# American Health Information Community

**Workgroup on Consumer Empowerment**

Summary of Web Conference Held March 20, 2006

(3rd Web Conference of this Workgroup)

-   **Broad Charge for the Workgroup:** Make recommendations to the
    Community to gain widespread adoption of a personal health record
    (PHR) that is easy to use, portable, longitudinal, affordable, and
    consumer centered.

-   **Specific Charge for the Workgroup:** Make recommendations to the
    Community so that within 1 year, a prepopulated, consumer-directed,
    and secure electronic registration summary is available to targeted
    populations. Make additional recommendations to the Community so
    that within 1 year, a widely available, prepopulated medication
    history linked to the registration summary is deployed.

1.  **Call to Order and Welcome by Workgroup Co-chairs**

> The Web conference was called to order at 1:04 p.m. by Co-chair Nancy
> Davenport-Ennis of the National Patient Advocacy Foundation.
>
> Co-chair Linda Springer was unable to attend and was represented by
> Daniel Green of the Office of Personnel Management (OPM). Mr. Green
> expressed Ms. Springer's regrets about being unable to attend and
> relayed her thanks to the Workgroup members for their participation.
>
> Ms. Davenport-Ennis began by inviting David Brailer, the National
> Coordinator for Health Information Technology with the U.S. Department
> of Health and Human Services (DHHS), to offer his comments to the
> group.
>
> **A. Remarks by Dr. Brailer**
>
> Dr. Brailer thanked Workgroup members for giving so much of their time
> to Workgroup efforts over the past 3 months. He also thanked the
> support personnel at the Office of the National Coordinator for their
> role in organizing and assisting the Workgroup Web conferences. Dr.
> Brailer extended special thanks to Ms. Davenport-Ennis and Ms.
> Springer.
>
> Dr. Brailer reminded the Workgroup members that while maintaining an
> overall vision is important to the group's efforts, the Workgroup has
> the task of establishing a set of "pragmatic steps" toward achieving
> its specific charge. Dr. Brailer stated that it was his hope that the
> major barriers to achieving the specific charge could be identified
> and a process begun to remove those barriers. He noted that the next
> 60 days prior to the May meeting of the Community are critical for
> identifying barriers and formulating recommendations.

2.  **Roll Call of Participants**

> Meeting participants were introduced. (See the list of participants at
> the end of this document.)

3.  **Review of Meeting Agenda and Desired Outcome** -- **Nancy
    Davenport-Ennis, Daniel Green**

> Ms. Davenport-Ennis reviewed the meeting agenda.[^1] Kelly Cronin of
> the Office of the National Coordinator (ONC) amended the agenda,
> stating that Susan McAndrew from the Office of Civil Rights would give
> a briefing on HIPAA regulations. Ms. Cronin explained that Ms.
> McAndrew's briefing would provide structure and context for the
> Workgroup's subsequent discussion.

4.  **Review of Action Items from Last Meeting and Feedback from
    Community Meeting on March 7 -- Nancy Davenport-Ennis**

> Ms. Davenport-Ennis noted that an Action Item discussed at the
> previous Workgroup meeting involved organizing a panel presentation to
> propose refinements to the principles, policy, and open issues related
> to the Workgroup's charge which were presented to the Community at its
> March meeting. The refinements suggested by the panel would be geared
> toward deploying an electronic registration summary and medication
> history. The panel would be comprised of a consumer, a provider, and
> an IT expert among others.
>
> Ms. Cronin commented that the background work necessary for developing
> the panel presentation is underway and noted that the presentation
> might take place during a public meeting of the Workgroup in late
> April.

5.  **Review of Streamlined Principles -- David Lansky**

> Ms. Davenport-Ennis reported that a set of streamlined principles for
> consumer empowerment with respect to PHRs based on previous Workgroup
> deliberations was presented to the Community and accepted by the
> members. It was suggested by Community members that the principles
> continue to be refined and additional principles be developed and
> added as needed.
>
> David Lansky continued the discussion of the principles as agreed to
> by the Community. Those principles include the following:

-   Individuals should be guaranteed the right to access their own
    health information.

-   Individuals should be able to access their personally identifiable
    health information conveniently and affordably.

-   Individuals should know how their personally identifiable health
    information may be used and who has access to it.

-   Individuals should have control over whether and how their
    personally identifiable health information is shared.

-   Systems for electronic health data exchange must protect the
    integrity, security, privacy, and confidentiality of an individual's
    information.

-   The governance and administration of electronic health information
    networks should be transparent and publicly accountable.

> The principles were part of the "March Notebook"[^2] that was created
> and presented to the Community detailing the progress of all four
> Workgroups. In addition to presenting the Principles, representatives
> from the Consumer Empowerment Group also detailed policy issues,
> barriers, breakthrough models, potential target populations, open
> issues, and next steps.
>
> Ms. Davenport-Ennis reminded the group of the three sets of principles
> discussed during the February 21 meeting of the Workgroup. Those
> principles addressed PHRs, Information Access and Control, and
> Disclosure and Accountability. They are detailed in the Consumer
> Empowerment Workgroup Summary from February 21.[^3] Ms.
> Davenport-Ennis posed the question to the group to determine whether
> those principles needed to be re-examined or work should proceed with
> the six streamlined principles detailed above and presented to the
> Community.
>
> Ms. Cronin stated that it was the task of a subgroup to streamline the
> three separate principles into those that were presented to the
> Community. Ms. Cronin proposed that the broader principles be
> revisited only if needed for context and clarity when the panel
> discussion takes place in April.
>
> Ms. Davenport-Ennis opened the floor for discussion, questions, and
> comments regarding all the principles that had come before the
> Workgroup.
>
> Justine Handelman of Blue Cross Blue Shield brought up the issue of
> HIPAA regulations. She informed the group that during the Community
> meeting it was stated that HIPAA regulations take precedence in
> situations involving treatment, payment, and health care operations.
>
> Several other Workgroup members had comments and concerns regarding
> the role of HIPAA regulations in PHRs and how HIPAA regulations could
> be incorporated into the principles. It was decided that Ms. McAndrew
> would present her prepared briefing on HIPAA regulations immediately.
>
> **A. HIPAA Regulations and PHRs -- Susan McAndrew**
>
> Ms. McAndrew explained that HIPAA regulations apply only to "covered
> entities," which include health plans, health care clearinghouses, and
> health care providers that engage in electronic transactions for which
> HIPAA standards have been adopted. Ms. McAndrew noted that many other
> types of entities maintain or obtain medical information but are not
> subject to HIPAA regulations, including employers, certain types of
> insurers, and providers that do not engage in electronic transactions.
> Ms. McAndrew closed out her explanation of entities covered by HIPAA
> by detailing the nature of contractual relationships between covered
> entities and their vendors.
>
> Ms. McAndrew stated that the HIPAA privacy rule covers protected
> health information that is individually identifiable. This type of
> information is protected in oral, written, and electronic form. Ms.
> McAndrew noted that de-identified medical information, as defined in
> the HIPAA privacy rule, is not controlled by the HIPAA privacy rule.
>
> Ms. McAndrew then discussed how medical information covered by the
> HIPAA privacy rule can be used. She noted that under HIPAA, health
> information can flow, without explicit individual consent, among
> covered entities for treatment, payment, and health care operations.
> Furthermore, she noted the HIPAA does not limit the exchange of
> information between covered entities and individuals themselves. She
> explained that even in the situations where health information flows
> between various entities without explicit individual consent, HIPAA
> places certain constraints on disclosures of health information,
> including how much and to whom information can be disclosed. Ms.
> McAndrew noted, however, that once health information is disclosed to
> an entity not subject to HIPAA regulations, HIPAA places no further
> restraints on that entity's use of the information.
>
> After discussing the "who," "what," and "how" of HIPAA, Ms. McAndrew
> was asked to provide examples of health care operations. She noted
> that health care operations vary among entities but offered that the
> term could be defined broadly as "what a provider would need to do to
> run their business." After providing several examples, Ms. McAndrew
> summed up by saying that for a provider, "health care operations"
> refers to most routine activities outside actual treatment functions.
> For a health plan, "health care operations" refers to most routine
> activities outside their payment functions.
>
> Another Workgroup member asked Ms. McAndrew to explain what a
> clearinghouse is with respect to HIPAA regulations and to discuss
> whether or not PHR vendors might fall under the clearinghouse
> categorization. Ms. McAndrew responded that a clearinghouse is
> essentially an entity that takes information that is in nonstandard
> form and transforms it into standard form or vice versa. She added
> that unless standards for the contents of PHR are incorporated into
> HIPAA regulations, PHR vendors would not be categorized as
> clearinghouses.
>
> **B. Closing Comments on Principles**
>
> Dr. Lansky commented that the principles under discussion were quite
> high level and not developed specifically to address PHR. Noting that
> the current HIPAA regulations did not develop in a health care
> environment of electronic networks and PHRs, he suggested that the
> Workgroup consider mechanisms to establish privacy protections outside
> of those offered by HIPAA. Ms. Davenport-Ennis thanked Dr. Lansky for
> his suggestion and asked if any Workgroup members would volunteer to
> develop further recommendations for privacy mechanisms with respect to
> PHR. Jodi Daniel and Ross Martin volunteered. Ms. McAndrew said that a
> representative from OCR would participate as well.
>
> Dr. Brailer raised two questions that arose during his review of the
> principles with different parties around the country. The first
> question addressed members of the behavioral health substance abuse
> and mental health treatment community. He noted that there are laws in
> existence written to protect patients in this broad community from the
> stigma that could result from the revelation of their health status.
> On the other hand, he noted that there is growing concern that failing
> to disclose health conditions could have bad consequences, including
> adverse drug interactions. He asked the group to consider delving into
> these opposing considerations.
>
> Dr. Brailer also asked the group to consider the implications of
> discriminatory use of genetic information, noting that both the
> Administration and Congress have recognized genetic discrimination as
> a potential issue.
>
> **[Action Item:]{.underline}** The Workgroup agreed to give further
> consideration to the discriminatory use of genetic information and the
> issues surrounding laws protecting the mental health and substance
> abuse treatment communities.

6.  **Discussion of Roadmap to Achieve Goal of Submitting Concrete
    Recommendations to Secretary and Other AHIC Members at May Meeting**

Ms. Davenport Ennis reviewed the PowerPoint presentation entitled
Consumer Empowerment Workgroup Workplan.[^4] The presentation included
sections on the sample objectives, sample required functions, and sample
populations to be served. It also discussed sample policies needed with
respect to a potential consumer empowerment project to make available an
electronic registration summary and a prepopulated medication history
for targeted communities. Scott Serota asked that payers be included as
the Workgroup develops criteria for a medication history and
registration summary. He noted that payers have "a wealth of data" to
contribute. Linda Fischetti said that the U.S. Department of Veterans
Affairs (VA) would be able to contribute to the process of developing
these criteria, as did Loraine Doo on behalf of the Centers for Medicare
& Medicaid Services (CMS).

**Prioritization of Sample Required Functions**

The group held ample discussion on prioritizing the list of sample
required functions for a medication history and electronic registration
summary. The list is detailed below:

-   Authenticates and identifies individuals uniquely to the
    satisfaction of all data suppliers

-   Provides secure downloads of registration or medication data into a
    consumer-facing application

-   Enables consumers to append comments to professionally sourced
    medication data

-   Enables consumers to record adverse events associated with their
    medications and to submit the information electronically to the
    prescribing clinician

-   Enables consumers to add other medication, OTC drug and supplement,
    allergy, and adverse reaction history via structured pick lists and
    text fields

-   Has the simplest possible user interface with translations into
    plain language and integration of patient education materials

-   Contains a condition/problem list with the ability to designate
    linkage to medications

-   Features printer-friendly options

-   Enables consumers to control when and with whom information in the
    consumer application may be shared.

Referencing the list, Charles Safran pointed out that pursuing any
single item could demand significant time and resources. He suggested
that the Workgroup might need to identify items which it would not want
to pursue. Dr. Lansky added to Mr. Safran's comments by suggesting that
the Workgroup's focus should be on those areas in which the Community
could add value to what is already happening in the PHR market. Ms.
Daniel and Mr. Martin agreed with Mr. Safran's suggestion to limit the
Workgroup's focus with regard to the sample required function list. Ms.
Daniel added that the Workgroup might consider inviting public testimony
in order to help prioritize the functions. Mr. Martin suggested that the
Workgroup propose "just enough functionality for this initial
breakthrough" when making recommendations to the Community.

Davette Murray agreed that the Workgroup should prioritize its areas of
recommendation and added that the recommendations should focus on areas
that fit within existing privacy protections for consumers. Jodi Daniel
suggested that in addition to making recommendations that fit within
existing protections, it would be helpful for members to identify areas
in which policy issues and barriers prevent the Workgroup from achieving
its charge, even if addressing those issues and barriers may require a
long-term process.

Noting that companies are already developing minimum datasets for PHRs,
Kat Mahan suggested that the Workgroup focus its work on addressing
policy barriers and pushing for interoperability among existing PHR. Ms.
Mahan also suggested that the Workgroup consider a "consumer campaign"
designed to encourage widespread adoption of PHRs. With respect to a
consumer campaign, Myrl Weinberg commented that the Workgroup consider
working with national organizations such as those dealing with cancer,
heart disease, diabetes, and Alzheimer's. Justine Handelman added that
consumers "really need to see value" in using PHRs.

Returning to the point that PHR applications already exist on the
market, Dr. Lansky suggested that the Workgroup should determine whether
existing applications, or features of those applications, "add value"
for consumers before beginning a new project. He commented that the
Workgroup could focus on the "network" issues of interoperability among
existing PHRs, thereby creating "an environment in which creative,
innovative application offerings come forward and figure out where the
value is." He noted, however, that this approach might not lead to
increased adoption if consumers do not see the value in the
functionality of applications.

**Comments from Dr. Brailer Regarding the Role of the Workgroup**

Dr. Brailer noted that although the Community and the Workgroup were
chartered as advisory bodies to the Federal Government, the Workgroup
members should not limit their advice to the Federal Government. He
commented that the Workgroup's advice could include recommendations for
what needs to be done by such diverse bodies as CMS, health plans, and
PHR vendors.

**Role of HITSP in Establishing the Minimum Dataset for the Registration
Summary and Medication History**

Ross Martin suggested that the work of establishing a minimum dataset
for a registration summary and a medication history be left to the
Health Information Technology Standards Panel (HITSP) with input from
Workgroup members.

Attempting to sum up the discussion, Ms. Mahan suggested that the
Workgroup's recommendations could fit into three categories or
"buckets." These buckets include:

-   **Policy Review,** which includes recommendations related to HIPAA
    regulations and privacy concerns

-   **Interoperability,** which would include discussions of standards
    and possibly a recommendation that HITSP take the lead on developing
    the minimum dataset for a registration summary and a medication
    history

-   **Education,** which could include, for example a recommendation
    that the government partner with a national organization such as the
    American Cancer Society to develop a consumer education program.

> **[Consensus:]{.underline}** The Workgroup agreed to Mr. Martin's
> suggestion that HITSP take the lead on developing a minimum dataset
> for a medication history and registration summary.
>
> **[Consensus:]{.underline}** The Workgroup agreed to group its
> recommendations according to Ms. Mahan's bucket approach.

**Prioritizing Sample Required Functions (Continued)**

Ms. Davenport-Ennis brought the group back to a discussion of
prioritizing the sample required functions. Dr. Lansky noted that the
current list of functions was meant to reflect functions that require
interoperability. He noted that allowing HITSP to take the lead in
developing standards for a minimum dataset does equate to promoting
interoperability among PHRs. One Workgroup member noted that patient
authentication is crucial to achieving interoperability. Dr. Lansky
suggested that the Workgroup select one of the sample functions it deems
to be of particular value to the consumer and advance recommendations
around that function to the Community and to HITSP.

Myrl Weinberg agreed with Dr. Lansky's suggestion to focus on one or two
of the sample functions deemed to be of high value. She suggested that
the function "Has the simplest possible user interface, with
translations into plain language and integration of patient education
materials" would help address the issue of consumer literacy raised
earlier in the discussion. She also suggested that the function "Enables
consumers to control when and with whom information in the consumer
application may be shared" would be valuable to consumers. Ms. Cronin
suggested that it may be possible to gather a group of experts on issues
related to patient literacy and PHRs to address the group. Charles
Safran recommended that Alexis McCrae at Harvard University could be a
good expert resource.

**Pilot Testing**

Mr. Safran suggested that for a "fourth bucket," the Workgroup might
consider a category of recommendations dealing with government support
for pilot tests of the consumer empowerment principles among
underserved, inner-city populations. He commented, "No one else is going
to deal with these populations by and large, and we ultimately pay the
cost." Dr. Brailer raised two questions with regard to pilot testing:

-   How do we find projects that are already under way in the United
    States that we could pay attention to, watch, and evaluate --
    perhaps not scientifically, in a controlled sense, but at least
    empirically?

-   How do we construct pilot projects?

Dr. Brailer noted that while pilot programs may be helpful for testing
PHR principles, these tests would require significant time and
government funding. He commented that the Workgroup needs to make
recommendations to the Secretary on what it will take to advance PHRs
independent of the results from pilot tests.

> **[Consensus:]{.underline}** The Workgroup agreed to develop a fourth
> bucket for recommendations on pilot/demo projects

7.  **Review of Matrix and Discussion of Priority Areas and Preliminary
    Recommendations on Who, What, and How to Meet Specific Charge --
    Nancy Davenport-Ennis and Daniel Green**

The Workgroup had ample discussion around the Regions of Interest
Matrix,[^5] a document which identifies several regions in the country
in which PHR programs exist. For each program, the matrix identifies,
where available:

-   Data source for registration summary (basic description of data
    available)

-   Data source for medication history (basic description of data
    available)

-   Existing PHR or organization sponsor (e.g., health plan, employer,
    other)

-   Size and type of population served by the PHR program

-   Organizational capacity or infrastructure to reach special patient
    populations (e.g., Medicare, Medicaid, chronically ill, pediatrics)

The Workgroup had ample discussion around the matrix. The highlights of
the discussion are listed below:

-   Ms. Cronin thanked Blue Cross Blue Shield for their input into the
    matrix. She noted that the matrix would be a valuable to help the
    Workgroup members sort through what is being done across the country
    and what data sources are currently available. She suggested that
    members of the Workgroup think about which populations they would
    like to target with their recommendations when deciding with which
    of the regional programs they would like to work.

-   One workgroup member suggested that before making recommendations
    about target populations, the Workgroup invite testimony from the
    "people on the ground" currently using PHRs to identify existing
    opinions and issues.

-   Lorraine Doo suggested that members of the Workgroup try to use an
    existing medication history or PHRs to "experience it for real."

-   Ms. Fischetti said that the VA would be happy to present on the
    consumer experience in the VA with regard to PHRs.

-   Ms. Mahan offered that SureScripts could reach out to some of its
    vendors for their perspective on using PHRs.

-   Helen Burstin commented that the Agency for Healthcare Research and
    Quality (AHRQ)'s CAHP survey could contribute valuable data about
    the consumer experience with PHRs.

-   Mr. Martin noted that although information on different PHR programs
    might be helpful to the Workgroup, the information does not focus
    necessarily on interoperability, a primary concern of the Workgroup.
    He suggested that some of these programs would "develop as they are
    developing without a major intervention from our Workgroup and from
    the Community."

-   Another Workgroup member agreed with Mr. Martin's comment that the
    Workgroup needs to maintain focus on interoperability and the
    "broader scope" of the Workgroup's charge, but suggested that
    surveying current perceptions of PHRs could work on a parallel track
    to addressing larger issues of interoperability.

-   Ms. Daniel noted that the Paperwork Reduction Act requires that a
    Federal advisory committee seek Office of Management and Budget
    approval before conducting a formal survey.

-   Ms. Cronin added that organizations could do their own research, not
    sponsored by the government, and report back to the Workgroup.

-   Dr. Lansky suggested that there should be two halves to the data
    collection activity: (1) inviting testimony on various groups'
    experience to date using PHRs and (2) finding out what providers,
    plans, and patients want with respect to PHR.

-   The workgroup observed that a better sense of how various groups
    perceive PHRs can come from non-government funded research of
    existing data.

8.  **Next Steps, Assignments, and Timeline for Developing
    Recommendations to the Community by May 8 -- Nancy Davenport-Ennis**

> **[Action Item:]{.underline}** Reach out to HITSP to find out their
> time frame for developing a minimum dataset for medication history and
> registration summary.
>
> **[Action Item:]{.underline}** A member of Ms. McAndrew's staff will
> work with Ms. Daniel, Ms. Doo, Diane Orion of the National Patient
> Advocate Foundation, and Mr. Safran to provide additional information
> around HIPAA and other privacy mechanisms, which fit within the
> Workgroup's policy review bucket. This group will survey existing PHR
> programs to determine which operate within HIPAA covered entities.
>
> **[Action Item:]{.underline}** Mr. Safran, Ms. Mahan, Ms. Doo, a
> representative from RxHub, and Ms. Handelman will work to further
> recommendations in the interoperability bucket focusing on issues of
> patient authentication and identification.
>
> **[Action Item:]{.underline}** Robert Tennant will provide information
> and materials from the House Energy and Commerce Health IT hearing.
>
> **[Action Item:]{.underline}** Mr. Weinberg, Ms. Cronin, Mr. Martin,
> and Dr. Tennant will work to further recommendation from the education
> bucket, focusing on sensitivity to use of PHRs by people different
> ethnicities and with different language and learning needs.
>
> **[Action Item:]{.underline}** Ms. Cronin will provide further
> information related to the demo and pilot bucket, drawing on existing
> surveys. Dr. Burstin will share information from AHRQ's CAP Survey.

Ms. Cronin suggested that the Workgroup should spend the next 3 weeks
working at the subgroup level, finding facts and identifying experts to
submit testimony to the Workgroup. The

Workgroup will aim to develop high-level recommendations from the four
bucket areas it identified by April 15. A subgroup of Workgroup members
will formalize the recommendations in a letter to the Secretary to be
circulated to the Workgroup members during the last week of April.

The Workgroup briefly discussed scheduling another Web conference for
late April, but a final decision was not reached.

9.  **Public Input**

There was no public input.

10. **Adjournment**

Ms. Davenport Ennis Adjourned the Web conference shortly after 5 p.m.

**[Workgroup on Consumer Empowerment Members and Designees Participating
in Web Conference]{.underline}**

Nancy Davenport-Ennis National Patient Advocate Foundation

Co-chair

Daniel Green (for Linda Springer) OPM

Co-chair

Kelly Cronin ONC/DHHS -- Staff Co-chair

David Brailer DHHS

Helen Burstin AHRQ

Jodi Daniel ONC/DHHS

Lorraine Doo CMS

Linda Freschetti (for Robert Kolodner) Veterans Health Administration

Justine Handelman (for Scott Serota) Blue Cross Blue Shield

Robert Kolodner Veterans Health Administration

David Lansky Markle Foundation

Kat Mahan SureScripts

Ross Martin Pfizer

Susan McAndrew DHHS

J.P. Little (for David McLean) RxHub

Davette Murray Tri-Service Infrastructure Management Program Office

Mari Johnson (For Nancy Nielson) American Medical Association

Lynne Rosenthal National Institute of Standards and

> Technology

Charles Safran American Medical Informatics Association

Scott Serota Blue Cross Blue Shield

Patrick McMahon Microsoft

Robert Tennant Medical Group Management Association

Myrl Weinberg National Health Council

[^1]: Available at <http://www.hhs.gov/healthit/ahic/ce_archive.html>

[^2]: Community Meeting materials are available at
    <http://www.hhs.gov/healthit/documents/AHICMarchNotebook.pdf>.

[^3]: Available at <http://www.hhs.gov/healthit/ahic/ce_archive.html>

[^4]: Available at <http://www.hhs.gov/healthit/ahic/ce_archive.html>

[^5]: Available at <http://www.hhs.gov/healthit/ahic/ce_archive.html>