Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

National Health Information Infrastructure (NHII) Workgroup

2004 CORNERSTONES FOR ELECTRONIC HEALTH CARE

July 23, 2004

Washington, D.C.

Meeting Minutes

The NHII Workgroup of the NCVHS was convened on July 23, 2004, at the Washington Convention Center in Washington, D.C. The meeting was open to the public.

Workgroup Members Present:

  • John R. Lumpkin, M.D., Chair
  • Jeffrey S. Blair, M.B.A.
  • Justine Carr, M.D.
  • Simon P. Cohn, M.D.
  • John P. Houston, J.D.
  • Stan M. Huff, M.D.
  • Anna Poker, M.S., R.N.
  • C. Eugene Steuerle, Ph.D.
  • Kevin C. Vigilante, M.D.
  • Judy Warren, Ph.D., R.N., B.C., F.A.A.N.

Workgroup Members Absent:

  • Richard K. Harding, M.D.
  • Robert W. Hungate
  • Harry Reynolds

Staff and Liaisons

  • Mary Jo Deering, Ph.D., NIH, Lead Staff
  • Marjorie S. Greenberg, M.D., Executive Secretary, NCVHS, NCHS
  • Eduardo Ortiz, M.D., M.P.H., AHRQ
  • Steven J. Steindel, Ph.D., CDC
  • William A. Yasnoff, M.D., PhD., OS/ASPE
  • Michelle Williamson, NCHS, CDC

Invited Participants

  • Laura Adams, R.I. Quality Institute
  • Marc Boutin, J.D., National Health Council
  • David J. Brailer, M.D., Ph.D., National Coordinator for Health Information Technology
  • Susan M. Christensen, BearingPoint National Health Care Practice
  • Carol Diamond, M.D., M.P.H., Markle Foundation
  • Mark Frisse, M.D., Vanderbilt University
  • John D. Halamka, M.D., Beth Israel Deaconess Medical Center
  • Rainu Kaushal, M.D., M.P.H., Harvard Medical School and Brigham and Women’s Hospital
  • David Lansky, Ph.D., Foundation for Accountability
  • Marty LaVenture, Ph.D., M.P.H., Minnesota Department of Health
  • Richard D. Marks, J.D., Patient Command, Inc.
  • Robert Miller, Ph.D., University of California–San Francisco
  • Joyce C. Niland, Ph.D., City of Hope Medical Center
  • J. Marc Overhage, M.D., Ph.D., Indiana University School of Medicine
  • Suniti Ponkshe, Ponkshe Consulting Group
  • Wes Rishel, Gartner, Inc.
  • Elaine R. Rubin, Ph.D., Association of Academic Health Centers
  • Paul T. Smith, Davis Wright Tremaine, LLP
  • Peter Swire, J.D., Ohio State University

EXECUTIVE SUMMARY

Agenda Item: Welcome and Introductions

Dr. Lumpkin introduced participants and reviewed the agenda for the day. The Workgroup will hear testimony from the eight NHII conference stakeholder groups, followed by a question and answer period; listen to conference closing remarks by David J. Brailer, M.D., Ph.D., the new national coordinator for HIT; receive an update on the Connecting for Health Road Map project; synthesize what it hears today; and set an agenda for the Workgroup’s future work.

Testimony and Recommendations

Agenda Item: Personal Health

Marc Boutin, J.D., reported on the six Personal Health recommendations. The Office of the National Coordinator for Health Information Technology should: accelerate national adoption of personal health records (PHRs); ensure patients are involved in all NHII policy and advisory groups; ensure creation of a core functional standard for PHRs; establish an approach to uniquely identifying patients; run at least three types of demonstration projects; and have HHS work with Congress on a tax-reform bill that rewards individuals who purchase PHRs.

Agenda Item: Governance

Laura Adams and Richard D. Marks, J.D., delivered two categories of recommendations related to Local Health Information Infrastructures (LHIIs) and resources. Under LHII, the Governance group recommended that HHS define the governing and functional relationships of the NHII to LHIIs; furnish minimal interoperability standards of the NHII and LHIIs; and establish a set of guiding principles for LHII governance. Under resources, the Governance group recommended that HHS establish a resource center for LHIIs and the people who want to establish LHIIs; establish a national database of NHII–LHII legal analyses; establish a program of LHII planning grants on governance issues; and fund critical analysis of initiatives that can be used as LHII models to identify best practices.

Agenda Item: Incentives

Susan M. Christensen reported three categories of Incentives recommendations: policy, up-front funding, and private-payer compensation. Policy recommendations for the Office of the National Coordinator for Health Information Technology include expanding the Agency for Healthcare Research and Quality’s HIT resource center to include support for all stakeholders; educating consumers and providers about the benefits of EHRs; establishing a certification process for EHRs; creating an interoperability standard; and asking Congress to pass safe-harbor legislation that protects those involved in NHII activities. The policy recommendations for Congress primarily involve reforming the Medicare reimbursement system for physicians. Up-front funding recommendations include creating pilot projects to test whether larger physician incentives increase physician adoption of EHRs; and establishing a way to provide grants and loans to finance up-front adoption of HIT. Private-payer compensation recommendations include reforming reimbursement; paying for quality improvement data from an interoperable system; establishing equitable payments for the use of improved outcomes from HIT; performing a gap analysis to ensure consensus quality indicators exist for each discipline; and creating special emergency medicine codes for use of EHRs.

Agenda Item: Standards and Architecture

Recommendations of the Standards and Architecture group were presented by J. Marc Overhage, M.D., Ph.D. They include having Dr. Brailer’s office convene, in partnership with the private sector, a permanent independent body focused on interoperability. This new body should create an interoperability model, standards, and architectures; develop and establish the infrastructure to facilitate implementation of security and privacy mechanisms; and conduct a reference implementation demonstration project within 12 months. NCVHS should recommend within six months whether a national patient identifier should be used within NHII. Dr. Overhage also recommended that Dr. Brailer’s office identify and fund an entity to create educational and startup resources for LHII early adopters, practices, communities, and hospital systems.

Questions and Comments on the Testimony

The Committee heard comments, concerns, and suggestions from 30 individuals.

Agenda Item: Confidentiality, Ethics, Privacy, and Access

Suniti Ponkshe reported Group A recommendations. Its key recommendation was that a committee or task force be established to identify potential users of an LHII and NHII, analyze gaps under the current privacy laws, and develop policies that addresses uses and disclosures. Group A also recommended balanced education to consumers and providers about privacy risks, safeguards, and rights of health information networks; creation of a patient information roadmap that acknowledges consumer interests and rights as primary; establishment of a cross-industry group to create a working Regional Health Information Infrastructure privacy model; a regulation that assigns ownership of the EHR to the consumer; and specific exclusion of the use of identified EHR data for individual underwriting or other exclusionary activities for coverage. Group B recommendations, presented by Paul T. Smith, include actions to ensure consumer support of EHRs and development of: understandable privacy rules; comprehensive and accessible educational resources and compliance materials; standards and tools that ensure accurate location and matching of patient health records; definitions of ownership and control of information in EHRs; and recognition of the ethical issues beyond privacy and security. Group B also tasked HHS with supporting or conducting research and development of privacy-enhancing technologies for incorporation into the NHII.

Agenda Item: Measuring Progress

Recommendations were presented by Rainu Kaushal, M.D., M.P.H.. HHS should: convene and fund an expert group that should define metrics for measuring the NHII and produce actionable items within nine months; conduct a multilevel inventory of NHII components including functionality and interoperability; create an NHII directory, perhaps as a Web site, documenting existing LHII networks and sharing best practices of LHIIs; determine the effects of existing policies on the rates of adoption of the NHII; provide financial incentives to primary-care physicians for using EHRs; and reduce malpractice rates for physicians using CPOE (computerized physician order entry).

Agenda Item: Clinical Research

Joyce C. Niland, Ph.D., read a preamble of basic tenets modeled on the “self-evident” truths stated in the U.S. Declaration of Independence followed by five of the group’s 10 recommendations: NHII should encourage the re-use of clinical-care data for research; HHS should create a task force to define and disseminate best practices for identifying and linking unique individuals across multiple relevant databases; the Office of Human Research Protections (OHRP) should create a national Institutional Review Board (IRB) standard for accessing and processing the data; NCVHS should ensure that HIPAA rules are reviewed and amended to take into account evolving demands; and HHS and the Department of Commerce should evaluate the capacity of existing controlled research vocabulary resources to support the integration of clinical practice and research data. Elaine R. Rubin, Ph.D., reported the remaining five recommendations: funding agencies should promote informatics research that spurs development of the NHII architecture; HHS should support creation of managed open-source requirements for interoperable tools, applications, and infrastructure for the clinical research lifecycle; HHS should ensure that emerging processes, models, and standards are used as metadata standards in the Public Health Information Network (PHIN) and the NHII; HHS should fund demonstration projects of connectivity between clinical-care networks and research networks; CMS should implement new technologies to provide Medicare claims-data compression and export to researchers; and NHII should establish a means of data exchange among researchers.

Agenda Item: Population Health

Population Health included both public health and clinical quality-improvement issues. Marty LaVenture, Ph.D., M.P.H., presented the group’s recommendations: HHS should identify Population Health needs that are reflected in all four dimensions in the NHII model; a task force should be created to map Population Health strategies into a bigger framework of public health; full Population Health functions should be infused into EHRs and PHRs; participation by public and private Population Health stakeholders in standards development and implementation of LHIIs should increase; processes, policies, and incentives for Population Health access to EHRs should be defined; the ability to send alerts to 90 percent of rural and underserved populations and clinicians should be developed; federal agencies should increase grants to rural areas that accelerate adoption of LHIIs that include Population Health strategies; and Population Health stakeholders should be identified and engaged. They also recommended HHS enhance consumer choice; establish strategies to meet the needs of underserved and vulnerable populations; require feedback based on the data collected by EHRs and LHIIs to support community Population Health activities; ensure that all HHS HIT demonstration projects by FY 2005 address Population Health needs; and require all EHRs to be capable of community-health surveillance. Other recommendations included collaborating with other stakeholders to achieve consensus on data elements useful for Population Health; complementing and migrating national health information systems with an EHR/PHR-based system; implementing the public health informatics core competencies developed by the CDC taskforce in 50 percent of the public health workforce by 2005 and 85 percent by 2006; and tasking a group of Population Health experts to establish a comprehensive model for the data traditionally collected in Population Health records.

Questions and Comments on the Testimony

The Committee heard comments, concerns, and suggestions from 22 individuals.

Agenda Item: Closing Remarks: 2004 Cornerstones for Electronic Health Care Conference

David J. Brailer, M.D., Ph.D., HHS’s new national coordinator for HIT, plans to focus on the role his office plays as well as what role the government should play in developing the NHII, in particular how the government can help finance the creation of the NHII without creating dependency. After noting that media in the United States, Europe and Japan, have covered this conference and that members of Congress are talking about the conference, he outlined plans for the next meeting.

The conference then officially ended.

Agenda Item: Presentation of Connecting for Health Road Map Report

Dr. Lumpkin convened a meeting of the NHII Workgroup the same afternoon. Following introductions of those present, Dr. Lumpkin introduced Carol Diamond of the Markle Foundation, who chairs Connecting for Health.

Dr. Diamond reviewed the three overarching themes that comprise the Connecting for Health roadmap to an NHII and noted that the recommendations of the Connecting for Health steering group represent the agreed-on next steps that should be taken in the next one to three years.

Infrastructure recommendations were reviewed by Dr. Overhage. Wes Rishel talked about the common framework that has to exist in order to support the infrastructure. John Halamka noted that identifying patients is critical, but argued against a health identifier uniquely issued to each individual. Peter Swire noted that the NHII should be patient-centered and that the biggest roadblock to public acceptance of EHRs is privacy and security. Swire also discussed the risk of too closely linking biosurveillance and public health with law-enforcement surveillance. Robert Miller discussed the financial and support mechanisms needed for widespread adoption of EHRs in mostly small- and medium-sized physician practices, which account for the large majority of U.S. physicians. David Lansky talked about two Connecting for Health actions on behalf of personal health: ways to support greater public interest in the NHII, and the next steps in the PHR environment. The presentation was followed by a question and answer period.

Agenda Item: Discussion of Strategies

Dr. Lumpkin asked the Workgroup to synthesize the recommendations heard today and to set an agenda for future work. The Workgroup discussion included: how the roadmaps of other groups should affect its agenda;Dr. Yasnoff’s suggestion that the Workgroup consider three issues—interoperability, legal obstacles, and certification of EHRs; incentives, which the Workgroup decided not to consider since consensus already exists that incentives are needed and the HHS Secretary has already begun forming a group to look at incentives; a request from Dr. Carr that the Workgroup discuss how information about quality is collected and how primary and secondary use of data affect quality requirements; Dr. Steindel’s suggestion to group interoperability, legal aspects, and certification under a new category: “The rules of the road for the NHII”; Dr. Greenberg’s observation that the overall NHII vision includes the PHR, secondary uses of it, and other community and population information; policy barriers to consumer-driven healthcare; ways to ensure accurate individual patient identification besides a unique patient identifier and Dr. Steindel’s suggestion that within six months the Workgroup provide guidance to industry on patient identification; and information management.

Mr. Blair raised three issues: the importance of defining the purpose of incentives correctly; cases in which national standards are not needed because the marketplace is already providing standards; and conformance testing for interoperability.

Ms. Cronin asked the Workgroup to continue communicating with the new HHS office since it is working on many of the same issues as the NHII Workgroup, in particular certification and incentives.

Agenda Item: Discussion of Workgroup’s Next Steps

Dr. Lumpkin asked the Workgroup for recommendations of areas it should take on, based on three criteria: the significance of the issue; areas to which the Workgroup can add to the debate; and areas not being addressed by any other group. He also suggested the Workgroup create a research agenda for NHII identifying where research ought to be done in the near term.

The Workgroup discussed proposed topics and decided to ask the Standards and Security Subcommittee to address the process of patient identification, which Dr. Cohn accepted on behalf of Standards and Security; to ask the Privacy Subcommittee to address privacy and confidentiality; and to revisit metrics and conformance testing in six months and determine then whether the Workgroup could be helpful in that area.

The four topics remaining for the Workgroup to address are secondary uses of data, rules of the road, research agenda for NHII, and personal health record. The Workgroup will consider holding a hearing on the PHR, particularly the federal role in developing it.

Dr. Steindel agreed to head work on the concept of the rules of the road, and Dr. Lumpkin asked for a volunteer to take the lead on how the Workgroup should address secondary uses of data. The September meeting will be devoted to discussion on holding a hearing on the PHR in fall 2004, sketching out a work plan related to secondary uses of data and rules of the road, and working on a schedule (which will probably include holding a hearing in early 2005) related to the NHII research agenda.

DETAILED MEETING SUMMARY

Agenda Item: Welcome and Introductions

Dr. Lumpkin, chair of both The National Committee for Vital and Health Statistics (NCVHS) and the Workgroup of the National Health Information Infrastructure (NHII), opened the meeting by introducing the participants and reviewing the agenda for the day.

The NHII Workgroup first heard testimony from representatives of four of the eight topic-areas of the NHII: Personal Health; Governance; Incentives; and Standards and Architecture. Following a question-and-answer period, the Workgroup took testimony from representatives of the remaining four groups: Confidentiality, Ethics, Privacy, and Access; Measuring Progress; Population Health; and Clinical Research.

The Workgroup will again take questions and comments. Then the Workgroup heard an update from Connecting for Health and discussed the Workgroup’s future agenda.

Testimony and Recommendations

Agenda Item: Personal Health

Marc Boutin, J.D., National Health Council (Mr. Boutin gave the report.)

Suzanne Bakken, R.N., D.N.Sc., F.A.A.N., Columbia University.

The Personal Health group made six recommendations:

  1. Dr. Brailer’s office should accelerate momentum toward national adoption of personal health records (PHRs) by taking the following actions within the next year: reconvene stakeholders (within the next 60 days); foster basic consumer research (within six months); develop messaging and branding strategy (within nine months); and implement education strategy (within 12 months).
  2. Ensure that patients, consumers, and families are represented on all policy groups.
  3. Regarding PHR standards, Dr. Brailer’s office should ensure creation of a core functional standard for the PHR (ANSI-accredited SDO) (within 12 months) to enable subsequent certification. Dr. Brailer’s office should also collaborate with the Consolidated Health Informatics group to identify data standards needed to support PHRs (within six months) and commit to developing and/or adopting and implementing those standards (within 12 months).
  4. Establish an approach to uniquely identifying patients.
  5. Demonstration projects should include:
    • A CMS pilot program to establish beneficiary access to a free PHR, including standard intake/history/health summary forms;
    • A privately funded demonstration project that addresses PHR support of chronic medical conditions and lifestyle management; and
    • PHR pilot projects with broad applicability to specific issues such as medications, prescription drugs, and immunizations.
  6. The HHS Secretary should present to Congress by January 2005 a bill supporting tax reform that gives an individual purchasing a PHR a tax deduction or tax credit.

Agenda Item: Governance

Laura Adams, Rhode Island Quality Institute

Richard D. Marks, J.D., Patient Command, Inc.

Governance delivered recommendations in two categories: LHIIs and resources.

Under LHII, the Governance group recommended that HHS:

  • Define the governing and functional relationships of the NHII to LHIIs;
  • Furnish the minimal functions and technological and interoperability standards of the NHII and LHIIs; and
  • Establish a set of guiding principles for LHII governance, assuring appropriate community representation, and differentiating between governance (strategy) and administration (tactics).

Under resources, the Governance group recommended that HHS:

  • Establish a resource center for LHIIs and the people who want to establish LHIIs that provides the following information: starter kit, white papers, funding guidelines, best practices, checklists, actual objective case studies of successes and failures, and interactive portal for national collaboration among NHII and LHIIs;
  • Establish a national database of NHII–LHII legal analyses;
  • Establish a program of LHII planning grants focusing on governance issues such as identification of stakeholder issues, trusted conveners, and strategic and structural development; and
  • Fund critical analysis of initiatives that can be used as models for LHIIs to identify governance and operating best practices and lessons learned.

Agenda Item: Incentives

Mark Frisse, M.D., Vanderbilt University

Susan M. Christensen, BearingPoint National Health Care Practice. (Ms. Christensen gave the report.)

Recommendations from the Incentives group fell into three broad categories: policy, up-front funding, and private-payer compensation.

Policy recommendations for the Office of the National Coordinator for Health Information Technology include:

  • Expanding the AHRQ’s (Agency for Healthcare Research and Quality) HIT resource center to include support for all stakeholders, with information about certification standards, an assessment tool for product implementation, best practices, product scorecard, and funding sources;
  • Creating a campaign to educate consumers and providers about the benefits of adopting EHRs. Also create a public reporting system to highlight physicians who have adopted and are using EHRs;
  • Establishing a certification process for EHRs to inform physicians and the public;
  • Creating an interoperability standard funded by all appropriate parties; and
  • Working with Congress to pass safe-harbor legislation that protects providers, payers, and vendors in NHII activities.

The policy recommendations for Congress involve reforming Medicare reimbursement for physicians. The new system should include payments for quality, care and disease management, data sharing, and publishing/subscribing performance accountability.

Up-front funding recommendations include:

  • Creating pilot projects that will test whether larger physician incentives increase physician adoption of EHRs that conform to standards, and using the results to build a generalized business case; and
  • Establishing a mechanism for providing grants and loans (with a match requirement); and loan guarantees from public and private sources, to finance up-front adoption of HIT. Consider tax credits.

Private-payer compensation recommendations include:

  • Reforming reimbursement to encourage appropriate use of HIT, including care coordination, disease management, and data sharing;
  • Paying for submission of quality improvement data from an interoperable system ($5 per visit);
  • Establishing equitable payments by all payers for the ongoing use of improved outcomes from HIT;
  • Performing an analysis to ensure consensus quality indicators exist for each discipline leading to pay for performance, based on clinical information from EHRs; and
  • Creating special emergency medicine codes for use of EHRs. There would be more funding for greater use and for contributions to the LHII.

Agenda Item: Standards and Architecture

J. Marc Overhage, M.D., Ph.D., Indiana University School of Medicine

Recommendations of the Standards and Architecture group include:

  • The office of the national coordinator should identify, or convene in partnership with the private sector, an independent body focused on interoperability with the appropriate authority, funding, and support. This body must be permanent, with broad representation and actual staff or ability to contract. The tasks for that interoperability body should include translating the strategic framework into a tactical plan with specific manageable, achievable, and measurable stops; and promulgating specific interoperability tasks, including developing functional requirements or business processes as defined by the end users.
  • An interoperability model, standards, and architectures should be created, along with a testing process and procedures built around that information.
  • The interoperability body should develop and establish the infrastructure to facilitate implementation of security and privacy mechanisms.
  • The interoperability body should conduct a reference implementation demonstration project within 12 months that implements specific-use cases that define its scope.
  • NCVHS should recommend within six months whether a national patient identifier should be used within NHII.
  • The office of the national coordinator should identify and fund an entity to create educational and startup resources for LHII early adopters, practices, communities, and hospital systems.

Questions and Comments on the Testimony

The Committee heard comments from 30 individuals.

Valerie Harvey recapped her comments from the previous day related to the importance of considering an appropriate model for data sharing. She identified four populations with peculiar needs: individuals in the federal witness protection program, adoptive children, intersexed individuals (those who manifest ambiguous genitalia on birth and are subjected to involuntary surgical intervention), and those who have gender reassignment.

Bruce Taffel raised concerns about protections and consideration for early adopters of electronic medical records, specifically with regard to incentives and protections against changes that may occur as new standards are developed.

Rick Schuler asked what incentives were discussed in the conference workgroups related to health systems and hospitals, which traditionally have funded local initiatives.

Jack Davies strongly endorsed the recommendation to quickly define an LHII, since it would not only be helpful for communities already working to establish an LHII, it would provide guidance on what to prioritize.

Janet Martino said that for true interoperability, there must be standard interfaces between component-based EHRs, and that vendors will have to be pressured into breaking their systems into meaningful components. She advocated creating standard interface definitions through a standards organization.

Mark Shields suggested determining the total amount needed for physician incentives. If the goal is for half the 200,000 physicians to use interoperable EHRs within 10 years, and the incentives are expected to be $15,000 per physician, then $4 billion is needed.

Carol Bickford found the idea of giving incentives to only physicians “very biased” and asked the Committee to be inclusive of all healthcare practitioners. She also raised a question on the Standards and Architecture report about its assumption of a human-computer interface for consumers and practitioners.

Francis Koster recommended that the Committee make available an easily installed web-based facility for the 65 percent of American physicians who belong to practices with three or fewer people. He also suggested that a central body make interface engines with standard definitions available as shareware, so vendors could upload and download data.

In response to Charles Kidd’s question about the timetable and medium for responding to the recommendations from this meeting, Dr. Lumpkin explained that NCVHS, at its September meeting, will forward recommendations from the July meeting, mostly without comment, to the HHS Secretary. For the status of particular recommendations, he suggested people follow the activities of the office of the national coordinator for health information technology (http://www.hhs.gov/healthit/).

Kate Cauley asked that NCVHS, to create LHIIs, tap people all over the country who have been working together in the healthcare arena for years.

Tom Sullivan objected to Dr. Overhage’s comment that Connecting for Health prefers to interact with end users rather than proxies, such as associations. He thinks professional medical organizations have a role to play and is concerned about the undue influence of academics and a small group of “informaticians.”

Joseph Schneider suggested Medicaid be incentivized to take the same steps Medicare does relative to funding incentives, quality, and standards related to EHRs and LHIIs.

Dr. Lumpkin clarified a comment from Ms. Frazer about the need to look at recommendations that have a code, and look at the best place for those codes to appear.

Vi Shaffer requested that NCVHS bring together JCAHO, NCQA, , and the trauma registries to decide on standard data definitions that do not conflict with the nomenclature being developed for NHII, so that suppliers can act on them with consistency.

Mr. Andrews asked whether the recommendations from this meeting could be reported to the HHS Secretary immediately to enable early feedback. Dr. Lumpkin noted that though the recommendations will not formally go to the HHS Secretary until September, several federal staff at the meeting—including the national coordinator for HIT—will ensure that the recommendations go sooner to the Secretary and the public for debate and discussion.

Bob Dickler suggested that the national coordinator’s office have the ability to help the local and regional level work with governments in the local and regional areas, and that the coordinator’s office assist and guide groups thinking of starting an LHII.

Larry Kleinman detailed two reasons why he thinks incentivizing physicians for performance-based quality measures is good in concept but problematic in reality. He also encouraged the Committee to be aware of the assumptions made about the NHII and to continually test and challenge those assumptions.

Kent Summers suggested the Committee bring in pharmacy as a key stakeholder, since giving physicians access to accurate and timely information on patient prescriptions is likely to increase physician participation in EHRs. Dr. Cohn responded by talking about the work NCVHS is doing on e-prescribing, in which pharmacies and the National Council for Prescription Drug Programs, Inc. are very involved. Under the Medicare Modernization Act of 2003, the Committee is responsible for identifying standards-free prescribing and expects to come out with recommendations for the September meeting.

Juggy Jagannathan endorsed the notion of complement-based architecture and sole-source architecture, and he asked the Committee to consider whether independent personal health banks, modeled after financial banks, could work. Individuals would be the custodians of their health records and the arbiter of who gets that information, just as individuals decide which financial institutions get their money.

Todd Fitzgerald spoke about the importance of moving quickly from demonstration projects to standards that can be used by everybody else, and he noted that though there is still a prohibition on using the Internet to communicate with providers, he would like to see NCVHS use this platform to accelerate the adoption of being able to use the Internet.

Valerie Harvey spoke a second time; this time noting that to secure the reliable use of the Internet, there may have to be infrastructure changes to the Internet. She suggested NCVHS consider itself a stakeholder in this global issue. Dr. Yasnoff reminded attendees of the 2001 report from the National Research Council Computer Science and Telecommunications Board called “Networking Health: Prescriptions for the Internet,” that dealt with these very issues and made a number of recommendations. Dr. Lumpkin recalled the series of hearings the Workgroup held on this topic and its recommendation encouraging HHS to be more involved in some of the national collaboratives within the federal government related to the Internet.

Robert Frank noted that the amount of documentation of data within a patient record will grow exponentially. Therefore having a robust search engine available at the point of care for the clinician to use is necessary and should be part of any demonstration project.

Besides noting the importance of having requirements before specifications, Gary Dickinson would like to see a second track of incentives that encourage development of an EHR that is robust, that can be used for clinical purposes, and that clinicians can trust. For example, physicians need to know when a record presented is not a complete record

Jay McCutcheon emphasized that LHIIs should not only gather data and provide access to the data to clinicians, they should also be able to connect up data into the EHRs in the community, especially for small physician practices.

David Harrington noted in response to Juggy Jagannathan’s comment that the nation already has an electronic health record bank—the MedicAlert Foundation—which has been in business for 48 years.

Maureen Levy raised two questions: Are CMS’ Quality Improvement Organizations (QIOs) going to be considered a significant stakeholder? And what is the role of the QIO in terms of developing programs to assist physicians to use or adopt EHRs, especially in rural and underserved areas?

Barry Blumenfeld urged the Committee to examine the possibility of ratifying or at least examining the information model that should be backing up the electronic medical record, and how that might play into the ultimate structure for information around medical care. Dr. Lumpkin told him the Committee would be interested in looking at candidates for models that NHII can use as building blocks, particularly those that have been vetted by a Standards Development Organization (SDO).

Alan Brockner made four recommendations to help promote development of NHII:

  • The education of the LHIIs should include the continuity-of-care record, which helps distinguish information of value within institutions at the time of care from that which is of value for continuity of care afterwards.
  • To encourage interoperability, two-way communication between physician information systems and pharmacy information systems should be promoted.
  • The investment in SNOMED is going to require encouragement to integrate and facilitate its use within systems that this process can encourage.
  • A digital signature must be demonstrated and integrated into the NHII.

John Cassilas noted that HIPAA has broken the barrier between the healthcare system and banks, and that while banks are eager to help implement the health information infrastructure, the policies for privacy and security need to be harmonized between the two industries. He asked CMS to affirm the existing HIPAA regulations.

Following a brief recess, the meeting resumed with reports from the remaining four stakeholder groups: Confidentiality, Ethics, Privacy, and Access; Measuring Progress; Population Health; and Clinical Research.

Agenda Item: Confidentiality, Ethics, Privacy, and Access

Group A: Suniti Ponkshe, Ponkshe Consulting Group

Group B: Paul Smith, Davis Wright Tremaine, LLP

Group A recommendations, with its key recommendation first:

  1. Set up a committee or task force to:
    • Identify potential users of a collaborative (local, regional, or national) health information infrastructure;
    • Analyze gaps under the current privacy laws; and
    • Develop policies that addresses uses and disclosures.
  2. Provide balanced education to consumers and providers about privacy risks, safeguards, and rights of EHR and collaborative health information network(s), and fund it through foundation and government grants.
  3. Establish a patient information roadmap that acknowledges consumer interests and rights as primary, and sets the rules and standards for content, information flow, role-based access, and audit control.
  4. Set up a cross-industry group to create a working Regional Health Information Infrastructure privacy model that addresses how participants will interact within their region and across state boundaries.
  5. Establish a regulation that will assign ownership of the EHR to the consumer, and clarify the rights and responsibilities of “ownership,” including in the situation of incapacity, guardianship, and emergencies.
  6. Specifically exclude the use of identified EHR data for individual underwriting or other exclusionary activities for coverage, but allow it for payer-based care-coordination activities. Group A acknowledges this recommendation is controversial.

Group B recommendations:

  1. Assure consumer support by ensuring:
    • Consumer involvement in developing standards through participation of consumer advocates at the local, regional, and national levels;
    • Strong security management;
    • Clearly defined and enforced access restrictions, with authentication, non-repudiation, and effective audit trails;
    • Protection of telehealth and e-mail communications;
    • System transparency for participants, with registration and disclosure of non-Treatment Payment Operation (TPO) users and uses, and centralized management of access to the system;
    • Effective enforcement of privacy violations; and
    • Education of consumers about the benefits of health information sharing for themselves, public health, and research.
  2. Develop and provide readily ascertainable and understandable privacy rules, and provide federal leadership to resolve pre-emption issues or marshal resources at the state level and at the federal level to develop an authoritative road map to the particular privacy rule that applies in a given situation.
  3. Give participants comprehensive and readily accessible educational resources and compliance materials, including model agreements.
  4. Develop standards and tools to ensure accurate location and matching of patient health records, by, for example, creating a privately managed, patient-controlled, voluntary, unique individual health identifier.
  5. HHS should support or conduct research and development of privacy-enhancing technologies and mechanisms for incorporation into the NHII.
  6. Define ownership and control in detail, answering questions such as:
    • When should individuals be able to withhold information from the record or opt out of it altogether, and what are the implications for providers?
    • When should individuals be able to restrict access by specific providers?
  7. Recognize the significant ethical issues beyond concerns of privacy and security, including management of genetic information, appropriate use of IT tools in diagnosis and treatment, the relation between informed consent and privacy; and the scope of consent for secondary use of data.

Agenda Item: Measuring Progress

Rainu Kaushal, M.D., M.P.H., Harvard Med. School and Brigham and Women’s Hospital

After noting that the group’s perspective was a variation of management guru Peter Drucker’s quote, “If you can’t measure it, you can’t improve it,” Dr. Kaushal reported four recommendations:

  1. Recognizing the critical importance and complexity of measurement in achieving success, HHS should convene and fund an impartial expert group, such as an IOM committee, to define metrics for the measurement of the NHII. This expert group, which should produce actionable items within nine months, should have a leader assigned by HHS, have broad representation of experts, and be advised by stakeholders as needed. The three tasks of this group should be to:
    • Create clear and consistent definitions of components of the NHII as basis for metrics, for example, LHII, EHR, and computerized physician order entry (CPOE). Dr. Kaushal also described a conceptual model of the NHII pulled from a white paper that informed the metric group and was based on structuring the NHII in nodes and clusters.
    • Define a set of metrics and develop a methodology to test their reliability and validity.
    • Define additional test metrics to be released, but not required.
  2. Using expert-panel definitions, conduct a multilevel inventory of NHII components including functionality and interoperability. This would include the population covered with the existing NHII, and this type of inventory would occur at intervals.
  3. Create an NHII directory, perhaps as a website, documenting existing LHII networks and sharing best practices of LHIIs.
  4. Determine the effects of policy options on the rates of adoption of the NHII, such as providing financial incentives to primary-care physicians for using EHRs, and reducing malpractice rates for physicians using CPOE.

Agenda Item: Clinical Research

Joyce C. Niland, Ph.D., City of Hope

Elaine R. Rubin, Ph.D., Association of Academic Health Centers

The presentation began with the group’s preamble of basic tenets:

“We the people hereby recommend that the NHII ensure that clinical and translational research needs are interwoven through the foundational NHII strategic plan, in order to form a more perfect Union between clinical care and research endeavors.

“Be it known that we also urge our nation’s government to articulate the long-term vision and mission for research within the NHII, in addition to the articles set forth herein, enunciating our short-term actionable articles of faith.

“NHII should be concerned with all facets of research related to human health and well-being, including but not limited to clinical research, basic science, population research, environmental sciences, bioengineering, and informatics.

“… We hold these truths to be self-evident.”

Recommendations:

  1. HHS should develop the NHII in a manner that encourages the re-use of clinical-care data for research.
  2. In lieu of a singular master ID, HHS should create a task force to define and disseminate best practices for identifying and linking unique individuals across multiple relevant databases.
  3. The Office of Human Research Protections (OHRP) should create a national Institutional Review Board (IRB) standard for how we access and process the data.
  4. NCVHS should ensure HIPAA rules are reviewed and amended to take into account evolving demands that emerge because of universal access to electronic health data.
  5. In collaboration with the healthcare and research communities, HHS and the Department of Commerce should evaluate the capacity of existing controlled research vocabulary resources (including animal, vector, environmental, and other nonhuman data related to human health) to support the integration of clinical practice and research data. HHS should maintain these standard terminologies in the public domain, in a non-proprietary fashion.
  6. Funding agencies should promote, and investigators should conduct, informatics research that assists the further development and implementation of the NHII architecture, in a manner conducive to supporting research as well as patient care.
  7. HHS should support creation of managed open-source requirements for interoperable tools, applications, and infrastructure for end-to-end clinical research lifecycle (e.g.,community, private practice). HHS should ensure that emerging research work flow processes, information models, protocol representation, and data representation standards being developed by the Clinical Data Interchange Standards Consortium (CDISC) via HL–7 RCRIMand the Clinical Genomics Special Interest Group are used as metadata standards in the Public Health Information Network PHIN and NHII.
  8. HHS should fund demonstration projects of connectivity between existing clinical-care networks and existing research networks.
  9. CMS should implement new interoperable and universally accessible technologies to provide Medicare claims-data compression and export (e.g. via XML and ASCII format) to researchers.
  10. NHII should establish a communication vehicle for the timely and appropriate data exchange among researchers, including computable research results, and the dissemination of summarized research results and publicly accessible databases for consumers and healthcare providers.

Agenda Item: Population Health

Marty LaVenture, Ph.D., M.P.H., Minnesota Department of Health

Population Health included both public health and clinical quality-improvement issues. Though the strategic framework is an important part of the discussion, the group recognized that the four goals and 12 strategies within that framework were not intended to address all of the Population Health needs.

  • HHS should identify Population Health needs that are reflected in all four dimensions in the NHII model, and assign authority to begin strategic actions associated with that particular model.
  • A task force should be created to map Population Health strategies into a bigger framework of public health, and present those to HHS and the larger public health community for action.
  • Full Population Health functions should be infused into EHRs and PHRs, broader than surveillance.
  • Broad participation by both public and private Population Health stakeholders in standards development and implementation of LHIIs should be increased, which is critical for clinical care and prevention activities.
  • The processes, policies (for example, privacy issues and HIPAA-related issues), and incentives for Population Health access to EHRs should be defined.
  • Within three years, population-level alerts should be able to be sent to 90 percent of rural and underserved populations and clinicians through the PHR/EHR.
  • Federal agencies should increase grants to rural and frontier areas that accelerate adoption of LHIIs that include Population Health strategies.
  • Population Health stakeholders should be identified and engaged in the continued development of the framework for strategic action.
  • HHS should establish a goal of enhancing consumer choice by including provider information (including volume, outcomes, and satisfaction data).
  • HHS should establish strategies to meet the particular needs of underserved and vulnerable populations as LHIIs and PHRs are implemented.
  • HHS should require all EHRs to be capable of community-health surveillance, including emerging and routine health surveillance. To that end, Dr. Brailer should assemble a Public Health task force to identify the data set within 90 days.
  • Collaborate with other stakeholders, including consumer groups, to achieve consensus on EHR/PHR data elements and functions useful for Population Health.
  • Within five years, complement and migrate national health information systems (for example, BRFSS and NHANES with an EHR/PHR-based system, including a demonstration project in one year.
  • Implement the public health informatics core competencies developed by CDC in 50 percent of the public health workforce by 2005 and 85 percent by 2006.
  • HSS should require feedback of value-added information and knowledge based on the data collected by EHRs and LHIIs to support community Population Health activities.
  • By FY 2005 all HHS HIT demonstration projects should explicitly address Population Health needs.
  • Identify, mobilize, and task a group of Population Health experts to establish a comprehensive model (including normalization) for the data traditionally collected in Population Health records (e.g. cancer registries).

Questions and Comments on the Testimony

The Committee heard comments from 22 individuals.

David Sinclair urged the Committee to:

  • Address whether or not consumers’ participation in networks is opt in or opt out, and whether or not express authorization for storing and transferring records is required, or whether implied authorization is sufficient; and
  • Spend more time trying to address the legitimate needs of payers, both public and private, for access to data and use of identified data.

Lenel James participated in the Personal Health group at the conference and expressed concern that legal issues be looked at more closely. He referred attendees to an article in the June 2004CEO magazine on the healthcare crisis and recommended providing legal protection to physicians who are early adopters of EHRs.

Larry Kleinman made four comments.

  • The public health infrastructure could provide a centralizing force with which the LHII connects and perhaps be the place where some standards should be developed.
  • Groundwork must be laid to ensure databases and registries are functional and useful.
  • With regard to the metrics group, standard definitions for the various components of the NHII must be identified, but thinking also needs to be done about the NHII building blocks and the strength and extent of each.
  • Determine how to evaluate the impact of NHII, as well as the extent of its implementation and how it affects the health of the people affected by it.

Michael Kahn observed that the most powerful ideas tend to be the simplest, and asked the Committee to look for ways to simplify things instead of “complexify” things.

John Loonsk emphasized the need for incremental deliverables, especially those that support national preparedness. EHRs, PHRs, LHIIs, and NHII should support early-event detection and surveillance, but also functional activities in the context of supporting public health needs for outbreak management, urgent communications, and the administration of countermeasures and response.

Stephen Lau proposed a mechanism be created to enable people who provide data to be informed if it is later discovered that they are part of a cluster at-risk for health problems.

Michelle Thomas asked for clarification about specifically where the biopharmaceutical industry’s needs would be best served and where its priorities, needs, requirements, and contributions can be communicated and incorporated as the NHII moves forward. As with all special interest groups, Dr. Lumpkin responded, two messages ought to be very clear. One is that all the stakeholders are in this together and must think of ways to work more closely together, with the goal of interoperability. The other is that patients have to be considered the center. The Committee is asking people within organizations and across organizations to help move the NHII forward by setting aside some proprietary things. “If we don’t all work together, this agenda will not progress,” he said.

David Kibbe recommended that the NHII include some active measures to inspect the effect and effectiveness of privacy policies, and spread that information around so that people can use it to compose policies for operating their LHIIs.

Deborah Linzer commented on the Human Genome Project and its connection to the NHII; the importance of finding literature and practice on community-based, culturally competent family-centered care for children with special healthcare needs and the disability community; the advisability of looking at already established models that have consumer representation across the population and lifespan; and projects that technology enables to deliver healthcare to difficult populations, such as migrant workers; and the maternal and child health block grant, which she said should be factored into the NHII.

Koko Kono expressed concern about data accessibility and confidentiality. She recommended that the government establish a guideline regarding who can access EHR data and for what purposes it can be used, and that the guideline consider self-employed people as well as small business owners.

Karen Chang asked that the Committee be sure to build upon last year’s work, in particular what Connecting for Health is doing, and that the Committee specify more clearly what is to be measured and what the priorities are.

Jay Goldstein suggested trying to create a universal medication record as an earlier step to the universal health record, since it would give creators the opportunity to prototype some of the same issues as the EHR, such as interoperability and privacy.

Scott Williams commented on the gap between public health practice and theory, and noted that the EHR is being held to a higher standard than that to which the paper health record has ever been held. He would like to see attention paid to identifying the necessary levels of interoperability needed to make the record better than it is now, and good enough rather than perfect. He also raised two process issues—the first reflecting the view of the Population Health group that there be a validation process for its recommendations, and the second asking that group discussion of NHII goals could employ group process technology to allow broader participation.

Dr. Schneider complained about the poor usability of EHRs. He encouraged HHS to support research into how the EHR and LHII contribute in some ways to medical errors and how they can be avoided, especially during the transition to EHRs and LHIIs.

Mark Wieder commented that the Committee will have been successful when health reports based on 20-year-old data (such as “To Err is Human”) are no longer cited because more recent data will be available. He suggested leveraging some existing sources of national data, including putting Medicare claims data on CD or DVD and increasing funding for national data collection efforts such as AHRQ’s and the CDC’s.

Michelle Thomas spoke again, this time about the CDISC.

Laura Adams pointed out that the country is already spending the money necessary to buy this system, so the money must be redirected to buy the needed systems. To sustain the energy generated by the conference, she read a quote by Don Berwick.

Tom Leary lauded two HIMSS members, Steve Steindel and Jeff Blair, for their efforts on the NHII survey and reported two survey results: respondents had an increased awareness about what an NHII is, and the largest barriers to the NHII are lack of agreement on access to patient data and lack of standards to support data sharing.

Laurie Reid Forcat encouraged the Workgroup and stakeholders to look at the security and privacy standards developed by ASTM and by ISO Health Informatics, and provide feedback on them to help advance the NHII.

A participant from Johns Hopkins University drew on the history of the slow development of the Internet before calling on the NCVHS to encourage the government, rather than industry, to set the standards and define how the standards will work. That will enable industry to develop products and services compliant with the standards and to achieve an interoperable system.

Cynthia Molina applauded HHS for highlighting the importance of the consumer in the NHII, and for the shift in vocabulary to a consumer-centric system.

Dennis Nave encouraged the Committee to elicit input from psychiatrists, mental health professionals, and consumers on privacy and security as they relate to treatment of mental illness. He also suggested doing away with the Medicare psychiatric outpatient discount since it contributes to Louisiana doctors’ resistance to EHRs, due largely to their objection to its front-end costs.

Dr. Lumpkin explained that the reports, comments, and materials presented today to the NCVHS will be posted on the website and transmitted to HHS at its next meeting.

He then introduced David Brailer, the first coordinator of national HIT.

Agenda Item: Closing Remarks: 2004 Cornerstones for Electronic Health Care Conference, David J. Brailer, M.D., Ph.D., National Coordinator for Health Information Technology

The role his office plays in advancing the NHII as well as what role the government should play will be a focus of Dr. Brailer’s. It makes sense for the government to have a financial role, “given the incredibly large footprint of the federal government” in buying and paying for healthcare. The government must play the appropriate catalytic role that results in moving the NHII forward, but in such a way that is sustainable across the entire industry, and creates its own support as opposed to dependency.

Dr. Brailer noted that this 2004 conference has been the subject of media coverage in the United States, Europe, and Japan, and that numerous members of Congress are already talking about this discussion. He thanked the conference planners, the Committee, and the NHII Workgroup for its hard work, intelligence, and passion, and he outlined plans for the next meeting. The conference then officially ended.

Agenda Item: Presentation of Connecting for Health Roadmap Report

Carol Diamond, M.D., M.P.H., Markle Foundation

Dr. Lumpkin convened a meeting of the NHII Workgroup the same afternoon. Following introductions of those present, Dr. Lumpkin introduced Carol Diamond, of the Markle Foundation, who chairs Connecting for Health. Dr. Diamond explained that Connecting for Health is an initiative funded and operated by the Markle Foundation since June 2002, with additional support from the Robert Wood Johnson Foundation.

Three overarching themes comprise the Connecting for Health roadmap to an NHII: the need for a clear message to the public about the importance of IT in health care; the importance of considering the needs and the changing roles of patients and their families in the healthcare system as a result of IT; and the need for a system designed from the front-end for privacy and security.

The following recommendations of the Connecting for Health steering group represent the agreed-on next steps that should be taken in the next one to three years, she said.

Dr. Overhage reviewed the primary recommendations regarding infrastructure:

  • Establish interconnection between healthcare applications. The most likely path to success is a health information infrastructure built on the Internet that safeguards privacy; leverages top-down, bottom-up approaches; is incremental in nature; and is based on the decentralized federated model.
  • The networks should not contain a central repository.
  • Clinical information standards should be developed.
  • Methodologies to test interoperability must be based on use cases that involve the interoperation of these systems at different levels of sophistication.

Wes Rishel talked about the common framework or set of pieces that have to exist in order to support the infrastructure. Architecture and standards have to take into account the variability that will exist in sophistication and capability among EHRs, he said. There will be heterogeneity across even the smallest network. Rather than allowing only those that are highly sophisticated to participate in the NHII, or limiting interoperation to a common denominator, Overhage and Rishel advocate another solution that would enable many kinds of EHRs to participate. They would like “to architect” the way the standards are applied, so that the data is provided with the best capability of the system that sends it and interpreted with the best capability of the one that receives it.

To accelerate EHR adoption among providers, there should be a certification approach regarding the functionality of the EHRs, and intellectual support for physicians. Rishel also said standards should be evolutionary and that it is important to focus the standards organizations on those areas associated with EHRs.

John Halamka noted that there has to be a process for identifying individual patients, but argued against a unique health identifier for each patient. Identifying patients should be premised on keeping existing IT systems in place and leveraging what exists. There should be a central mechanism that is standards-based and distributed for identification of patients, and it should have pointers to distributed locally controlled data in a network of networks. A national health identifier is “a bad idea,” because it is another piece of data prone to error, because the process of implementing a national ID would be long and expensive, and because both patients and policymakers are not receptive to the idea.

Peter Swire noted that:

  • The NHII should be patient-centered.
  • The single greatest roadblock to public acceptance of electronic health records is likely privacy and security.
  • Patient ID can be accomplished through multiple systems that use multiple points of information that use multiple tokens plus information plus passwords. That is how distributive systems have worked in other industries.
  • A network of networks, or federated idea, for how the records will be held is advisable because it avoids the single point of failure that centralized databases are vulnerable to and they are not likely to be very sustainable.

Swire also discussed the risk that would result from too closely linking biosurveillance and public health with law-enforcement surveillance.

Robert Miller discussed the financial and support mechanisms needed for widespread adoption of EHRs in mostly small- and medium-sized physician practices, which account for the large majority of U.S. physicians. Though his workgroup also addressed the organizational and legal issues necessary to achieve interoperability, Dr. Miller submitted written materials on that debate to the Committee.

He recommends realigning the financial incentives to encourage physicians to adopt EHRs. Currently the financial and time costs are too high, and the financial benefits are too low. Incentives at $3 to $6 per patient visit, or 50 cents to $1 per member per month over the three-year period, appear to be a sufficient starting point to encourage and sustain widespread adoption and use of EHR technologies in solo small-group practices.

Some physicians can implement the incremental applications as steps towards the full implementation of an EHR, but only if they are not dead-end applications. He also pointed out that the greater the electronic information exchange among IT systems, the better is the business case for EHRs. Further, small- and medium-sized groups require greater support services to help them use IT.

David Lansky talked about two Connecting for Health actions on behalf of personal health: ways to support greater public interest in the NHII; and the next steps in the PHR environment. He advocated demonstration projects and summarized some findings from research with the general public.

Questions

Dr. Cohn asked for clarification of the ambiguity about whether a national patient identifier is needed. Dr. Overhage said a national patient identifier is not critical and even if it existed, the NHII would not rely solely on it as a linking mechanism. Dr. Swire concurred that a national patient identifier would be just one more piece of data that would make matching data to patient easier. He emphasized the NHII is not dependent on it. What is important is creating a reliable process to identify patients, not a national patient ID per se, Dr. Yasnoff summarized.

Dr. Miller discussed the basis for the financial incentives he recommended and the philosophy that the incentives should pay physicians for the cost of the system, taking into account the likely benefits, over the three-year period. Dr. Yasnoff noted that the only data point he knows of, the experiment in Maine where physicians were offered one-time incentives of $5,000 to adopt EHRs. Though $5,000 far less than the cost of EHRs, there was almost universal adoption. Dr. Cohn recalled testimony regarding a successful $15,000 to $20,000 payment to physicians as incentive to get them to e-prescribe.

In response to Dr. Steurele’s question about whether physicians’ concern that EHRs would be more time-consuming had been a subject of incentivizing, Dr. Miller said the physicians’ loss of time is accounted for under the productivity loss category. Dr. Overhage confirmed that physicians’ workflow is critical and that buying an electronic system represents only a tenth of its full cost.

Dr. Halamka noted that starting this year, he will lead a required one-day course at Harvard Medical School in the use of information technology, but he is not aware of a more widespread effort to orient medical students to the new electronic world.

In response to Dr. Vigilante’s question about whether physicians have been invited to focus groups or surveyed about what incentives appeal to them, Dr. Diamond said yes, but more are needed.

Mr. Blair asked Connecting for Health to be sure the phrase “dead end” does not also include standards or terminologies that do perform or meet a business need, and that just need to be mapped or linked.

Dr. Deering congratulated Connecting for Health on taking the language of personal empowerment and PHRs and translating it into language that policy makers and people in the world of standards and legal issues can understand. In response to Dr. Deering’s question about how patients will be able to control their health information, Dr. Diamond said the Connecting for Health model is premised on patient authorization about what can be shared, when, and how. “Anything short of giving patients the opportunity to decide whether or not they want health information to be shared will not succeed.”

Agenda Item: Discussion of Strategies

Dr. Lumpkin asked the Workgroup to synthesize what it heard today and to set an agenda for future work. He suggested creating and then winnowing down a list of topics for the Workgroup to pursue, and finalizing the list at the Workgroup’s September meeting.

The Workgroup discussed how the roadmaps of other groups should affect its agenda. Ms. Poker asked whether the Workgroup should analyze others’ roadmaps and create a synthesis. Dr. Steindel and Dr. Yasnoff both felt studying other groups’ roadmaps would not be productive because the pace of activity and accomplishment is so rapid that the roadmaps will be outdated before the Workgroup could complete its analysis.

The strength of the Workgroup is its ability to systematically solicit and synthesize all the stakeholders’ views and to provide those views to HHS, Dr. Yasnoff said. He cited three issues—interoperability, legal obstacles, and certification of EHRs—that the Workgroup has tremendous potential to contribute to by assuring comprehensive input from all the stakeholders. Incentives do not belong on the list because consensus already exists that they are needed, and HHS has already begun forming a group to look at incentives.

Based on a request from Dr. Carr, the Workgroup discussed looking at how information about quality is collected, and the effort to get quality data elements through the UB code, and how primary and secondary use of data affect quality requirements.

A discussion of incentives ensued, with some (Dr. Ortiz, Dr. Vigilante, Dr. Warren, and Dr. Houston) arguing for keeping incentives on the Workgroup’s agenda since so little is known about which incentives work and which barriers inhibit adoption of EHRs. They also point out that incentives should not be monetary only and that incentives can ultimately establish a standard of care that physicians simply have to comply with.

Dr. Steindel suggested grouping interoperability, legal aspects, and certification under a new category, “What are the rules of the road to get onto the NHII?” and holding hearings on them. He also suggested referring to the Workgroup’s vision for 21st century to see how it addresses secondary use of data and in what way it should be updated..

One role of NCVHS and the NHII Workgroup is to keep the overall NHII vision alive, Dr. Greenberg noted. That vision not only includes EHRs and secondary uses of the EHR; it includes the personal health record, secondary uses of that, and other community and population information. She supported the Workgroup adding a research dimension.

Progress on incentives will occur, Dr. Yasnoff believes, not by having the Workgroup synthesize experts’ views, but by survey research and actual experiments with incentives. Since the Workgroup’s ability to do research is limited, the Workgroup should not take the lead on incentives. Similarly, though secondary uses of data are critical, Dr. Yasnoff argues the Workgroup can contribute best to urgent issues where the obstacle to progress lack of agreement about what should be done. The Workgroup is experienced in this area and it has the mechanisms to reach out to stakeholders and synthesize opinion that will be very helpful to HHS and to the Congress if action needs to be taken, he said.

Regarding PHRs, Dr. Deering asked whether the Workgroup should look at issues besides patient control, such as the actual policy barriers preventing person-centered, patient-centric, consumer-driven healthcare.

Dr. Huff noted that if there is no unique patient identifier, then the Workgroup has to inspire an authoritative body to generate interoperable standards about the elements needed to ensure accurate patient ID. Companies want to see implementation guides that detail national standards for, for example, sending laboratory or prescription data, he said.

Dr. Ortiz believes the Workgroup, rather than the Standards and Security Subcommittee, should address the patient identifier issue and the process for identifying patients.

Dr. Steuerle raised several issues related to information management. How well does the Workgroup’s roadmap reflect what is currently taking place? How does the Workgroup choose which issues to focus on? Who is in charge of resolving the problems identified—the government or the market? What are the options for solving the problem?

Mr. Blair raised three issues:

  • The importance of defining the purpose of incentives correctly. The Workgroup should not view the goal as EHRs and then use incentives to encourage physicians to adopt EHRs. Instead, improved quality of care should be the goal and physicians should see EHRs as a tool to improve quality of care.
  • Cases in which the marketplace is providing standards and national standards are not needed (such as e-prescribing).
  • Conformance testing for interoperability. He suggested adding conformance testing to the NHII Workgroup agenda since conformance tests have to be developed quickly, and industry cannot do it alone.

Ms. Cronin asked the Workgroup to continue communicating with the HHS’s new office of the national coordinator for HIT since it is working on many of the same issues as the NHII Workgroup, in particular certification and incentives. She also suggested a mechanism be put in place to ensure the Workgroup is aware of the progress of the national coordinator’s office and asked the Workgroup to keep in mind the current statutory authority and how it might need to evolve to enable EHRs and PHRs.

Dr. Steindel suggested the Workgroup provide guidance to industry within six months on patient identification.

Since Ms. Cronin agreed with Dr. Yasnoff that determining which incentives to use should not be the purview of the Workgroup, Dr. Vigilante removed his request to restore incentives to the Workgroup’s agenda.

A private-sector representative, Ms. Molina reinforced the importance of having “rules of the road.” She said that in the marketplace, companies are holding back from full-scale adoption because they are waiting for the government’s rules.

Agenda Item: Discussion of Workgroup’s Next Steps

Dr. Lumpkin reviewed the Committee’s role, and some of the accomplishments of the Workgroup and NCVHS. He then asked the Workgroup for recommendations of areas it should take on, based on three criteria: the significance of the issue; areas to which the Workgroup can add to the debate; and areas not being addressed by any other group. For example, since other groups, including the HHS office of the national coordinator, are addressing incentives, Dr. Lumpkin agreed that the Workgroup should no longer pursue incentives.

He suggested the Workgroup create a research agenda for NHII identifying where research ought to be done in the near term.

The Workgroup discussed the list of proposed topics, which includes:

  • The interface of research with data collection, population health, and other areas.
  • The personal health record and the personal health dimension.
  • Population health, and to what extent standards are being developed there, as well as public health.
  • Incentives.
  • Interoperability issues.
  • Legal obstacles for implementation, including the issue of certification and reference for implementation.
  • The interaction between quality and electronic health records.
  • Secondary uses of the electronic health record, generating things in both research and population health as well as quality.
  • Rules of the road.
  • Revisiting the 21st century health statistics report, and looking at how that interacts with the development of the NHII.
  • Movement of data from one dimension to another, which may be the same as secondary uses.
  • How people are identified within NHII (including the concept of a patient ID).
  • The NHII research agenda.
  • Metrics—how to measure how the NHII is being implemented.
  • Confidentiality and options.

After discussion of which areas could be taken off the list or combined into other areas, the Workgroup decided to ask the Standards and Security Subcommittee to address the process of patient identification, which Dr. Cohn accepted on behalf of Standards and Security; to ask the Privacy Subcommittee to address privacy and confidentiality; and to revisit metrics and conformance testing in six months and determine then whether the Workgroup could be helpful in that area. The four topics remaining for the Workgroup to address are: secondary uses of data, rules of the road, research agenda for NHII, and personal health record. The Workgroup will consider holding a hearing on the PHR, particularly the federal role in developing it.

Dr. Steindel agreed to take the lead on defining the concept of the rules of the road, and Dr. Lumpkin asked for a volunteer to take the lead on how the Workgroup should address secondary uses of data. The September meeting will be devoted to talking in more detail about holding a hearing on the personal health record in fall 2004, sketching out a work plan related to secondary uses and rules of the road, and working on a schedule (probably holding a hearing in early 2005) related to the research agenda for the NHII.

Dr. Cohn suggested asking AHRQ to brief the Workgroup on its work on a research agenda. Dr. Deering suggested the Workgroup ensure that the metrics and research agenda address population health and personal health.

Dr. Lumpkin adjourned the meeting.

Approved:

_______________________________

John R. Lumpkin, M.D., M.P.H., Chair