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

IV. Commentary: Critical Challenges for the Federal Government

Public or private, any organization involved with personal health records must address questions of cost and financial sustainability, interoperability and portability, data accuracy and timeliness, privacy and security, and liability and information control, among others. Connecting for Health and other partnerships as well as standards-development organizations are pursuing consensus groundwork for solutions in these areas. This discussion paper confines itself to the critical challenges the federal government uniquely will face as it grows more involved with PHRs and the priorities calling for its attention in the near term, as perceived by the project team.

Our nation looks to the federal government as the arbiter of the public interest across our pluralistic health care marketplace—whether addressing medication safety, public health, or insurance for the most vulnerable Americans. The fragmentation of the health care delivery system and the "disintermediation" of individual consumers by their employers, health plans, and other payers means that there are few mechanisms other than federal action for addressing the public interest in the emerging transformation of the health care system. Public officials also bear responsibility for the effective and appropriate use of the enormous federal financial resources committed to health care. To the degree that PHRs may become one of the integrating tools across our health care system, the government should regard them as instruments of efficiency and accountability. The government is also expected to play a protective role in ensuring that access to care and needed services is afforded to all Americans—a role that no other component of our health care system can play. The government has a unique opportunity to establish a constructive climate for PHR adoption that anticipates and advances the public interest, specifically in those domains where normal market forces may not be sufficient.

In its varied capacities, government can lead by example, support best practices in the field, and fill gaps in areas not addressed by the private sector. This section considers the major challenges associated with carrying out these roles. The challenges revolve around five fundamental questions:

1. What vision of health care and health system reform will inform the government's involvement with PHRs?
2. What is the government's vision for empowering consumers, and how will it be translated into policies and programs?
3. What is the government's role in encouraging multiple types of PHR uses in the public interest?
4. What federal actions are needed to promote population-wide benefits for PHRs?
5. How can the coordination of federal policy decisions be strengthened and enhanced, and how will progress be assessed?

1. What vision of health care and health system reform will inform the government's involvement with PHRs?

As noted, many people see PHRs as an important contributor toward bringing about fundamental health system reform. The early evidence suggests that PHRs are causing some patients to experience their health and health care in new and positive ways. Some analysts and policy makers view PHRs as a "disruptive technology" with the potential to accomplish a major paradigm shift in health care. As noted, several interviewees pointed out that given the potential power of this tool, it would be prudent for government at this early stage to clarify its vision for the kind of health care system it wants to help bring into being, in consultation and collaboration with other stakeholders with a commitment to system reform. The practical decisions about governmental involvement with PHRs can then be made in that light. Congress and the Administration have stated their commitment to increasing consumer roles in health care—the ability to manage chronic illness, to select hospitals and physicians based on quality data, to manage their own health care costs through programs such as health savings accounts, and so on. All of these policy objectives could be supported by appropriate design and use of PHRs.

These broad objectives point urgently to the need for appropriate health care financing policies to encourage greater consumer participation in health management. More specifically, the government's participation is needed in the search for sustainable models for paying for PHRs, given that consumers thus far have shown little inclination to pay themselves. Some interviewees commented on the role incentives can play in stimulating the use of PHRs as a vehicle that leads to more continuous healing relationships between clinicians and the patients and families they serve. The hard policy decisions around incentives illustrate the need for a guiding vision. Despite the great potential of PHRs, the early record on consumer and provider adoption is at best only mildly promising. What incentives, if any, should government offer to encourage providers to offer PHRs to their patients or contribute data to their patients' PHRs hosted by third parties? What specific behaviors does it wish to "incent," and by whom? And what forms of provider and consumer education are required to encourage these changes?

Finally, an interviewee reported that AHRQ and AMIA are looking at social marketing as a way to increase consumer demand for PHRs. This prospect raises a related set of questions. What are the behavioral objectives of such a campaign? How would such marketing be coordinated with the efforts of industry and consumer groups? And what kind of incentives could or should reinforce these campaigns?

2. What is the government's vision for empowering consumers, and how will it be translated into policies and programs?

• Empowering consumers for health self-management
  The personal health record is just part of a much broader trend in policy, technology and health care toward greater attention to and responsibility by the consumer. While PHRs may be an instrument to achieve many governmental goals—quality improvement, cost savings and system reform, to name a few—above all our interviewees stress their importance for helping people manage their health. PHRs are envisioned as the gateway and organizing application for all of consumers' personal health management activities. Importantly, these activities transcend the medical model and the relationships between the consumer and the health care system. They also encompass consumers' decisions and record-keeping about health behaviors, prevention activities, chronic disease, health-related administrative and financial matters and more, for themselves and their families. Most observers believe that the personal health record cannot be detached from these broader personal health management functions. Among other things, this has implications for the context in which consumers connect to the PHR and the control questions discussed below.

  Because of its broad perspective and responsibilities, government has a key role in promoting understanding—within government, in other sectors, and among consumers themselves—of the principles of personal health management. Promoting understanding in this area depends on having adequate research to determine what diverse consumers want and feel able to do on their own in regard to their health, and what programs and forms of communication will serve the full continuum of consumer capacities and interests¹⁴. The research findings will have important implications for governmental decisions about what PHR models it supports and endorses.

• Empowering consumers as purchasers
  PHRs can assist health care consumers in making purchasing decisions and managing benefits. Governmental decisions to promote consumer-driven health care and health savings accounts promise to increase the decision-making and cost-bearing burdens on consumers and heighten the need and demand for decision support tools. In addition, federal agencies can influence purchasing decisions by supplying consumers with price and quality data on providers. PHRs hold the promise of personalizing the distribution of relevant provider data and of permitting collection of quality and evaluation data directly from patients. This raises questions about consumers' varying levels of capacity to handle an increased decision burden as well as how much pressure government is willing to exert on the private sector, and in what form, to bring about desired reforms. More narrowly, the agencies will have a fundamental business decision about whether to provide needed quality information directly to consumers or through intermediaries.

• Record control issues
  As noted, Connecting for Health's survey and focus group research found that consumers are more comfortable with the prospect of their health care providers serving as the supplier of PHR applications than with payer entities such as their health insurance company or the government. In addition, consumers express a desire to decide who has access to their records, with audit trails¹⁵. How will government translate its stance toward consumer empowerment into policy regarding control of the record? Connecting for Health has written in detail in its 2004 report Connecting Americans to Their Healthcare about the levels and types of authorization and consent needed for shared access and contributions to PHRs, and about the related topics of privacy regulations and the management of expectations and liability¹⁶. The question of control of the record generates lively disagreement between those who emphasize patients' right to control their records and those who argue that health records must be controlled by providers because of liability issues. Arguably, this is a false dichotomy, because it is the project team's view that PHRs can and should evolve in a framework of shared access based on mutually agreed responsibilities and consent between clinicians and their patients. After all, PHRs are not meant to replace clinicians' legal and practical need to maintain an official record of their patients. Still, these divergent views signal the need for careful analysis and discussion with all stakeholders.

3. What is the government's role in encouraging multiple types of PHR uses in the public interest?

To a great extent, both the concern and the enthusiasm for PHRs stem from the same source: the breadth of possible uses of PHRs. The multiplicity of potential uses stems from the many governmental roles discussed above—provider, payer, researcher, and so on. Some questions about the federal role and impending challenges for government lie in this area.

• Public trust and appropriate governmental roles
  Government's interest in using PHRs as a public health tool suggests activity across the continuum of health care, prevention, and disease management. As it moves across this continuum, it is likely to encounter new issues related to privacy, trust and intrusion into market domains. The possible involvement of payers such as CMS in tailored prevention efforts illustrates the challenges for government, or possibly any payer, in undertaking such a role. People are accustomed to sharing their personal health information with health care providers. It is not certain that an intervention by payers will be as acceptable, especially if this involves access to personal health information. Will the public accept a governmental role in health management outside the context of those agencies that function specifically in the role of health care provider (e.g., the VA or DoD)?

  If government has an important role but is not the appropriate host of personal health records, third party PHR suppliers could be used as intermediaries and data integrators between the beneficiary and the government partner. For example, CMS might not host any new clinical information on an individual, but rather could supply the benefits or claims information it already holds into the third-party-supplied PHR of an individual. In short, any agency contemplating roles in these areas will need to determine the likely public concerns and do what is necessary to protect privacy and ensure public trust.

• Different models for different needs?
  This paper emphasizes the fact that many types of PHRs are available. The government has decisions to make about the PHR tools it purchases or creates for the people in its care—and some coordination in this area would be beneficial. The lack of a standard model may make it hard for individual agencies to avoid fragmented and idiosyncratic approaches. Indeed, at this stage they are making independent decisions about the type of PHR services they are offering. Cross-governmental coordination challenges related to PHR models are discussed below.

  There may be advantages to offering different types of PHR applications for different purposes—provided they are designed for interoperability. Connecting for Health reports point out that there is no one-size-fits-all approach in health because of the variety of consumers, health issues, life stages, and so on. Some agencies have expressed interest in offering consumers a more limited PHR emphasizing prevention uses—the kind of model that could function as a set of PHR "training wheels" to introduce slower adopters to the uses of online health information. Such a federal contribution to preparing the user base for PHRs might be welcome to the field as a whole. One such "introductory" tool being considered would involve messaging and record-keeping capabilities but no professionally-sourced content. However, surveys indicate that many consumers (especially those with chronic illnesses) have a strong interest in having convenient access to their clinical data¹⁷, and some PHR models are generally evolving in that direction. This raises the question of whether free-standing models without a connection to EHRs have enough viability to warrant a federal investment.

4. What federal actions are needed to promote population-wide benefits for PHRs?

As noted above, the President has set the goal of making interoperable electronic health records widely a vailable within a decade. This sets the bar very high for extending the potential benefits of PHRs to as many Americans as possible. Should government choose to actively promote and use PHRs to help achieve population health benefits and reduce disparities, it will meet a number of challenges. Meeting the needs of this country's diverse communities will require research and applied learnings about literacy, linguistic and cultural appropriateness, usability, and technology access. Among other things, the effectiveness of PHRs as vehicles of prevention messages has yet to be established empirically. In addition, achieving the President's goal implies a commitment to ubiquitous access to high-quality digital technology.

Some interviewees believe the federal government should, and eventually will, encourage the participants in its safety net programs to use PHRs. Doing so would first require research, design and dissemination strategies to determine how to reach and serve the diverse, low-income clients of Medicaid and HRSA and to identify what models government could build on in such an effort. Some of the answers are likely to come from the government's own test beds in VA, DoD and other federal programs.

It is unlikely that these challenges will be addressed, nor the broad access goals met, without federal leadership. Clearly, these are responsibilities and activities in which government is already heavily involved, in related spheres. To the extent that the private sector shares responsibility for the health of diverse populations, there may be opportunities for public-private collaboration in working for the broadest availability and use of PHRs.

5. How can the coordination of federal policy decisions be strengthened and enhanced, and how will progress be assessed?

The need for coordination and integration underlies much of the rest of the discussion of the federal role in PHRs. Nearly all of the potential federal contributions outlined above involve the participation of multiple agencies. This suggests a new level of coordination and planning and new and specific mechanisms, as well as clear assignment of responsibility within and across agencies¹⁸. The coordination and partnerships must extend to industry, as well, since PHRs are a shared investment—carrying both opportunities and risks—with the private sector. The many existing forms of interagency and public-private cooperation, some of them noted above, provide models, momentum and opportunities for synergy. There are threshold questions about where the appropriate boundary between private sector PHR development and public sector initiatives lies, and where and how the "hand-off" should take place.

Within government, coordination must be built on explicit plans and strategies. The interviews for this paper show considerable variation in the extent to which PHRs are now an explicit part of today's federal agency policies and programs. As noted, the PHR is a well-established part of some agency programs, while in other agencies it is just a gleam in the eye of a few individuals. Hence, Dr. Brailer observes that PHRs are often more a matter of personal vision than organizational policy. Federal agencies have embarked on the PHR activities and plans described above because they help to realize key objectives. This being the case, one of government's tasks for the future is to make PHRs an explicit part of various strategic plans, as they are in the Department's Strategic HIT Framework.

In this country's pluralistic health care system, the federal role has been compartmentalized and poorly coordinated, largely expressed through individual agency objectives and programs. While public health agencies have population health goals such as those outlined in Healthy People 2010, these goals are not easily translated into huge, statutorily constrained programs such as those of CMS. But with their power to bridge the domains of health care, personal health and population health, HIT systems have the potential to traverse many programmatic divisions within government in ways that necessitate a more coordinated approach. In general, this informal study found somewhat ad hoc and preliminary attempts at coordination and communication around PHR activity; governmental mechanisms for these purposes are not yet mature or comprehensive. To change this, long- and short-term objectives must be clarified, both for individual agencies and for government as a whole. Once PHR roles and responsibilities have been worked out in terms of agency and Departmental objectives, the task of operationalizing them within existing structures and programs is itself considerable. (As just one example, a host of practical details regarding clinical information management must be worked out, involving the relationships among public and private sector health care providers across the continuum of care.) Finally, specifying the metrics for evaluating progress on federal objectives for PHRs will be an essential part of ensuring that they fulfill their potential as an instrument of public policy.

Federal agencies might begin the move to a more strategic and coordinated approach to PHRs by expanding and formalizing discussion and coordination mechanisms to bring all relevant players to the table. ONCHIT has a clear mandate and charge to play the lead coordinating role within government and between government and industry. A central question concerns whether this Office has the financial and other resources it needs to do so in the most timely and effective manner. ONCHIT has identified other short-term priorities that it regards as building blocks for an interoperable health information network. Given the extent of federal PHR activity, however, can coordinated action in this area wait until ONCHIT has sufficient resources to take the lead?

The links between PHR and other federal initiatives such as the DoD network design, genomics, and consumer strategies also must be worked out, along with collaborations with other federal agencies responsible for research and development. Over all, it will be important to distinguish between key policy issues and PHR actions that require a unified stance and those that can be left to individual agencies to manage. As noted, data standards and interoperability stood out in the interviews as the top priority for unified governmental action. The NCVHS January and February 2005 hearings call particular attention to issues related to privacy, control of the record, and taxonomy. These represent possible short-term priorities for unified governmental action. The following sections review six areas in which the project team believes coordination and integration are particularly needed.

• Dealing with diverse PHR models
  The issues in which a coordinating body might play a role in this area pertain both to internal governmental affairs and more generally to the HIT field, and they concern both the multiplicity of PHR models and the ways of talking about them. (See Appendix 1.) First, those responsible for coordination would need to determine whether consensus about PHR definitions and attributes is needed within government and even beyond; if so, the next question is how it can best be promoted. At the January NCVHS hearing on PHRs, after hearing testimony about the profusion of PHR models and definitions, committee members identified as a priority the need for a taxonomy to facilitate communication. As an advisor to HHS on health information policy, NCVHS could influence the federal role in this area. Both of these entities would still face choices about whether to be descriptive or prescriptive—simply to devise a logic for talking about the variety of models, or to use that as a basis for recommending standardized terms or models for HHS use. (Dr. Brailer stresses that the term "personal health record" should be reserved for tools that provide access to interoperable EHRs (e.g., covering the continuum of care between DoD and VA. He calls e-health tools without this capacity "precursors and enablers," but not PHRs.¹⁹)

  As for a coordinated approach to which model or models government should offer, there are several possibilities. One is that all PHRs offered by government agencies would provide a core set of functions and be promoted under a single "brand." Another is that tools would be highly customized for each constituency. Some choices in these areas may have consequences for market products, and may even provide a tipping point toward certain PHR models. Competing benefits are at stake here. On the one hand, there is broad agreement among interviewees that government should take pains not to impede experimentation and innovation at this early stage. Many believe that experimentation is critical to create the best, most cost-effective PHR models. On the other hand, government is making significant programmatic and budgetary decisions and to the extent possible needs to make wise spending decisions and avoid adding to the fragmentation. In addition, wanting to promote public trust and confidence in its health information web sites, government may decide that a consistent "public face" will aid this process.

• Standards
  In the standards area, many factors must come together to facilitate interoperability among PHRs, EHRs and the health information infrastructure. Future standards activity is likely to continue the consensus-based, partnership model that has worked well in the past, with strong roles for standards development organizations and public-private collaborations. A broad question for government concerns what kinds of planning and coordination are needed to ensure that general standards activity paves the way for PHRs. What impact would a more comprehensive commitment to promoting PHRs have on the federal involvement in standards and interoperability efforts? With regard to CHI, it is reasonable to wonder whether these standards will indeed "glide" to the private sector, as some interviewees predict, or if more is needed to make that happen. The same can be said of the Federal Health Architecture.

  It has been suggested that the NLM should help work on consumer-friendly medical terms and on mapping consumer terms to controlled clinical vocabularies, particularly those that the government is promoting such as LOINC and SNOMED. Theoretically, if the government made such mappings broadly available, it would lower costs for PHR suppliers, aid consumer understanding and promote long-term interoperability with EHRs as the recommended vocabularies become more widespread. In addition, a minimum data set is needed to permit information exchange between EHRs and PHRs. Some observers believe that the emerging Continuity of Care Record may evolve into such a data set. Another issue that must be addressed is the accurate authentication of patients, which has been fraught with controversy.

• Privacy Issues and Relevant Laws and Regulations
  It is the government's responsibility to create the optimal regulatory environment for PHR use, and finding ways to protect the personal health information of PHR users without creating unnecessary barriers to other important activities is a priority. Specific issues that may require attention stem from the proposed uses of personal health information in PHRs for public health and research purposes, the possibility of expanded governmental prevention activity, balancing the tradeoffs between interoperability and privacy, and constructively addressing public perceptions in this area. The policy issues that suggest a regulatory response—for example, the possible certification of PHRs that meet governmental specifications—will need to be identified. In addition, some agencies have identified regulatory obstacles that must be removed. For example, current regulations prohibit using EHR data to populate FDA clinical trials registries, making it necessary for investigators to re-enter all data, even if they are already in a patient's EHR. A consequence of this requirement is that all the investment in clinical trials does nothing to incentivize EHRs for those institutions.

  The government will need to work with the private sector and consumer groups to devise appropriate laws and regulations, security protections, consent and authorization mechanisms and audit devices to protect confidentiality and build public trust in this area.

• Other jurisdictions
  One interviewee drew attention to the need for federal help in addressing the barriers in other jurisdictions. For example, inconsistency in the uses of terminology in emerging state legislation (e.g., on e-prescribing) could create policy platforms that will further complicate movement toward standardization. The federal government might help foster compatibility between different levels and branches of government, for example by offering sample legislation or proposing standard terminology.

• Research
  This paper has noted the importance of conducting research to examine different models, find out what works, determine the impacts on health and other outcomes, establish the business case, and so on. Thus a major element of the coordination role will be identifying what governmental actions are needed, and by whom, to develop a comprehensive research agenda on PHRs, to support and coordinate the research on these questions, and to disseminate the findings. Besides an integrated research agenda and dissemination plans, mechanisms will be needed to coordinate the efforts of AHRQ, CDC, NLM, FDA, and other agencies with research responsibilities.

• Costs and capacities
  As in the private sector, cost is a dimension of virtually every question for the government about its involvements with PHRs. The Department and its agencies, along with VA and DoD, are already examining the cost implications of alternative forms of federal involvements and how they will be borne. As new coordination mechanisms become available and new PHR activities are considered, the federal government can compare the costs and benefits of separate versus coordinated action in specific areas. For example, would it be cost-effective for all Federal programs to adopt a common strategy or even software platform to support PHRs, or is experimentation likely to produce a more efficient solution? In either case, how will the roles of different payers be sorted out? And how can investments in PHRs be used optimally to support the larger investment in the HIT infrastructure?

  There are also capacity questions to be borne in mind. As agencies consider taking on new roles with PHRs in any of the areas outlined above—research, service provision, and so on- how can they assess their capacity to carry out these roles, and what clues do their track records offer about the prospects for new endeavors?

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