Meeting Report

American Health Information Community

November 13, 2007

The American Health Information Community (AHIC), a federally chartered commission formed to help advance President Bush’s call for most Americans to have electronic health records (EHRs) within 10 years, held its 17th meeting on November 13, 2007, at the Sheraton Chicago Hotel and Towers/Cityfront Center, Ballroom 6, 301 East North Water Street, Chicago, IL 60611.

The purpose of the meeting was to bring together Community members to continue discussion of steps toward ways to achieve its mission of providing input and recommendations to the U.S. Department of Health and Human Services (HHS) on how to make health records digital and interoperable, and assure that the privacy and security of those records are protected in a smooth, market-led way. The meeting focused on: (1) an update on Nationwide Health Information Network (NHIN) trial implementations, (2) an update on the Certification Commission for Healthcare Information Technology (CCHIT), (3) a discussion of a health information technology (HIT) physician adoption survey, (4) a presentation on advancing the national framework for uses of health data, and (5) recommendations to HHS on a data stewardship framework.

HHS Secretary Michael O. Leavitt chairs the Community. The remaining 16 members, selected by Secretary Leavitt, are key leaders in the public and private sectors who represent stakeholder interests in advancing the mission of the Community and who have strong peer support. Members serve 2-year terms.

A summary of the discussion and events of that meeting follow.

Call to Order

Joining Secretary Leavitt around the table were:

Robert Kolodner, MD, National Coordinator for Health Information Technology

Kerry Weems, Acting Administrator, Centers for Medicare and Medicaid Services, and Vice-Chair, AHIC

Scott Serota, President and CEO of the Blue Cross Blue Shield Association

Charles N. (Chip) Kahn III, President of the American Federation of Hospitals

Julie Gerberding, MD, Director of the Centers for Disease Control and Prevention

Gail Graham, Director of Health Data at the Department of Veterans Affairs, Veterans Health Administration

Kevin Hutchinson, CEO of SureScripts

Craig Barrett, PhD, Chairman of the Board, Intel

Lillee Gelinas, RN, MSN, FAAN, Vice President and Chief Nursing Officer of VHA, Inc.

Dan Green, Deputy Associate Director, Office of Personnel Management (Mr. Green represented Linda Springer, Director of the Office of Personnel Management)

Steve Lampkin, Vice President, Benefits, Compliance, and Planning, Wal-Mart (Mr. Lampkin represented John Menzer, Vice Chairman, Wal-Mart)

S. Ward Casscells, MD, Assistant Secretary for Health Affairs, Department of Defense

Nancy Davenport-Ennis, founder of both the National Patient Advocate Foundation and the Patient Advocate Foundation

E. Mitchell (Mitch) Roob, Secretary of the Indiana Family and Social Services Administration

Jason Mitchell, MD, Assistant Director, Center for Health Information Technology, American Academy of Family Physicians (Dr. Mitchell represented Douglas Henley, MD, Executive Vice President, American Academy of Family Physicians)

Cita Furlani, Director Information Technology Laboratory, National Institute of Standards and Technology, U.S. Department of Commerce (also represented by Bettijoyce Lide, Scientific Advisor for Health Information Technology, NIST)

Introductory Comments

HHS Secretary Michael O. Leavitt

Secretary Leavitt opened the meeting by thanking participants for either coming to Chicago to participate in person, or for joining the meeting via Webcast/teleconference. He announced that through the Centers for Medicare and Medicaid Services (CMS), HHS put forth a proposal to adopt new standards for aspects of e-prescribing under the Medicare prescription drug benefit. This development is an important initiative tied to AHIC activities. The Secretary noted that implementation of the first set of e-prescribing standards began last year. At that time, a pilot was launched to involve providers, pharmacies, and plans to test these standards. Through the pilot, lessons were learned regarding the strengths and weaknesses of that first set of standards; these lessons were incorporated into the new proposed set of e-prescribing standards. All providers and pharmacies transmitting prescriptions electrically for Medicare will have to comply with these new CMS standards. The Secretary commented that adopting this rule will move closer to the connective system that AHIC is working towards, and will represent an improvement in the safety and quality of health care that all of patients receive.

Next, Secretary Leavitt informed the Community that 2 weeks ago, a new Medicare demonstration program was announced that promotes adoption of HIT. The demonstration will award providers who use certified EHRs to develop high-quality care in small- to medium-sized practices across the country. This is where most Americans get their health care, and it is also where there are the lowest adoption rates of HIT. Under the demonstration, Medicare will pay higher rates of reimbursement to physicians who use certified EHRs. The demonstration will involve 1,200 small- to medium-sized physician practices and reach as many as 3.6 million patients, making this a significant step forward. Many private insurance companies have, since the announcement, indicated that they plan to take similar, parallel actions.

The Secretary thanked the CCHIT for their work in creating the standards for certified EHRs. This is the designation that will be used to determine those practices that are qualified for this demonstration. Last year, the CCHIT certified roughly 75 percent of the EHR products that are now being used by doctors. Secretary Leavitt reported that the products already certified by the Commission account for approximately 25 percent of those used in hospitals. The percentage of certified hospital EHR systems will increase fairly quickly, just as the percentage of outpatient systems has; Secretary Leavitt noted that momentum in this area is growing.

Secretary Leavitt noted that he would not be announcing the AHIC 2.0 award at this meeting as had been planned. Agreements are still being finalized, and the Secretary intends to announce the award before the next AHIC meeting. A broad coalition of significant players has been created that will convene in an aggressive effort to ensure that the AHIC 2.0 deadline is met.

FCC Chairman Kevin Martin

In introducing Federal Communications Commission (FCC) Chairman Kevin Martin, Secretary Leavitt explained that the FCC is working to fund the delivery of broadband connectivity to rural and underserved communities, placing a particular emphasis on health care providers. The Secretary thanked Chairman Martin for attending this AHIC meeting, and commented that there is not another part of the U.S. economy in which the government could invest in the development of this type of infrastructure that will have more rapid or lasting social and economic benefits.

Chairman Martin acknowledged the importance of the role that the FCC is playing in its efforts to deploy the infrastructure that can make some of AHIC’s goals possible. He also characterized the work that AHIC is doing as not only important for health care, but also for the overall economy. Chairman Martin has made broadband deployment the FCC’s top priority, given that broadband technology is a key driver of economic growth, productivity, and innovation. In April of 2004, the President issued an Executive Order to provide leadership for the development and nationwide implementation of an interoperable HIT infrastructure, and a key goal of AHIC is to help Americans obtain access to electronic medical records (EMRs). To receive the benefits of EHRs, Chairman Martin explained, health care providers must have access to underlying broadband infrastructure. Without this underlying infrastructure, efforts to implement EHRs cannot succeed (this also is why creation of the NHIN is a key element in the national HIT agenda, which the FCC supports).

It is the FCC’s vision to see that every health care facility in the nation is connected to each other with broadband access. To that end, on September 26, 2006, the Commission launched a rural health care pilot program to provide funding for up to 85 percent of an applicant’s cost of deploying a dedicated broadband network for connecting health care providers in rural and urban areas with a state or region. It also provides for funding of up to 85 percent of the applicant’s cost of connecting the state or regional network to Internet2 and/or National LambdaRail, the dedicated national backbones, as well as the public Internet. In an overwhelming response, 81 regional and state health networks across the country have submitted applications. The FCC is preparing to dedicate significant funding to spur the deployment of broadband networks for these health care facilities.

Chairman Martin has proposed dedicating more than $400 million over the next 3 years to the construction of broadband networks for statewide and regional health care networks in 42 states and 3 U.S. territories, all connected to the national backbone providers. The FCC, through this funding, will connect more than 6,000 health care providers across the country, including hospitals, clinics, public health agencies, universities and research facilities, behavior health sites, community health centers and others. These networks will support telehealth, telemedicine, clinical care, consumer and professional health education, public health, health administration, research, and EMRs. The pilot program is structured to encourage applicants to aggregate the needs of health care providers in both rural and urban areas and select the most efficient technology based upon their network needs. For example, the pilot program encourages multiple health care providers in a state or region to join together, allows flexibility and network designs that will be able to meet the specific needs of health care providers, encourages the creation of self-sustaining networks, and encourages broadband connections (particularly for rural health care providers).

Chairman Martin commented that this program aligns with the goals of the HHS and AHIC, which is why he believes it is important that the organizations participating in this pilot program use their resources in a manner consistent with the HIT initiatives being promoted by HHS. This includes the implementation of interoperable HIT systems and the use of certified HIT products. Additionally, the participants are expected to coordinate with HHS and the Centers for Disease Control and Prevention (CDC) during public health emergencies such as pandemics and bioterrorism events.

Discussion Highlights

“This is a potentially powerful energizing opportunity for the creation of our network…There is a need for us to make certain that the standards that we’re developing for health information technology records are incorporated. How do we actually go about assuring that those standards are built in? Would there be opportunities for these grants to be conditioned upon their acceptance of those standards?”
Secretary Leavitt

“I don’t think that we’re able to explicitly condition it on having … the records, but we have conditioned it on trying to coordinate with HHS and CDC, and [applicants] actually are required to have meetings to understand both the process and opportunities, and the best way that we could end up coordinating them. Now, the grants, themselves: because they are through the Telecommunications Act, which has a different standard, we can’t explicitly condition on the grant of coming into compliance with the work of another agency, but I think that we’re going to be able to accomplish the same goals by the close coordination and requiring them to at least go through the processes of meeting with HHS.” Chairman Martin

“We had a very effective program to connect schools and libraries throughout the country using broadband, but on the health care side, we’ve actually had a significant amount of money that’s gone underutilized or not fully utilized. And I think the key to trying to unlock that was actually to try to think about this in terms of networks of networks, where we’re trying to connect rural health care facilities back to the urban facilities, and paying for thatfor those regional networks as opposed to just individual grant applications.” Chairman Martin

“[VHA has] over 600 small and rural hospitals in our network. And I’m curious, just as a practical application, how we could be supportive of the implementation of the pilot. We can perhaps take it offline, but I have to tell you, this is really exciting for our rural providers.” Ms. Gelinas

“I appreciate it, and we should end up following up on how you can end up being most supportive and seeing which ones of those clinics that you’re talking about may actually already be implemented in one of the different networks that we’re trying to provide.” Chairman Martin

CMS Acting Administrator and AHIC Vice Chair Kerry Weems

Mr. Weems announced that this morning, proposed standards for e-prescribing and for formulary and benefits and medication history were put on display in the Federal Register. The availability of a standard for formulary and benefits will enable the prescriber to see upfront which drugs are covered under a beneficiary’s drug planin this case, Medicareas well as a list of alternative drugs that would allow the provider to substitute a generic drug. Mr. Weems noted that this type of information will streamline prescriber workflows, eliminating calls to the plans, as well as callbacks from pharmacies. Although e-prescribing is voluntary under Medicare, if prescribers and pharmacies transmit subscriptions for Medicare-covered drugs electronically, they are required to comply with any standards that are in effect. Four more standards are still being considered, and Mr. Weems expressed hope that the normal commenting process will occur quickly so that these rules can be in place soon.

Mr. Weems also described the Medicare demonstration project. The focus over the next several months is going to be on recruiting 12 communities; then CMS will work with those communities to recruit 100 participating physicians. By early winter, it is hoped that the criteria will be in place for “wired for wellness” communities. Bonuses will be paid to physicians who use EHRs: initially for reporting on quality standards, and then later, on pay for performance. This demonstration serves as a reminder that an EHR is not an end in itself. The end is patient safety and overall performance of the health care system.

National Coordinator for Health Information Technology Dr. Robert Kolodner

Dr. Kolodner welcomed new AHIC member Cita Furlani, who is representing the Department of Commerce and is the Director of the Information Technology Laboratory at the National Institute of Standards and Technology (NIST). He also announced that Dr. Chuck Friedman has joined the Office of the National Coordinator (ONC) as the new Deputy National Coordinator.

Dr. Kolodner noted that the Community received the requested report from the Institute of Medicine (IOM) that evaluated standards-setting activities and highlighted some of the issues related to pacing, depending on the complexity of the standards that the Community will be considering. In its report, the IOM recognized that ONC and HHS have advanced the national HIT agenda over the last 3 years and have accelerated the development and advancement of standards. The report also acknowledges that AHIC has helped to launch several standards related to organizations, has established a process that did not previously exist for harmonizing and identifying those standards, and has taken a full cycle of standards development into the implementation process. Dr. Kolodner announced that Secretary Leavitt is scheduled to recognize the first set of interoperability standards in December of 2007, before the next AHIC meeting. These standards will then be incorporated into the ambulatory and the inpatient certification criteria starting in mid-2008. In addition, the IOM recommended that the ONC develop a strategic plan to guide the national HIT agenda, and develop a security and privacy framework. Both of those recommendations are now being acted on.

Dr. Kolodner also noted that the Community received a report in September from the Population Health and Clinical Care Connections Workgroup with some recommendations that are still being considered and will be discussed at the January AHIC meeting.

Approval of September 18, 2007, Meeting Minutes

Minutes from the September 18, 2007, AHIC meeting were distributed, reviewed by Community members, and approved unanimously with no changes.

NHIN Trial Implementation Update

Dr. John Loonsk, Director of ONC’s Office of Interoperability and Standards, reported that the awards for the first nationwide health information network exchanges (NHIEs) that will be participating in the NHIN cooperative have been announced. The following health information exchanges (HIEs) have been awarded and are participating in this process:

• New York E-health Collaborative (New York State)

• Lovelace Clinic Foundation (New Mexico)

• West Virginia Health Information Network (West Virginia)

• North Carolina Health Information and Communication Alliance (North Carolina)

• MedVirginia Health Information Exchange (Central Virginia)

• Delaware Health Information Network (Delaware)

• Long Beach Network for Health (Long Beach and areas of Los Angeles)

• CareSpark (tricities region of Eastern Tennessee and Southwest Virginia)

• Federal NHIE (DoD, VA, DHHS, others including participating Indian Health Service regions).

Others also have indicated an interest in participating, according to Dr. Loonsk.

The NHIN is currently identifying the specific core services (i.e., that minimal set of national standards that need to be advanced to have a network of networks) and has identified, through the course of the prototype work from last year, four basic standards that need to be advanced to support networks working together. Dr. Loonsk explained that many of the HIEs have rightfully been thinking about activities in their own jurisdictions, and the NHIN is trying to create a single set of standards that would:

• Identify the services for looking up patient data across HIEs.

• Support the retrieval and delivery of that data.

• Standardize consumer access controls, so the consumer can have a say in who can access their personal health information, and whether they choose to or not choose to participate in the electronic network exchange.

• Create guidelines for reporting and other uses of electronic data.

Dr. Loonsk stressed that this is a network of networks, not a central infrastructure. By the end of this first year’s performance, it is hoped that the technical obstacles for health information exchange between the participating HIEs have been removed. Some critical leadership roles for the HIEs have been identified. The Core Content Working Group is being led by the representatives from the Lovelace Clinic as well as the New York Healthcare Information Collaborative. The Core Technical and Security Working Group has Co-Chairs from West Virginia and from the federal health NHIE. The Data Use Working Group is being led by representatives from the North Carolina Health Information and Communications Alliance and MedVirginia. Testing is being advanced in conjunction with representatives from NIST, as well as the Indiana University and the Indianapolis Health Information Exchange.

Dr. Loonsk explained that the Centers for Disease Control and Prevention (CDC) is another partner in the project that will help advance the vision of a reusable foundation, an infrastructure that can be used to advance public health needs even beyond creating a method for provider information exchange in individual health information access.

Liesa Jenkins of the CareSpark Health Information Exchange explained that CareSpark started approximately 4 years ago and was one of the early participants in the e-Health Initiative. The goals for their community and region align very closely with the e-Health Initiative goals (engaging the clinicians, engaging the patients, working on public health, and aligning financial incentives). It has been important for CareSpark to stay connected with activities at the federal level, because the organization straddles state lines of not only Tennessee and Virginia, which is where the bulk of their providers are, but also North Carolina, West Virginia, and Kentucky. That is why CareSpark participated in the first round of the NHIN prototypes. Ms. Jenkins indicated that it was a challenge for many of their small, entrepreneurial organizations with few resources to learn how to work with a large corporation and federal contracts. However, the group has been successful in its demonstration.

Ms. Jenkins explained that the process was valuable because CareSpark and others in the region would not otherwise have had the ability to keep up to date with the standards that were being defined, much less have a voice in their development and contribute to them. Secondly, it allowed CareSpark to connect with other communities engaged in similar activities, which allowed them to build not just a technical network, but the human infrastructure and connections between people that Ms. Jenkins believes are key to success. Third, the initiative brought awareness and education about HIT to their region. Ms. Jenkins has seen an increase in adoption of EMRs among physicians in CareSpark’s rural area, and a growing awareness about issues of privacy and security among citizens in the community.

The initiative has educated local elected officials as well. CareSpark worked with Virginia and Tennessee (the Governor of Tennessee serves as the Co-Chair of the National Governor’s Association State Alliance for e-Health). Their involvement in NHIN1 and now NHIN2 has helped them serve as a conduit for those state officials to align what they are doing, what CareSpark is doing, and what is happening at the national level. Ms. Jenkins also noted that CareSpark is very interested in how it connects with the regional Veterans Administration (VA) medical center, which is an important partner in this process.

Maggie Gunter, CEO of the Lovelace Clinic Foundation, explained that her organization is devising solutions to improve health care quality, cost effectiveness, and efficiency, and is pioneering the sort of disease management that is integrated into group practices every day. Lovelace applied for Agency for Healthcare Research and Quality (AHRQ) implementation funding to create a means for sharing information across its community. The resulting grant was in the form of matching funds, so that the community was required to support and participate in the project. Intel participated as well, demonstrating that the Lovelace Clinic Foundation felt that employers had a critical role to play, not just health care organizations.

Ms. Gunter reported that after three years, the Lovelace Clinic Foundation has made significant progress in establishing the community governance and trust necessary, given that the field of providers are in some cases competing with each other and have diverse points of view and motivations. The Foundation has established the basic technology infrastructure and conducted some pilot information exchange programs. There also have been collaborative efforts with the New Mexico Department of Health, and with New Mexico Governor Bill Richardson, who is trying to pass legislation to reform health care in the state and increase uninsured coverage. The state is putting a plan together to require participation in EHRs and HIE as a way to increase efficiency and to cover more uninsured patients. Ms. Gunter noted that New Mexico is one of the poorest states and has one of the highest levels of uninsured and Medicaid recipients.

In terms of progress, Ms. Gunter indicated that the community collaboration and matching funding have not yet been as extensive as hoped. Plans called for a community-wide disease management system and a fully operational exchange to provide comprehensive information across various health settings, available to the physician at the point of care. It was also hoped to have had a patient portal developed by now, especially for patients with asthma and with chronic diseases like diabetes, so that they could better self-manage their own illnesses. Ms. Gunter emphasized that Lovelace has not given up on accomplishing these goals or on the importance of a health information exchange. She did acknowledge that building HIE is more about the sociology than the technology, and that innovation is challenging, especially when it requires reaching consensus among many different community organizations with diverse and sometimes competing interests.

Ms. Gunter noted that regional health information organizations (RHIOs) across the country are taking longer than expected to develop into fully operational systems with solid business cases. Federal grants and contracts alone are not the answer, but because of the expense involved and the technology required, federal support is critical for moving RHIOs towards solid business models.

Ms. Gunter characterized the project’s aggressive one-year timeline as both scary and wonderful. The timeline allows participants to show the nation that HIE both within and across states is feasible; it also requires them to quickly come into compliance with standards. This timeline is only achievable through a very collaborative effort that allows participants to share their expertise, which is helpful because each individual participating practice has limitations and constraints in personnel and expertise. Another significant strength in the project’s model is that each site is required to create its own business model depending on the needs of its community, which will ensure that the interoperability that has been created is sustainable after the project’s grant funding is over. Ms. Gunter stressed that is essential to engage both large national employers and local employers in these projects, given how much U.S. employers have at stake as health care costs continue to escalate. Some companies are unable to compete in the global market because of the enormous amounts of money that they must spend on health care. Corporate participation is also important because corporations have expertise in the area of business models.

Secretary Leavitt noted that Google and Microsoft, among others, are beginning to develop platforms for personal health records. He asked Dr. Loonsk for an update on progress in the ability to send data for health exchanges like the ones being created through the NHIN projects to such private platforms. Dr. Loonsk indicated that this has been part of the NHIN vision from the start. With the connectivity and the single set of standards being created through the NHIN projects, the private “health vaults” will have access (with the appropriate controls) to all the networked hospital and ambulatory care data. Without that access, the health vaults will not be as valuable. Dr. Loonsk also noted that the importance of the standards being developed will become self-evident to companies like Google and Microsoft.

Discussion Highlights

“When I talk to legislators and citizens about this, they kind of nod and say, ‘That’s really important. I know how frustrated I am. I can never get all my records wherever I go,’ and mostly, they’re surprised and dismayed that this doesn’t already occur. [They say] ‘Well, I just supposed that we already had this kind of linkage across places. We have it with Jiffy Lube. Why don’t we have it with our health care data?’” Ms. Gunter

“If the health records bank is the model, our region is quite likely to fall even farther behind than we are now, because we have a lot of folks who really don’t have the education, the income level, the computer access, and all the other things it would take to manage that. So we’re literally building on the relationship between the clinician and the patient to figure out how to integrate that information from the patient and the clinical setting.” Ms. Jenkins

“What are you doing, within your programs, to engage consumers as you’re building the networks, and in trying to measure with consumers and patients, what are they looking for specifically at the end of the day so that they do want to become engaged, and they do feel comfortable with the process?”
Ms. Davenport-Ennis

“We have been very publicly now, for almost five years, talking to this about our community in the media, in presentations to everything from civic clubs to seniors groups to Sunday school classes…We’ve done fairs and focus groups, and solicited input from people in our community…about what benefits would this bring to you, what risks do you perceive, what kind of information would you be willing to share, with whom, for what purpose…So we have been very, very public in about what we’re doing.”
Ms. Jenkins

“We have taken a much more active consumer role in the last year, as we have understood that the concerns nationally about privacy are very substantial. It is not only what you can do from a HIPAA standpoint, but what is wise to do from a consumer standpoint…We’re working with lots of different stakeholder groups, consumers, about privacy; but trying to find a way to balance the needs of privacy…And every one of us in our family has somebody that probably has a mental illness or AIDS or something of that sort, where there is a great concern that they have about having their data shared.”
Ms. Gunter

“There were a lot of comments made by other networks, RHIOs, and HIEs about the value of NHIN2 in moving their own strategies forward, and whether or not they could be supportive of participating in the trial implementations in the next phase, given the pressures they’re under from a business perspective, as well as the demonstrations and the implementation of the standards that they feel they need to move forward with. What made these two organizations or other organizations feel differently to participate in these implementations, which we all feel are very important?” Mr. Hutchinson

“I think we also have a philosophy of collaboration, and we know that it takes work at various levels, but even more importantly for us are really kind of two things. Number one was probably timing...[we had] done a lot of the planning and tracking along pretty closely, so the timing for us was a good match with what NHIN2 was proposing. The other thing was…my board and volunteers and partner organizations were very adamant about this, too: only if it meets the needs and priorities for our community. The outcomes that we know we need to get in health improvement and cost savings, those use cases have to line up with our needs. If they don’t, it’s just a distraction for us to work on something that’s not that important to us. Those were really the criteria.” Ms. Jenkins

Certification Commission for Health Information Technology Update

Dr. Mark Leavitt, Chair of the CCHIT, announced that one week ago, the first inpatient EHR products were certified. Last year, the CCHIT worked on ambulatory products for physicians’ offices, and this year they have started working on products for hospitals. Certifications are announced on a quarterly basis, and six hospital EHR products have now been certified. Four are full certifications, meaning they are existing products already in use in the market. Two of them are what CCHIT terms “pre-market certifications,” meaning that they are new products. The Commission will wait until these new products have been in use with at least one customer for 45 days who will verify it. Then, CCHIT will issue a full certification.

In speaking to the vendors, the CCHIT learned that this certification initiative was a primary driver in the decision to invest in new product development. Mr. Leavitt commented that the Commission is actually encouraging capital investment in health information technology. In the ambulatory sector, in the first four quarters, the CCHIT certified 44 percent of the vendors who deliver the product used by more than 75 percent of the doctors using EHRs. There were about 200 vendors of ambulatory care EHR products.

Mr. Hutchinson explained that in the hospital market, there are only about 25 vendors, so the six certified vendors represent 24 percent of the total. So in the first quarter, the CCHIT is ahead of the pace it set in the ambulatory area, in terms of the percentage of vendors involved. Applications were being accepted for the next round until November 14, 2007, and several applications have already been received. In the ambulatory sector, the CCHIT updated the criteria in 2007. In particular, standards-based e-prescribing is required. Nine products have been certified, and about six more are in process. The total number of ambulatory products now certified is nearly 100.

Mr. Hutchinson then updated the Community on the development work for 2008 standards. In e-prescribing, standards will also include medication history and formulary checking beginning in July 2008. The Commission is adding four new domains this yearthe HIEs or networks, plus three areas which the marketplace requested of the CCHIT (emergency department systems, child health care, and cardiovascular medicine). The CCHIT received about 1,000 public comments to the environmental scans, which is the first step in drafting the criteria. Mr. Hutchinson expects the first draft to be released on November 21, 2007, followed by a 30-day comment period.

To ensure that interoperability testing is carried out thoroughly, The CCHIT announced a collaboration with the MITRE Corporation, a nonprofit, federally funded research and development organization. The MITRE Corporation will be the technical lead on the project to develop testing tools in open source code. A kickoff teleconference announcing this project was scheduled for November 15, 2007.

Mr. Hutchinson summed up the progress in accelerating HIT adoption by pointing to the financial incentives that are starting to emerge from both public and private payersparticularly the announcement made earlier from the CMS about their pilot project. States and regions are working with the CCHIT to develop their initiatives. Finally, the Certification Commission is working with Ms. Karen Bell at the ONC to examine the possibility of malpractice premium discounts for physicians using EHRs.

Discussion Highlights

“Tell us about volunteer fatigue. How are we doing on that?” Secretary Leavitt

“We’re actually doing okay on it. We became aware of the issue fairly early on, because so many initiatives started and they all depended on volunteers. So we added staff this year, last July, so that the volunteers didn’t have to do quite as much homework. And we also added new areas so that people could focus on what they cared about most. A new privacy and compliance group, for example. Volunteers are the key resource of CCHIT, and you really have to monitor how happy they are…It’s not easy, but we’re not hearing that they’re fatigued.” Mr. Leavitt

“Our goal has been to get through three complete turns of the crank from use case all the way to [the CCHIT] where it comes together. Could you give us an assessment of where you think we are right now? Can we get the three turns of the crank if we just keep turning? Are we pushing too much material through it? What about our pace and productivity?” Secretary Leavitt

“I think actually the pace now is right. The start was [challenging], because we tried to start things in parallel that people thought should be sequential, but you couldn’t make them sequential. But actually it’s lined up very much now. So the use cases coming out of the Community now are the ones that are real practical things that we can drive a standard into the HIT systems about. And so I think that 2008 is the year that you’ll actually see all the pieces.” Mr. Leavitt

“I asked the NHIN panel about the number of new large technology players who are seeing an opportunity in the personal health records space. In my judgment, that will be the energy that ultimately drives this whole thing. But they have to have the ability to populate those electronic health records, or personal health records with data coming from the 98 systems that you have now certified. Could you elaborate some on just how much work are you seeing between those systems and those large technology providers, and the extent to which this system of standards is necessary to enable that?”
Secretary Leavitt

“The system of standards is needed, not only to enable it, but to make sure that patients have freedom of choice. So we wanted to actually energize competition between providers for not just quality and safety, but [also convenience]…You really want those standards now, because you don’t want it to evolve into a proprietary world, where it’s not as competitive. So I think we need them very much.” Mr. Leavitt

“I’m still looking at all of the data that suggests that thousands or tens of thousands of people in this country are impacted each year because we don’t have 100 percent e-prescription. And so my question is, this is the 17th meeting of this body. We’ve discussed this at meetings number one, two, three, four, then we went dark, and now we’re back at [meeting] 17. Where are we?” Dr. Barrett

“Right now we don’t require it as a condition of writing a prescription, but if you write an electronic prescription, then you must use our standards. And certainly, there is a considerable push out there to do that…We are not completely deaf to those exhortations, but we’re not yet in a position to require it.”
Mr. Leavitt

“[the IRS and EPA] don’t seem to hesitate to put requirements in without the necessary base involved. I go back continually to the issue of patient safety as our highest priority. This is an obvious issue, and we seem to just be moving ever so cautiously and slowly on it when we could make a giant leap and perhaps facilitate the movement of the infrastructure and the capability.” Dr. Barrett

“As good as something might be as an idea, until you have a base in there that in some cases may be up at the 30 or 40 percent range, you haven’t worked through all the issues. And if you put an arbitrary date in before having that, at least in the health care arena, it has sometimes caused a problem. Now, the question is how you put incentives in, so you can get to that more quickly rather than starting with the stick.” Dr. Kolodner

“In terms of individual physicians, you’re not going to get to 40 percent in this century unless you require it, frankly. You’re not going to get to 50 percent. You’re not going to get to 20 percent. So I think it’s really the only way to go. You’re going to have some use, but it’s not going to happen until you just tell people. And I think this is one area where if you tell them, I think they’re going to have to do it.”
Mr. Kahn

“We stand today with 40,000 of the 55,000 pharmacies in the United States live on the network and ready to do electronic prescribing, and that continues to grow. There is an average of about 100 physicians a day that are logging on to the network and registering to get the network to do electronic prescribing…But we’re not seeing the utilization that we would expect to see. It’s still very much in a pilot mode. Even those physicians that are coming onto the network are processing maybe 10 to 15 percent of their total prescriptions electrically, and still picking up the pad. And we go back to this issue of the DEA. We have to solve this DEA issue…on controlled substances for schedule two through fives, because it causes physicians confusion and concern about when they can write electrically and when they can’t.” Mr. Hutchinson

“The one number I would remind everyone…when we get to the tipping point, is about a 30 or 40 percent range, but it’s not about 30 or 40 percent of physicians. It’s about 30 or 40 percent of the volume. And 30 percent of the physicians of the United States write 80 percent of the prescriptions. So if you’ve automated 80 percent of the prescriptions of the United States going electrically, you have, in fact, improved enormously patient safety, and it’s those 30 percent of physicians writing 80 percent of the volume that we really need to get to.” Mr. Hutchinson

Health IT Physician Adoption Survey

Dr. Jane Sisk of CDC’s National Center for Health Statistics presented the current statistics regarding EHR adoption in physician’s offices, gleaned from the National Ambulatory Medical Care Survey (NAMCS) and the National Hospital Ambulatory Medical Care Survey. These surveys reach 3,350 office-based physicians, which will grow in 2008 to an additional 2,000 when a mail survey is added. Additionally, the surveys include 500 hospitals. In both surveys, representatives conducted in-person interviews, followed by medical record abstractions. There was approximately a 63 percent response rate in offices, and a 92 percent response rate among hospitals. EHR use has been increasing, and in 2006, an estimated 29 percent of physicians reported using either full or partial electronic medical record systems, a significant increase from 2005.

The surveys defined the percentage of office-based physicians using various EMR features, and also showed how these features correspond with the features that were identified in another study as being necessary for minimally functional systems: clinician notes, prescription orders, test orders, and imaging results. About 12 percent of the physicians surveyed reported that they had those minimally functional selected features in their EHRs. Findings indicate that the more physicians there are in a practice, the greater the reported adoption rate. Physicians in health maintenance organizations reported a significantly higher rate, as did those in the west compared with doctors in other regions of the country. About 34 percent of all physicians in this country are solo physicians, accounting for about two-thirds of the practices. Their reported rate of any use is 24 percent, and of the minimally functional features, about 7 percent.

2005 data show that the number of patients having access to practices using EHR systems in urban areas was significantly higher than in rural areas. Privately insured patients are more likely to have them than are Medicaid or Medicare patients. Hispanic patients were significantly less likely to be visiting practices with EHRs than non-Hispanic black or non-Hispanic white patients. There was no significant difference between the two non-Hispanic categories, whether black or white.

Dr. David Blumenthal of the Massachusetts General Hospital Institute for Health Policy then discussed an ongoing survey on HIT adoption that was mailed to about 5,000 currently practicing physicians randomly selected from the American Medical Association master file. It is expected that responses from about 3,000 will be collected, for a target response rate of about 60 percent. Dr. Blumenthal indicated that the results he presented to the Community were taken from a sample of only 400 physicians and may not be representative of the final numbers.

Dr. Blumenthal presented the definitions of an EHR. The historical definition has allowed providers themselves to define an EHR (excluding billing records). Then there is the minimally functional, or selective EHR, which encompasses a set of minimal functionalities. Finally, there is a

functional EHR, which fully encompasses the basic functionalities that should characterize an EHR. The minimally functional EHR has six of the 17 functionalities that a fully functional EHR would have. About 39 percent of physicians answer positively to the historical NAMCS definition. They indicate that they have an EHR system, without the surveyors defining it for them. About 14 percent have minimally functional EHRs, and about five percent have fully functional EHRs.

Dr. Blumenthal presented the following barriers to EHR adoption as indicated by preliminary survey data: (1) lack of capital (70%), (2) finding a system that meets their needs (56%), (3) uncertainty about the return on investment (55%), (4) fear of systems becoming obsolete (47%), (5) loss of productivity (39%), (6) capacity to implement (37%), and (7) physician resistance (33%)

Discussion Highlights

“The best information available suggests that there are some gains to physicians, but they are very small compared to the gains that are realized by other parties that participate in the health care system. And the parties that gain most are insurers and ultimately, employers…if you’re looking for rapid adoption, the major incentives will be felt by groups that have internalized the financial gains.” Dr. Blumenthal

“Monetary incentives or pay for adoption is clearly a key component, and I would just like to hear a little bit about that, why it’s not a part of this conversation here…We absolutely have to overcome this particular aspect, so I would love to hear what the survey said in terms around incentives.” Ms. Gelinas

“We have some information that wasn’t presented here that looks at incentives reported by physicians that we queried. And the top two are financial. One is the availability of capital. The other is additional compensation for care rendered. So it’s pay for performance or pay for use of the electronic health record. And a third, which has also come to light here, and been mentioned, is relief from fear of liability.” Dr. Blumenthal

“We have tried on numerous occasions to give away practice management technology to physicians, and they won’t take it. So it’s not simply that they can’t afford to pay for it, it’s more like they don’t want to change the pattern of practice that they have in order to adopt the technologies that are required. And I also raise a little bit of concern, as you might expect, to the comment that insurers and employers are the ultimate beneficiaries. Patients are the ultimate beneficiaries of this. The objective of the electronic health record is to improve the quality of care. The economics will follow, because high quality care is more cost effective.” Mr. Serota

“How do we construct a business model that will motivate change, or at least complement our need to change in other ways? We may have to say ‘Society demands this occur, and we’re going to demand that it occur in the following ways.’ But somehow we’ve got to make this business model transition so that some of the savings that comes from quality finds its way into the pocket of the physician.”
Secretary Leavitt

“At some point, we need to use the purchasing power of the federal government. And I expect that it’s at a point where when it’s done, the private insurers will begin to do the same thing, where we say ‘It’s now an expectation, if you’re going to do business with us, that you use these.’ Where we are on this process of tipping is an important thing that this group could give me some advice on.” Secretary Leavitt

“Everybody finds these current commercially available systems still frustratingly slow. It still interrupts the doctor/patient relationship…the speed of the systems is still frustrating….You know that it’s going to improve your quality of care, and the patient is going to benefit, and you, as the doctor, are going to look better and [have] less chance for a malpractice lawsuit. But somehow, it just still grates on doctors to have a machine questioning their judgment.” Dr. Casscells

“One of the big problems is that when you document things, which is critical for quality of care…the malpractice risk is still overwhelmingly weighted towards things that you do, rather than things that you fail to do. So a lot of these people just feel safer by not documentingthe less they put down, the better they feel…You have to be reimbursed that week for the notation that the colonoscopy was scheduled or was declined, because we still are so underpaying for preventive care and paying for procedures to a large extent.” Dr. Casscells

“If you have more data on physician resistance, and on this question of loss of productivity, if you can give us more breakdown…that would be very helpful, because we’re redrafting policies for our 10 million beneficiaries now in defense. And that alone would be a big service to us.” Dr. Casscells

“We will be able to get you additional data, perhaps not all the data you’d like in terms of motivation, and psychology, and physician attitudes, but we will be able to get you more data about some of these barriers and incentives in our next presentation.” Dr. Blumenthal

“I tried to prescribe a sulfa drug to a patient who was allergic to it, and the [electronic] record said, ‘You can’t.’ And that was, to me, a seminal moment in my use of the record. It didn’t endear the record to me when it also prevented me from ordering a stress test on a patient who wanted it, because it said the indications weren’t there, but I think you take the good with the bad in these things.” Dr. Blumenthal

“There may be some parallels in some other aspects of business. For example, Congress passed something called Sarbanes-Oxley. Every public corporation in the United States had to immediately change the way it did business, had somebody looking over its shoulder, public auditors, public reports about how you did this, how you did not do it. It cost us all millions of dollars….This is not a new issue. Every other business in the United States has done this. As I keep trying to remind this audience, I know that medical care is different. Everybody says their industry is different, but there are innumerable instances where massive changes have taken place almost overnight in the way we do business. Somehow, we’re more resistant in this area than every other business that I know of.” Dr. Barrett

“All of the data is there that suggests that all of the parties that are participants in this process benefit from it. Some would say, ‘Well, then why are the physicians bearing all of the cost of this?’ And that’s not true. The physicians aren’t bearing all the cost of this. The pharmacies have borne a lot of cost in implementing and upgrading all of their systems to support these standards that have been required by HHS with NCPDP script standards…I think there is recognition that all parties benefit from the process. The question becomes, how we should incentivize the physicians to adopt, whether it be through positive incentives or negative.” Mr. Hutchinson

“I was intrigued when Kevin said that 30 percent of physicians represent 80 percent of the prescriptions…So if 30 percent have the large majority, what’s the cost to get the 30 percent automated? And I don’t think we’ve ever approached it that way before, because then you’re really reaching the tipping point. Do we have a handle on that number or not?” Ms. Gelinas

“I’m looking for ideas for a kind of demo we can do. It may be that a year from now, the Navy doctor or Air Force doctor doesn’t get their check on time, until they get their certain percent of prescriptions done electronically…I don’t want to suggest anything we do is really going to be very instructive to the larger group of physicians. But I do think a clear demonstration of these kinds of microeconomic incentives that the Secretary mentioned is necessary.” Dr. Casscells

“I did take the liberty of checking with counsel, and that points to one of the great differences between business and government, and why we have government and why we have business. And that is that it would require a change in the statute for us to compel this. So it’s not within our means. Certainly it is within our means to ask the legislature for that change.” Mr. Weems

“I don’t need to see any more data. I’ve got data everywhere. I don’t need to have people waste more time, doing more research, doing more surveys. We know the answer. And maybe we, as AHIC, need to collectively put pressure on Congress through a letter to the Secretary, through a letter to the leadership and Congress to say ‘We have studied this until we’re blue in the face, and there is only one solution, and that is to mandate compliance with electronic prescribing.’” Mr. Serota

“I am very sensitive to the physician’s practice disruptions. I resisted e-mail and all those things, too, but eventually you got to do it. And now I don’t know how I existed without it. And I suspect once we get over the hump of ‘I didn’t really want to do it,’ once the practices go electronic, they’ll wonder how they ever operated with paper and pencil before.” Mr. Serota

Advancing the National Framework for Uses of Health Data

Dr. Don Detmer, President and CEO of the American Medical Informatics Association (AMIA), explained that AMIA’s goal is to make IT work effectively for health professionals. The Association has approximately 4,000 members from 53 nations. Two-thirds of the members are involved in clinical health care and in informatics. About a quarter of the members are in public health or population health, and the rest are in translational bioinformatics. AMIA started with some colleagues from Pfizer Pharmaceuticals in 1985 with the support from a variety of corporate supporters. Its first conference was held in 2006 with about 30 experts.

Dr. Charles Safran, Associate Clinical Professor of Medicine at Harvard Medical School, explained that AMIA’s research starts from the premise that use of health data is a good thing, and that more of it would be better, under appropriate conditions. AMIA wants to facilitate more and better use of health data information to: (1) enhance experiences for individual citizens, (2) expand the knowledge about disease and treatment, (3) strengthen the understanding and effectiveness and efficiency of the health system, (4) support public health and homeland security, and (5) help businesses meet the needs of their customers.

AMIA published a framework that was provided to AHIC in January of 2007, and convened a second conference in June of this year. The Association has presented to AHIC’s Consumer Empowerment Working Group, testified before the National Committee on Vital and Health Statistics (NCVHS) in July of 2007, and submitted its taxonomy to NCVHS in September. It also has submitted a consumer checklist to Dr. Kolodner and the Office of the National Coordinator.

The 2006 AMIA meeting provided a great deal of useful information. AMIA found that the uses of health data were very widespread, sometimes beyond the existing policy and legal framework. Issues of privacy dominate the public policy discussion. In addition, technology and business development outpace policy and practice. AMIA uncovered businesses whose fundamental business case was that they were operating beyond the HIPAA framework. The organization grew concerned that that the emerging RHIOs would eventually discover that perhaps they could resell their data, and that this might be a part of their evolving business model. AMIA also felt that it was not productive to talk about data ownership, and that to forward a policy discussion, it was perhaps important to put forward the idea of stewardship. AMIA also identified the need for more leadership at the national and state levels. Dr. Safran commended the Secretary, Dr. Kolodner, and others for pushing these issues forward on a national scale.

Dr. Safran reiterated that his use of the phrase “reuse of health data” refers to data that are being collected for or used for reasons other than those for which they were originally collected. These data are valuable for reasons of quality, safety, public health, payment, business operations, research, provider certification, accreditation, post-marketing surveillance, and a variety of appropriate business uses. The reuse of health data introduces the issue of what are questionable or inappropriate uses of data.

AMIA has defined a framework for reuse of health data in the following six dimensions:

• Accountability. The levels of sanctions or penalties for disclosure or inappropriate use of patient health data, transparency, the extent to which the practices governing the use of patient’s health data are known and understood by those who disclose or use patient data, and to the patients whose data are subject to use.

• Transparency the extent to which the practices governing the use of patients’ health data are known & understood by those who disclose or use data and to the patients whose data are subject to use

• Patient Consent/Notification. The opportunity offered to patients to allow or permit the use of their health data. Notification refers to the mechanism by which patients are informed of their right to consent.

• Cost (Resources Required) of Re-Identification. A proxy for the nature, complexity, & extent to which patients can be re-identified in a database(s)

• Oversight. The extent to which the entity is subject to governance or supervision, including the ability to impose remedies for breaches.

• Regulatory/Law. The framework for regulations and law that governs the use of health data, including penalties and enforcement guidelines.

Within that framework, AMIA created a consumer checklist for awareness about personal health information, how it was being used, and how policy might be devised, particularly for non-Health Insurance Portability and Accountability Act (HIPAA) covered entities. The checklist indicates that a data reuse policy should:

• Be prominently posted, with an effective date

  • Written in clear understandable language

  • Identify contact to resolve privacy issues

• Describe any and all uses of health data and any sharing of data with other organizations, whether you can be identified or not

• Describe how personal data are protected

• Describe how to receive a free report of who has accessed your data, and when.

• Describe how your permission is obtained to share data with others

  • Decisions to opt-out of data sharing should not result in denial of services

  • Provide advance notification of any changes

• Allow termination, without penalty, if you do not agree with the changes.

• Describe whether, upon termination of the agreement, you can remove your data & prevent further disclosure, whether identifiable as yours or as part of a group.

• Describe how your data are handled if the organization is sold, merges with another organization, or files for bankruptcy.

Dr. Detmer explained that AMIA thought it was important to define the language that is used when discussing issues and creating policy. To that end, the Association created a taxonomy that identifies possible uses of personal health information to clarify societal, public policy, legal and technical dimensions. AMIA is proposing the concept of “data stewardship.” The idea is that certified data stewards (however those are defined) would be able to transact with other certified data stewards under the same umbrella, so that citizens would trust that the people or the entities to whom they are handing their data would abide by the same rules and philosophy and policy of the original entity to which they contributed their data.

There is a need for a standard set of data analytic principles to be used with EHRs for the following reasons:

• A statistically sound approach is necessary for analysis of large clinical practice data sets.

• Random analysis or unstructured data mining could yield associative conclusions and potentially introduce false positive associations.

• Standard data analysis principles provide a framework for sound studies with credible and reproducible results, and for minimizing errors possibly introduced during analysis.

• Data analysis principles mitigate the risk of false positives that could cause misidentification of a safety problem.

• They provide a grounding for multiple parties such that analyses can be more readily compared.

It will be necessary to refine the data stewardship principles, which have been discussed in their broader framework. These principles include: (1) accountability (including governance, oversight, and extent and level of applicable regulations); (2) openness and transparency (including structure, processing and delivery of data, plus business processes and practices); (3) notification to patients; (4) privacy and security (including data quality, de-identification, and costs of re-identification); (5) granularity of consent; (6) permitted uses and disclosures (including data aggregation and analyses); (7) data analysis principles; and (8) enforcement and remedies. Future activities for AMIA include the following:

• Differentiate appropriate and inappropriate use of data.

• Develop recommendations to assure maintenance of the Use Taxonomy.

• Refine the stewardship principles, including the data analysis principles.

• Publish white papers.

• Participate with AHIC, NCVHS, IOM and others, particularly with respect to negative impacts on biomedical and health-related research

Discussion Highlights

“How would you ascertain industry alignment of other major groups, in getting behind this work, endorsing it, and vetting it?” Ms. Gelinas

“The part that was hardest for us was getting any sort of alignment around what was a use of data where there was an exchange of money. So we sort of abandoned the term ‘commercial’ use of data, because what it meant to be a commercial entity was a sticking point. But if you look at the uses of data around where there is an exchange of money…we need to refine the framework as it might apply to that specific area.” Dr. Safran

“The use and the rules guiding the work are totally appropriate and already safeguarded, according to the principles. The issue is, when is it inappropriate, and…how do you reach those communities and deal with that? If you have ideas for us, we would be open to it, because I think in our complex society, it’s really important.” Dr. Detmer

“I’d like to challenge you to look at what is going to be available to patients in the event that their information is breached and becomes public…I’m delighted to hear that [opting out without any denial of services] is an issue that you’re looking at, and one that continues to probably need discussion and review…What can be done to ensure some form of safety for consumers if there is a breach?...What are the steps that data stewards will go through to become certified, so that as we move to assist them, where perhaps we don’t own data, but we become stewards of data, there is an accountability?”
Ms. Davenport-Ennis

“To build a system where there is a chain of trust, the citizen needs to believe that the steward is, in fact, doing the things that will protect the citizen, and at the same time, that there is remedy and recourse. On the other hand, there is a concern among health service researchers and others about issues of opt-in versus opt-out, and the quality of data, and what we’re going to be able to do to protect the public health and a variety of other issues.” Dr. Safran

“These are very, very tough issues, and there is not necessarily a clean, right answer. But you do need the best legal minds, I think, and the data minds, as well as the society more broadly. And really, the Institute of Medicine is probably in the best position to take on some of those kinds of questions.” Dr. Detmer

Further Discussion of e-Prescribing

Following the AMIA discussion, Mr. Serota moved that AHIC adopt a resolution requesting that the Secretary recommend to Congress that it grant CMS the statutory authority to mandate e-prescribing through the Medicare program. The motion was seconded and passed. Mr. Weems noted that he had spoken to the Secretary in anticipation of such a motion. He commented that the Secretary would be anxious to receive this recommendation, and suggested that the Community’s EHR Workgroup, under the guidance of Ms. Gelinas, quickly such a recommendation. As quickly as the rules of public notice allow, a teleconference meeting of the AHIC will then be scheduled.

Dr. Kolodner requested that the record show that all Community members supported Mr. Serota’s motion.

Enhanced Protections for Uses of Health Data: Recommendations to HHS on a Data Stewardship Framework

Dr. Simon Cohn, Associate Executive Director for Health Information Policy at Kaiser Permanente and Chair of the NCVHS, explained that the NCVHS is a statutory public advisory committee to HHS and the Secretary. For 58 years the Committee has advised on a variety of health information policy areas and issues, including health data, health statistics, and health information privacy. Dr. Cohn also noted the trouble with the use of the term “secondary” use of data. There is no universally accepted standard definition, nor is it always clear whether primary uses are always more important than secondary uses. In its work, the NCVHS Work Group on Health Data Uses concluded that it is best to avoid the uses of such terms as “secondary” or “reuse,” and instead try to be very precise about the use being discussed (e.g., direct patient care, data for submission to public health and communicable diseases, information for quality improvement, etc.).

Dr. Justine Carr, Senior Director for Clinical Resource Management at Beth Israel Deaconess Medical Center framed listed the following reasons why it is important to address the uses of health data now:
(1) electronically available health data are no longer just claims data, but include more clinically rich data; (2) electronic data can be linked more readily with other databases; (3) sources of electronic health information are expanding beyond HIPAA protections of covered entities and their business associates; and (4) electronic solutions to protect and secure data continue to evolve, including approaches to allow individual consent to follow data. She reported that there were two recurring themes heard in the testimony to the NCVHS Work Group on Health Data Uses. First, recognition of the great benefit that can be achieved by using electronic health data. Benefits include an increase in the ability of use health data to benefit health care; enhancements of quality measurement and reporting with a more real-time quality improvement cycle; support in public health surveillance and responsiveness; and an acceleration of accrual of cases for timely identification of complications that may occur from new medications or new procedures, technologies and devices. The second theme is a concern about the potential for harm. There can be erosion of trust in the health care system with potential compromise to health care when individuals do not trust that their privacy can be protected. There also is a concern about potential or actual discrimination or confidentiality violations that may occur with increased ability to collect longitudinal data, coupled with sophisticated methods to re-identify data.

Dr. Carr defined HIPAA and discussed where NCVHS perceives gaps to be. She indicated that HIPAA’s focus was on the promotion of electronic exchange of data for administrative simplification. Therefore, HIPAA regulates entities that electronically transmit health information, and this includes health care payers, providers and clearinghouses. HIPAA also regulates business associates and their agents. A key concern is the fact that there are a growing number of entities that are not covered by HIPAA, including some vendors of personal health records. Another concern is the lack of detail on the expectations of HIPAA-covered business associations and their agents with regard to the ongoing uses of health information. As part of HIPAA, Congress required DHHS to adopt regulations safeguarding the privacy of individually identifiable health information (i.e., the HIPAA Privacy Rule). This covers individual identifiable health information in any formpaper, electronic, spoken, or any format held or transmitted by the covered entity. This is protected health information, but the regulations do not cover personal health information held by any organization outside the scope of HIPAA.

HIPAA requires authorization for disclosures of protected health information except for uses for treatment, payment or health care operations, or when required by law, as in public health. Health care operations include an array of activities, such as quality assessment, competence and review, compliance activities, business planning, etc. HIPAA privacy does not protect de-identified data. The NCVHS heard concerns related to the sale of de-identified data. To begin to address this, they have created a health data stewardship conceptual framework. This framework is intended to outline how an organization may approach evaluation of intended uses of data, and recognize where it may elect to enhance data stewardship processes. The framework is as follows:

• Health data user and use profile

• User: provider, payer, clearinghouse, business associate or agent, researcher, public health, PHR vendor, other

• Regulatory status: HIPAA, state data statutes, IRB, FDA, VA, privacy board, other state laws, FTC, other

• Identity status: identifiable, HIPAA de-identified (safe harbor), HIPPA de-identified (statistical), limited data set, anonymization, pseudonymization, other.

• Analysis of benefits and potential risks

• Intended use of data: treatment, payment, health care operations, research, public health, other

• Impact: benefits to individual and society, potential risk for harm.

• Data stewardship considerations

• Accountability chain of trust, transparency, individual participation and control, HIPAA de-identification, security safeguards and controls, data integrity/quality, oversight of data uses.

For example, a business associate of a payer that is covered by HIPAA, who wishes to use identifiable data for quality measurement under health care operations, would describe the benefits of the use, consider the potential risks for harm, and then consider how it would address each of the data stewardship considerations. In some areas, the user may believe it provides appropriate stewardship, but in other areas, it might see an opportunity for improvement, such as improved transparency or stronger security controls. Stewardship addresses not just data collection at transmission; it also includes data aggregation and use of the data. Focus is needed on completeness and accuracy of data, and processes to assure correct application of methodologic rules, as well as valid application of the rules related to statistical significance.

The NCVHS has identified guiding principles, against which each of the recommendations on enhanced protections for uses of health data is evaluated. Protections should do the following: (1) maintain or strengthen individuals’ health information privacy, (2) enable improvements in the health of Americans and the health care delivery system of the Nation, (3) facilitate uses of electronic health information, (4) not place an undue administrative burden on the health care industry, (5) increase the clarity and uniform understanding of laws and regulations pertaining to privacy and security of health information, and (6) build upon existing legislation and regulations whenever possible.

Harry Reynolds, Vice President of Blue Cross/Blue Shield of North Carolina, explained that NCVHS’ draft recommendations call for enhanced HIPAA protections and data stewardship for all uses of health data by all users, independent of whether an organization is covered by HIPAA. Most of the recommendations do not require legislation, and take the form of such measures as inclusion and requirements for contractors, incentives, conditions of participation, and interagency collaboration. The recommendations, which fall under four main categories, are as follows:

Principles of Data Stewardship

These draft recommendations address the areas and the framework having to do with accountability and chain of trust, transparency, individual participation and control, de-identification, security, and data integrity, data quality. The recommendations are as follows:

• Accountability and chain of trust within HIPAA

• Covered entities specify in business associate contracts terms that: (1) clearly describe uses of identifiable health data and de-identified health data; (2) require a contract between business associates and agents, and identification of all agents to the covered entity; and (3) include a yearly confirmation of compliance with the contract.

• Business associates include all companies requiring access to protected health information during transmission.

• Transparency

• Enhancements to notice of privacy practices.

• Make information available, upon request, about specific uses and users.

• Make information available, upon request, about specific information disclosed to other organizations, such as public health.

• FTC uses its authority to ensure that privacy policies fully inform and do not mislead the public.

• Individual participation and control over personal health data

• Assure authorization for personal health information uses not protected under HIPAA.

• Evaluate technologies to manage individuals’ authorization.

• De-identification

• HIPAA definition (safe harbor or statistical process) is the only currently recognized means to de-identify protected health information.

• NCVHS will further investigate uses of de-identified data, and potentially offer recommendations for guidance.

• Security safeguards and controls

• Promote technical security measures and compliance with HIPAA Security Rule by all business associates and their agents.

• Data integrity and quality

• Data for quality measurement, reporting, and improvement follow rules and guidelines to ensure precision and reliability of quality measures.

Oversight for Specific Uses of Health Data

These draft recommendations address enhanced oversight for specific uses of health data, since NCVHS recommendations also focus on uses of health data for quality measurement, reporting and improvement.

• Quality measurement, reporting, and improvement

• Uses of health data for quality measurement, reporting, and improvement are within scope of HIPAA health care operations.

• Use a proactive oversight process accountable to senior management and governance to ensure compliance with HIPAA.

• Assess risk and apply further protections as appropriate when quality activities are conducted across different covered entities within an organized health care arrangement.

• Research

• Harmonize research regulations.

• Clarify the definition of research and provide methodologies that help differentiate research from quality.

• Widely disseminate quality/research guidance.

• Identify approaches to ensure that when a quality study becomes generalizable and evolves into research, that HIPAA Privacy and IRB requirements are respected.

Transitioning to an NHIN

These draft recommendations deal with evaluating new tools and technologies as the industry makes a transition to HIE and an NHIN:

• Adopt data stewardship principles in NHIN activities.

• Use NHIN trial implementations to evaluate:

• Individual choice applications.

• Data stewardship principles in comprehensive databases.

• Potential new de-identification techniques.

• Chain of trust enhancements.

• Educational modalities to improve understanding.

Additional Privacy Protections for Health Data

These draft recommendations focus on additional legislation to broaden the scope of privacy coverage to all who may have access to personal health information, and on anti-discrimination consequences that may arise out of the wrongful uses of health data

• Address the need for:

• More inclusive, federal privacy legislation for health data.

• In the absence of comprehensive federal privacy legislation, an expanded definition of covered entities under HIPAA.

• Promote legislative or regulatory measures on anti-discrimination.

• Use findings from the Health Information Security and Privacy Collaboration to encourage states to map their data restriction laws to one another in order to promote interoperability.

In terms of future activities, the NCVHS will address additional public comments to finalize the draft recommendations (this presentation was part of the public comment process). The NCVHS has its full committee meeting November 27-28, 2007, and all of these recommendations will then be sent to the Secretary. Mr. Reynolds anticipates an ongoing analysis and subsequent recommendations.

Discussion Highlights

“I love the approach you’re taking which is a small number of absolute principles. Those should trump all else. And if you effectively implement the principles, then you don’t have to effectively go after every minute process within the system. Am I understanding correctly the direction you’re taking?”
Dr. Barrett

“Yes…and we’re obviously trying to make this along the lines of best practices, model agreements, and contracts with the idea that hopefully it will lessen the administration burden.” Dr. Cohn

Public Input Session

Speaker Number 1 Dr. Alan Zuckerman, representing the American Academy of Pediatrics, with its 60,000 pediatricians, also represents America’s children on the Health Information Standards Panel and co-chairs CCHIT’s Interoperability Expert Panel. Dr. Zuckerman reminded participants that he addressed the Community 2 years to state the importance of reciprocal registration, whereby providers would register with patients. This is the interoperability with personal health records that he is still seeking. Dr. Zuckerman also emphasized the importance of including children, pointing out that the EHR pilot will not include this population. He indicated that it is necessary for the Community to make a statement on the importance of including children in HIT so that there is not a repeat of what occurred at the U.S. Food and Drug Administration regarding the certification of use of drugs for children.

Dr. Zuckerman also emphasized the importance of building acceptance, adoption, and demonstration of tools such as a portable family history and immunization and response management. In addition, he discussed e-prescribing, pointing out that the use case that AHIC adopted 2 years ago, with the registration summary, could be a huge enabler of e-prescribing by facilitating work flow, enabling a patient’s usual pharmacy, their insurance, their existing medications to move seamlessly into physicians’ systems. However, Dr. Zuckerman pointed out that there is very little awareness of this, and there needs to be a greater focus on the aspect of workflow facilitation.

Speaker Number 2 Hugh Zettel of GE Healthcare serves as Vice Chair of the Healthcare Information and Management Systems Society’s (HIMMS) EHR Vendor Association (EHRVA), a trade group of more than 40 EHR providers for both inpatient and ambulatory care. Recognizing the benefits of interoperability in healthcare, the HIMSS EHRVA has released a quick-start guide for the ASTM HL-7 continuity of care document standard. The organization developed the guide, which is available at no charge at www.himssehrva.org, as a resource to help speed up interoperability in health care.

Speaker Number 3 Mr. Jackie Jacamathan, who works for a transcription service company, commented on the fact that there does not seem to be a focus on removing regulatory barriers for physicians wishing to practice in multiple states. He asked if there was any such focus on the part of the Community.

Closing Remarks

Before adjourning the 17th meeting of the AHIC, Dr. Kolodner thanked the Community members, speakers, and participants for their attendance and participation.