Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

June 21-22, 2006

Hubert H. Humphrey Building
Washington, D.C.

MEETING MINUTES

The National Committee on Vital and Health Statistics was convened on June 21-22, 2006 at the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:

Committee members

  • Simon P. Cohn, M.D., M.P.H., Chair
  • Jeffrey Blair, M.B.A.
  • Justine M.Carr, M.D.
  • John P. Houston, J.D.
  • Stanley M. Huff, M.D.
  • Robert W. Hungate
  • A. Russell Localio, Esq., M.A., M.P.H., M.S.
  • Carol J. McCall, F.S.A., M.A.A.A.
  • Harry Reynolds
  • Mark A. Rothstein, J.D.
  • William J. Scanlon, Ph.D.
  • Donald M. Steinwachs, Ph.D.
  • C. Eugene Steuerle, Ph.D.
  • Paul Tang, M.D.
  • Kevin C. Vigilante, M.D., M.P.H.
  • Judith Warren, Ph.D, R.N.

Staff and liaisons

  • Marjorie Greenberg, NCHS/CDC, Executive Secretary
  • James Scanlon, ASPE, Executive Staff Director
  • Karen Trudel, CMS liaison
  • Steve Steindel, Ph.D., CDC liaison
  • Irma Elo, Ph.D., NCHS Board of Scientific Counselors liaison

Others

  • Debbie Jackson, NCHS
  • Katherine Jones, NCHS
  • Maya Bernstein, ASPE
  • Elizabeth Halley, Mitre
  • Julia Holmes, NCHS
  • Jeanette Thornton, AHIP
  • Robin Thornhauser, CAQH
  • Don Asmonga, AHIMA
  • Audrey Burwell, OMH
  • Nancy Farris, Government Health IT
  • John Quinn, Accenture
  • Don Detmer, AMIA
  • Miryam Granthon, OMH
  • Ginny Wagner, IBM
  • Jody Daniel, ONC
  • Michael DeCarlo, BC/BS
  • Suzie Burke-Bebee, ASPE
  • David Slaughter, Thompson Publishing
  • Carol Bickford, Amer. Nurses Assn.
  • Bill Alfano, BC/BS

EXECUTIVE SUMMARY

ACTIONS

  1. The Committee approved a letter commenting on Consolidated Health Informatics recommendations on the multimedia domain.
  2. The Committee approved a letter with preliminary observations and recommendations on the implementation and impact of HIPAA.
  3. On the occasion of her retirement from HHS, the Committee approved a letter of appreciation to Dr. Maria Friedman for her service as lead staff to the Subcommittee on Standards and Security.
  4. The Committee approved a report on privacy and confidentiality in the Nationwide Health Information Network (NHIN).
  5. The Committee deferred a letter on matching patients to their records.

INTRODUCTORY REMARKS

Dr. Cohn announced the creation of an ad hoc work group on the NHIN, which he will chair, to help the Office of the National Coordinator (ONC) synthesize and refine the minimal but inclusive functional requirements for the NHIN.

The Workgroup will hold hearings in conjunction with an ONC-sponsored forum on the NHIN to take place June 28-29 and again on July 26-27. Its recommendations will be brought to the full Committee at its September meeting.

UPDATE FROM THE DEPARTMENT

  • Data Council— James Scanlon, ASPE
  • HIPAA implementation—Karen Trudel, CMS
  • Privacy Rule Compliance—Sue McAndrew, OCR

Mr. Scanlon reported that deliberation is underway on the 2007 budget; most major HHS statistical systems are being funded at straight-line levels. The Data Council has begun work on the 2008 budget. It has developed a list of nine “HHS Priorities for America’s Health Care,” for the Secretary’s 500-Day Plan. The Data Council is looking at how HHS data systems and plans can support the priorities. It is also initiating a project on secondary uses of EHR data

Ms. Trudel reported on activities related to e-prescribing, provider enumeration and the CMS role with respect to PHRs. HIPAA complaint rates are holding steady.

Ms. McAndrew reported that the patterns of complaint responses are holding steady, but more complaints are expected in the near future. OCR is also working with the American Health Information Community (AHIC) and working on emergency preparedness.

NCVHS members asked questions about privacy rule enforcement and public education, provider enumeration, and cost-benefit analysis of the privacy rule.

ONC UPDATE: CONTRACTS, AHIC COORDINATION EFFORTS AND NHIN – John Loonsk, M.D., Director of Interoperability and Standards

Dr. Loonsk reported on recent AHIC workgroup recommendations, the work of the Standards Panel and Certification Commission, the forthcoming hearing on functional requirements, and next steps for the AHIC workgroups.

Committee members had questions and comments about building future work on the foundation laid by the Consolidated Health Informatics initiative; the need for AHIC activity on clinical decision support; and the high cost of certification. Dr. Cohn said clinical decision support should be bookmarked for attention by the ad hoc NCVHS Workgroup.

SUBCOMMITTEE ON STANDARDS AND SECURITY LETTERS—Mr. Reynolds

Mr. Reynolds introduced the first of a series of draft letters for Committee review. The first conveys the Committee’s comment on CHI recommendations. The letter was read and briefly discussed, and then approved.

The second letter provides preliminary observations and recommendations on the implementation and impact of HIPAA, marking its tenth anniversary. The letter was discussed and referred to the Subcommittee for revision. On day two, the Committee discussed and approved the revised version.

BRIEFING: CERTIFICATION COMMISSION FOR HEALTH INFORMATION TECHNOLOGY (CCHIT) —Mark Leavitt, M.D., Ph.D., Chair

The purpose of CCHIT is to accelerate the adoption of robust, interoperable HIT. It operates in parallel with efforts by other AHIC contractors that together are carrying out a broad strategy. The chief CCHIT goal is to reduce risk for providers as they invest in health IT; others are to accelerate adoption, facilitate interoperability, and enhance incentives and relieve regulatory barriers. Dr. Leavitt described how CCHIT works with other contractors and how it is structured. Most of its work is done by volunteers. The organization uses a consensus-based process and makes a major effort to ensure openness and transparency. The work is divided into three phases, with certification of ambulatory EHRs in the first year. The criteria for ambulatory EHRs, which are posted on the CCHIT Website, are in three areas—functionality, interoperability, and security/reliability.

In the discussion period, participants had questions about data for quality reporting and biosurveillance; the cost of certification; and integrating standards and interoperability criteria over time.

LETTER TO DR. MARIA FRIEDMAN—Dr. Cohn

Dr. Cohn read a letter to Dr. Friedman on the occasion of her retirement from HHS, thanking her for her service as lead staff to the Subcommittee on Standards and Security. The letter was approved with appreciation.

LETTER ON THE NHIN BY THE SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY —Mr. Rothstein

Mr. Rothstein presented a detailed report on privacy and confidentiality in the NHIN, drafted by the Subcommittee on Privacy and Confidentiality. It conveys findings and recommendations based on four hearings held in Washington, D.C., San Francisco and Chicago in 2005. The Subcommittee heard from a broad range of stakeholders in these hearings and also in a series of open meetings and conference calls. Mr. Rothstein noted the lengthy report development process, and thanked Ms. Bernstein for her support as lead staff. He stressed that the most important contribution of the report is in framing a set of complex, controversial and politicized issues. It is the product of a serious effort to reach consensus among Subcommittee members in as many areas as possible, and it also identifies areas in which this was not possible. The Committee engaged in a wide-ranging discussion of the draft report and proposed a number of revisions. The report was revised overnight and presented for approval on day two, when it was discussed, revised further, and approved.

DRAFT LETTER—Mr. Reynolds

Mr. Reynolds read aloud a letter on matching patients to their records, drafted by the Subcommittee on Standards and Security. The letter was discussed on day one and deferred for consideration after hearings by the ad hoc Workgroup.

SPEAKERS IN PREPARATION/TRANSITION FOR FULL NCVHS RETREAT

Dr. Cohn welcomed two speakers who were invited to help the Committee prepare for the strategic planning retreat that follows this meeting.

  • Don Detmer, M.D., President & CEO, American Medical Informatics Association: “Issues Deserving Attention to 2010”

Dr. Detmer began his remarks by reviewing the dominant goals of the past decade, as expressed through the IOM reports on errors and the quality chasm, with the Committee’s work on the NHII as a major response. He described his findings and observations from a study of health IT in five English-speaking countries outside the US. He contrasted the impacts of the countries’ health care security and “social solidarity” values with the situation in the US, especially in terms of attitudes toward privacy. Regarding future NCVHS priorities, he proposed three possible new agenda areas: value (quality and safety in relation to cost); research and development; and education and training. He suggested the possibility of creating ad hoc workgroups in these areas, populating them with NCVHS and non-NCVHS members, and having them each work on three Committee priorities. He described a new National Academy of Sciences report and several AMIA projects and reports that could serve as resources in these areas.

  • John Quinn, CTO, Accenture Health and Life Sciences Provider Practice

Mr. Quinn said he did not anticipate widespread use and networked communication of EHRs in the US for about another two decades, due to barriers that are primarily not technical. He contrasted the government-financed health information infrastructure development in the UK with the market-driven, bottom-up process in the US. After outlining the logical sequence of EHRs ’ RHIOs ’ NHIN, he noted that the network is of little value without EHR systems, and he pointed to the disappointing EHR adoption rates, especially outside large ambulatory care organizations. RHIOs, he said, are suffering the same fate as CHINs. The big questions about the NHIN are who will pay for it when the developmental stage is finished, and what there will be to attach to it in a few years. Mr. Quinn noted that provider organizations need to invest in EHRs and local connecting infrastructure but have little available capital to invest. Payers and pharmaceutical manufacturers have the most capital to invest, but they lack a clear understanding of how they could gain from investing in interoperable EHRs (though this is beginning to change). Concerning HIT vendors and HIT technology, he stressed that because of the complexities and the time it takes to develop HIT (10-15 years), the general IT industry has not figured out how to successfully invest in health care.

In the discussion period, the speakers were asked to suggest next steps for NCVHS to encourage HIT development. Dr. Detmer suggested leveraging the computer-based work of the VA and DoD. He also suggested using e-prescribing as “the poster child” for HIT. Mr. Quinn pointed to leveraging the electronic claims attachment transaction.

DETAILED SUMMARY

—DAY ONE—

CALL TO ORDER, WELCOME, INTRODUCTIONS, REVIEW OF AGENDA

Dr. Cohn called the meeting to order and asked all present to introduce themselves. He announced the following dates for 2007 NCVHS meetings: February 13-14, June 20-21, September 25-26 and November 27-28. He announced that he had created an ad hoc workgroup on the NHIN to assist ONC, at its request, in synthesizing and refining the minimal but inclusive functional requirements for the NHIN. The makeup of the workgroup: Simon Cohn, Chair; Jeff Blair and Harry Reynolds, Vice Chairs; Justine Carr, John Paul Houston, Paul Tang, Kevin Vigilante, Judy Warren; Mary Jo Deering, Lead Staff; Margaret Amatayakul, Consultant. The Workgroup will hold hearings on day two of an ONC-sponsored forum on the NHIN to take place June 28-29. Hearings also will be held on July 26-27. Its recommendations will be brought to the full Committee at its September meeting.

Dr. Cohn noted the considerable activity planned by several NCVHS sub-groups, foreshadowing a busy year ahead. Mr. Houston and Mr. Rothstein are the NCVHS liaisons to the American Health Information Community workgroups. He acknowledged the service of Dr. David Brailer, who recently resigned as National Coordinator for Health Information Technology. Finally, he noted his own testimony before the House Ways and Means Health Subcommittee on April 6, 2006, on issues relating to health IT.

UPDATE FROM THE DEPARTMENT

  • Data Council— James Scanlon, ASPE

Mr. Scanlon observed that Congress is showing a lot of interest in health IT, with several bills introduced, one of which gives NCVHS a role regarding new standards. Deliberation is underway on the 2007 budget; 2007 will be a very tight year for non-defense domestic spending. Most major HHS statistical systems are being funded at straight-line levels. The Data Council has begun work on the 2008 budget. It has developed a list of nine “HHS Priorities for America’s Health Care,” framed as vision statements. These are priorities for the Secretary’s 500-Day Plan, and he regards them as possibilities for change that can move other changes, as well. The priorities are: health care value incentives, health IT, Medicare Rx, Medicaid modernization, New Orleans health system, personalized health care, obesity prevention, pandemic preparedness, and emergency response and Commissioned Corps renewal. Mr. Scanlon commented briefly on each of these priorities. The Data Council is looking at how HHS data systems and plans can support the priorities. IT solutions are implicit in several—e.g., e-prescribing in Medicare Rx.

The Data Council is initiating a project on secondary uses of EHR data as a resource for provider-based survey purposes. It will be a joint project with AHRQ and NCHS, with a workshop in which NCVHS will be involved.

  • HIPAA implementation—Karen Trudel, CMS

On e-prescribing, Ms. Trudel reported that consistent with an NCVHS recommendation, an interim final rule has been published that moves forward the voluntary adoption of script standard version 8.1. The five e-prescribing pilots have completed their first two quarters, and data are expected shortly. On HIPAA, the number of complaints is holding steady. On the National Provider identifier, enumeration is moving along well, with 700,000 providers completed; bulk enumeration began on May 1. The compliance rate for Medicare HIPAA implementation is at 99 percent.

Turning to personal health records (PHRs), Ms. Trudel described CMS efforts to get industry input on its role. It is evaluating issues related to the use of Medicare data to populate an existing PHR for beneficiaries. Initially this will not include Part D data, but the importance of that component is recognized for the future.

In response to a question, she said it is hard to know the number of providers, individual and institutional, in the US, which would provide the denominator for its enumeration effort. It is working with WEDI and willing to work with others to speed up NPI adoption.

  • Privacy Rule Compliance—Sue McAndrew, OCR

As of the end of May, OCR had received roughly 20,000 complaints. The closure rate has been holding steady, with about 5,000 open complaints in any given month. It is expecting an upsurge in complaints in reaction to recent large, well-publicized system breaches. They have not yet imposed any CMPs. Despite recent public criticism of the government’s “lax enforcement,” the Department remains committed to its current approach, which involves problem-solving and voluntary compliance, which it believes is working. OCR also has been active working with AHIC workgroups and on emergency preparedness. It is preparing a tool to help planners understand how to comply with HIPAA as they deal with emergencies.

NCVHS members raised a wide range of questions. Mr. Blair asked about educating the public on the role of the HIPAA privacy rule and tracking public perceptions. Ms. McAndrew said OCR has a new consumer-oriented flyer on OCR’s civil rights protections and HIPAA. It does not have the capacity to do surveys but pays attention to those done by others. Mr. Scanlon added that ASPE is considering a project with OCR and others to look at how to measure things in this area. Mr. Rothstein suggested a small study of the satisfaction level of complainants whose issues were addressed by OCR. Dr. Steuerle suggested looking at costs as well as benefits of the HIPAA privacy rule. Mr. Localio asked for an estimate of the number of complaints received from “non-covered entities”; Ms. McAndrew said it is “in the thousands.” Dr. Tang inquired about the limits of the government’s ability to hold individuals accountable.

Mr. Houston said he regards the general OCR complaints process as “very good.” He asked what it is doing about disparate state privacy laws, possibly to bring about some uniformity. Ms. McAndrew said they are looking at that.

Before moving to the next agenda item, Dr. Cohn observed that in the future, full Committee agendas need to allow more time for reports and discussions on Departmental activities as this agenda item always takes more time than allotted.

ONC UPDATE: CONTRACTS, AHIC COORDINATION EFFORTS AND NHIN – John Loonsk, M.D., Director of Interoperability and Standards, ONC

Dr. Loonsk began with an update on recent AHIC recommendations from the workgroups. The HIT Standards Panel (HITSP) will deliver implementation-level guidance on standards for the breakthrough initiatives in September. AHIC also issued recommendations on regulatory issues related to CLIA and licensure, and on federal implementation of technology standards in its contracts and systems. Next steps for AHIC include concentration by the working groups on broader charges, creation of a new working group on data for biosurveillance, and a new working group on privacy and security issues.

Other AHIC activities include the work of the Certification Commission on health IT, which has now received its first applications for certification, and the development of a clinical decision support roadmap, a joint project between ONC and AMIA. In addition, ONC presented a document on goals, objectives and strategies to facilitate greater specificity for actions to move the national health IT agenda forward.

Finally, Dr. Loonsk commented on the forthcoming NHIN forum on functional requirements, which will provide opportunities for public input and discussion. Developing clarity on common requirements and architectural differences is regarded as a critical step in several activities including standards harmonization and certification. He thanked NCVHS for its partnership in this effort.

Discussion

Mr. Blair asked how the aforementioned activities and priorities relate and connect to the work of the Consolidated Health Informatics initiative, and he expressed hope that the foundation laid by it with respect to terminology would not be lost in the next phase. Dr. Loonsk assured him that the CHI work is integrated into the work of the HITSP. He noted that the latter is a public-private process while the former focused on federal systems; nevertheless, ONC is making sure that HISTP considers the CHI standards and work, and has engaged the NLM and NIST in this activity. He described the testing and education that will be needed to continue the progress on terminology and standardization.

At Mr. Rothstein’s request, Dr. Loonsk described the process and timetable for the four architecture consortia projects. The first year is focused on architecture, he said, starting with the public fora. The anticipated product is “an architecture with variations.”

Mr. Hungate noted the absence of an entity for clinical decision support development, and Dr. Loonsk acknowledged that the current requirements on the table are not complete but rather “initial.” AHIC and its workgroups will guide the prioritization of next step activities, one of which is likely to address priorities for consumers.

Dr. Fitzmaurice commented on the high cost of certification and concerns about it “on the street.” He wondered if the cost was out of HHS’ control. Dr. Loonsk noted that the potential revenues in this area are significant for EHR vendors and that certification is a costly process. On the forthcoming HITSP standards and certification criteria, Dr. Fitzmaurice asked who would certify or endorse them as suitable. He noted that the federal health architecture and CHI efforts were modified to fit into the emerging NHIN process and wondered how the new standards and criteria would be mapped to federal priorities.

Dr. Cohn said NCVHS looked forward to a conversation with HITSP in September or November, and said clinical decision support should be bookmarked for attention by the ad hoc Workgroup.

SUBCOMMITTEE ON STANDARDS AND SECURITY LETTERS—Mr. Reynolds

Mr. Reynolds introduced the first of a series of draft letters to be reviewed by the Committee. This one conveys the Committee’s comment on CHI recommendations for the multimedia domain. He read the letter and acknowledged Dr. Steindel’s assistance in its preparation. After brief discussion and one stylistic suggestion, the Committee approved the letter.

The second letter provides preliminary observations and recommendations on the implementation and impact of HIPAA, marking its tenth anniversary. After noting that the Subcommittee has held numerous hearings on the subject, Mr. Reynolds read the observations and recommendations contained in the letter. At the outset, the group discussed at some length how to express the gap between initial expectations and reality with respect to HIPAA. The Committee’s annual report to Congress on HIPAA implementation was cited as a source of commentary. Members then discussed various aspects of the substance of the letter and how to maximize its impact. Mr. Reynolds said that many of the recommended changes are already happening in industry, partly thanks to the Subcommittee’s public hearings. The letter will be revised and presented on day two of this meeting.

BRIEFING: CERTIFICATION COMMISSION FOR HEALTH INFORMATION TECHNOLOGY (CCHIT) —Mark Leavitt, M.D., Ph.D., Chair

The purpose of CCHIT is to accelerate the adoption of robust, interoperable HIT. It operates in parallel with efforts by other AHIC contractors that together form a broad strategy. CCHIT was founded by AHIMA, HIMSS and the Alliance and is funded by a 3-year contract to develop compliance criteria and inspection process for EHRs and their networks. The chief, and most achievable, goal is to reduce risk for providers as they invest in health IT. Dr. Leavitt noted that there are both horror stories and success stories about HIT investments. The other CCHIT goals are to accelerate adoption, facilitate interoperability, and enhance incentives and relieve regulatory barriers. It has worked with a broad array of stakeholders from the private and public sectors and has identified six guiding principles, the chief one of which is privacy of personal health information. Another important principle is a sense of urgency.

Dr. Leavitt described how CCHIT—the interface between policies and standards and “the rough and tumble marketplace” — works with the other contractors. He noted that the problem in the past was not the absence of standards but the way they were implemented. He then described the way CCHIT is organized, with an all-volunteer Board of Commissioners plus a small staff. There are five work groups, each with volunteer staff and a coordinator. One group serves as the “watchdog” on the certification program. The organization uses a consensus-based process and makes a major effort to ensure openness and transparency. The work has three phases: certification of ambulatory EHRs in the 1st year, inpatient EHRs in the 2nd, and networks for EHR interoperability in the 3rd. The work of updating and refining ambulatory criteria will continue for all three years. The developmental process begins with an environmental scan, followed by criteria development, inspection process development, pilot testing of the criteria, finalization, and finally launch of the certification program. The process road map has proven to be a powerful tool. The first results will be out July 18. In response to a question, Dr. Leavitt said PHRs are not part of the CCHIT contract, but it is aware of stakeholder interest in them.

The criteria for ambulatory EHRs, which are posted on the CCHIT Website, are in three areas—functionality, interoperability, and security/reliability. The certification program involves scripted demonstration of the product before expert juries. Products have to be finished and installed in at least one site to be eligible. There are quarterly certification cycles. The criteria will be updated annually, in May. One of the most contentious topics, Dr. Leavitt said, is CCHIT’s 100 percent compliance requirement. Because this is so stringent, it has introduced fail-safe mechanisms involving retests and appeals to reduce the possibility of error by the jurors. Finally, he described the plans for 2007 for the ambulatory and inpatient “tracks.”

Discussion

Dr. Vigilante asked where quality reporting and biosurveillance standards figure in the planning, and was told that the first step for the former is a requirement that the system be able to collect structured data for quality reporting. Other factors will be added as quality organizations agree on them. Biosurveillance did not emerge initially as an issue; the earliest it could be on the roadmap is for 2008, with a data element requirement possible a year later. Dr. Steindel added that several building blocks will be in place from the outset.

Noting the cost of certification, Dr. Fitzmaurice suggested the possibility that government should support this activity. Dr. Leavitt said CCHIT’s contract includes development of a business plan to become self-sustaining once it ends (with a one-year extension of support allowed). He added that it would probably need funding if it gets into new areas such as PHRs.

Mr. Scanlon asked how standards and interoperability capabilities will be factored into products over time, given that there is less progress in these areas initially. Dr. Leavitt said the 2007 criteria are expected to include interoperability. Certified products can operate for 3 years as certified, but he is hoping that market pressure will encourage companies to meet new standards sooner than that. This should “blossom” by 2008 because of the HITSP process. To other questions he said that about two dozen vendors have applied, of a total of more than 200 now marketing products, and that usability is not being tested.

LETTER TO DR. MARIA FRIEDMAN—Dr. Cohn

Dr. Cohn read a letter to Dr. Friedman on the occasion of her retirement from HHS, thanking her for her service as lead staff to the Subcommittee on Standards and Security. The letter was approved with appreciation. In return, she expressed her thanks to the Committee. The group also honored her at a dinner the following evening.

LETTER ON THE NHIN BY THE SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY —Mr. Rothstein

(Several hours of the meeting were devoted to discussing and revising this document. The details of the discussion can be found in the meeting transcript [pg. 144 ff. of day one and pg.6 ff. of day two], and the final version of the report is posted with other NCVHS reports and letters. Both are on the Website, ncvhs.hhs.gov.)

Mr. Rothstein presented a detailed report on privacy and confidentiality in the NHIN, drafted by the Subcommittee on Privacy and Confidentiality. It conveys findings and recommendations based on four hearings, held in Washington, D.C., San Francisco and Chicago in 2005. The Subcommittee heard from a broad range of stakeholders in these hearings and also in a series of open meetings and conference calls. Mr. Rothstein noted the lengthy development process, which included earlier discussions with the full Committee about aspects of the report. He thanked Ms. Bernstein for her support as lead staff. He stressed that the most important contribution of the report is in framing a set of complex, controversial and politicized issues. It is the product of a serious effort to reach consensus among Subcommittee members in as many areas as possible, and it identifies areas in which this was not possible. He stressed the importance of reaching closure on the report and getting it into circulation, because timing is critical.

Mr. Blair praised the report as “the most beautiful explanation about the complex subject of privacy and confidentiality that I have ever read.”

The group then reviewed the report from beginning to end and considered many revisions. Early on, they agreed that for policy issues on which the Committee does not reach agreement, the report should recommend that HHS use an open, public and transparent process to gather additional information and ultimately move to a resolution.

Mr. Hungate asked that Committee members have a chance to talk through key issues on which Subcommittee members had been unable to reach consensus. A predominant focus of the ensuing discussion was the issues surrounding opt-in vs. opt-out approaches. Dr. Steuerle urged that the policy recommendations and decisions be as empirically grounded as possible, and he noted the growing literature on participation rates in pension policies. There was discussion of the possibility of having consumers bear some of the financial consequences of a decision not to participate in the NHIN; but members agreed that this raises policy questions beyond the topic on the table.

As a general observation, Mr. Reynolds reminded fellow members that nobody knows what the NHIN is or will be, so at this point recommendations must be general in nature. Ms. Greenberg reiterated that the Committee is making an important contribution by framing major public policy issues that will have to be resolved through a participatory public process. She also noted the importance of evaluation by the Department. Mr. Rothstein stressed that however the opt-in/opt-out question is resolved, education and materials to ensure that decisions are informed will be essential. Dr. Vigilante suggested that local rather than national policy-making on this matter may be more appropriate in the early stages of information networking.

In the course of the discussion, several members stated their desire for the Committee to approve the report, and their view that there are no “deal-breakers” in its contents. They stressed the urgency of getting the report into circulation because things are moving so rapidly. The group spent some time talking about the secondary uses of PHI, such as for research, and agreed that this large topic would be addressed in future NCVHS hearings and strategic planning. Another focus of discussion was how to extend protections beyond the entities currently covered by HIPAA; and it was noted that the status of PHRs with respect to the NHIN is still not determined.

Mr. Rothstein said the Subcommittee on Privacy and Confidentiality would revise the report based on the foregoing discussion and bring the revised version to the Committee for review on the following day.

DRAFT LETTER—Mr. Reynolds

Mr. Reynolds read aloud a letter on matching patients to their records, drafted by the Subcommittee on Standards and Security. He thanked Dr. Warren for her leadership in the drafting. In the discussion, Mr. Scanlon urged the Committee to distinguish technical and public policy issues and to be cautious about its recommendations on the latter. The discussion was deferred to the Subcommittee on Standards and Security break-out session that followed this session.

The group then recessed into breakout sessions.

—DAY TWO—

SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY LETTER ON THE NHIN —Mr. Rothstein

Mr. Rothstein presented a revised version of the report on privacy and confidentiality in the NHIN. He and Ms. Bernstein read aloud the revisions, and there was considerable further discussion. Most of the discussion of the new draft was confined to the wording of the report; fewer broad issues surfaced than on the previous day. One issue that received attention was the nature of a proposed “right to privacy” and its tension with the greater social interest. Members debated a related question about the feasibility of using information derived from medical records for public health-oriented activities such as public health surveillance, research and quality assessment. Some asserted that parallel systems are warranted for these functions. Dr. Steindel said CDC is rolling out a parallel system for biosurveillance, and he urged that the discussion of rights be kept separate from questions of public health monitoring. As they had the previous day, questions arose about the extent and nature of the Department’s authority to make certain recommended decisions. Mr. Reynolds and Mr. Rothstein urged the Committee, in view of the activity now under way, to make clear recommendations and not to dilute them with temporizing or “waffling language.” Members also, however, stressed the value of simply framing the issues.

After reviewing the new draft, the Committee passed a motion approving the letter, as revised, and authorizing Mr. Rothstein and Ms. Bernstein to do further wordsmithing as needed. Dr. Cohn congratulated the Subcommittee on Privacy and Confidentiality for this major accomplishment and thanked Mr. Rothstein for his leadership.

SPEAKERS IN PREPARATION/TRANSITION FOR FULL NCVHS RETREAT

Dr. Cohn welcomed two speakers who were invited to help the Committee prepare for the strategic planning retreat that followed this meeting.

  • Don Detmer, M.D., President & CEO, American Medical Informatics Association: “Issues Deserving Attention to 2010”

(Also see Dr. Detmer’s slides atncvhs.hhs.gov/060622p1.pdf )

Dr. Detmer, a previous NCVHS Chair, said that while some of his comments reflected AMIA positions, he was not speaking officially. He began by reviewing the dominant goals of the past decade, as expressed through IOM reports on errors and the quality chasm. The reports emphasized the need for a national commitment to build a national health information infrastructure, to improve national health and health care. NCVHS, among others, took up this challenge with its NHII vision, and the nation is still struggling to finance this effort. He noted that first-class health care is achievable at the intersection of the three dimensions outlined in the NHII vision.

Dr. Detmer recently studied health IT systems in five English-speaking nations (not including the US) and parts of Europe, commissioned by AARP. He reviewed some of his findings, which AARP published in March. The nations have in common an emphasis on standards to enable connectivity and the view that privacy is a priority. The public in all these nations is increasingly using the Internet to get health information, and all the countries show rising concern about the sustainability of their systems. Social solidarity is an ascendant national value in the countries studied. It is a basis for collective trust, and it tempers concerns about privacy. In these countries, unlike the US, confidentiality and security are emphasized more than privacy. Another significant factor in these nations is people’s assumption that they will receive needed care. In the US, Dr. Detmer noted, the dominant focus with respect to trust is not social solidarity but individual autonomy and personal control.

With personal health records, he found that not much is happening in the nations studied “because of their solidarity strategy.” They emphasize education more than patient control, and public policies assure equity of access to care. He noted that equity is not a top policy priority in the US. In addition, a unique personal health ID is treated as a practical necessity in these countries. Relative to their national budgets, the other countries are investing far more in HIT than the US is.

Dr. Detmer called attention to a new National Academies initiative on “informatics to assure value,” starting with a May, 2006 planning workshop. He also noted the report, Building a Better Health Care System, which makes contributions related to work flow, innovation and other matters. He encouraged the Committee to approach quality and safety issues in terms of value—i.e., as a function of cost—because of the issue of sustainability. He also noted the important dimensions contributed by health informatics, in contrast with simply “health IT.”

He then turned to what NCVHS might do in the future. He proposed two new agenda areas besides the value area described above: research and development, and education and training. All three areas, he said, cut across the personal, population and professional dimensions of the NHII to constitute “interlocking Computer-based Health Records, supported by knowledge.” He suggested that the three areas might be the focus of ad hoc workgroups, comprised of Committee members and outside people, that would each identify and pursue three top priorities for NCVHS. In the R&D area, he pointed to AMIA’s “Roadmap for National Action on Clinical Support.” One specific issue that he proposed for investigation is an opt-out personal identifier. In the education area, he commented on different varieties of informaticians and the idea of a “public policy informatician” who would bring additional ethical and value perspectives to other informatics approaches. Noting the aging of the general population and the nursing workforce, he asserted that education and training should “not be a sleeper issue.” He also noted a recent AMIA report on workforce issues. Finally, in the value area, he proposed that an integrated PHR with the patient “tethered electronically to their care” is an emerging model with the capacity to deliver value.

  • John Quinn, CTO, Accenture Health and Life Sciences Provider Practice

Mr. Quinn chairs HL7’s Technical Steering Committee and serves on its Board. Picking up on Dr. Detmer’s comments on the UK, he observed that the British seem to regard free health care as an inalienable right. He stated his chief message: “I do not see widespread use and networked communication of EHRs in this country as likely” for about another two decades. The barriers, he said, are primarily not technical. The US approach is market-driven and from the bottom up—a market that “looks like a spider’s nest.” He contrasted this with the UK approach, which is top down and directed by the NHS, which is building a National Health Information “Spine” and dedicating some 20 billion pounds to building its health information infrastructure. He noted that the differences between the countries stem from their different health care systems; the science of informatics is virtually identical. Still, he cautioned against dismissing the UK’s NHS as so different that nothing can be learned frenom it.

He outlined the logical sequence for EHR systems in the US as “EHR systems to RHIOs to NHIN.” The network is of little value without EHR systems, and he pointed to the disappointing adoption rates for EHRs, especially outside large ambulatory care organizations. So far, initiatives to induce adoption by small and medium size practices have not been successful. Regarding RHIOs, he said they are suffering the same fate as CHINs. State governments have a significant stake in the formation of RHIOs, but there is no money forthcoming from the federal government. The interest of state government therefore becomes critical, and only seven states are providing meaningful support. As for the NHIN, he noted that his company is one of four building a prototype. The big questions concern who will pay for the NHIN when the developmental stage is finished, and what there will be to “attach to the NHIN” in a few years.

Regarding alternative and supporting interests, Mr. Quinn noted that while provider organizations need to invest in EHRs and local connecting infrastructure, they have little available capital for investing. Payers and pharmaceutical manufacturers have the most capital to invest, but they lack a clear understanding of how they could gain from investing in interoperable EHRs. He noted the recent interest in EHRs from the payer industry, stimulated by the proposed HIPAA 275 healthcare claims attachment response transaction rules and e-prescribing. “Providers will be buried in these requests if they don’t have EHRs,” he said. Some payers are making funds available to local providers for e-prescribing solutions and are expanding into EHRs, making this “the most promising funding alternative for EHRs” in the US. Pharmaceutical companies are also recognizing the potential value to be derived from EHR systems. He noted that in contrast with the governmental role in the US, the British NHS is deploying “GP systems” to all practitioners in its local primary care trusts.

Concerning HIT vendors and HIT technology, he stressed that because of the complexities and the time it takes to develop HIT (10-15 years), the general IT industry has not figured out how to successfully invest in health care. IT in health care tends to be exclusively within the HIT industry. Mr. Quinn asserted that there is a supply capacity problem for EHR systems and a lack of competition because of the high barrier to entry into the marketplace. Because of the extreme difficulty of building systems that can support tens of thousands of users, no vendor today supports the variety and scale necessary for the largest organizations. He described early vendor experimentation with sharing EHRs between owners of similar systems; however, sharing within a single vendor (which he likened to “an organizational RHIO”) can become a barrier to competition and may undermine the intended national EHR sharing architecture.

Discussion

Mr. Localio expressed appreciation for the “good dose of realism” from Mr. Quinn, and offered his own list of EHR data problems. Mr. Quinn commented on an additional problem, that industry has invested heavily in legacy systems and is reluctant to spend more money to upgrade to systems that will make EHR data more widely useful.

He added that it will take 15-20 years for industry to make the changes that will permit interoperable EHRs.

Dr. Detmer suggested leveraging the computer-based work of the VA and DoD, which is part of this market, to start creating movement.

Mr. Blair asked for comments on the next major opportunity that NCVHS should focus on to accelerate development of HIT. Mr. Quinn pointed to leveraging the 275 and electronic claims attachments in general, because they require structured clinical information and induce providers to eliminate their overhead in providing attachments. Dr. Detmer suggested taking on e-prescribing as “the poster child.”

Dr. Steindel connected Mr. Quinn’s comments to those of Dr. Detmer’s on the concept of value, noting that “interoperability will happen when people see value in it.” He observed that the NHIN is not value oriented at present and it will be important to change that orientation. Dr. Detmer agreed that in the US, solidarity may be best achieved by framing issues in terms of value.

HIPAA LETTER—Mr. Reynolds and Dr. Friedman

The final action of the meeting was to review the changes to the letter on HIPAA, drafted by the Subcommittee on Standards and Security and discussed the previous day. Dr. Friedman read the changes, there was brief discussion, and the letter was approved, as revised.

Dr. Cohn then adjourned the meeting, announcing that the Committee would reconvene an hour later at the Watergate Hotel for a strategic planning retreat.

I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.

/s/ 9/13/2006

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Chair Date