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

II. Evolving Federal Activity and Conceptions of Federal Roles

• Government as Health Care Provider
• Government as Payer
• Government as Participant in Standards Efforts
• Government as Regulator
• Government as Researcher
• Government as Public Educator and Knowledge Disseminator
• Government as Guardian of Population Health and the Public Interest
• Government as Employer

Personal health records (PHRs) are developing rapidly in both the private and public sectors, designed to meet a range of consumer needs in a variety of environments. To take a few examples, enrollees in some private sector and government-sponsored health care systems can view their data stored in clinician-controlled electronic health records through portals that also enable them to communicate with physicians and perform other functions. Individuals with chronic health conditions have access to several PHR products to help them manage their self-care and chart longitudinal data, which may be derived from monitoring devices or electronic patient diaries. And some pharmacy patrons can view their prescription history through retail pharmacy or pharmacy benefit manager web sites. The governmental agencies starting to explore uses of PHR technology are moving into a terrain in which there is already considerable private sector activity (described briefly in Appendix 1). Questions about the federal role have become urgent and concrete because the evolving public, private and joint activities can either complement each other for the good of the nation's health care consumers, or they can add to the fragmentation of the health system.

The President provided the highest-level rationale and context for a federal involvement in PHRs when he declared in April 2004 that within a decade, every person in the United States should have access to interoperable, personally controlled electronic health records⁴ . In addition, many governmental agencies have espoused the principles of patient-centered care, greater consumer control and empowerment, improved chronic care management and fuller translation of knowledge into practice with respect to both public health and health care. If PHRs are a means toward these important policy goals, as many believe, then government can be expected to help nurture their development in its own programs and in the country as a whole.

The Department's work on an interoperable infrastructure, or National Health Information Network (NHIN), has begun to make an explicit place for PHRs in national strategy. They are named in the Health Information Technology (HIT) Framework for Strategic Action⁵ , which is designed to help achieve federal objectives outlined in such documents as the HHS Strategic Goals and Objectives⁶ and Healthy People 2010⁷. Office of the National Coordinator for Health Information Technology (ONCHIT) was established by Presidential Executive Order on April 27, 2004 and charged (among other things) with "avoiding duplication of efforts and helping to ensure that each agency undertakes activities primarily within the areas of its greatest expertise and technical capacity." National HIT Coordinator David Brailer, M.D., frames his office's purpose as helping to create the conditions in which the market can deliver health solutions to the nation. He affirms that coordinating federal PHR activities is part of ONCHIT's charge⁸. ONCHIT views PHRs as a longer-term goal, once it establishes three critical building blocks: facilitating EHR adoption and creating regional health information organizations (RHIOs) and health information exchange networks.

In broad terms, federal engagement with PHRs falls into three areas. First, PHRs can be viewed as a natural extension of existing federal roles, such as providing health services to veterans. Second, PHRs offer new ways to achieve existing and emerging federal goals; for example, as a potential new vehicle for disseminating targeted and possibly tailored prevention messages. Third, PHRs challenge gov-ernment to frame its approaches in terms of a transformative vision for health care and population health.

Before looking at the longer-term questions, it is useful first to have a sense of the activities and thinking already under way in federal environments. The next few pages briefly survey this thinking, as expressed in the interviews. As noted, this is not intended as a comprehensive inventory, but rather as a sketch of the leading edges of government activity. In every case, as in the private sector, these activities should be seen as developmental and experimental.

Government as Health Care Provider
Four government agencies provide health care services to defined segments of the American population: the Department of Defense (DoD) to military Service members, their families, and other eligible beneficiaries, the Veterans' Administration (VA) to veterans, the Indian Health Service (IHS) to American Indians and Alaska Natives, and the Health Resources and Services Administration (HRSA) to underserved Americans through its system of primary health care clinics. The VA and DoD are pioneers in developing and rolling out PHRs for their enormous enrollee populations. The VA has already released My HealtheVet nationally (although uptake is happening slowly); and the PHR being developed by DoD's TriCareOnline, an expansion of the existing Personal Health Journal, is partly in place and has planned incremental improvements to enhance capabilities. Both agencies plan to provide patients with access to their data contained in clinician-controlled EHRs. Besides managing these new national services, the DoD and VA are working toward interoperability between their two systems and talking with the National Library of Medicine (NLM) about providing links to MedlinePlus. They also have active relationships with private sector entities, with which they collaborate and from which they purchase or lease products.

The IHS works closely with the VA and DoD and is able to use many of their resources in its own services. For its part, HRSA, which serves as a health care provider of last resort for the country through 3500 primary care clinics, has begun to develop EHRs for its clients. These relationships and activities represent potential for possible consumer-facing applications in the future.

Government as Payer
The Center for Medicare and Medicaid Services (CMS), the nation's largest payer, regards the PHR as a tool for personalizing care and helping beneficiaries become more effective health care consumers with greater ability to manage their chronic illnesses. For Medicare enrollees, it has a two-pronged initiative for PHR services: providing a Medicare Beneficiary Portal, now being piloted in Indiana, and encouraging Medicare providers to support their patients' use of PHRs. The Medicare Portal provides online access to benefits information plus targeted prevention messages. CMS intends to support the creation of PHRs for its beneficiaries through business relationships with private sector developers, rather than by developing PHRs itself.

For the longer term, CMS is investigating alternative approaches to and uses of PHRs and considering the roles it should play in the PHR arena. For example, it is considering offering beneficiaries price and quality information about providers, as well as recommending or requiring a set of PHR attributes for vendors and providers. It is being cautious about entering into a role that would involve becoming the physical custodian of beneficiaries' PHR information (beyond the information it already stores to adjudicate claims), recognizing that the public shows hesitancy about entrusting personal health information to government programs⁹ . In general, CMS recognizes its ability to influence the market for good or ill because of its size and is seeking advice from the Connecting for Health public-private collaborative on possible roles it might play.

Government as Participant in Standards Efforts
The federal government is already making an important contribution in the standards domain for health information technology. There is considerable collaboration in place both within government and between it and the private sector. Standards activity cuts across other governmental functions, as reflected in the fact that nearly all the government employees interviewed for this paper participate in standards development efforts. Government also has the de facto power to shape private sector behavior by compelling uniform use of data standards by federal agencies and those who contract with them. (We discuss standards in more detail in Section III.)

The NLM deserves mention in this context because of its long history of supporting EHR research and standards development. These investments are based on the National Library's expectation that EHRs (and by extension PHRs) will enable tailored decision support and enhance research as a byproduct of care. The NLM is a leader in developing vocabulary and terminology standards to permit unified clinical coding in EHRs. These standards are regarded as an essential element in establishing interoperability among electronic records. The Library also has a key role as a content provider, as discussed below.

Government as Regulator
Creating and modifying the regulatory environment is another activity in which federal agencies with an interest in PHRs either are or can expect to become involved. In this regard, it is relevant that although not all PHR suppliers are technically "covered entities" under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, most large PHR suppliers consider HIPAA's privacy and patient authorization provisions to be their de facto regulatory floor.

Government as Researcher
As noted, research and development on the technical groundwork for EHRs (and, to a much lesser extent, PHRs) has been under way for many years, particularly through the NLM. Now, actual PHR initiatives inside and outside government offer real-world laboratories for studying the deployment, functioning and impact of various models. Our interviewees had many comments on the need for a well thought-out research agenda to realize the learning potential of these early experiments (as discussed below). It is worth noting that federal research capacities extend well beyond HHS; Dr. Brailer points out that ONCHIT's coordinative role "covers every cabinet department" and links the Department to research organizations in other agencies that have relevant charges. These organizations can help answer technical and policy questions such as how to make PHRs useful for diverse populations and how to maximize security.

The attractiveness of the PHR as a new tool for carrying out federal responsibilities—the second broad area of federal engagement noted above—is evident in the research domain. For example, the National Cancer Institute has begun a pilot in California of a program called caMATCH. It will enable cancer patients to maintain records and gather information on their conditions, and it also gives them a virtual interface for matching their profile to clinical trial enrollment criteria. For its part, the Food and Drug Administration (FDA) is developing mechanisms for electronic patient-reported outcomes in pharmaceutical clinical trials. The FDA's approach to research links back to regulatory issues, as it regards addressing regulatory barriers to research (for example, in the Privacy Rule) as a pivotal activity.

The January 2005 NCVHS hearing on PHRs generated discussion about their potential uses for public health and health services research. It is evident from that discussion and from our interviews that researchers, clinicians and public health professionals see these tools as a possible new source of data about consumer health behaviors (for example, their compliance with medical instructions and their use of complementary and alternative medicine), consumer-reported outcomes, and environmental and other contextual information. There are hopes that with proper consent mechanisms and privacy protections, consumers might make available information that could lead to improvements in person-centered health care and public health surveillance. In the NCVHS hearing as in the interviews, the discussion of these possibilities goes hand in hand with recognition of the significant privacy and confidentiality protections that must be worked out in order to realize this potential.

Government as Public Educator and Knowledge Disseminator
Many federal agencies involved in knowledge dissemination and health communication recognize the potential uses of PHRs for targeted and tailored knowledge delivery and decision support. As a content provider, the NLM is now working with provider organizations in both the private and public sectors to link PHR users to MedlinePlus, a major information source for consumers and health professionals¹⁰. It is worth noting that the dividing line between consumer and professional users and content grows ever more blurred as consumers gain sophistication in going directly to the research literature for health information.

Several other federal agencies with information resources for consumers are also exploring the potential of PHRs as vehicles for personalized prevention, health management and consumer assistance messages. They include the Centers for Disease Control (CDC), the National Institutes of Health (NIH), FDA, CMS and ODPHP. For its part, a number of CDC programs are currently tailoring prevention content already being included as part of PHRs. CDC is also interested in PHRs as a possible channel for public health alerts and notifications, though important privacy policy decisions remain to be made. The types of information that might be disseminated by federal agencies include research findings, prevention messages, and price and quality information to assist health care consumers and motivate quality improvements among providers.

The interest of the Agency for Healthcare Research and Quality (AHRQ) in PHRs derives from its responsibility for improving health care quality. Recognizing an opportunity to empower and engage consumers to this end, AHRQ and the American Medical Informatics Association are considering social marketing campaigns to educate consumers about PHRs and to drive demand for them in regions where RHIOs have been established.

Government as Guardian of Population Health and the Public Interest
Protecting the interests of underserved and disadvantaged segments of the U.S. population and compensating for market failures with these population groups are federal responsibilities embodied in several agency missions and programs. Those looking at PHRs through the health disparities lens are beginning to think about how to ensure that as many Americans as possible can gain access to and benefit from PHRs, as well as about how PHRs might be used in the government's programs for diverse and underserved communities.¹¹

Government as Employer
In its role as the employer of millions of Americans, the federal government is influenced by the same factors as any employer paying for employee health insurance and wanting a healthy workforce. For this reason, the government may want, at a minimum, to give employees and their health care providers incentives to engage more fully in their health and health care aided by the use of PHRs. On the broader question of data collection, some observers find it significant that the Office of the Secretary recently crossed a threshold in HHS involvement with personal data collection, demonstrating people's willingness to voluntarily use a government-sponsored vehicle to record personal data about physical activity. The President's Challenge Web site, an extension of the fitness programs of the President's Council on Physical Fitness and Sports, enables individuals to store personal data about their physical activity on the Web [www.presidentschallenge.org]. It was also used as part of the HealthierFeds program for federal employees, managed by the Office of Personnel Management.

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