Identifying Appropriate Federal Roles in the Development of
Electronic Personal Health Records: Results of a Key Informant Process

Executive Summary

Personal health records (PHRs) are an emerging technology to enable people to manage their health information and health care transactions electronically. By facilitating a host of health management activities, PHRs have the potential not only to improve personal and family health but also to support major national health objectives. Several federal agencies have begun to include PHRs in their programs and plans. In speeches, the President has championed the widespread availability of interoperable, electronic, patient-controlled medical records. This expanding federal activity is generating questions about how government can best support positive trends and serve the public interest as PHRs evolve. Awareness is growing within and beyond government of the need for a more strategic and coordinated federal approach in this area.

This discussion paper is the product of a small study by FACCT-Foundation for Accountability, commissioned by the Office of Disease Prevention and Health Promotion of the Department of Health and Human Services (HHS). The study identified strategies and perspectives on federal roles in PHRs that are emerging within and outside government. The primary source is a series of 15 interviews with individuals in key positions in the federal government and the health care and health information technology industries. (The interviewees are listed in Appendix 2.) The paper builds on a recent series of foundational reports by Connecting for Health, a collaborative among government, industry and health care leaders. It also draws on presentations and discussions at two recent hearings on PHR models held by the National Committee on Vital and Health Statistics (NCVHS) Workgroup on the National Health Information Infrastructure (November 12, 2004 and January 5-6, 2005). The project team's findings, commentary and conclusions are intended to inform the policy discussion by identifying points of consensus and disagreement and suggesting possible priorities for the federal government as it moves forward.

Evolving Federal Activity and Conceptions of Federal Roles
The federal agencies exploring the uses of PHR technology are moving into an environment in which considerable private sector activity is already under way. Appendix 1 briefly describes these activities along with the evolving conceptions of PHRs and their related functions. The federal agencies' interest in PHRs grows out of the specific roles with which these agencies are charged—roles as:

  • Health care provider
  • Payer
  • Participant in standards efforts
  • Regulator
  • Researcher
  • Public educator and knowledge disseminator
  • Guardian of population health and the public interest
  • Employer

Although this paper is not an inventory of federal PHR activities, it begins with brief descriptions of several important federal efforts to provide context for the rest of the discussion. These activities include:

  • PHR development and rollout to health care enrollees by the Veterans Health Administration (VA) and the Department of Defense (DoD).
  • Pilot-testing of the Medicare Beneficiary Portal by the Centers for Medicare and Medicaid Services (CMS).
  • Research support and standards development by the National Library of Medicine (NLM), and health information content development and provision by NLM and other agencies in HHS.
  • Coordination of key infrastructure building blocks by the Office of the National Coordinator for Health Information Technology (ONCHIT).

Interview Themes: Opportunities for Federal Contributions
The interviewees were asked for their views on the federal role in PHRs. Their comments clustered around four critical contributions they believe the federal government can and should make to the development of PHRs.

  • Visioning and strategic leadership.
    Many observers see in PHR technology the potential to stimulate fundamental change in health care. Because of this potential, the interviewees stressed the need for government to clarify its vision for the health care system so that its decisions on PHRs can work together toward the desired outcomes.

  • Leading and facilitating standards-based approaches.
    Facilitating standards-based approaches is the interviewees' top priority for federal action. They called particular attention to the potential influence of the Consolidated Health Informatics (CHI) standards and stressed that standards work should be done in a manner that paves the way for PHRs.

  • Enforcing laws and creating the right regulatory environment.
    The interviewees noted the importance of regulations in some areas, especially to protect privacy and confidentiality, as well as regulatory obstacles that are impeding some possible uses of PHRs.

  • Supporting experimentation and facilitating the evolution of PHRs.
    Government can facilitate the evolution of PHRs by supporting research and development, sharing the learnings from federal PHR experiments, educating the user base, advancing security protections and in other ways creating an atmosphere of public trust.

Commentary: Critical Challenges for the Federal Government
In addition to the many issues that any organization involved with PHRs must address (e.g., financial sustainability, interoperability and privacy), government will face a number of unique challenges as it moves further into this arena. The project team believes these challenges revolve around five basic questions:

  1. What vision of health care and health system reform will inform the government's involvement with PHRs?
    The government has critical decisions to make about sustainable PHR payment models, incentives, and health care financing policies that encourage greater consumer participation in health management. These decisions are more likely to lead to the desired ends if they are guided by a shared vision for system reform and population health.

  2. What is the government's vision for empowering consumers, and how will it be translated into policies and programs?
    PHRs can be a gateway and organizing application for consumers' personal health management as well as their purchasing decisions and benefits management. To help realize this potential for consumers, the government needs a clear stance toward consumer empowerment, informed by research and dialogue among stakeholders. Its decisions about control of the electronic medical record will ideally promote shared access based on mutually agreed-upon responsibilities and consent between clinicians and their patients.

  3. What is the government's stance toward the many possible uses of PHRs?
    Federal agencies are considering multiple uses for PHRs across the continuum of its health care, prevention and disease management responsibilities. Some options being considered raise issues about privacy, public trust and possible intrusion into areas traditionally reserved for health care organizations and the commercial sector.

  4. What federal actions are needed to promote population-wide benefits for PHRs?
    The President's goal for all Americans to have an interoperable, patient-controlled electronic health record (EHR) within a decade sets a high bar for access. Meeting this goal will require many forms of federal leadership, including determining what works best for different population groups and how diverse consumers can be engaged in their health management using PHR technology.

  5. How can the coordination of federal policy decisions be strengthened and enhanced, and how will progress be assessed?
    Both the involvement of multiple agencies in PHRs and the potential connectivity of health information technology will necessitate new levels of coordination and planning across the federal government. This opportunity calls for clear assignment of responsibility within and across agencies, active coordination mechanisms that explicitly address PHR-related activity, and metrics for assessing progress. Coordination and integration are especially needed in these areas:

    • Dealing with diverse PHR models
    • Standards
    • Privacy issues and relevant laws and regulations
    • Other jurisdictions
    • Research
    • Costs and capacities

Conclusion: Emerging Decisions and Priorities for the Federal Government

This discussion paper explores the thinking about PHRs across multiple federal agencies. The interviewees displayed significant consensus about federal roles in two priority areas:

  • Standardization in data:
    The federal government should facilitate standards-based approaches to health data collection and exchange.
  • Experimentation in models:
    The federal government should encourage, finance, coordinate and help disseminate findings from a wide range of experiments to find the most successful PHR applications and models.

The federal government is an inevitable player in the evolution of personal health records, through the many roles discussed in this paper. Its health policy thought leaders show a high level of enthusiasm for PHRs; and policymakers are under pressure to make tangible strides toward the President's goals. This paper notes a wide range of PHR activity within the federal government and in the private marketplace. The pluralistic backdrop creates a relatively open landscape of possibilities for federal investment in PHRs. As it moves forward, the government can be most effective by avoiding two possible pitfalls: 1) sponsoring a superficial one-size-fits-all PHR offering, and 2) allowing a plurality of agencies to offer independent PHR applications with little coordination or strategic vision. Either path could add to the health services fragmentation the public already faces and potentially distract from an historic chance to transform health and healthcare in this country.

Electronic personal health records present new opportunities and challenges to federal policy makers. The real test for PHRs is whether they make it easier for ordinary people to engage more actively in their own health and healthcare—with enhanced communication, improved safety, enriched knowledge and confidence, and trusted safeguards to their privacy. Strategic vision and coordinated tactical steps—in both public and private sectors as well as jointly—are necessary to propel a widespread PHR availability that helps patients and their families play a transformative role in the U.S. health care system.

To these ends, this discussion paper proposes the following near-term steps for the federal government, beginning with appropriate levels of funding for ONCHIT to serve with overall responsibility for coordinating federal PHR activities:

  • Clarifying objectives by defining a process for research-driven answers to questions such as those posed in Section IV of this paper.
  • Strengthening the mechanisms and resources available for coordinating the PHR-related activities of federal agencies. The need for coordination applies equally to activities within agencies, between agencies, and with private industry—the latter best carried out in public-private bodies.
  • Assigning responsibilities and specifying the metrics to evaluate progress toward meeting those objectives. Such responsibilities may include:
    • Expediting federal implementation of CHI.
    • Developing and maintaining an inventory of PHR-like activities sponsored or funded by federal agencies.
    • Developing a government-wide research plan to advance the federal approach to PHRs.
    • Nurturing a public-private policy framework, including the need to address, for example
      • Achieving full interoperability among federal PHRs and PHR components, e.g., among VA, DoD, CMS.
      • Aiding efforts for a core level of interoperability between EHRs and PHRs, such as through a standard minimum data set.
      • Examining privacy laws and regulations in the light of anticipated increases in PHR use.
      • Examining reimbursement policy to increase incentives for health professionals to engage consumer participation in electronic health management tools.
      • Identifying policy issues requiring a unified stance across government.
      • Exploring ways to provide patients with electronic access to their own information as a key design component of emerging RHIOs.

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