Testimony to American Health Information Community

Consumer Empowerment Workgroup

Hearing on Personal Health Records

September 18, 2006

Thank you for this opportunity to discuss the federal role in
encouraging consumer and clinician adoption of personal health records
(PHRs). Our group, consisting of Mary Jo Deering from the National
Cancer Institute, Jason Bonander from the Centers for Disease Control,
Michelle Murray and Kelly Cronin from the Office of the National
Coordinator, Helen Burstin from the Agency for Healthcare Research and
Quality, and Lorraine Doo and William Crawford from the Centers for
Medicare and Medicaid Services, have worked together to enumerate a set
of opportunities for the federal government to support adoption of PHRs.
In our work we focused particularly on opportunities for the government
to streamline PHR deployment and to broaden the potential set of
applications for PHRs.

**Disclaimer**

The analysis of the policy options presented in this testimony
represents solely the opinions of the authors and does not represent the
official opinion of the Department of Health and Human Services or any
other government agency.

**Assumptions**

Privacy and security concerns are extremely important but were not
directly considered in our analysis.

We believe that consumers generally trust their clinicians and follow
their advice, and that the majority of consumers would prefer PHRs that
are automatically populated with their medical information. By
extension, we believe that clinician adoption of PHRs helps support
consumer adoption of PHRs, and acknowledge that consumers must be
included in outreach efforts to accomplish the goals of consumer
empowerment, particularly consumer control and portability across
locations and providers.

**Introduction**

The deployment of user-friendly tools that enable individuals to manage
their personal health information could encourage individual involvement
in self-care and care management. Many healthcare experts believe
widespread use of personal health records (PHRs) may have short- and
long-term benefits for consumer health and healthcare utilization.
Consumer commitment to PHRs could increase efficiency in the healthcare
system, lower overall costs, and improve healthcare information access.
While consumers say they value specific services that PHRs can provide,
consumer PHR demand today is fairly low. Current interest in PHRs is
found largely among employers, health plans and software vendors.
Providers are playing a lesser role but may become more engaged and
offer more PHR-related services as electronic medical records evolve.
The federal government may be able to play an important role in
encouraging PHR adoption by consumers.

The role of the federal government in encouraging PHR adoption includes:

-   Supporting the development, dissemination and adoption of standards

-   Defining certification criteria for tools and/or entities that
    provide and manage PHRs

-   Protecting and including special and underrepresented populations

-   Providing appropriate incentives

-   Removing regulatory and infrastructure barriers

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-   Promoting education

The following are criteria for evaluating incentives, policy levers, and
specific programs that could accelerate PHR adoption. Government
initiatives should:

-   Encourage consumer adoption of PHRs

-   Encourage the integration and use of PHRs in clinical settings

-   Encourage and enable interoperable data exchange for PHRs

-   Encourage innovation and competition in the marketplace

The table below the potential options the group considered, and rates
them on each of the four criteria listed above. We also suggest agencies
that may be involved with those efforts, even though the listed agencies
may not currently be pursuing the activity.

**Policy Options for Encouraging PHR Adoption**

+--------------------------+--------+-------+-------+--------+-------+
| *Activity, Incentive or  | *A     | *     | *     | *Enco  | *     |
| Lever*                   | gency* | Encou | Encou | urages | Encou |
|                          |        | rages | rages | i      | rages |
|                          |        | con   | cli   | nterop | innov |
|                          |        | sumer | nical | erable | ation |
|                          |        | adop  | adop  | data   | and   |
|                          |        | tion* | tion* | exc    | co    |
|                          |        |       |       | hange* | mpeti |
|                          |        |       |       |        | tion* |
+--------------------------+--------+-------+-------+--------+-------+
| **Program Evaluation     |        |       |       |        |       |
| and**                    |        |       |       |        |       |
|                          |        |       |       |        |       |
| **Evidence Development** |        |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Create evidence base to  | HH     | ++    | +++   | \+     | ++    |
| establish value and      | S/AHRQ |       |       |        |       |
| determine mechanisms to  |        |       |       |        |       |
| integrate PHR into       | H      |       |       |        |       |
| clinical care            | HS/ONC |       |       |        |       |
|                          |        |       |       |        |       |
|                          | H      |       |       |        |       |
|                          | HS/CMS |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Use PHRs with EHRs for   | H      | \+    | ++    | ++     | ++    |
| disease management       | HS/NIH |       |       |        |       |
|                          |        |       |       |        |       |
|                          | H      |       |       |        |       |
|                          | HS/CMS |       |       |        |       |
|                          |        |       |       |        |       |
|                          | H      |       |       |        |       |
|                          | HS/IHS |       |       |        |       |
|                          |        |       |       |        |       |
|                          | VA     |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Implement a linked       | HH     | \+    | ++    | \+     | \+    |
| EHR/PHR system in        | S/HRSA |       |       |        |       |
| Community Health Centers |        |       |       |        |       |
| and fund initiatives     |        |       |       |        |       |
| through faith-based      |        |       |       |        |       |
| networks                 |        |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| **Standards Development  |        |       |       |        |       |
| and Adoption**           |        |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Adoption of PHR related  | H      | ++    | ++    | +++    | +++   |
| standards through CMS    | HS/CMS |       |       |        |       |
| and FEHBP sponsored PHRs |        |       |       |        |       |
|                          | OPM    |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Sponsor Standards        | H      | \+    | \+    | ++     | \+    |
| Development              | HS/ONC |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| **Education, Health      |        |       |       |        |       |
| Literacy, and the        |        |       |       |        |       |
| Consumer Experience**    |        |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Develop and disseminate  | Coord  | +++   | ++    | \+     | \+    |
| consumer education       | inated |       |       |        |       |
| campaign about benefits  | HHS    |       |       |        |       |
| of PHRs, and help define | effort |       |       |        |       |
| the PHR for the public   |        |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Establish standards for  | H      | \+    | ++    | ++     | \+    |
| and                      | HS/CDC |       |       |        |       |
| contribute science-based |        |       |       |        |       |
| health information       | H      |       |       |        |       |
|                          | HS/NIH |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| *Activity, Incentive or  | *A     | *     | *     | *Enco  | *     |
| Lever*                   | gency* | Encou | Encou | urages | Encou |
|                          |        | rages | rages | i      | rages |
|                          |        | con   | cli   | nterop | innov |
|                          |        | sumer | nical | erable | ation |
|                          |        | adop  | adop  | data   | and   |
|                          |        | tion* | tion* | exc    | co    |
|                          |        |       |       | hange* | mpeti |
|                          |        |       |       |        | tion* |
+--------------------------+--------+-------+-------+--------+-------+
| Establish standards for  | H      | ++    | \+    | \+     | \+    |
| content and presentation | HS/NIH |       |       |        |       |
| to improve the user      |        |       |       |        |       |
| experience.              | H      |       |       |        |       |
|                          | HS/NLM |       |       |        |       |
|                          |        |       |       |        |       |
|                          | H      |       |       |        |       |
|                          | HS/CDC |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| **Data Availability**    |        |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Develop data standards   | H      | \+    | \+    | \+     | \+    |
| for use and exchange of  | HS/CMS |       |       |        |       |
| claims-based PHR data    |        |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Develop guidelines for   | HHS/OS | ++    | \+    | ---    | ---   |
| authorization of data    |        |       |       |        |       |
| release to a 3^rd^ party | H      |       |       |        |       |
|                          | HS/CMS |       |       |        |       |
|                          |        |       |       |        |       |
|                          | VA     |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Implement                | H      | \+    | \+    | \+     | ---   |
| pay-for-performance      | HS/CMS |       |       |        |       |
| programs with measures   |        |       |       |        |       |
| encouraging              |        |       |       |        |       |
| communication between    |        |       |       |        |       |
| clinicians and patients  |        |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| **Enrollment             |        |       |       |        |       |
| Incentives**             |        |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Automatically enroll new | H      | ++    | ---   | \+     | \+    |
| Medicare beneficiaries   | HS/CMS |       |       |        |       |
| into a PHR program       |        |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Use PHRs in              | H      | \+    | ---   | \+     | \+    |
| post-marketing           | HS/FDA |       |       |        |       |
| surveillance of patients |        |       |       |        |       |
| and patient registries   |        |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Use PHRs to promote      | H      | \+    | \+    | ++     | \+    |
| enrollment in clinical   | HS/NIH |       |       |        |       |
| trials                   |        |       |       |        |       |
|                          | H      |       |       |        |       |
|                          | HS/FDA |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Enroll newborns and new  | DoD    | ++    | \+    | \+     | \+    |
| recruits covered by      |        |       |       |        |       |
| TRICARE in a PHR program |        |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Enroll veterans in       | VA     | ++    | \+    | \+     | \+    |
| MyHealtheVet and use     |        |       |       |        |       |
| online consultations     |        |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Enroll disability        | SSA    | ++    | \+    | \+     | \+    |
| beneficiaries in a PHR   |        |       |       |        |       |
| when they become         |        |       |       |        |       |
| eligible for disability  |        |       |       |        |       |
| benefits                 |        |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Pursue SCHIP-sponsored   | H      | \+    | \+    | \+     | \+    |
| PHRs                     | HS/CMS |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+
| Use the emergency        | HHS    | ---   | ---   | \+     | ---   |
| responder EHR model      | /OPHEP |       |       |        |       |
+--------------------------+--------+-------+-------+--------+-------+

Legend: +++ Policy lever meets criteria maximally

++ Policy lever meets criteria moderately

\+ Policy lever meets criteria minimally

--- Policy lever does not meet criteria

Agency Key: HHS Department of Health and Human Services

AHRQ Agency for Healthcare Research and Quality

CMS Centers for Medicare and Medicaid Services

FDA Food and Drug Administration

HRSA Health Resources and Services Agency

IHS Indian Health Service

NIH National Institutes of Health

NLM National Library of Medicine

OPHEP Office of Public Health Emergency Preparedness

OS Office of the Secretary

DoD Department of Defense

OPM Office of Personnel Management

SSA Social Security Administration

VA Veterans Administration

I will now provide a more narrative explanation of each of the options,
and will discuss the potential impact for each one.

**Program Evaluation and Evidence Development**

In order to make consumer-oriented decisions about using PHRs in
healthcare programs, more information is needed about consumers' needs
and preferences. More needs to be known about best practices for
integration of PHRs into clinical practice, disease management, and
community healthcare as well. There is a role for federal government in
collecting information and implementing e-health tools to help serve
certain populations.

*Create evidence base to establish value and determine mechanisms to
integrate PHR into clinical care.*

While there is good evidence to suggest that more than two-thirds of
patients have concerns about the security and privacy of their personal
health data, information about consumer needs and preferences is
limited. It is also not clear which components of the personal health
record will have the greatest effect on personal health and healthcare.
Different patient populations will likely have different expectations
for PHRs based on their own demographics, socioeconomic status, and
health literacy. There are many healthcare related issues, such as
integration into clinical care, that remain unexplored. Further evidence
is needed on how to best integrate PHRs into clinical workflow and on
the varying ability of different PHR models to protect personal health
privacy. Agencies such as AHRQ and CMS may be able to collect data on
these issues. Finally, while there is concern that failure to adopt PHRs
by more vulnerable patients will lead to greater disparities in
healthcare, there is some emerging evidence that diverse populations can
and will use e-health tools.

*Use PHRs with EHRs for disease management.*

PHRs may become important tools for disease management.  Enhancing
patients' ability to routinely access their own medical information
could dramatically improve the success of disease management programs.
 Patients with more self-care resources are better equipped to reduce
costly complications from chronic illness.  Successful national
demonstrations, with robust evaluations of value, would be important
drivers of PHR adoption in the private sector.  PHRs could be explicitly
incorporated into future CMS chronic care and disease management pilots,
and could also be explored by the National Institutes of Health.

Research has shown mixed economic results for disease management
initiatives by private insurers. It has been suggested that this is
partially due to the rate at which patients change plans, causing many
to leave disease management programs before results can be fully
realized. As CMS and VA do not face the same level of plan change by
patients, the two agencies are well positioned to develop an evidence
base about the role of PHR enabled disease management.

*Implement a linked EHR/PHR system in Community Health Centers and fund
initiatives through faith-based networks that support
underserved/uninsured populations.*

The Community Health Centers (CHCs) program supported by HRSA represents
a major component of America's healthcare safety net for the nation's
indigent populations, and is a leading Presidential and Congressional
initiative to increase healthcare access in the nation's most needy
communities. As CHCs move towards greater use of clinic-based EHRs,
there is an opportunity to put additional information into patients'
hands by linking the EHRs with PHRs. In support of this effort, the
government can work with community organizations such as faith-based
networks, which can provide community-based access points for health
information technology (HIT) functionality for the many patients who may
not have connectivity on their own.

**Standards Development and Adoption**

The Presidential Executive Order entitled "Promoting Quality and
Efficient Health Care in Federal Government Administered or Sponsored
Health Care Programs" from August 22, 2006, calls for the federal
adoption of interoperability standards for HIT. The implementation of
this executive order presents the federal government with an opportunity
to advance interoperability of PHRs as standards are recognized by the
Secretary of HHS. In addition, the federal government also plays a key
role in supporting standards development in partnership with the private
sector and can support the development of new standards needed to
realize secure, consumer-controlled health information exchange.

*Adoption of PHR related standards through CMS and FEHBP-sponsored
PHRs.*

Adoption of standards for PHR data formatting, PHR data exchange, and
for the contribution of data to a PHR from diverse sources would allow
CMS, its carriers, and the Federal Employee Health Benefit Plans
administered by OPM to contribute data to a patient's PHR, and for the
patient to transition their previous record to a CMS or FEHBP-sponsored
application. These standards will drive adoption in three ways. First,
reducing the burden of populating a PHR will remove barriers to consumer
adoption. Second, making PHR data portable across PHR applications will
encourage users to make the investment in populating their data.
Finally, interoperable PHRs will be able to integrate with a wider range
of applications, including disease management and remote monitoring
systems, driving use in new contexts.

The executive order requires each agency to require in contracts or
agreements with healthcare providers, health plans, or health insurance
issuers that as each provider, plan, or issuer implements, acquires, or
upgrades health information technology systems, it shall utilize, where
available, health information technology systems and products that meet
recognized interoperability standards. As these standards are recognized
and included in contract language, there will likely be a very positive
impact on enabling data exchange across PHRs and between PHRs and other
HIT applications. As PHRs become more interoperable they will make
consumers' personal health information more portable accelerating
adoption among consumers and their clinicians provided that requirements
for security and consumer control are met.

*Sponsor standards development.*

The federal government has been a long-term supporter of standards
development through government funding and the contribution of technical
and programmatic expertise to the standards development process.
Numerous standard development organizations have successfully developed
and maintained HIT standards with the support of federal agencies. As
the HIT Standards Panel identifies gaps in the existing suite of
standards needed for interoperable and secure data exchange to support
the use of PHRs, the federal government should continue its partnership
with the standards development community to address those areas that
lack standards by supporting the development and testing of new
standards. While this effort will not have a short-term impact on
interoperable data exchange, standards development will support
PHR-related data exchange over time. Its impact on consumer and clinical
adoption is indirect and longer-term.

**Education, Health Literacy, and the Consumer Experience**

As federal agencies analyze the weaknesses of traditional educational
approaches and examine new ones based on more advanced health literacy
principles, the agencies are well-positioned to promote standards in the
area of health content presentation in PHRs and to demonstrate
leadership in promoting and marketing the benefits of PHR use. The
following opportunities could further encourage both consumer and
clinician adoption of PHRs as well as contribute to interoperable health
information exchange.

*Develop and disseminate consumer education campaign about benefits of
PHRs and help define the PHR for the public.*

The public is largely unfamiliar with e-health tools such as PHRs and
with the general concept of personal health management. Confusion should
not be a surprise given that there are over 100 PHR products on the
market. A common understanding of the benefits of personal health
self-management and the role of e-health tools is essential. Broad
attributes of e-health tools, such as consumer-centeredness,
interoperability, security, and consumer control are central to this
communication effort.

Mass media campaigns can help set the public agenda, create awareness
and provide specific information to large patient groups.

Mass media approaches would need to be combined with community and
interpersonal approaches to provide more detailed information from
trusted, credible sources. Extensive consumer research is needed to
develop the campaign strategy, content and resources, and ongoing
evaluation would provide process and outcome data on campaign effects.
To learn more about how campaigns could be used to inform the public
about personal health self-management and PHRs, pilot campaigns could be
conducted in phases and tied to PHR demonstration projects. Campaign
activities would need to be coordinated with private sector efforts (and
potentially with safety net providers or other organizations serving
disadvantaged groups in the community) to market specific PHR products
on a local level. Patient advocacy groups will also play a very
important role.

*Establish standards for and contribute science-based health
information.*

Many HHS agencies have large repositories of credible science-based
health information. The National Institutes of Health, the Centers for
Disease Control and Prevention, the Substance Abuse and Mental Health
Services Administration, the Food and Drug Administration, the HHS
Office of Women's Health and many other agencies and offices offer
health information in a variety of formats and languages. These
resources could be used to deliver personal health information to
support decision making and enable benchmarking, all of which contribute
to personal health self-management.

Existing technologies such as mark-up languages (XML) and web feeds
(RSS) support standardizing health information presentation within a
PHR. An increasing number of e-health tools are under development in the
areas of prevention, behavior change, decisionmaking, and chronic
disease management. The research and literature regarding the
effectiveness of these e-health tools and of PHRs as vehicles for
prevention and other health-based messages is growing. Federal agencies
such as NIH and CDC should play a lead role in guiding and defining the
standards for science-based health information and its appropriate
dissemination. With such standards, having "ready-made," science-based,
consumer-tested health information available for the clinician and a
standard means of presenting health information in PHR-mediated consumer
communications could encourage clinician adoption, as research shows
this contributes positively to consumer adoption. The availability of
federally-supported health literacy materials would lower the barriers
to the inclusion of patient-focused information in PHR systems that
might otherwise present raw clinical information. Efforts by CDC, NIH
and others to make this information readily available through standard
consumer-specific XML, RSS, metadata and vocabulary schemes would be a
boon to PHR standardization efforts.

*Establish standards for content and presentation to improve the user
experience.*

Lack of portability of information as well as lack of consistency in the
usability of information are both barriers to adoption. Therefore,
standards for PHR usability, usefulness and appropriateness are
critical. The ability to access health information using common symbols,
consumer-friendly vocabularies, appropriate language and culturally
sensitive design contributes to the ease of access, familiarity with
content, and usability necessary for the increased adoption of PHRs by
consumers. Leveraging existing standards and best practices for health
literacy, cultural competency and user-centered design; using existing
technologies such as XML and RSS to support standardizing health
information presentation; and expanding emerging standards regarding
universal symbols in healthcare settings all contribute to enhanced
consumer PHR portability and usability. Ongoing research, development
and federal guidance is needed around standards for appropriate health
symbols for PHRs as well as the standards for and creation of a robust
consumer vocabulary. NIH funding of research in this area, and HHS and
NLM guidance of standards definition and development will likely
contribute to the adoptability of PHRs by consumers. These factors will
help set the expectation that the "consumer PHR experience" will be
consumer-centered, continuous and common regardless of how the
information is accessed.

**Data Availability**

The federal government may be able to help develop the infrastructure
needed to implement PHRs on a nationwide scale, and may be able to help
provide protection for consumers in the area of privacy and security of
their health data. Additionally, as a payer for healthcare services, the
federal government can offer financial incentives, such as appropriately
designed pay-for-performance programs, to encourage the use of PHRs to
enhance communication between providers and patients.

*Develop data standards for use and exchange of claims-based PHR data.*

Claims data has been frequently mentioned as ideal "seed" data for PHRs,
but poor data quality and availability are major barriers to adoption of
this idea. "Upcoding," where claims contain information that is not
clinically relevant to the patient, has been cited as a major problem,
as is the lack of specificity in the ICD-9 and CPT codes used to
represent procedures. Prescription information is generally either
missing or incomplete, and inpatient visits covered under DRGs may
provide even less information. Depending on the source, the availability
of claims data may lag behind the original clinical event, increasing
risk for patients and providers if they rely on medication or condition
lists that could be six or more months old. CMS can help address the
data specificity issues by pushing ahead with adoption of the ICD-10
code set, and ensuring that Part D claims data can be made available to
patients. CMS can investigate opportunities to provide
pay-for-performance and Quality Improvement Organization (QIO) data to
Medicare patients' PHRs, potentially increasing data quality and
availability.

*Develop guidelines for authorization of data release to a 3^rd^ party.*

Federal agencies, particularly the Centers for Medicare and Medicaid
Services and the Veteran's Health Administration, already act as
custodians of patient data. In most cases, existing rules prevent
release of this information, even when the patient is the intended
recipient. CMS could agree to work with PHR applications that meet
certain privacy and security conditions, including appropriate
beneficiary authorization, to exchange clinical information through the
claims contractors currently supporting CMS claims functions. 

A uniform authorization form could be created by the HHS Office of Civil
Rights. The standard form would not only support this program, but would
also go a long way toward building a unified industry view of the varied
privacy-related issues for which patient authorization is required.
Broader industry adoption could encourage the use of claims data in PHRs
that are not directly administered by insurance companies. Since
consumers have indicated a low level of comfort with payer-based PHRs
(although more research is required) appropriate data release standards
could break down a serious barrier to adoption.

*Implement pay-for-performance programs with measures that encourage
communication between clinicians and patients.*

PHRs are a valuable tool for care coordination. Patients with chronic
illness in particular stand to benefit from improved recordkeeping and
communication with providers. Pay-for-performance measures that measure
the frequency and quality of patient-doctor communication could provide
an incentive for doctors to promote PHRs and related services (such as
secure messaging). In addition, providers could be encouraged to
recognize the value of the PHR in relation to existing performance
metrics. Meeting baselines for regular hA1c testing for diabetics (hA1c
is a measure of the average blood glucose level over a period of time,
and is a critical diagnostic test for diabetic patients), for example,
will be much easier when the patient's computer reminds them to schedule
the test, thereby using the PHR to enlist patients' cooperation in
meeting pay-for-performance requirements.

**Enrollment Incentives**

There are a variety of incentives for PHR enrollment that federal
agencies could offer across diverse populations. The following
incentives would encourage adoption by consumers with some being
feasible in the short term.

*Automatically enroll new Medicare beneficiaries into a PHR program.*

Each year, approximately 2.2 million older Americans enroll in the
Medicare program. As a result of the Medicare Modernization Act of 2003,
every new beneficiary is eligible for a screening exam or "Welcome to
Medicare" physical exam. This encounter presents an opportunity for
Medicare to offer new beneficiaries automated enrollment into a
pre-populated PHR. Enrollment in Part D drug coverage or movement
between Medicare plans may also provide opportunities to introduce
patients to the PHR. Such a tool could be offered in
culturally-sensitive formats and would comply with the HIT standards
adopted by the Secretary. CMS PHR pilots planned for 2007 would yield
the "lessons learned" necessary for automated enrollment and use of a
pre-populated Medicare PHR. The impact on PHR adoption in the Medicare
population would be gradual, however; it would engage the baby boomer
population that is largely computer-literate and more likely to engage
in the use of a PHR. There would likely be little integration of
Medicare PHRs into clinical care until health information exchange
becomes more seamless across HIT applications via and EHR adoption
reaches a majority of physician practices caring for Medicare
beneficiaries. Clinical adoption of Medicare PHRs in routine clinical
care will also require integration into the clinical work flow of a
healthcare setting. Despite the challenges with clinical adoption,
automated enrollment into a pre-populated Medicare PHR could be an
effective incentive for new Medicare beneficiaries.

*Use PHRs in post-marketing surveillance of patients and patient
registries.*

Every year, approximately 25,000 adverse events (AEs) related to medical
products are reported by healthcare consumers and professionals to the
FDA through the MedWatch program. A much larger number go unreported.
Tracking them is crucial for determining if and when action is
warranted, ranging from notices to providers to recall of the medical
product. Presently, these AEs are reported by providers and consumers
through the FDA's Adverse Event Reporting System (AERS), which includes
the consumer-focused MedWatch web site. The benefits of automated
reporting through electronic health records have been suggested
elsewhere, and work to include this functionality in EHRs is already
underway. However, enabling patients themselves to report errors through
PHRs could potentially capture AEs more quickly and identify AEs that
are not brought to a provider's attention. Patients and their family
caregivers are the first to experience the AEs and have strong personal
interest in addressing them. The reporting of medication AEs could be
facilitated by other efforts to promote the medication list and by
efforts of the clinical research community to develop functional
requirements and interoperability standards for post-marketing
surveillance.

A unified post-marketing surveillance system, based on interoperable
PHRs with permissions granted by patients, could produce a less
burdensome system for patients, expanding the number of drugs which can
be monitored practically and encouraging PHR adoption. The path forward
would entail federal promotion of this functionality in EHRs and PHRs,
and specific communication to both providers and patients to encourage
self-reporting. However, since there is no single established
institutional framework within which such an initiative could be
implemented, coordination would be difficult. Also, care would be needed
to avoid duplicate reporting of errors from both the provider and the
patient. Moreover, this function would need to be carefully communicated
to consumers and patients to avoid concerns raised by the term
"surveillance."

The FDA has recently approved drugs contingent upon the establishment of
online registries of all patients taking those drugs. Patient registry
functionality could be integrated into PHR applications, and the FDA
could accept appropriately certified PHR data as part of these drug
safety plans. The primary implementation challenge mandatory
surveillance is not compatible with the idea of a patient-controlled
personal health record. PHR-based surveillance would either need to be
voluntary, or standards for required disclosure would need to be
developed. Patient compliance could conceivably be quite high if
patients desire updates on drug safety.

*Use PHRs to promote enrollment in clinical trials.*

Each year, up to 85% of clinical trials are significantly delayed due to
enrollment problems. These delays are extremely costly to industry, as
every additional day of delay adds development costs and postpones
revenues. Equally important, the percentage of patients who enroll in
clinical trials compared to the total number who could benefit from
innovative treatments that could enhance or extend life is very
low---estimated at about 5% for cancer patients, for example.
Well-populated PHRs could be an effective data source for clinical trial
recruitment. Many patients, particularly with chronic and/or terminal
diseases, are eager to learn about opportunities to participate in
research. An automated system for identifying patients and appropriate
trials could overcome many of the difficulties faced by patients,
providers and patients. First, enabling the patient to match their
personal health data to the eligibility criteria of available trials
would help them to locate potential trials then take this information to
their provider or follow up directly with the trial sponsor. Second, PHR
software that allows the patient to consent to share their health
information with research sponsors or their intermediaries could provide
the sponsors with a pool of potential research participants, as well as
supporting more generic population research. Finally, adoption of a
standard "eligibility query" would allow PHR providers to deliver
clinical trial announcements to targeted patients without disclosing
patient information to sponsors. The National Cancer Institute and
related NIH organizations could take a leading role in developing these
standards and promoting the concept to patients. Difficulties faced by a
pilot in promoting such PHRs include the reluctance of many healthcare
providers to recommend clinical trials and the lack of a defined
institutional framework for execution.

*Enroll newborns and new recruits covered by TRICARE in a PHR program.*

Each year, 114,400 infants are born to military families, and 185,000
men and women are recruited into active military service. They are
automatically covered by TRICARE and will have certain expected
healthcare services provided during the period they are covered by
TRICARE. Their health records will be electronic and will follow HITSP
interoperability standards. The barriers to establishing a "tethered"
PHR for these patients are therefore relatively low in comparison to
healthcare recipients and providers outside the public delivery sector.
The benefits of establishing a PHR for infants include the ability to
track important preventive screenings and services such as immunizations
as well as to capture baseline personal health information for reference
later in life. However, because most of these patients, infants and
recruits, are not likely to remain in TRICARE their entire lives, it
will be important to ensure portability so that their PHRs can follow
them when they leave the program.

*Enroll veterans in MyHealtheVet and use online consultations.*

The VHA currently serves about 7.7 million enrollees and provides care
to 5.3 million patients. Their health information is captured
electronically by their VistA system and made available to clinicians
across the VHA system. The VHA's PHR tool, MyHealtheVet, will soon be
linked to the veteran's electronic medical record. The PHR has been
popular, as indicated by the more than 284,000 registered users who have
access to the portal's full range of features, and the more than
7,500,000 total visits to MyHealtheVet since it was launched on November
11, 2003. This is a promising start but leaves plenty of room for
growth. New features are being rolled out incrementally and will soon
include a secure copy of key portions of the medical record, extracted
from VistA. A "tethered" PHR like MyHealtheVet is particularly
appropriate for promotion of care coordination and continuity for these
veterans, who may receive all or most of their healthcare services
through VHA for the remainder of their lives. On the other hand, as a
"tethered" product, it may not initially be portable, although VHA will
follow HITSP interoperability standards that will facilitate portability
over time. Moreover, no mechanism currently exists to populate VistA
with data aggregated through the MyHealtheVet Personal Health Record.
The use of online consultations has been shown in other settings to
increase efficiency, extend reach of services; reduce visits and costs.
While MyHealtheVet does not yet offer secure clinical messaging, that
functionality is being planned for future upgrades.

*Enroll disability beneficiaries in a PHR when they become eligible for
disability benefits.*

Each year, approximately 3 million Americans file for social security
disability benefits and, in 2004, Social Security Disability Insurance
(SSDI) benefits were paid to 7.4 million and at a total cost of over
\$70 billion. Over 90% SSDI recipients were workers who filed for
disability. The process of filing for disability requires assembling a
range of health and medical assessments and there is also a need for
this information in coordinating rehabilitation and healthcare of the
disabled individual. The adoption of PHRs in the disability community
would result in increased efficiencies in obtaining a disability
determination and result in better coordinated care throughout the
duration of the disability. Use of PHRs for disability would promote
continuous personal care management by integrating medical assessment
and treatment records in a manner that allows for active involvement by
user. PHRs can be used to help coordinate services (rehabilitation,
transportation, etc.) provided as part of disability benefits. PHRs can
be used across of a range of programs, including SSA, workers
compensation, private insurers, and for employer claims. A barrier is
that the target population, disabled individuals, does not receive
healthcare services from the \"host\" institution, the Social Security
Administration (SSA); rather SSA can only provide guidelines for PHR
use. Moreover, disability assessment and rehabilitation involves a
diverse group of assessors, providers and care coordinators, who have
varying levels of electronic health records in place. However, the
application of PHRs to disability cases represents a definable target
population with demonstrable need to coordinate medical assessments and
treatment records. Cost savings from efficient treatment of disability
could directly impact public costs, such as social security support
costs. SSA is currently investigating these options and this will
continue the investigation in fiscal 2007.

*Pursue SCHIP-sponsored PHRs.*

SCHIP covers healthcare services to approximately 4 million children who
would otherwise be uninsured. The potential benefits of offering a
record of care for these children include strengthening care
coordination and continuity and capturing baseline personal health data
such as immunizations that will be useful in subsequent years. Because
some of these children switch coverage type often, a portable personal
health record would be important to their caretakers. However, because
SCHIP is administered by states, the federal government has limited
authority to create a pilot project that could be implemented
consistently across states, but the states might be able to conduct a
PHR pilot. SCHIP healthcare providers have limited reimbursement may
pose additional barriers to their acceptance of a PHR pilot.

*Use the emergency responder EHR model.*

There are a variety of federal and private sector efforts to establish
infrastructure to make personal health information available to
authorized clinicians and their patients in an emergency situation
through electronic records. Emergency EHR functionality and PHR
infrastructure development are mutually reinforcing. Mechanisms to
deliver access to patient information in emergencies could be utilized
to deliver the same information to existing PHRs; conversely, the
existence of PHRs that make personal information accessible in an
emergency helps accomplish the core purpose of the emergency program. At
this point in time, when emergency responder EHR pilots must address a
large number of policy, technical, and workflow issues, attempting to
link a PHR pilot could be counter productive. It might be more
productive to be able to identify other successful PHR pilots that could
help provide access to critical personal health information in an
emergency situation. In this scenario, it isn't necessary for the PHR to
directly share information with a centralized emergency database, only
for it to provide the information to a new provider when care is needed.

**Conclusion**

In summary, the federal government has a role to play in encouraging
consumer and clinician adoption of personal health records. From data
collection to standards-setting to implementation of PHRs in government
health programs, the options are varied across the agencies and over
time. The list of policy options I have presented today is certainly not
an exhaustive one, but we believe that it represents some federal
actions that could be very effective in encouraging adoption of PHRs.

I am happy to take questions.  Once again, the analysis of the policy
options presented in this testimony represents solely the opinions of
the authors and does not represent the official opinion of the
Department of Health and Human Services or any other government agency.