there are issues in other areas as well, and in particular, diverse state laws, industry investment in this, business case, National Health Information Infrastructure, and privacy, confidentiality and security.
The second section to this major section is current status of data standards.
DR. COHN: Margaret, do you want to just stop there?
DR. AMATIOKAN: Sure.
DR. COHN: As you know, Dr. Lumpkin had to leave, so I will be chairing the next 45 minutes until we break. I think that was a pretty heady section, and I think we need to let people respond. I think, first of all, did everyone understand this? Are we comfortable with it? Okay, are there comments then about the section? Kathy?
DR. COLTIN: I had a comment about the section on data quality. I thought it was terrific that you provided definitions and examples of the importance around accountability and integrity, but you listed in the first paragraph these other properties, accuracy, consistency, comprehensiveness, timeliness. I think it would be helpful to actually describe each of those in a little bit more detail as to what you mean by them and how standards would be beneficial in each area, how would they contribute to improving accuracy, and how would they contribute to improving comprehensive or consistency and so forth. I would just do the same thing for those that you did for the accountability and integrity concepts. That was one observation.
One thing that I did not see here which has, in my experience, contributed quite a bit to data quality issues has been the lack of any consistency around modifiers for codes that are used. For instance, rule outs or pertinent negatives assigned to particular codes. You mentioned the issue of information being captured in text strings, and sometimes that happens because you do not have a modifier so you put it in the text string. You can have a woman who comes in for a comprehensive annual exam, and the provider checks off a code for routine GYN exam, and in free text says, "Not done today, menses, patient advised, return two weeks." Now, for someone who is reading a paper version of that, they will see all of that, that is great, or if they are reading a computer image of that text, they will see it. To have the benefit that you describe of reminder systems, of quality, the computer has to be able to recognize the pertinent negative that is imbedded in the text.
I do not know whether you talked about the issue of modifiers or lack of modifiers. To the computer, it looks like there is a code for routine GYN exam so the woman had it. The default is that it was done, the code is there, because it is not reading the comment that says it was not done and why. Given concerns about malpractice and errors of omission, we often see entries of information with explanations for why something was not done. I do not think that systems handle that well when I do not know whether you get into that at all in terms of discussing these. I did not really see that come out.
DR. AMATIOKAN: If I could just comment, I think that would be a very good example. I think what we were focusing on was data of all different kinds not just codes from classification systems. So, getting at the notion of a very much more granular level of terminology use that would in fact allow you to see those pertinent negatives and so forth. I think that is a really good example that we could use to explain that.
DR. COHN: Barbara?
DR. STARFIELD: With regard to the quality issues, I do not know whether you have really -- whether you have seen the NCQA road map, the road map for information systems, but I think that would be really useful to review in the light of what Kathy has talked about and also in general.
DR. COHN: In the section on data quality, I would -- just myself, as I look at what I do in my clinical life -- observe that probably my most frequent problem with data quality does not have to do with multiple systems sending data back and forth but just the fact that I get them wrong, I put the wrong data down, I do something in error. I am not sure where that is in this data quality paradigm and probably just needs to be referenced some way or another.
Other comments or questions? I guess going back to this other issue, it is that those of you who heard Margaret A. describe the issues, did it make sense to you? Was there something that was missing that was pretty obvious to you that somehow was not included? Obviously, I think Kathy has come up with one good example. Is everyone comfortable with the section?
Jeff, do you have a comment?
DR. BLAIR: One other question that I might ask to solicit feedback on this a little bit is are we keeping the reader focused? At this point, we want to try to get the reader focused on standards for PMRI not the design of information systems. I am not -- I think we have made some progress in doing that, you know. This is not a report on computer-based patient records; it is on standards for PMRI. Do we need to reemphasize periodically on that, that we are not designing an information system? Can I get some feedback on that?
DR. COHN: Jeff, I think everyone is silent. Certainly, I think that probably needs to be reemphasized from time to time or at least reminded that we are talking about enabling rather than constructing.
PARTICIPANT: We need to do a little more to remind.
DR. COHN: Other comments, or should we move on to status of data standards?
DR. FITZMAURICE: I have just a comment that as I read through this, I do get the sense that we are talking about patient medical record information in a context and that it is not just data for data's sake itself. If sometimes it lapses into explaining what an information system does with the data, that is probably for the benefit because it puts it into the context that if the data are not accurate, if they do not have these properties, then the things that you want to do with that information system, the things that you want to do with the data even if it is on paper may not work out for the benefit of patient care.
DR. COHN: Margaret.
DR. AMATIOKAN: The current status of data standards. Here basically we are just making sure that the reader understands what standards we are talking about and also to give some idea of where they are today. Under message format standards, we identify that they have been developed in the private sector. Many of them have had considerable market acceptance. We have a diagram there in which we try to explain where the different standards organizations are with respect to the various types of data and uses. The message format standards developers in that figure are listed down below on page 16.
We note that as these standards evolve, they are beginning to address interoperability among different health care facilities and including clinical specific terminology. That is beginning to happen. There are also information and reference models being developed, new standards being looked at such as XML.
Under medical terminologies indicating that comparability of data can be achieved through use of standard medical terminologies and that it is not as mature in terms of their adoption. We have a diagram here that identifies the medical terminology domain areas. Again, we are using the term "terminology" very consciously to mean this is the entire body of classifications, vocabularies, et cetera.
Then at the bottom of the page, the ability of the computer to translate PMRI into clinically specific codes is perhaps the greatest barrier to adoption of medical vocabularies to achieve comparable data and that national standards are needed. We have recommended in the guiding principles to include interoperability characteristics and attributes but also on the top of page 18 that the terminologies have specific strategic initiatives as well.
Under data quality, we identify that again there are few measures to evaluate the quality of our data and that standards to address interoperability and comparability should include the principles of data quality, accountability and integrity. There was a comment made earlier. If I could just pause, I think this is the end of this section, and I wanted to get clarified the comment here. I think it was the sense of the work group that there were not separate standards for data quality but that data quality characteristics and features needed to be imbedded in message format and terminology standards. I just wanted to make sure that is clear, and maybe it is not and we need to make that clear.
DR. COHN: Comments?
DR. STARFIELD: An example would help me to understand the distinction that you are making.
DR. AMATIOKAN: Jeff.
MR. BLAIR: Barbara, could you say again your question?
DR. STARFIELD: I said that an example would help me to understand the distinction.
DR. BLAIR: Okay. [Comments off microphone.]
DR. COHN: Comments or questions about the section? Kepa?
DR. ZUBELDIA: Margaret, an editorial on page 17, the table that you have with medical terminology domain areas.
PARTICIPANT: A little louder, please. Use the microphone.
DR. ZUBELDIA: The table on page 17 with medical terminology domain areas. On the box that says "Diagnosis and procedure codes," I would add hick-picks(?) to that. It is distinct from CPT. On the box that says "message related codes," I would add X-12 that has a set of codes.
DR. COHN: Paul Newacheck.
DR. NEWACHECK: In terms of making this report accessible to a wider audience who may not be familiar with the standards already, I think in the beginning of this section, as you begin discussing figure one, it would be helpful to have a little bit of historical background, perhaps a few sentences or a paragraph explaining why there are so many different standards and how they have developed over time for the reader who is not familiar with the different standards. The same thing might apply to the medical terminologies as well.
DR. COHN: A point well made. Other comments on this section? Kepa?
DR. ZUBELDIA: I just have another editorial thing. On table one -- I am sorry, on figure one, where you have the message format domain areas, at the bottom of it, you have the meaning of the acronyms and the acronym for ASTM is incorrect. It is American Society for Testing and Materials.
DR. AMATIOKAN: Thank you.
DR. COHN: Margaret, I have a question or two here. It actually has to do first of all with your first sentence of medical terminologies where it says that comparability of data may be achieved through the use of standard medical terminologies. My issue here is that I think the central problem that we are dealing with is that there are generally not a lot of standard medical terminologies. Probably that needs to be somehow observed that that is really the issue that I think we are trying to deal with, at least as I understand it.
The other piece and perhaps I just need to understand this a little better, but you have a sentence here that I underlined that you actually commented on. It is found on page 17 where it says, "The ability of the computer to translate PMRI into clinically-specific codes is perhaps the greatest barrier to adoption of medical vocabularies to achieve comparable data." Can you explain what that means?
DR. AMATIOKAN: Do you want me to explain that now or explain it in here for the next draft?
DR. COHN: I guess I am trying to figure it out.
PARTICIPANT: Right now.
DR. COHN: Why don't you try now? I mean, it sounds really good. I just do not know what it means.
DR. AMATIOKAN: Okay. I think the issue, well, depending on your viewpoint, ability or inability, yes. I think the point is that you take text. You have a large amount of narrative information, and you want to use the most granular terms possible. You want to use a structured vocabulary, but to get your narrative data down into that coded form is very difficult.
DR. COHN: Okay, so what you are saying is that one of the greatest barriers is the issue of taking narrative text and parsing it out into codes.
DR. AMATIOKAN: Right.
DR. COHN: Maybe if you said something more like that, it would be -- I mean, as I read this, I was trying to figure out what it said.
DR. FITZMAURICE: It sounds more like an inability rather than an ability.
DR. COHN: Yes, okay.
PARTICIPANT: [Comment off microphone.]
DR. COHN: Thank you. Other comments or questions about this section? I guess the question I would ask, a couple of you made comments dealing with the accessibility of this section and needing some things to make this a little simpler and a little more approachable to the reader. Certainly the intent of the section is not to scare someone away from the recommendations which follow. Is it the view of everyone here that if you put a couple of sentences in there that we can somehow make this a little more approachable?
I remember way back when, when Dr. McDonald used to tell me about all of these standards organizations, and I used to wonder how I would ever keep them all straight. It has worried me a little bit to actually understand them all very well now. I also recognize that I am not the norm, so I think that we do need help from the committee, and I know Jeff is in the same position as well as Kepa to make sure that this is understandable by a layman who has not gone to standards meetings. Paul?
DR. NEWACHECK: I think if you look at figure one, it is very off-putting to a layperson, I suspect. I mean, things like the X-12 and things like that are kind of obviously not common language. On the other hand, this is a report for the Secretary at the same time and you do not want to sort of dumb it down too far. One way to address it might be to take, say for example in figure one and also in figure two, perhaps to make those more conceptual figures and not have as much of the -- for example, not having the code names and things like that in them perhaps.
I actually do not feel that it is a problem. I mean, it think that it is okay because it is meant to serve multiple audiences. I do think that for a layperson, it will be a little bit of a challenge.
DR. BLAIR: Let me ask you this, because I almost felt like when you were making your comments, we were starting at the idea that we want to make this understandable for a layperson, and then I thought I heard you saying on the other hand maybe this is the area of the report where we do have to make a transition to greater specificity because it is starting to also begin to address the audience, that is the medical informatics industry at this point. This where we start to engage them as well. Is that correct? So, we have to somehow do it artfully. Did I understand your comments correctly?
DR. NEWACHECK: I think that is correct. I feel a bit ambivalent about it. On the one hand, it needs to be made a little more accessible. On the other hand, we have to be careful that we do not leave out important information for the audience that is more sophisticated. Perhaps by adding some more additional explanation, we would get to that point.
DR. COHN: Jim Scanlon.
DR. SCANLON: Following up on the same idea, I actually like the idea of graphs and pictorial frameworks for how this all fits together and what part of it are we talking about. The National Research Council report that is being released today on the health requirements for the next generation internet actually has a nice series of graphics that shows, say within an institution, the interconnections as well as among institutions and with the global health information. We may want to borrow -- pictorially, we may want to borrow some of those conceptualizations. I will be sure that everybody gets a copy of that. It just sort of leads you to this stage where you are talking about individual standards.
DR. COHN: Dan Friedman and then Kathy.
DR. FRIEDMAN: Jeff, this is a minor point in terms of making it more accessible. I think the glossary is really an excellent addition at the end. I would suggest that somebody go through the report once or twice more and really very, very carefully and pick up additional items and acronyms that you could add to the glossary. It is a real service, and it really helps.
DR. COHN: Kathryn Coltin.
DR. COLTIN: I would agree with that. I was going to actually point one out. On figure one, you have ADT, and I had to ask Kathleen what it was. Now I know what it is, but it is not in the glossary, and it might actually help to have it defined in the figure itself. It is not obvious to someone who does not deal with these data all of the time.
DR. FRIEDMAN: I was too embarrassed to ask. That was one problem that I had.
[Laughter.]
DR. FRIEDMAN: What does it mean?
DR. COLTIN: Admission, discharge and transfer.
PARTICIPANT: It is not widely known in the industry as that anymore. It is called patient administration.
DR. COLTIN: I have another comment.
DR. COHN: Okay, go ahead.
DR. COLTIN: I want to pick up on the comment that I made earlier, and that is that it is not clear to me from what I have seen here whether you are looking at standards or conventions around some of the contextual or temporal factors that relate to, for instance, the medical terminology. So, things like a provider at a visit, with a particular visit date, telling you that he or she gave an immunization at that visit or entering that an immunization had occurred in some other setting on some previous date.
So, it is not clear to me whether you are even getting into that area or whether you are recommending standards for how one should distinguish in these records events, diagnoses, services, whatever, that are being rendered at that point in time or whether you are recording past medical history, for example. That is one aspect that is a temporal one in a way. The other is the sort of contextual one that I described earlier. How are you able to differentiate a rule out or a status post or some other modifier to a term as opposed to proliferating more terms.
DR. COHN: Yes.
DR. COLTIN: I am not just saying which is better or worse, but are you dealing with that?
DR. COHN: Can I make a comment because obviously I know this document well, and I think you are bringing up a very interesting issue that I think actually needs to be referenced. When you said this before, it was kind of clicking in my mind that there are some conventions in some contexts that probably help or would be useful if they went beyond terminologies. If we are recognizing that there need to be multiple terminologies used in multiple different environments, there may be some value to various conventions such as negation, time. There are probably a couple of others that would help sort of to interlock or make them a whole if there were some agreements. Once again, I am not suggesting this as a recommendation, but it is an issue that somehow needs to be referenced in the medical terminology area if we are saying that indeed one single terminology does not solve every problem. Yet, if every terminology does everything completely differently and you are moving from one terminology to another, it may cause some confusion and may be a barrier. Is that another way of describing I think some of your concern?
DR. COLTIN: Yes, I think so. Different systems handle things in different ways. For instance, you may have a system where you have a whole separate table for family history, where all of the diagnoses in that table mean that someone in the family had that, not the patient. If you are going to transmit that information, how do you convey the notion that that is not the individual's diagnosis, it is a family history diagnosis or a past medical history and so forth? It is just not clear to me if you are thinking about how this information would be shared how that would be handled. Each system may have a way of handling it and making those distinctions, but if there is no standard, how does one share it.
DR. COHN: Sure. I will make a comment. I think Jeff probably has a comment on this, and then there is a comment from the floor. I would just comment that this is a very slippery slope between medical terminology and information models. Just to observe, I am not sure that I have a solution to it, but you bring up a major issue. Jeff, did you have a comment?
DR. BLAIR: The only thought that I have here is that again, I consider this a relevant reaction to the report. Somehow, we have to communicate to folks so that they understand where the boundary lines are between standards and the design of a system. We will have to work at that, yes.
DR. HANDLER: Aaron Handler from Indian Health Service again. I have a suggestion that may require additional work. It probably would require additional work. Maybe you should have two versions of this document. One version would be for medical setting administrators and another document along the same lines, following the same outline as this, for laymen. Instead of considering it laymen, consider the audience Senators and Congressmen. Do not think of laymen as the person on the street; think of laymen as Senators and Congressmen.
DR. COHN: I think you make a very good comment. My hope is that the executive summary might serve some of that purpose. Other comments?
DR. ROTHSTEIN: I was just going to say that from a layperson's perspective, I think figures one and two are absolutely crystal clear because if the point that you are trying to make is this is a very complicated system, and it is not very streamlined, and there is a problem with people speaking the same language and communicating with each other, and we need to fix something, you do not have to know what any of these words mean or what these arrows mean. It is perfectly clear that there is a problem. Then the people who are concerned about the specifics can go in there and worry about the details.
DR. FYFFE: One picture is worth a thousand words.
DR. COHN: I guess the picture has done its job then. Other comments on this section? Margaret, would you want to lead us through some of the recommendations?
DR. AMATIOKAN: Okay. Page 19 begins the issues, observations, assumptions and recommendations, and we have three general recommendations on this page, and then we go into recommendations by focus area. Here, in the general recommendations, noting that there are a variety of issues and that HHS needs to take a leadership role in accelerating the adoption of uniform data standards and specifically address message format medical terminology, data quality and other issues. The first recommendation relates to the leadership role. The second one relates to authorizing NCVHS to make specific recommendations and selections for uniform data standards. Third, making the recommendation that HHS should support strengthening the leadership role of and encourage government participation in NCHISB to promote harmonization.
DR. COHN: Questions? Comments? Dan?
DR. FRIEDMAN: It is a semantic question, but I just want to see if I am missing something which is recommendation three, harmonization? Is that a term of art or a euphemism? Literally, I am not being cute. I am not quite sure what it means, and we may want to be a little bit more direct.
DR. BLAIR: More direct, okay. The word "harmonization." Harmonization has been used widely in international and European standards communities to reflect how do you wind up coordinating different standards, harmonizing them. Apparently that is -- okay, we may need a better word.
DR. SCANLON: A question about the recommendations. These are the things most people are going to end up paying the most attention to, so in the end. Recommendation one suggests that the Secretary should take a leadership role in supporting development and implementation. Is it your view or the view of the work group that the HIPAA authority provides the basis for moving forward on this, or is it the view that -- a rhetorical question, maybe, or that some other authority is needed. If so, that should be pointed out.
DR. BLAIR: Can I partially address that? It almost leads to the question that I wanted to ask the group as a whole. When we were going through our debate on recommendations, there was a discussion of how proactive do we be? Do we wind up going all the way to selecting specific message format standards and medical terminologies? The discussion that we had in the work group was that we felt as if the way the administrative simplification provisions were written for this work effort, where it said that we should study and make recommendations on uniform data standards for patient medical record information, we felt as if those words did not give us as much authority as the mission set forth for financial and administrative transactions and identifiers and data security. That led us to wind up trying to make recommendations to, in short, solicit the Secretary's support for making the selections. We wound up saying, here is the guidelines, the criteria we would use, the process we would use, here are the areas, but we stepped back from actually saying here are the choices, here is the selection.
Does the full committee think we did the right thing? I think I am piggy-backing Jim Scanlon on what you may be trying to reach for. I would really like to have the full committee's opinion. Did we interpret the law correctly in terms of our mission here?
DR. COHN: Mike, do you want to go, and then I will go.
DR. FITZMAURICE: I think in our deliberations, there was a kind of an adjustment. We would like to have a force of law and the industry mandate to go forth and put out patient medical record information standards. It would be great. I am not sure that these standards, as they exist, are mature enough, comprehensive enough or fully tested and used. Therefore, as Jeff said, there might have been a hesitation, but there was a recognition of what could be accomplished and in what time period and what has to mature more. We focused on finding out where this maturity needed to take place, what things needed to be done, and what should the Secretary do as the industry matures to support this, support development where there are gaps, support use of standards that are already in existence in programs so that it provides an example to lead the private sector forward.
DR. COHN: Maybe I can make a comment here also. I first of all want the committee to be aware that the area that is probably still the roughest in this report are the recommendations. Let's be honest about it. Indeed, every time we have gotten together, they have changed substantially. We are asking for input. These are likely to change significantly as we fight about them -- as we discuss them in the next couple of work group meetings. I can already see some areas where I am going to want to weigh in on. I think that is the nature of the discussion. We are really asking you all for help at a very formative stage. The other areas, I think you see, are 90 percent done. We are now actually just grappling with recommendations.
Now, there are opportunities for how something like this could be implemented. One would only have to look at page 10 to recognize that there are some areas where the Secretary already has authority, for example, for use within agencies of the HHS. Things could be mandated or recommended, also probably within agencies and mental health plans that cover government employees. Now, as we move toward wider use, certainly the need for additional legislative support, which I think Jeff was commenting about, becomes an issue. We obviously need, I think, to come back with slightly more refined recommendation around this knowing that the Secretary can do some things, cannot do others, at least with our understanding, with the legislative authority that has been quoted under HIPAA. That is perhaps a slightly more refined statement. I think we are probably likely to come back with this one with something where we recommend at least that the Secretary do this, potentially seek additional legislative authority to do two or three more things in this area. Once again, we do not have that authority today.
DR. BLAIR: Is John, Dr. Lumpkin, here?
DR. COHN: No, I am chair.
DR. BLAIR: We would really like to have his thoughts on this.
PARTICIPANT: He will be back.
DR. COHN: We can certainly go back to these after the lunch hour. It might be useful, actually since we are making comments about appendix C, which is sort of a forgotten area but is sort of a nubbin of how one would make decisions about standards, that it might be of use for the next couple of minutes to at least look through that. Have any of you looked through Appendix C at this point? It is the guiding principles for selection of PMRI standards. It is sort of the criteria which we are proposing be used to decide what ought to be a standard or not, be it being done by NCVHS, by HHS, or by whatever group. Potentially, that is a good use for the next couple of minutes, and then we can start back and run after the lunch.
DR. SCANLON: Before we leave, let me make another point. I think as you indicated, Simon, if you are making recommendations to the Secretary or to Congress or whomever, a general exhortation to go forth and do well is fine, but to the extent that they could be --
DR. COHN: Actionable?
DR. SCANLON: Well, something that, yes, whether it is in terms of a legislative framework, a policy framework or whether it is -- and they are a number of tools, a research and development initiative, a leadership or convening role, to the extent that it can be at least somewhat defined. I mean, we may already have a model with the administrative simplification for the implementation of the standards once there is agreement on them. I think the recommendations as they stand are so broad so that it would be hard to know what exactly was thought.
DR. COHN: Jeff, would you like to comment?
DR. BLAIR: I guess I would like to have your view in particular, though. Do you feel like -- I am sorry. Do you feel like we are at the right balance here where we are basically asking for support and the recommendations are generally at the right level? Or should we be more proactive? Do you think we should have --
DR. SCANLON: I think we have to see all of the recommendations.
DR. BLAIR: That is fine. We will save it for later.
DR. SCANLON: The first couple are fairly broad, but I think as you go into more specific recommendations, you have ways to suggest, and that may be the thing to do. Besides the Secretary, there will be others to whom you could direct recommendations.
DR. AMATIOKAN: Simon, do you want me to review the guiding principles?
DR. COHN: That is sort of the wish of the committee. My suggestion, I think Jeff had asked that we have Dr. Lumpkin in attendance for the actual recommendations, which I agree with. I thought a good use of the next ten minutes, assuming that we can get into it, might be just reviewing Appendix C just for thoughts about it since it would be a sort of criteria. Jeff, does that make sense to you as an idea?
DR. BLAIR: Yes, thank you, Simon. Good idea.
DR. AMATIOKAN: Appendix C, the first items one through ten are essentially items that have been guiding principles for selection of other administrative simplification standards. They may have been modified a little bit to be more specific to PMRI. Then item 11 and item 12 were added. Item 11 refers to characteristics and attributes for vocabularies. As I mentioned before, there are a number of scholarly works. At this point in time, there actually is a standard that is being developed under ASTM called "standard specification for controlled health vocabularies" that outlines this. It is in final ballot stage at the highest level within ASTM. That was referenced to come up with the description. All of the other works are included here just to identify the sources that were used.
The last two references of Ross A. Maurey(?) and Peter Alkin(?) I need to flesh out and get more detail. I know that those are incomplete.
Number 12 is the guiding principle with respect to data quality, the features and characteristics. Here, the work that we referenced here was the work of the American Health Information Management Association that actually stems from an earlier work of Merrida Johns(?).
DR. COHN: Questions or comments? Paul Newacheck?
DR. NEWACHECK: I have to apologize because I was not able to read this in advance; we had a little address problem with my books, so I am kind of reading as we are going along. It strikes me that many of these recommendations that are at the beginning of this appendix might go into the body of the report as a way of establishing kind of the perspective of the work group and how it is viewing the notion of a medical record. I think they are important principles, and I sort of hate to see them in the appendix only.
DR. BLAIR: Explicitly are you saying that we really should include the guiding principles in the body, maybe in like the overview of standards or the general portion of our recommendations?
DR. NEWACHECK: It could be either place, and it could be just sort of a summary of the key principles that guided the thinking of the group.
DR. BLAIR: Do other committee members feel the same way and support that?
DR. COHN: I see a lot of head nods.
DR. FRIEDMAN: I completely agree, and I was going to suggest that, too.
DR. COHN: That is actually a very good suggestion. Are people generally comfortable with the guiding principles? I know that we will be looking at them, obviously, again. I actually have a question for, I guess Margaret and Jeff only because this is the first time that I have seen 11 and 12 so fleshed out. Do these apply -- does 11 specifically apply to all standards evaluations, or is it just medical terminology standards?
DR. AMATIOKAN: No, it says here, "are consistent with the characteristics and attributes for clinically specific terminologies."
DR. BLAIR: That is for 11.
DR. COHN: I know, but does that mean that this guiding principle only applies to the evaluation of medical terminologies, or does it apply to message format standards? If indeed it only applies to one, we just need to -- it was not clear to me.
DR. AMATIOKAN: I think the intent was that 11 applies to the selection of terminology but that 12 applied to the features and characteristics of any standard, message format terminology, whatever, that embedded in it data quality characteristics.
DR. COHN: The reason I am asking, just for further clarification, is that most message format standards have code sets imbedded in them. The question was does this apply to the actual evaluation of those message format standards or just to medical terminologies? I just was not clear, so it sounds like we need to discuss that further.
DR. AMATIOKAN: Let's work on that.
DR. COHN: Barbara Starfield?
DR. STARFIELD: This comment refers to recommendation 12 on page 45 and harps back to what Kathy Coltin mentioned before. I realize that you probably wanted to make these A through J compatible with the Health Information Management Association, but I think that there is another one that is interpretability.
DR. AMATIOKAN: Interpretability?
DR. STARFIELD: Yes. Can you correctly interpret the information as it was intended? I think the examples that Kathy gave before are very good in this context.
DR. COHN: Other comments? I think that was actually a very useful discussion. I think what we are seeing is that the appendix is important enough that it be in the body. I think we will figure out where to put it. Obviously, we have made a couple of modifications and clarifications. Certainly, one has to recognize that this is what we are presuming to be sort of a basis upon which we will work from. It is important that we be comfortable with it.
Now, with that, it is actually -- are people comfortable with stopping at this point? We are now at 12:45 at least by one person's watch. I am going to suggest that we adjourn for lunch and that we reconvene at 1:30. We will continue our discussions at that point.
[Whereupon at 12:45 p.m., a recess was taken until 1:30 that same day.]
DR. COHN: This is Simon Cohn again, acting in John Lumpkin's stead, as acting chair. Our apologies for running a couple of minutes late. I think we had expected that Dr. Lumpkin would be back in attendance by now, but I think it makes sense for us to get started.
With that, I think we have another 45 minutes to an hour to begin to talk about the recommendations. Jeff and Margaret, I guess I would have you start leading us over with them. I apologize because I know we had wanted to get Dr. Lumpkin's input as you move forward, but we will have to figure out another way to get that information from him.
DR. BLAIR: There is one other thing, a comment that came up just a few minutes ago from Aaron Handler, a perception that he had. Aaron, are you here?
DR. HANDLER: Yes.
DR. BLAIR: Could you share that with the rest of the group?
DR. COHN: Aaron, would you please come to a microphone and state your name, please.
DR. HANDLER: Aaron Handler, Indian Health Service. I thought about this at lunchtime. When I first read the report to the Secretary, the third draft, on the very top, it is titled, "Uniform Standards for Electronic Exchange of Patient Medical Record Information." I was thinking, maybe some members of the committee have obtained the misinformation and misimpression that this is a cookbook for accessing data automatically, almost like setting up a website. All you have to do is click on the internet and you get down what you wanted.
Basically, what this is is setting standards for automating records, but built in are controls of who can access it, and built in controls of who can make releases and what items of information can be released to who. That is not clear from this title. I think the title sort of sets the tone for what people read afterwards. I suggested that maybe the phrase "electronic exchange" should be removed from the title and then explained in the body of the report itself. That was my suggestion.
Dr. BLAIR: Margaret, did you want to go on with the recommendations?
DR. AMATIOKAN: I think we talked about general recommendations.
DR. COHN: I think Kepa had a question or comment.
DR. ZUBELDIA: Following up on this comment, should we consider those other things that are necessary for the exchange as part of the report, like security agreements, all of these other -- the rules of engagement, business rules, rather than the formats and dictionaries and all of that. I mean in addition. Not rather than the dictionaries and formats but in addition. Should we consider all of those other business rules for the exchange of medical information.
DR. COHN: Without, I guess, trying to answer yes or no, why don't we hold that as an idea, and maybe we can have Margaret reference it, and we will see as we go through the recommendations. I think some of them are actually effectively business rules or business engagement issues, but I think as we move through the recommendations at the end, we can reflect and see if we have really addressed that or not. Certainly, I think we are all sort of nodding that it makes sense to have that be part of the charge.
Margaret, where are we? Are we still dealing with one, two and three?
DR. AMATIOKAN: Yes, I was wondering if we were finished with that and can move on, or are there any more comments on that first, page 19?
DR. COHN: Yes, if you could introduce yourself.
DR. STEINDEL: Steve Steindel, CDC. General recommendation number three. I think it should be expanded to just not limit the role of the government, government participation actually is, but we should also recommend to the Secretary that the government be involved in other SDOs.
DR. COHN: Michael?
DR. FITZMAURICE: I would pick up on that. I think it is a good point, and I think the point is that not only should the government support the coordination but where it is beneficial to its programs, make sure that the standards that it wants for its own programs are compatible with the industry and vice-versa. There is a general OMB directive out to encourage agencies to do that, but it is also good, I think, for us to say that as a recommendation to the Secretary.
DR. COHN: Very good. Other comments in relationship to that?
DR. FITZMAURICE: I would note that many agencies are already doing this. CDC is probably in the forefront of doing this.
DR. COHN: Just to reflect on our earlier discussions about one, I think there is obviously a recommendation that that needs to get a lot more specific and actionable, which I think is the other piece. We are all aware of it, and what we can do to make these things actionable and specific is all to the good, but we are also trying to work through layers and make sure that we are okay with the general direction of the recommendations. Maybe from there we can drill down. Michael?
DR. FITZMAURICE: Another comment. There was some discussion, I think before the break, about should the agency become a member of ANSI as a supporter of standards? For an agency, that might cost -- for HHS, that might cost, I think, $25,000. Each agency pays $2,000 or $3,000 or $4,000 based upon their revenue. Some agencies are already members, but I do not think the department as a department is a member.
DR. COHN: That is of ANSI or ANSIHISB.
DR. FITZMAURICE: Of ANSI.
DR. COHN: ANSI itself, okay.
DR. FITZMAURICE: The FDA is a member of it. I think CDC is a member of ANSI.
DR. COHN: Other comments?
DR. AMATIOKAN: Mike, is your recommendation that the department become a member then?
DR. FITZMAURICE: Yes. I think that should be considered by the committee as part of leadership. That is part of being at the table.
DR. COHN: Let me bring up an issue before we move on to the next set of recommendations which is number two which really actually has not been discussed. In selecting or recommending to the Secretary the standards and all of that, I guess I would open up to the group is, from your view, this the right level of recommendation? The work group itself had mulled over whether we should get more specific and actually begin to recommend some standards, which actually, as I am thinking about it, that may be brought up later on. I think effectively here what we are saying is set this system up and let's go forward with it. Is everyone comfortable with that and the role of the NCVHS in helping to specify these? No comment. It sounds fine. Okay.
DR. AMATIOKAN: The next set is the first focus area, message format standards. We have a summary of the issues, observations and assumptions. Some of this is repeated from earlier, but noting that there has been considerable progress. Detailed implementation guides do not typically exist, lack of conformance testing, coordination would help promote harmonization and acceleration. Although development of message format standards should be guided principally by market forces, the process is slow, and there is need for leadership and broader and more active participation, especially by clinicians.
The recommendations here, there are five of them. What I have found helpful is to look at them as something of a continuum so that the first one is recommending adoption of interoperable PMRI standards for use within all HHS agencies and health plans that cover government employees which was level two of those four levels that we had listed before.
Second refers to standard implementation guides. Third is conformance testing. Four is filling the gaps and addressing inconsistencies through funding some standards development activities. Then fifth is coordination among message format standards and medical terminology developers. They are recommendations specifically relating to data registry, conferences and workshops, and government agency participation in the SDOs.
DR. COHN: Comments? After lunch, huh? Michael.
DR. FITZMAURICE: Let me ask myself, since I helped craft this. What do we mean by the PMRI message format standards? For example, do we mean the kind of wrappers that X-12 has on the transactions? Do we mean the formats that are imbedded in HL-7 messages? Do we mean things sent by email or things sent using extensible mark-up language? Adopt a certain format as soon as it comes out? I am just wondering what we are saying here, about which messages and which format standards, or is that too detailed right now and we should keep it as a general statement and then adopt it as we start passing messages around?
DR. BLAIR: We had in that overview the two graphics. One was trying to give kind of an overview of message format standards. Now, is it because we have had lunch in the meantime or is there another -- should we make a reference here before we go into this section to refer back to that picture of what message format standards are?
DR. FITZMAURICE: No, I think you are probably wise to refer me back to that diagram.
DR. BLAIR: Add a reference back to the diagram on message formats.
DR. FITZMAURICE: So you would be talking about messages sent according to figure one, whenever we send hospital pharmacy messages, it ought to be in the dominant message format standard, HL-7 here?
DR. BLAIR: At least that is what we were thinking about.
DR. FITZMAURICE: I am just thinking that it needs -- if we are going to make a recommendation, at some point, it needs to be more specific. Maybe the Secretary should also look into which message standards are applicable for which transactions her agencies engage in and begin a process of adopting these standards. That is not all at once and turn it on but let's identify them, let's look at the reasonableness of them, and then let's do them. If they do not fit, then maybe that is not reasonable to do that.
DR. COHN: Jim and then Marjorie.
DR. SCANLON: I am sort of looking for a basic strategy for these recommendations. So far, they seem to throw everything at HHS. I guess I am -- is there not a role for -- well, there are two things. There is the issue of what the standards themselves are, and then there is the issue of how do such standards get adopted and implemented. I think there are a lot of things being thrown together here. The other thing I am struck by is this sort of is giving the picture that this is entirely an HHS operation, and I really think here, as in the admin standards, isn't there a balance between what the industry does best and what HHS does best. HHS mandating a lot of things may not be the best way to start along these lines. So, I guess I would look for recommendations of what does the industry do best as well and other recommendations.
DR. BLAIR: The perception in this section was that the DHHS [commenting off microphone].
DR. COHN: Just so that I understand better what you are saying, I think we had been looking for recommendations that somebody could act on. I guess the question I would have to you is that we could certainly comment that certain things -- and there are many very good things that private industry does, for example, create standards. They are directly responsible for creating the implementation guides and maintaining them. We were not sure exactly who to make the recommendation to that that is what they ought to do.
DR. SCANLON: Some of them clearly involve -- obviously the recommendations to the HHS Secretary. I think for a fuller picture, I think it is up to you. I would certainly include some recommendations to the industry, give them some ammunition as to the rationale for doing something that they do best. I mean, HHS does not do some of these things better than the industry. To the extent that there are existing standards that could be adopted and again, the process ultimately would have to be discussed. Is it a HIPAA-like process or something else. I guess I would look for more balance in terms of who does what and then what the HHS role is.
DR. COHN: Marjorie?
DR. BLAIR: Interestingly, you will find that that observation that you just made, Jim, applies throughout the entire document. Virtually the entire recommendations section was written in terms of what the Secretary of the DHHS can or should do.
DR. SCANLON: I guess that is fine. I guess I -- and it is hard to even draft recommendations, the first draft of recommendations, but I think we may want to think of who are the other players --
DR. BLAIR: Some balance in there.
DR. SCANLON: -- and it may not even be a balance. It may be a preponderance of HHS. It almost looks like these will not happen unless HHS literally develops everything, and I do not think that is the impression that you want to give.
DR. BLAIR: Especially on the developing piece, no, we certainly do not want to give the impression that we are looking for the Secretary to develop these things. We were hoping that the DHHS could serve as a catalyst.
DR. SCANLON: Right.
DR. BLAIR: Okay, and maybe those are the kind of missing words or thoughts.
DR. SCANLON: This might be the area.
[Simultaneous discussion.]
DR. COHN: Marjorie, do you have a comment?
DR. GREENBERG: Getting back to Mike's question, I just want to know if I am interpreting this right. When you say here in the first one, "The Secretary of HHS should require that the PMRI message format standards be used," are you referring to those standards which the Secretary has asked, authorized NCVHS to make specific selections for?
DR. AMATIOKAN: Yes.
DR. GREENBERG: You are not saying all of these standards here in this diagram, because obviously there are competing ones. That would not work. So, that really flows from, am I correct, flows from the recommendation that the Secretary ask the national committee to actually make selections. Then based on those selections --
DR. BLAIR: Exactly.
DR. GREENBERG: -- then those be required. Okay. That is not altogether clear, and I think it was not from what Mike asked.
DR. COHN: I think there needs to be some adjective in there that indicates that these were the ones that were actually approved, not everything that is --
DR. GREENBERG: Yes, because otherwise, which ones are you talking about? Right. Also, getting back to what Jim was just saying, I think that -- now, I am not sure of the extent to which the report describes what the ANSIHISB is supposed to do. I think there what you are trying to get at by recommending that the Secretary support their leadership role, et cetera, was really to be pointing to the industry that they have this group for coordinating, and that that should be, if anything, strengthened and supported, and that maybe that needs to be fleshed out more. Then it takes the emphasis from being just totally on what the Secretary can do. Actually, you are asking the Secretary to promote that kind of voluntary standardization.
DR. COHN: Thank you. Kepa.
DR. ZUBELDIA: Yes. I think that some of the discussions that we had in the work group were along the lines that the process would have like three phases. Initially, NCVHS could decide on what aspects of the PMRI need to be automated or need to be automated first, much like the list of nine transactions that appear in HIPAA where the list specified claims without specifying whether it was going to be UB-92NSF or A-37. Then let the industry come to a consensus in the second phase based on those functionalities that need to be automated. Let the industry come to a consensus as to what standards will be ones that should be adopted. NCVHS then adopts those standards and recommends to the secretary those standards for adoption. Then finally, like this is asking in the first recommendation, HHS would actually implement those standards to lead the process with this industry-leading, big implementation of the standards.
DR. BLAIR: I was with you until the last piece. You are saying agencies within --
DR. ZUBELDIA: Agencies with HHS --
DR. BLAIR: -- HHS would be required to implement it.
DR. ZUBELDIA: Implement it. Much like they are required to implement the HIPAA administrative simplification transactions.
DR. FITZMAURICE: Now we go back to the first statement about the industry decides which standards, sometimes federal programs need to move data around for public purposes that sometimes you do not find them in industry. You do not find all of the data needed in industry. Would you then suggest that the government go to the standard developing organization and plead the business case for having these, the government business case for having these, and work within existing standards to expand them to create something situational rather than saying, here is what we need for our business.
DR. ZUBELDIA: I think that is a good approach because we need to get the industry involved in it if you want it implemented. If the need is only for the government, that is possibly a margin of requirement and may not be -- the standards need to be adopted first. I think that those developed at first will probably have much wider application than just the government.
DR. FITZMAURICE: What I am thinking of is, for example, the race and ethnicity data. The government can say, this is the way that we are going to do it. The government can say, let's go to X-12 and say here is our business need for that, you do not have a business need for it, but we have a business because our business is the public good, and we want to work with you to get a specification and incorporate it as a potential use in an existing standard. Now, the industry may not have the right kind of standard so it will work with a government program, but in working together, we get a standard that we can both work. So, I just caution to say that the industry does not decide which standard, but working together, those who need to use the standards work together to get a standard that all can use.
DR. ZUBELDIA: Yes, and potentially there could be the possibility of the industry cannot make up that kind of decision like what happened with NSF UB-92 and A-37, and that decision needs to be made here.
DR. FITZMAURICE: Yes.
DR. ZUBELDIA: After hearings and all of that. That is also a potential.
DR. COHN: I would just insert a comment. I think what we are describing is a process that we are hoping -- we are trying out right now with the administrative and financial transactions. One should be aware that we are just in the process now of everybody suddenly saying, oh, my, we are implementing this new thing, does it meet my business need. Hopefully, this will sort of smooth out, and all of the business needs will get represented appropriately in these standards. I think what you are trying to do is to suggest that the same process would also be applicable to these standards.
DR. FITZMAURICE: You are exactly right. I am more comfortable if I see that there are potential processes on which we have agreement. Then if we state something general, then it is fine. I know there is at least one example of how it could work.
DR. BLAIR: I understand that our chair, Dr. Lumpkin, has just returned. Is that correct?
DR. LUMPKIN: I am here.
DR. BLAIR: Wonderful. There were a couple of topics that we were saving for you.
DR. LUMPKIN: It's funny. They did the same thing to me back on my conference call. Yes?
DR. BLAIR: Let's help you maybe get settled a little bit. We went through a good part of the document, and we are in the section on recommendations. There is a mindset that the work group gravitated towards. We really want to have your thoughts on whether you think that it is the right balance and the right approach. If you could turn or maybe somebody could help you find the page where we start to begin to discuss the recommendations and we have overall general recommendations.
DR. LUMPKIN: Yes.
DR. BLAIR: The things that I am about to tell you are not in the document. They are the thinking behind how we came to some of these recommendations, and we are not positive that this is the right balance. Namely, in HIPAA, the administrative simplification provisions, when it wound up referring to the work effort that became this work group, the words were that we were to study and recommend uniform data standards for patient medical record information and the electronic exchange of that information. That is fine.
When we began to go through this process in terms of what those recommendations should be, the feeling in the work group was that we did not have the same level of authority as the work effort that selected the standards for financial and administrative standards, selected the standards for or rather the identifiers, provider identifiers and health plan identifiers, or selected the code sets that went along with the financial administrative transactions. Those were actually where the NCVHS made recommendations that the DHHS should adopt specific standards or terminologies or identifiers. We interpreted those words as not getting quite to the point where we had the authority to do the selection. You authorized the NCVHS to do the selection process, and here is how we do it. Okay? We wanted your reaction to that.
DR. LUMPKIN: Yes and no. The charge, which is to adopt -- study the issues. So in a sense, this document can respond to that charge. However, under the charter of the committee, which is under Tab 3, the committee is given fairly broad authority including to identify strategies and opportunities to achieve long-term consensus on common health data standards that would promote availability of valid, credible and timely health information and multiple uses of data collected once. Recommend actions that the Federal Government can take to promote such a consensus.
I think that either approach is supported by either the charter or the specific charge under HIPAA. So, I think taking the tack of making these recommendations are fine, but I would not necessarily wait or I do not necessarily think that we need to ask the Secretary for authority to go ahead and work on specific standards. That is how I would read that. Jim, do you?
DR. SCANLON: I think that is true. I think the philosophy you are suggesting, Jeff, actually is at least getting sort of an assent from the Secretary that yes, you should proceed to that level, but you are not proposing to actually recommend specific standards as part of this report. That is what I am understanding.
DR. BLAIR: I think that is correct.
DR. SCANLON: You are laying out the elements of the process.
DR. BLAIR: Yes.
DR. SCANLON: It sounds like implicitly it is much like the admin simp process, although there may be others. It is much like the HIPAA process for the EDI standards. It is more implicit at this point. You may have to make it a little more explicit. But you are not recommending -- you are saying that is the process that we would use, and this is sort of a field from which they would be drawn, the process of developing consensus would be similar, but you are not actually saying, "At this point I will recommend the following," which is fine. I do not think it in any way slows down the committee if it was to continue to actually begin looking at those standards. You are giving the Secretary sort of the courtesy of responding at that stage, saying yes, this is a generally acceptable process that I see here. I do not have any trouble with that.
I think what you are implicitly, though -- the committee implicitly is proposing a process for the adoption of PMRI standards --
DR. BLAIR: And defining the criteria as well, yes.
DR. SCANLON: That is right, and it is modeled, implicitly at least, over what has already been done in the HIPAA area. I think, in my own view, the HIPAA statute gives us the authority to do that. I mean, we would have to check with our lawyers specifically, and the Secretary has the authority to issue new standards. I think it all fits together. It is just that it is a conscious decision that you are not recommending a specific PMRI standard right now in this report.
DR. LUMPKIN: And that is fine. That is good.
DR. ZUBELDIA: Should it be explicit in being modeled after the administrative simplification standards?
DR. SCANLON: We were sort of raising the questions. Let me think about how explicit it should be and have are there other assets that would -- you want to make it different, I suppose.
DR. BLAIR: My inclination, to be honest with you, if this is okay. I do not think that it is necessary to say that we are modeling it after, and besides, what we are having to do is there is complexities involved with PMRI standards where we have to add new criteria and consider things in a different way. There is also not as much of a maturity in the message format standards, for example, and especially the terminology that existed in the financial administrative area, so we are calling for things like research and for other things. I do not know that it would be helpful for us to say we are modeling it. We are taking the things that might help and that are appropriate.
DR. LUMPKIN: I think that may be, "building upon the experience of."
DR. BLAIR: Building upon the experience, yes.
DR. SCANLON: You are specifically including, Jeff -- this is Jim again -- the idea of some developmental work or R&D and so on to precede the adoption of some of these standards.
DR. BLAIR: Other thoughts, observations?
DR. COHN: I guess I would just sort of to conclude this little set of comments which is that what I am referring to is that nobody thinks there is necessarily any limitation in the work group's report to have to stay at a higher level and that it is really the judgment of the work group on how specific we become. There are no artificial distinctions on that. Is that correct, from Jim and others, that we could -- I mean, for example, we could get -- I mean, we are unlikely in the next six months to identify a list of candidate standards, but we might, for example, identify a list of high priority focus areas, much in the same way, not to have it modeled after the administrative and financial transactions but that if one could, it might provide the next step of getting to identify standards for those areas, for example. A thought.
DR. SCANLON: In terms of limits to that authority, if you recommend to the Secretary that she adopt something that relates to HHS programs, that is one matter. If you recommend to the Secretary that she adopts, in essence the force of the law, regulations for the whole industry, we have to be clear that she has the authority for that. I think what we are concluding is that if it relates to standards, including PMRI standards, she probably does have that authority.
DR. BLAIR: Okay, she has the authority but we are trying to wind up saying here is our direction, the process we are setting up to do that, and does she sanction us going forward.
DR. COHN: Actually, let's just stop for just a second because this is this is sort of an important distinction. Is there a way to get a legal opinion on this particular piece? I think it might be very useful in terms of knowing how to approach this one. I am not a lawyer, but I find myself a little confused by the legislation as well as recognizing that the Secretary has other statutory authority that is beyond the 16 pages of the HIPAA administrative simplification regs.
DR. SCANLON: But it largely relates to federal programs are benefits. There are other authorities except in certain areas.
DR. LUMPKIN: Except that the HIPAA legislation, where it talks about standards.
DR. COHN: For administrative and financial transactions. That is the reason I sort of say this because as you look at it, yes, we have the power to advise the Secretary, but the question is do we begin to make recommendations assuming the Secretary actually has the authority to go beyond the financial and administrative transactions to begin to say this is going to be the national standard for this sort of message format standard or subject area, and is she empowered to do that with current legislation and authority.
DR. ZUBELDIA: One possibility would be to make a recommendation that the Secretary determines whether she has the authority to do it, and if she determines that she does not have the authority, that she should promote the legislation that gives her the authority to do it.
DR. COHN: You are probably right except it seems that we should be able to get that resolved prior to having to write a report asking that.
DR. SCANLON: We could get a reading of that.
DR. COHN: I am just sort of thinking that is a "to do" that could be handled between now and late March.
DR. SCANLON: We will get our general counsel reading on that. There certainly is at least residual authority in terms of the Secretary being authorized to issue such additional standards as she sees necessary, but we have to see what sections of the law they are included in. That is true, you could either recommend that she seek authority or simply proceed with the authority that she has. We can get a reading on that.
DR. LUMPKIN: The only other thing to toss into that is that the committee has broad authority and responsibility to advise the Secretary. I think in regard to the administrative simplification, the transaction standards, that the marketplace is different than that for computerized patient records. My guess is even if the Secretary did not have authority to act, if this committee were to make recommendations on standards by adopting those that have already -- much as we did with administrative simplification, it would give vendors someplace to go and someplace to market. It may, in fact, further the development of voluntary standards, much more so than we would have been able to do with HIPAA without the authority to impose them because I think there is a benefit. There is a benefit to the purchaser of these systems because they know that it will be standardized. There is a benefit to the vendor because they know that they can build to something. I think that we could have some private sector impact without adopting a mandate.
DR. BLAIR: Your statements are reinforcing then the importance of moving forward and the value of this. You did not mean to say by that that we should include the selection in this set of recommendations here though, right?
DR. LUMPKIN: That is correct.
DR. HANDLER: Aaron Handler, Indian Health Service. For about ten years, I used to be my agency's OMB information collection clearance officer, and I would submit packages to none other than Jim Scanlon over there. Basically, if the Federal Government requires standard questions to be asked, then you need OMB information collection clearance. The way to get out of requiring OMB clearance is similar to what National Center for Health Statistics does with the collection of birth and death data. They convene meetings periodically with state vital records registrars and everyone comes to a basic consensus of what is needed and what is of benefit. They may word the questions a little bit differently. They may format their forms a little differently. You do not need OMB clearance for that. It is a consensus of opinion from all 50 states. It is revised about once every ten years. Maybe that mindset is what is needed here. You do not have to go through the hoops of OMB clearance. HHS is a facilitator of a decisionmaking process. That is basically what is done.
DR. LUMPKIN: We are running a little bit short on time, so we probably need to start walking through the recommendations.
DR. BLAIR: Yes. Margaret.
DR. AMATIOKAN: We are on medical terminologies. Again, the issues and assumptions here are described that medical terminologies to achieve full semantic interoperability and data comparability really are not as mature as the message format standards. Data is not coded at a granular enough level. Most medical terminologies do not incorporate the characteristics and attributes that are necessary for confidence in them. So, the recommendations are first to fund research and demonstration projects into the feasibility of capturing clinically-specific information at the point of care and demonstrating the value of improving cost productivity and quality of care by using terminology standards. Even before we get to what terminology or recommending specifics regarding terminology, what is the value of capturing data at that granular a level.
Seven is that the Secretary should select medical terminologies to be adopted for HHS programs using those characteristics and attributes. Again, that is level two that we talked about earlier.
Recommendation number eight is to insure that medical terminology selected from the private sector as national standards are available at minimal or no cost. The Secretary should consider financing developers. There are some specific criteria there.
To cover gaps in data content and achieve convergence among terminologies, HHS should support ongoing gap analysis and testing of convergence tools in relation to the NLM. Ten is the evolution toward more effective mapping capabilities. Eleven, a drug reference terminology. Twelve, the adoption of correlating medical terminologies for projects in order to accelerate the development of these standards. Thirteen, there was sort of a caution there that the typical two-year time frame of implementation may be too fast for adoption of medical terminology standards, so a more prospective timeline would be needed.
DR. COLTIN: I hate to do this to you, but I actually had a comment on the message format standards. We were kind of in the middle of taking those comments when John came in, and the conversation shifted --
DR. LUMPKIN: Once again, it is my fault.
DR. COLTIN: -- to the overall standards. I do not want us to go back too far, but I did have a comment on the first recommendation under the message format standards which talks about the Secretary requiring that these message format standards be used in all health plans that cover government employees. That one, you know, it resonated with me because I went back, and I reread the definition of patient medical record information. You are talking about information that is collected in the direct care delivery process. Here, you are using the word "cover" which is an insurance process. I think that for those health plans that operate their own health centers or own medical groups, you can potentially require them to use these standards if they utilize electronic clinical information systems. Just like the administrative standards, they only apply to electronic transactions. If you have care delivery settings that are totally paper based, this would not apply.
I think you need to modify it in a number of different ways. You might say that all health plans that deliver medical care services in settings that utilize automated clinical information systems or something like that to make it more specific. The way that it is worded now, the majority of health plans do not deliver direct patient care services. The one exception to that may be case management services and plans that do deliver direct case management services and utilize automated case management systems perhaps should have to adopt these standards for that activity. This is very broad, and I think it really needs to be narrowed down to where it is applicable.
DR. AMATIOKAN: I think we can narrow it and focus it more. The reference, however, to health plans that cover government employees refers back to page 10 and a level to which the Secretary may adopt standards, that is use within agencies for government business, use within agencies and in all health plans that cover government employees. So, in other words, this recommendation is really for VA, DoD, CHAMPUS, et cetera, and not Medicare.
DR. BLAIR: I think that is an important reference. I think that Kathleen was simply trying to point out that this recommendation is assuming that we have gone through the selection process prior to this, and the providers had these systems implemented before we could in fact say that they should adopt that. I think that was our intent. Margaret?
DR. AMATIOKAN: Yes. I think there was --
DR. BLAIR: She was just asking that we express that in the phrasing.
DR. LUMPKIN: I think I would clarify the language. I do not think that the secretary has the authority over all of the plans that provide service to government employees, so it should be working with other agencies.
DR. SCANLON: That is about 300 health plans.
DR. LUMPKIN: Right. That would be through OPM, and I do not know where they hook up, but they do not hook up through HHS. I think that the point is that it is not only an issue of mandating it within HHS but working with other agencies to mandate it.
DR. SCANLON: It should probably also be clarified that it is federal agencies.
DR. LUMPKIN: Federal Government.
DR. AMATIOKAN: Comments on terminologies?
DR. COHN: I guess I just had a question about number nine about whether -- are you proposing that NCVHS do cap analyses and testing of convergence tools and processes?
DR. AMATIOKAN: That NCVHS be consulted to do that.
DR. COHN: I guess this needs to be modified to be clear on that. I guess also question number 11, are we encouraging the development of a drug reference terminology, or are we saying that the Secretary of HHS should fund, or what is the -- I am not sure what "encourage" means.
DR. BLAIR: I think Margaret and I both sighed when you asked that question. It is a relevant question. This is a sensitive area. I think that -- here, let me give just a tad of background. It was clear that there was a need for clinically specific standards for medical terminologies in this area. The question is, how do you go about doing it, because it did not appear as if the market forces were in place for us to have a whole lot of leverage on this. So, we really did not know how to phrase it very well. Now that you know the rest of the story, maybe you can help us. [Laughing.]
DR. AMATIOKAN: We did spend a lot of time debating about fund and finance and subsidize and encourage and support. All of those verbs mean such different things.
DR. COHN: Without trying to solve it right now, it is obviously an issue for the work group.
DR. BLAIR: What if we did this, if we mark it and maybe we ought to even -- I am not sure about this, but we could talk about it either by conference call or in our next meeting to see in what way we could constructively engage the actual drug knowledge based vendors so that what we are doing is constructive and moving the ball forward and helping them, okay? Do you feel like that would be useful?
DR. COHN: Actually, why don't you just bring it up in March? Bringing it up in March is fine.
DR. LUMPKIN: Dan?
DR. FRIEDMAN: I had a comment on recommendation six which is the --
DR. STARFIELD: Can I just address what we were talking about? We are talking about 11 now, right?
DR. LUMPKIN: Yes.
DR. STARFIELD: Could you just sort of clue me in on what the purpose of that is? Does it relate back to safety, that you know the whole purpose that we talked about right in the beginning of the introduction? Is that what we are talking about, identifying things that might be unsafe or more clinically effective than other things? What are we trying to do here?
DR. BLAIR: Why don't you read it?
DR. AMATIOKAN: To promote the ability to share clinically specific drug information, the Secretary should encourage the development of a drug reference terminology that incorporates NDC codes, generic names, drug classes, et cetera. Currently, there are some competing drug terminologies and knowledge bases. What is needed is convergence among those in a reference terminology. The other position you could take is to pick one, but that is unlikely to occur, so it is more likely that there would have to be some convergence.
DR. STARFIELD: Simon just pointed out to me that paragraph six on the previous page gives the rationale for this. Maybe it is just a matter of linking the two more clearly, Margaret.
DR. AMATIOKAN: Would it be helpful for each recommendation to come after the description?
DR. LUMPKIN: Yes.
DR. AMATIOKAN: You would like that? Okay.
DR. LUMPKIN: Dan.
DR. FRIEDMAN: I had a comment on recommendation six, which is the public and private demonstration projects and research projects, which I think is a very important recommendation. There are two parts to the recommendation, and I think there is essentially an imbalance between part A which talks about investigating the economic feasibility of capturing clinically-specific information at the point of care, though they can be used for payment, public health and other purposes, and recommendation B, which is demonstrating incremental value of improving cost, et cetera. I think the imbalance is that A is really investigating economic feasibility and only economic feasibility and refers to public health, among others. Then B talks about demonstrating the value and essentially sort of leaves out the public health implications. I guess what I would suggest is that we phrase A more positively and more broadly than just investigating economic feasibility and broaden B by adding public health.
DR. BLAIR: By "broaden," do you mean economic --
DR. AMATIOKAN: I have it.
DR. BLAIR: Margaret has it.
DR. LUMPKIN: Any other comments? Go ahead.
DR. GREENBERG: Getting back to -- this relates to the recommendation here but also to what we were discussing before. On the one hand, the report recommends that the Secretary should authorize the NCVHS to make specific selections for uniform data standards. I assume that is across all of these domains. Then it suggestions under seven here that the Secretary of HHS should select medical terminologies to be adopted for HHS programs. Are you making a distinction here?
DR. AMATIOKAN: No, I do not think so. I think it was simply that by putting up front that the Secretary would use the advice of NCVHS to make the selection, it was assumed that that advice would carry throughout the entire document. Maybe that is not a valid assumption and we should repeat that each time.
DR. GREENBERG: Yes, it was not necessarily obvious to me. On the previous one, you had said that the Secretary -- you did not mention about her selecting message standards. You said that she should require the message standards that had been recommended, basically, whereas here, instead of saying that, you are going back to having her select them. I think it could provide some confusion as to what you are asking to do and what the NCVHS would be asked to do.
DR. SCANLON: This recommendation applies only -- seven applies to HHS programs. It does not apply to everyone involved.
DR. ZUBELDIA: I think a general thread through several of these recommendations is the concept of put your money where your mouth is and drive the market by creating a market. Out of HHS' own needs, you can create enough of a market to drive the private sector to converge in it. That is throughout at least the message format standards and the terminologies. It is a common thread.
DR. LUMPKIN: We are over our time limit. How do you want to proceed?
DR. COHN: How about if we have them quickly review the remaining recommendations, and we can probably try to get any input offline because we have actually already talked about privacy and confidentiality. Do you want to talk briefly about data accountability and --
DR. AMATIOKAN: Actually, the rest of the focus areas have a smaller number of recommendations. In data quality, basically the recommendation is to incorporate the features and characteristics and guiding principles for selection and to provide incentives for their use. Under diverse state laws, the recommendation is for the Secretary to take steps to insure that electronic signatures are universally accepted which would promote the adoption of these standards, and to insure availability and accountability, to promote to uniform national standard for retention of PMRI.
With respect to the business case, the recommendations were specific to encouraging more diversity of expert representation and the position of the U.S. in the international standards scene. In the national health information infrastructure, to support informatics research, provide centers for the use of information systems, and provide incentives relative to the GCPR project. We did talk about privacy before.
DR. LUMPKIN: Any comments on the last group of recommendations?
DR. COHN: Could I just make a comment about next steps? Obviously, there is going to be a fair amount of work going on over the next six months to -- I think as we have all seen, the first part of this document is actually pretty good. It needs to be made more compelling but is, I think, pretty much right on, I think most of us feel. Obviously, the recommendations are going to be the areas that are going to be chewed on. I think you should expect that they will be at about a 45 degree angle to what they are right now in terms of what you find when we see you at the June meeting.
Now, the issue, of course, is that at the June meeting, at least according to the HIPAA timelines, you really should be prepared to have a final ballot and agreement on those. So, we will be trying to get all of you involved as we go through, after our March meeting, and discussions to sort of try to get comments from everybody about the recommendations. I do not think we are going to see any new, revised copies of the first 30 pages per se, but certainly the recommendations are the areas where we need to have all of your input.
Beyond that, Jeff, would you have comments about other next steps that we might be taking?
DR. BLAIR: No, I think you summarized it very well.
DR. STARFIELD: Jeff, there are 23 recommendations. Is there any way to sort of prioritize these on a timeline, which group should come first? I mean, it may not be that we have ten groups. You might want to take some from each group that should come first, the order in which these might be implemented?
DR. BLAIR: Whether it is on a timeline, I do think we should prioritize. Yes. Good idea.
DR. LUMPKIN: Thank you.
DR. COHN: Yes, Jeff, thank you very much. You and Margaret have done a great job of helping us put it all together. Now we have the hard work ahead.
DR. LUMPKIN: The duration of the outline, which is getting increasingly fleshed out related to the National Health Information Infrastructure. The work group tomorrow morning will be going over this is in more detail. We did send some materials to you by electronic mail and did not get any response, so the more -- the further down the road we get, the less chance you have to have input.
We are looking to engage in a process where the first step would be the development of a paper. What we are actually looking for the committee to approve is that we will issue that as a draft that will go out for public discussion. The process is that would be released for public discussion at the 50th anniversary. What do you call that?
PARTICIPANTS: Symposium.
DR. LUMPKIN: Half a century. There must be a term, but I do not know what it is. The 50th anniversary symposium. It would be released even before it is approved by the committee as a draft document if that is agreeable with the committee. At that point, we would have discussion, some discussion, a reactor panel, and then release that for much broader discussion. Then the committee would take those discussions, have some associated hearings in different parts of the country, and then bring back, either in the fall or next January, whenever the winter meeting is, with a final document for approval. That is kind of the process. Do we have any questions on the process?
[There were no verbal responses.]
Are we all comfortable with releasing the draft before the approval of the committee of the work in progress for public comment?
[There were no verbal responses.]
Okay. Let me kind of describe where we are at with the NHII project. Many of you would recognize this. Assuming that they have checked the jack screw in the back of the airplane, pretty much everybody in this room would be fairly comfortable getting into an aircraft and looking in at the pilots' area. They look like that.
DR. ZUBELDIA: I would be looking for the pilot.
DR. LUMPKIN: You would be looking for the pilot?
DR. ZUBELDIA: Yes.
DR. LUMPKIN: Oh, wow. Kepa, you threw me off. However, most of us would be fairly uncomfortable if we looked in the pilot compartment and all we saw were that, an altimeter, a compass and a speedometer. That, of course, is pretty much how we operate health care in this country. We do not use much of what is possible with automation in order to assure the best outcomes. We have had a fair bit of discussion about that, so I will not go into any great detail.
The basic concept that we have to start off with the NHII is to describe what our goal is. The goal is addressing health to improve health. Health is defined by the World Health Organization as a state of complete physical, mental and social well-being, not merely the absence of disease or infirmary and further that health is a state of well-being and the capability to function in the face of changing circumstances. So, it is a much broader definition than we tend to look at as just the treatment of health care, and it recognizes that health has to be defined in terms of not only what is going on with the human body but how they interface with the environment, particularly as the capabilities may change over time or circumstance.
Our ability to define the health of our community is, in many ways, based upon our experience in the past. As early as 600 B.C., Hippocrates noted that if you want to know about the health of a people, you note the winds and the character of the air, the water that they drink, the lay of the land, and the habits of the people. Our understanding of health and our impact upon health has to be reflective of our ability to define and interlace what is happening in a treatment environment as well as the overall health setting of an individual.
In many ways, we go back to an approach that Evans and Stoddard once looked at health as being more than just unifactoral, there are multiple factors. Those would be the individual response, how the host responds, whether that be behavior, the choice of whether or not to smoke, the choice of whether or not to exercise, probably the two most important choices related to health. An individual's biology. Not everyone responds the same way to medications or interventions. The social environment. The physical environment. Whether or not there is lead in a child's home is a very important component of their health.
Genetic endowment is increasingly becoming a factor as we begin to look at and determine what kind of interventions. The character of health care, an individual's well-being going into the process, which is sort of the whole outcome. How they function in society. Also poverty and prosperity have a dramatic impact. All of these and the impact of disease as we have seen diseases changing over a period of time in their ability to affect human beings.
People who trained at the early part of the last century had a lot of training on scarlet fever. Scarlet fever is a disease that is rated to betahumalytic(?) streptococcus. For some reason, we are not seeing as many kids who get that infection developing scarlet fever as we did at the earlier part of the century because the organism has changed, and which toxins it releases change, which strains we see going through.
Also recognizing that some of the earliest approaches, Dr. Shinell(?) in 1854, probably the most important development in epidemiology, used a graphic database analysis and a graphic information system to plot an outbreak of cholera. The GIS system that he used was a map and a pencil. That is really all that you need when you are dealing with a small number of cases. For us to understand more complex interrelationships, we need to have more information and a better ability to process that.
In order to address these issues, as you all know, we have had presentations from Australia, and they have been doing some very significant work on developing the national health data model. This is from their webpage. You can see some of the areas that they have done. You can click on those, and you can comb down further and further and begin to see the data standards that they are proposing in Australia.
We have to recognize that we will have typically an American approach. Winston Churchill once commented that you can always count on the Americans to do the right thing, but usually after they have tried everything else. We are going to try to do that by learning from the experience of other countries.
First of all, we have to recognize that the psyche of the people of this country are different than other countries. One, our concern and respect for individual privacy. We want to make sure that we can assure confidentiality of the system, and we want to make sure that the system is engineered for security. All of these are important points. When Bob comes back, please point out that I talked about privacy like right in the beginning of the talk.
Part of what the NHII is about is data models, data standards and connectivity standards. That is an important component of what we are going to be talking about. As we have discussed today with some of the work of the CPR work group and also the standards and security committee, that is an important piece.
We also have to recognize that standards are not enough. There needs to be more. In fact, I would propose that we would conceptualize that the goal of the National Health Information Infrastructure is to push knowledge to the point of service or point of contact. That means that we also have to look at the ability of the NHII, as part of its function, to have expert systems, decisional support, practice guidelines, and intelligent support to individuals as they are trying to engineer their own health care and their own pursuit of health within the system.
As we began to approach it, we realized that we had to describe how the NHII should work. We began to look at the universe of health data. Now, one of the interesting things about looking at this particular foil, when you look at it on this overhead projector, there is like a moray pattern in there. If you were to look at it under a microscope, you would find out that in fact this is a very granular universe of health data. I only point that out because we are not talking about health data as creating a data system. We have to recognize that there are little bits and holders of all of this health information that exist all over the country. Every clinician's office has some. Every parent has their own collection of health data about their child. The local health department has information about their community. The goal of the NHII is to try to bring that all together in a useful fashion, not to cohabitate but to make it available at the point in which decisions have to be made, decisions that may have to be made by the individual, decisions that may have to be made by the health care provider, and decisions that may have to be made on a community basis.
This universe of health data is made up of information. Some of it may be held by providers. Some of it may be administrative data. Some of it may be personal data, information that is only held by an individual, the kind of things that you are asked every time you see the doc complaining of whatever is going on. Some of it is community-based data either collected by survey, collected by doing soil sampling. All of that is reflective of health data that is in the universe. Finally, some of that may be data that is only related to quality.
These are the more traditional ways of looking at health data. What we propose, as you can see in the outline, and I am just going to finish up with the visuals, is taking three different approaches to looking at the health information. We have had discussions in the past. we started out saying that we are going to call them records, but they are not records. We were going to call them health cords because that was a term that was not a record, but no one understood what that was. We were going to call them views, but that implied that you could actually go out and buy a view or have a view. Then we were going to call them all sorts of things. We finally decided upon dimensions. It describes something that is not necessarily going to be created but which is an important test of how the information is created. Those three dimensions are a personal health dimension. A personal health dimension and all of these three dimensions, the personal health dimension, the care giver dimension and the community dimension, all overlap. Many times, the same data will exist no matter how you are looking at the care. The amount of overlap will depend from time to time.
The individual will become the keeper of the personal health data. It will be populated to depend upon that individual's choice. I may want to know about every laboratory test that I have ever had. Why not? There are other people who really do not want to know their -- you know, I can remember patients who said, when you asked them why they have an operation, and they had a scar that went from their neck all the way down to their bellybutton, and they said, because the doctor said I needed it. That may be all that they want to know. There are other people who did want to know more, and that data was not necessarily available to them in a useful fashion.
The three dimensions are the personal health dimension, the caregiver health dimension which is the information that an individual caregiver, physician, nurse, nurse practitioner, physician's assistant, whoever is providing that care, may need in order to make decisions and for which the individual is willing to give them that information. It may be that that caregiver may need some information for which the individual is not willing to provide, mental health history. They have to reach some accommodation just as they do in our paper-based system.
The third dimension for which they all share information is the community health dimension. This particular dimension may include information related to lead cases in the community, the number of houses built prior to 1970 which are at risk for lead. It may include information related to toxins that were formed in the environment. It also will get information that may be collected through health care encounters that would relate to the rate of breast cancer in a community, which would be totally unrelated to each individual case but when you put them all together you begin to see a pattern and say do we need to look and do an investigation.
This is a brief, a very brief description, because we have been talking about this for a while. The purpose of the session is to give the work group some input and ability to move forward. We are going to start writing because we are focused on getting this done, the first draft, for June, and we want to get as much input from the committee. We are hoping that when we send the first draft to you, you will comment upon it.
We will see if there are any general questions or comments?
DR. FITZMAURICE: One question. I can carry this outline, but when I see the outline filled out, I am not sure I could carry the weight of a disk that it would be contained. Is this going to be a large book? I mean, as I look through there, I do not see an awful lot that I disagree with. I think if you would ask me what I would cut out, I am not sure I would cut out anything. This is a very large undertaking in a period of four months.
DR. LUMPKIN: Yes, but I think it is the first approach. It will be for the committee, for the symposium. Let me just say, because I probably did not explain this as well as I should in the beginning. It is not the intent of the NCVHS to develop the NHII. I think what we are trying to do is to throw things out that will create the environment for which people can say, you know, this is where the piece I am working on fits in. Others may look and say there are gaps here, there are areas where standards need to be developed, and maybe we can develop them.
The Department of Health and Human Services, we had raised this morning, are looking at putting money into a data initiative, then the NHII would also provide a guide to where that information dollars can be spent. That really is the overall goal of this, to sort of put it out there, say this is kind of our overall picture, and then over a period of time, I think we will work on refining this as sort of a living document. I think it will be a sizeable document when it is finally done.
DR. FITZMAURICE: I can see this as a framework and a sense of prioritization to say where should we make the investments, but I can also see it being, here is a framework, but over the next year, we are going to develop this part of it, over the following year, we are going to develop that part of it. I see it as growing and growing into maybe the heavyweight tome that I envision when I see the outline. I applaud the outstanding work at collecting so much stuff and fitting it together in the right way. I am just worried that I would not be able to read the large document by June, that is all, and that there is so much in here that it is going to take a long time to do justice to it. It is hard to do it in a short time.
DR. LUMPKIN: Jeff?
DR. BLAIR: Forgive. I have been running so fast that I fall behind on my emails and was not able to turn around things. If this was a document that I needed -- I read through all of the briefing books, but I did not get to see this one. If my comment is covered already, then it is because I did not get a chance to read it.
My thought was that this framework that you just presented to us, I am kind of piggybacking on Michael's comment that a lot of the broad health care issues that we are trying to address needs data, and needs it in a certain level of granularity, in a certain time frame. If we develop this National Health Information Infrastructure document framework in a manner where it is something we could map national health care needs against, then we could wind up saying that we have the -- we need the ability to prioritize where we spend our funds, but we need better data, and here is the missing link in the information infrastructure where we cannot move forward. Maybe that is where we need to prioritize our investments for standards for health care information systems. Am I saying what you already had in there, or is that an additional idea?
DR. LUMPKIN: I am looking through to try to --
DR. SCANLON: [Commenting off microphone.] The standard is spelled out, but it is not to determine priorities of health care needs. [Moving to microphone.] The role of standards in NHII, Jeff, is discussed in this, where does it fit in among all of the other tools and framework with the National Health Information Infrastructure, but by no means is it suggested that that is the way priorities about health care needs in the U.S. are addressed.
DR. BLAIR: I was trying to do it the other way around. I was trying to say here we have these priorities, national priorities, or we are struggling to identify these national priorities, and here is where we need better data, and we are being blocked because that information infrastructure or certain standards do not exist, so I guess I was looking at a two-way street. It is pretty much there is what you are saying.
DR. LUMPKIN: No, I think what -- what I am hearing, and Dan, why don't you say it first.
DR. FRIEDMAN: I am not sure if I understand what you were going to say, but I wanted to respond to what Michael just said.
DR. LUMPKIN: Let me respond to Jeff.
DR. FRIEDMAN: I think this is also responding to what Jeff just said. Mary Jo and her staff, I think, did a really good job in putting together the outline. Jeff, we also -- it came in yesterday's email, so you have not had a chance to go over it yet. We will be talking about it tomorrow morning. My sense is that the parts of it that we have really massaged were what are sections 8 through 11, which are the individual health dimensions. My own sense of where I would like to go with it, and again, I know we are going to talk about this more tomorrow morning, is that I would rather not see a tome. I would rather see something that is short, makes a very convincing case for what a future could look like, makes a convincing case for what the barriers to that, to an NHIIR, makes a convincing case for the needs and then goes in in English really explaining our concept of an NHII. Even though, I guess, this is a report to the Secretary -- I do not know if it is a report to the Secretary, but I would hope that it would be something that would be convincing and much more generally convincing and less rather than more technical and addresses exactly the kinds of issues that Jeff is discussing, has discussed.
DR. LUMPKIN: If I could take that a step further. I think the point Jeff raises, which we will have to look through here and see if it is covered -- not covered, but it really is an approach. There is a lot of focus nationally on medical errors. If you really are going to address medical errors and medical decision making, then you cannot do that adequately. If as part of that pushing knowledge down to the point in which decisions are actually made, then the system has to have the ability to add to health care decision making as well as health decision making. That requires that you need to have the data for making the decisions. There are many levels of decisions that need to be made. Some are made for a whole community. Some are made for an individual. Some an individual makes for themselves. The technology of the NHII will facilitate that so that the likelihood of the best decision being made is greatest.
That is one example tying it into a national priority. I think there are other priorities for which we may want to look at this but look at it in a much broader health sense of developing the system.
DR. BLAIR: Can I give one example that is kind of a scenario, because this is really what I was thinking of when I was struggling to express myself. One of the documents that I read over the weekend with the briefing books that were sent out to us was this report by Los Angeles County on a new methodology for being able to help us prioritize where we focus health care public policy and resources. It was that global burden of disease methodology. As I read through that, the essence of it was that for the most part, we wind up having pretty good data on mortality. We know who has died and when they have died and what they died of, but it has been more difficult for us to get good statistics in other areas, although this took a methodology and wound up saying if we did wind up having a methodology where we said what is something that either causes premature death and put a factor for that or functionally disables a person to a certain degree, impacts their quality of life, let's quantify that, and then roll it into a number where we could have a new set of priorities, and then it matched it up against different geographies, different racial and ethnic groups, and it started to be, I thought, a very powerful tool to giving us new insights on public policy. The thought as I was reading through it, of course with the preoccupation that I have with the CPR work group, I was thinking right away, and the NHII as we begin to build that, is what data would you then need to be able to number one, execute the new methodology, and then number two, go the next step in terms of coming up with programs and plans and seeing improvements. That is what I was thinking of because that would trace right back down to the fact that we need an information infrastructure to support these new approaches in public policy.
DR. LUMPKIN: Other thoughts? Paul?
DR. NEWACHECK: In one of the sections of the report, there is a discussion of the benefits of fully integrating NHII. I am wondering if there should be also, for balance purposes, a section on the costs of integrated NHII, that is essentially outlining the kinds of resources that would be required to create the structure that you would like. They are listed in various parts of the report, but putting it a little bit more concisely and balancing it against the benefits so that the reader can get a sense of what it would cost and what they would get in return for that.
DR. SCANLON: I think there probably is a placeholder for this concept, but obviously the HII is part of NII. There is basic infrastructure that we do not want help to reinvent or invent differently; we want the health sector to build on and use the broader NII capability when it is available. Is that point made, John or Mary Jo, and are we clear that we are not talking about -- we are talking about building on the NII when we can and not creating entirely new approaches where we can build on others?
DR. DEERING: I will come to the table. I think that is very much intended to be there. In fact, one of the reasons why it probably looks heavier, Mike, than it actually is, part of the difficulty we have encountered in sending out our various stuff, as we all know, is different formats. This time, we decided we are just going to number everything. We are just going to number every single -- we cannot number lines because it would be printed out differently. I think it looks denser than it is.
More specifically, Jim, what is attempted to be captured there under some of the sections that say background and what exists is this feeling that there are numerous components already in place. There are numerous activities already in place. There are some data systems already in place. It is a difficult effort to say, Here is what is already there, so that people can then see to what extent there is the overlap, there is the -- where do the needs also exist. I think that it is going to be hard to communicate that succinctly. I know that the outline does not capture that, but at least in terms of pulling together what is already there, that was one of the intentions.
I know this also is not what Jeff was getting at, but I wanted to mention that there is a section in there that does include some of the Healthy People 2010 objectives that relate to this. Of course, a lot of those that it references do call on the development of data systems. Again, that is not getting the targeted data that I know you are getting at and that John is getting at in terms of what data do you need at any given point in time for a specific decision, be it an individual clinical or public health or policy decision, but at least it was, in the outline, an attempt to say that yes, we recognize that there is a lot more types of data out there that need to be considered to be part of this.
DR. LUMPKIN: I think that the -- let me sort of just piggyback on that answer because I am still stumped by Paul's question. I think part of the reason why I am is because it is going to be hard to dissect out what are the costs that are just of the NHII. The development of the internet and the new internet is an interchange channel. That is not NHII cost, but it certainly is an enabling technology. The development of standards for computerized electronic medical records. It is an enabler, but it is also a piece of this. I think we will struggle with the costs; I am not sure how easy that is going to be. Simon.
DR. COHN: I have a slightly rothogonal(?) question to ask here. Jeff was sort of asking one set of questions around value statements and all of this. I think, to me, these sorts of visions -- I mean, I buy into them pretty easily. I do not think that I need to look at -- I think the benefits are pretty obvious. The part that always stops me is sort of figuring out what to do to move us there. I do notice that in item 12, it says, what is needed to enable this vision of NHII. It seems to be pretty scant. Maybe it is not scant, but it is scant and very high level. I guess the question that I have is that, is that going to be something that is going to be fleshed out in a major set of next steps to move us toward this vision and what needs to be done, sort of an action plan, or is it going to be left to sort of the mind of the beholder? John?
DR. LUMPKIN: I am looking for someone with a better answer than the one that I have.
DR. COHN: It is really just a question -- [commenting off microphone].
DR. LUMPKIN: I really think that the primary goal of this process is that while a lot of us in this room have talked about and thought about the vision, there is not a vision out there. There is not a national vision of where it is that we are going. I think the goal of this is to put it out there, let there be a lot of discussion and modification, let people buy into it. Then there is a reference so that when people are beginning to do projects, we can flesh out what is missing and what do we need.
We know that we need more work on decisional support. What is the enabling technology for that. How does what we are doing with CPRI or the transaction standards or the population data that we are using, how will that flesh out pieces of this vision. So, when people start projects, if they have the vision in mind, they will ask themselves those questions. It is really that interoperability that we are looking at, the interfunctionality, the intervision. So many projects are kind of started and accomplished in isolation from everything else that is going on. The attempt is to try to bring things together rather than to set a specific agenda, I would think, of what is on the plate. We have a lot of stuff on our plate as a committee, but I think that as we accomplish some tasks, we should go back to the NHII, look at it and say, based upon where we want to go, what is the next thing that we should address. Mark.
DR. ROTHSTEIN: In Bob's absence, I would like to propose that the privacy element be moved forward, under this theory, and this will pick up on my statement earlier, but perhaps it is more appropriate at this point. From a patient standpoint, the most confidential system for protecting medical information is no record at all. The better, the more coordinated, the more detailed the medical record is, the less confidential it is, in theory at least, the less private it is, in theory at least. It seems to me that the public health advantages of this, even though they may be self-evident to the people at this table, may well not be self-evident to the public. I think we need to make a case for why the benefits to individuals will outweigh the increased risk of a loss of privacy and confidentiality as well as the protections that we envision building in to minimize those incursions. I think there is a great deal of concern in the public about how the new electronic age is creeping into what little privacy they have left, and I think we would be remiss if we did not try to confront that right up front.
DR. LUMPKIN: I think you are raising some important issues. I think the piece that we may need to add in there is to talk about -- in information systems, to talk about them being scalable. I think, in a sense, the privacy of this system can also be scalable. There are some people who are already putting all of their medical information out on the web today in locations that have questionable privacy. There are others who will never want to have their information anywhere. Our vision should incorporate the ability to have people from both directions in the system.
DR. ROTHSTEIN: There are people who do not want to undergo medical testing and procedures because they are afraid of what is going to happen if it is in their record. It would be a terrible sort of self-defeating act to go through a process to put together something that is going to promote public health in theory and then have people opt out of medical treatment or testing or undergo care anonymously or assumed names and things because they are afraid that now the system is so well coordinated that it is going to come back to haunt them.
I am not saying that is an accurate characterization of the system that is envisioned. All I am saying is that I think we need to be mindful of the great deal of concern in the public.
DR. LUMPKIN: Gary.
DR. CHRISTOPH: I think Simon's and Mark's points are well raised because ultimately, I think this is a sales document. You are selling a vision. You want something to happen. It is really important to make clear what it is that you want to have happen, what you want people to do, and in that sense, a return on investment, even if it is fuzzy, demonstrating that there is a huge amount of value but here are the tradeoffs. If you are going to sell something, you have to let people know what the costs are. I think the privacy tradeoffs, that is probably the biggest one, I would think, but that also is a pointer on these are the things that need to happen, that need to be established first. Yes, the internet is there. There is a lot of underlying infrastructure. There are some key pieces of infrastructure that are missing, and the ones that protect privacy are crucial ones. That may be one of the key recommendations that you come out with is there needs to be a push on development in this area or that area. Ultimately, again, it is a sales document, and you have to talk about the return on investment because it is going to take an investment.
DR. STARFIELD: What I am hearing you say, I think, is that the outline needs to be revised so that it focuses on the benefits and the costs rather than history and all of the way that it is done. Is that what I am hearing from you both?
DR. FITZMAURICE: I think you put your finger on something. It is a historical document, and it is a document of promise for the future. Maybe there does need to be some separation of that, although the history tell us how we got to where we are today. I like it for being a Christmas tree. There is not enough money in any of our budgets or all of our budgets combined to undertake the demonstrations and the evaluations of health systems that we would like to see, so we have to plunge ahead and do something partway and see if the benefits are worth the costs. This gives us a framework to go back and say, all right, let's put it under 11.1.5-B so that you can accumulate different lessons from other places and put them somewhere. I find a lot of value in that. Are we getting closer to the vision? Well, the vision says this. We put all of our research findings here. We put demonstrations here. A businessman comes and says, what do we have, what are the implementations of this vision. That is work for the future. That is the benefit that I see from this, and the vision shows what could be, the return on investment tells you where it has been implemented, and how can I find out what it costs, and how can I find out -- I was so mixed up with other things, could I do it in my place or is it just integral to that one site. It is a good starting place.
DR. LUMPKIN: Paul?
DR. NEWACHECK: If this is a marketing document, I think we need to make a compelling case at the beginning for the reader to follow through and complete reading the whole document. Starting out with the history and activities to date is pretty boring for most people. Moving some of the problem statement materials up to the very front, I think, creating a need for this right off the top, would be important. I think maybe with just some rearrangement, it would be much more compelling for the reader to complete the document at least.
I think with regard to the costs and benefits issue, I think that it is important to have some discussion of the costs. Even if we cannot quantify those costs, we can talk about the type of cost items. I think we can also say that many of the resources that are needed are already in place, and they need to be redeployed perhaps, or they are already being redeployed because of the internet or something else and we just need to tweak them a little here and there to make them work for this purpose. The costs may not be, at least in terms of the data side, may not be that monumental. Privacy issues and others might be more significant, but at least then it would have the balanced appearance that this really is a carefully thought through document and not just a marketing piece.
DR. LUMPKIN: Jeff.
DR. BLAIR: I have large spread shared concern about privacy and confidentiality and data security issues, and it was very enlightening reading our briefing book for Friday on privacy issues and exposures on websites. I am stating that as a beginning because I feel like it is a very, very important issue. On the other hand, and I do acknowledge the fact that there is a widespread perception that if you put this data in electronic format, the privacy concerns are increased. That is a widespread perception.
I think that we have to be proactive. I am not exactly sure who is saying that we have to -- I do not know if I would call it a marketing document, but I would wind up saying that I do not think that we should be defensive about privacy concerns, and I do not think we should take a look at it as saying if we put it in electronic form it is a negative or it is an additional risk. In reality, I think we ought to go forward by saying that in order to improve security and improve privacy, if we have that information in electronic form, that the individual can authorize who gets to see it, can have audit trails to see who has seen it, can wind up having controlled access within acute care institutions. You go on and on and on, and the electronic medium is going to dramatically increase the security and privacy over what we have today, and I do not think we want to dwell on how poor it is today. I think we have a positive story, and we do have to move it up front, and I think we should make that an advantage, a positive out of what we say about the National Health Information Infrastructure, and not be defensive about it.
DR. LUMPKIN: Let me toss out this idea and see how this floats as a way of describing it because I think about my dentist's office. He has a number of examining rooms. Each examining room has a bookcase full of charts. While I am waiting for somebody to come in, I could just pull out a couple of charts and start looking at them if I was so inclined. Someone would probably yell at me as they walked by, but I would have looked at this information. If his office were automated and the x-rays that they took were digitized, that could all be kept on one single computer. If it were not connected up to anything, it would not be any greater risk, in fact it would be less of a risk than the way he currently keeps his charts.
It is when we start putting all of these pieces together that we really need to talk about some ways of moving from that concept and that scenario to a national scenario and use some descriptors of the benefits as you described potential benefits but also the potential risks in ways that people can understand. I think that is a very important piece that we should add to this.
Let me just make one comment about the public health rationale for this. Those of us in public health have said that a lot of people do not understand public health. I think we are wrong when we say that. Everything from the Harris poll to the most recent poll that was done in Illinois by our comptroller, of all people, the importance that people place on public health is only second to education in where they are going to spend their next dollar, what they think is important. I think people value it when it is described to them and explained to them what public health does, so I think that tying the NHII to public health and using that as an explanation is a very good way to sell it. I think we should think about that as we write the document. Jim?
DR. SCANLON: Again, I guess I am looking for some basic principles and framework as well. When we speak of the NII, there are generic requirements for this to work for everyone, one, for example, being intellectual property, a sense of intellectual property laws in a regulatory and legal environment. The other deals with the digital divide or whatever people are calling it these days which we have always had in one way or another. If there is a strategy to provide much of the information that these three dimensions need through the NII, then is it also part of the strategy to include ways of providing those resources for populations and others that do not have access. It may be in your universal service outline where you discuss ways of approaching that as well, but it would be assuring equity for all populations if this is the strategy to proceed with.
DR. DEERING: I actually wanted to both answer that but then ask the committee a question, sort of an editorial question. First of all, in terms of assuring equity, I certainly know that I seem to recall that the work group talked about that a lot, so if it does not show up in the outline, it does not mean that the feeling was not there.
The question that I think would be helpful to us in staffing the work group and to whomever ends up actually writing the final words would be the sense of audience for this report. I think that I have heard today and we have heard in previous discussions some differing feelings about who this is written for. I can be both general and specific and say that on one hand, we think specifically of June and of what will be a fairly professional gathering at which you are going to be first releasing this, so that sort of naturally suggests that you are writing for a professional audience, be it policy or health professional or whatever but in their professional capacity.
On the other hand, there have been arguments or concerns raised from the beginning about privacy and about the public's interest in that. There is talk about whether it is a marketing document or a sales document. Clearly, public buy-in is going to be essential, so that suggests the tone is more for the citizen of the country. It is really hard to do both in one document. I think that some guidance from the committee on how to balance that, especially for the first iteration, would be probably really helpful for us.
DR. LUMPKIN: Let me toss this out because we have not discussed this as a work group, but it seems to me that we -- it may be hard for one document to do both. We may be talking about an executive summary, which is the marketing piece, and then the document itself which would be what would be presented to the more technical folks.
DR. BLAIR: Could I suggest that we use the word education instead of marketing?
DR. LUMPKIN: Okay. Mark?
DR. ROTHSTEIN: I just think that when we put this together, we need to keep in mind what the headline in U.S.A. Today will be after it is released, what we want it to be, and what would be a disaster if it were. I can imagine some headlines where the Congressional phone banks would be lighting up from constituents, What do you mean you are thinking about doing this? versus the kind of headline that we want. Even though it may be a document that is drafted for the Secretary, for professionals and so forth, when the press gets hold of it and it will be out there in the public arena, and I think we need to have that very, very much in our minds when it is drafted.
DR. LUMPKIN: Kathy?
DR. COLTIN: I am not sure that I understand the vision as well as I should because it speaks in a number of places about knowledge. When you talk about your dimensions, I was making the assumption, and I do not know if this is correct or not, that you have all of these knowledge bases out there. You have tools that allow you to apply that knowledge to particular situations, whether they are community issue, which one might look at for the community dimension, an individual care situation where a clinician is looking at the specifics of that patient's situation and trying to apply that knowledge to decision making, or a patient looking at all of that information out there and trying to do some self care or inform their own decision making about behaviors and so forth.
There is not any discussion in here that I can see about how those knowledge bases are going to somehow be put into some sort of a structure in the same way that you have defined somewhat these elements of the dimensions, the community, the caregiver and the personal. What is the knowledge base envisioned to look like? I mean, you talk about the problems with the fact that there is misinformation out there now, that it is haphazard. You refer to the availability of knowledge on the web, that it may be good, may not be good, whatever. How is this all going to address that aspect? The integrity of the knowledge base and the accessibility of the knowledge base? Doesn't all of this hinge on that?
DR. LUMPKIN: Rather than answering that question, I think that is a very good point. I think that is something that we need to emphasize in the next draft. Dan.
DR. FRIEDMAN: Just getting back to Mary Jo's questioning. I think whether it is one document for broader dissemination or two, I completely agree with Mark. I think we need to assume that any document will end up being widely disseminated. Personally, I would put the priority on a document for a more public audience. I think that it is possible to do that in such a way -- I think the -- I am pointing at Michael, but I think the Canadian Health Infrastructure documents manage to be substantive yet directed at a wide audience and were very convincing. I think that is absolutely essential that we do with this rather than think of it as a more technical piece.
DR. HANDLER: Aaron Handler, Indian Health, again. Now I am going to think a little bit out of the box from where we are now. When a policeman stops somebody for a moving violation, they do a check on the person by computer from the patrol car a lot of times, and they check a database to see if the person has a warrant against him, if he is wanted by somebody, and there is an exchange of information done very quickly. We also, in Montgomery County, have instituted photographs of people running red lights, and the licenses are checked, and then the person gets a ticket by mail. There are a number of different things like that going on. No one seems to be upset by that because it is the public's safety involved.
Now, here, everyone has a mindset that we have to protect confidentiality of the patients. Well, what about the public health of the larger community? What about the individual patient's health? We are protecting the patient's right to get the proper medical care if we exchange information between providers and find out what he is allergic to and what medicines he is taking. Maybe he cannot answer for himself. Basically, it is trying to -- what we should be doing is trying to explain to people why this is needed, why it will be useful to them. Nobody has a problem with police departments exchanging information, but there is this reluctance to share medical information. You have to sell people on why it is of benefit to them, why this will help them as a patient, not why it will help the doctors specifically but why it will help the patients.
DR. LUMPKIN: I think that we have to be careful because the last time I checked, it was a criminal offense to run red lights. It is not a criminal offense to seek your health care provider. That is really the big challenge that we have. Those of us who practice public health day to day know that trying to protect the confidentiality of information that we get is an ongoing battle. I have two ongoing lawsuits against me now trying to force the release of data. It just goes on and on and on. There are a number of my colleagues who have gone to -- who have been pulled into court trying to protect data.
That is the public health problem, but our challenge, and I think Mark said it very well, is how do we prepare a document that gives us the right headline that emphasizes the things that we think are positive yet also assures people that we have given a lot of thought into protecting them so that they can feel comfortable going to their health care provider and getting the needed care, can get the kind of information that they need to make the right sort of health decisions. How do we put that into a single document is also going to be a challenge because there are questions, for instance, of how we structure the knowledge base. I think we want to be detailed enough so that people who are looking for this as their vision when they do their very detailed work can grasp it and see what they are doing and where it fits in and at the same time uses terms and words that everyone can understand. We will have a challenge, but if it were not a challenge, I guess somebody else would have done it.
DR. DEERING: I only want to point out something that is very deep in there and was probably more prominent in some of the earlier discussions which is that, for example, in the concept statement, it is very clear that we are not talking about an "it." There is not a "the" here. That is a communication challenge. There is not "the" knowledge base. It is a virtual, it is an accumulation and a coordination and a linkage of multiple existing and to-be-created entities, many of which we will have no control over. That is a real difficult thing to communicate to anyone.
DR. LUMPKIN: We will get into this tomorrow, but there are different levels. There are the databases, and then there is the knowledge that is going to them, and we do need to think a little bit about how they interact. we have been thinking kind of flat of our data and how they interact, and we have to think a little bit more about the other dimension of knowledge.
I would like to thank all of you for participating in this discussion. I think it has been helpful for those of us on the work group as we move forward.
What I would like to do is when we have a draft prepared is to send it out to all of the committee. This would probably be in late May. Everyone can have a chance to make sure that there is not -- even though this is going to be a draft that we are going to have discussions, it is going to be very important for people to look in there to make sure that we have not put any land mines in that we do not want to walk on. Simon?
DR. COHN: So you are going to be sending this out in late May for a mid-June presentation?
DR. LUMPKIN: Yes. As a draft.
DR. COHN: As a draft, okay. I was just concerned that there is not much turnaround time there in case anybody has any either objection or suggestions for improvement.
DR. LUMPKIN: We will send out every draft that we have when we have it.
DR. COHN: Okay, that sounds good. That sounds fine, John.
DR. DEERING: It could also be that what we aim for is a more finished executive summary draft which is fully narrative, maybe has some visuals even though it is just draft but it is as pretty and as smooth and comprehensive as we can get it. Then the others are attachments for the time being for June, and they can be more technical, and they can have more holes in them if need be. That might be more doable maybe.
DR. LUMPKIN: The committee is meeting tomorrow at 8:00, the work group. Those of you who are not on the work group are certainly invited to join us. We are meeting here -- no, 405A.
[Whereupon, at 3:50 p.m., a recess was taken until the following day.]