American Health Information Community
Personalized Health Care Workgroup
Summary of the Twelfth Web Conference of This Workgroup
Thursday, February 14, 2008

PURPOSE OF MEETING
The Personalized Health Care (PHC) Workgroup meeting was convened to act on the revised recommendations submitted by the Newborn Screening Subgroup and to review and discuss the Clinical Decision Support (CDS) proto-recommendations. Meeting materials and documents referenced below are available at http://www.hhs.gov/healthit/ahic/healthcare/phc_archive.html.

KEY TOPICS
1. Acceptance of Meeting Summary [Doc 1]
The summary of the January 30, 2008 meeting was accepted as distributed.

2. Finalizing the Newborn Screening Recommendations [Doc 2]
An earlier version of the recommendations was presented by the Newborn Screening Subgroup co-chairs to the Workgroup at the January 30 meeting. The recommendations were subsequently revised and distributed to the Workgroup by e-mail on February 6. Members were asked to review the recommendations and submit comments in advance of the February 14 meeting. A modification to the paragraph on page 3, lines 16-21 was distributed by e-mail on February 13; the modification dealt with the reporting of quantitative test results.

Kristin Brinner, Office of the National Coordinator (ONC) staff, reviewed the changes that had been made to the recommendations after the receipt of comments and suggestions from the PHC Workgroup and the Population Health Workgroup. Overall, the revised recommendations reflect the suggestion to put some of the background information and detail in the introductory sections and to sharpen the recommendations themselves. The reference matrix (1.0.1) refers to standards development activity, not to a reference for use by providers or consumers. Recommendation 2.0 was developed in conjunction with ONC lead staff for the Confidentiality, Privacy, and Security Workgroup, and was informally reviewed by the United States Department of Health and Human Services (HHS) Office of Civil Rights. In addition, background research indicated considerable confusion at the state level as to the legal requirements for the electronic sharing of information. In section 3, the Subgroup added information describing activities in Regions III and IV to establish registries. Recommendation 3.0 now includes “state” as well as federal agencies.

Q and A Discussion
The registry described in the recommendations does not duplicate another registry being recommended by the Secretary’s Advisory Committee on Genetics, Health and Society (http://www4.od.nih.gov/oba/sacghs.htm). The Newborn Screening Subgroup is continuing to work on a prototype use case and on the reference matrix. The Health Resources and Services Administration (HRSA) is funding two complementary activitiesHL7 implementation guidelines and an outline of the business processes that are involved in the transfer of the information within the newborn screening program and at the intersections with health care delivery systems.

Action Item #1: The PHC Workgroup Co-chairs will present the recommendations on Newborn Screening to the AHIC for action February 26.

3. Comments on the Draft Detailed PHC Use Case
The PHC Use Case was presented at a previous meeting of the Workgroup. There have been several opportunities to submit comments. Members were reminded that the comment period closes February 15. Members had no additional comments at this time.

4. Clinical Decision Support [Doc 3, 4]
PHC Workgroup Co-chair John Glaser, who also chairs the CDS Planning Group, reviewed the composition, charge, and history of the Planning Group. It was formed in May 2007 with representation from five AHIC workgroups:

The CDS Planning Group members formulated proto-recommendations in seven areas:

The CDS Planning Group is now presenting these proto-recommendations to the five workgroups in order to obtain feedback. Revised recommendations will be presented again at the March Workgroup meeting. The respective workgroups will decide which recommendations they wish to forward to the AHIC for action at its April 2008 meeting.

Q and A Discussion
Need for Coordination
Several members of the Workgroup also serve on the Secretary’s Advisory Committee on Genetics, Health and Society. Chapter 6 of the committee’s draft report on Oversight of Genetic Tests focuses upon CDS. Members gave their opinions on the extent to which the two sets of recommendations were coordinated. ONC staff is concerned that Recommendation 1.4.2 be aligned with the recommendations in chapter 6. It was acknowledged that there are a number of governmental and private sector groups working in these areas; they are not necessarily aware of each others’ efforts.

Dr. Glaser agreed that these various groups should, in general, support each other. The Planning Group may serve as a spur to collaboration and resolution of inconsistencies.

Both the Planning Group and the Advisory Committee members understand the need to develop a research and evaluation agenda. Members and staff will review and attempt to coordinate the recommendations.

Capabilities and Resources
The time lag between the development of genetic tests and the evidence base surrounding the application of test results to clinical care was discussed. Translating the evidence into guidelines, and then the guidelines into CDS is a difficult process. The capability for translation is currently lacking. Is may be very difficult to implement these CDS recommendations. The AHIC workgroups have not had extensive discussions of how the guidelines will be formulated and what CDS will be required to implement guidelines. Guidelines can be based upon different levels of evidence; when evidence is limited, judgment may come into play.

One member asked what the Planning Group had in mind for the knowledge repository (Recommendation 1.0):

Although the answers to these questions are not available, The Agency for Healthcare Research and Quality (AHRQ) is supporting work on what such a repository would look like and what it would take to make it responsive. But these and many other questions have yet to be addressed.

The Morningside and AHRQ Initiatives may be relevant to Recommendations 1.1 and 7.1

Adding Something Specific Regarding PHC to the Proto-recommendations
Members discussed the value of adding to the recommendations to include more specific references to PHC. They recognized that the list is already a lengthy one. ONC staff would like to see specific references to family history tools and genetic test information in the introductory sections of the recommendations document. It was noted that if the PHC Workgroup adds to the recommendations, this will set a precedent for the other workgroups to make their own additions.

The recommendations are relevant for all of the workgroups, and throughout the text various examples are given (p. 17, 23). It is not necessary to add to them. The recommendations cover a range of issues and domains.

Action Item #2: Co-chair Glaser will report to the CDS Planning Group that the PHC Workgroup is supportive of the proto-recommendations as drafted without additions.

5. Pharmacogenomics Subgroup
Scott Boyle from the PHC Initiative in HHS reported that the Pharmacogenomics Subgroup met recently via conference call with 25 to 30 participants. They developed a list of persons to provide testimony on incorporating clinical trial data into the EHR and other issues pertinent to the charge of the Subgroup. The Subgroup is meeting every two weeks.

6. Next Steps
The next meeting is scheduled for Monday, March 17, 2008. Agenda items will include subgroup reports, a staff report on activities related to family health history, and an update on the plans to transition AHIC to the private sector. Staff offered to distribute the recently published (Federal Register) draft patient safety rule, which responds to a patient safety and quality act of 2005. The rule may overlap with subgroup’s interests.

7. Public Comments
None

SUMMARY OF DECISIONS AND ACTION ITEMS

Action Item #1: The PHC Workgroup Co-chairs will present the recommendations on Newborn Screening to the AHIC for action February 26.

Action Item #2: Co-chair Glaser will report to the CDS Planning Group that the PHC Workgroup is supportive of the proto-recommendations as drafted without additions.

MEETING MATERIALS
Agenda
DRAFT Meeting Summary (January 30, 2008) [Doc 1]
DRAFT Revised Recommendations from the Newborn Screening Subgroup [Doc 2]
Clinical Decision Support Proto-Recommendations Background [Doc 3]
Clinical Decision Support Presentation by John Glaser [Doc 4]

Personalized Health Care Workgroup Members and Others Participating in the Web Conference Thursday, February 14, 2008

Co-chairs

Douglas Henley

American Academy of Family Physicians

John Glaser

Partners Healthcare System, Inc.

Office of the National Coordinator for Health Information Technology Staff

Greg Downing

Kristin Brinner

Judy Sparrow

Lauren Kim

Alan Zuckerman

Scott Boyle

Members

Paul Cusenza

Entrepreneur and Consultant

Emory Fry

DoD

Kathy Hudson

Johns Hopkins University, Genetics & Public Policy Center

Amy McGuire

Baylor College of Medicine, Genetics & Public Policy Center

Allen Rudman for Felix Frueh

HHS/Food & Drug Administration

Lisa Rovin

HHS/Food & Drug Administration

Steve Teutsch

Merck & Co., Inc., SACGHS

Dennis Williams

HHS/HRSA

Grant Wood for Marc Williams

Intermountain Healthcare

Senior Advisors

Greg Feero

NIH/NHGRI

Michele Lloyd-Puryear

HHS/HRSA

Ronald Przygodski

Department of Veterans Affairs

Gurvaneet Randhawa

HHS/AHRQ

Mollie Ullman-Cullere

Harvard Partners Center for Genetics & Genomics

Disclaimer: The views expressed in written conference materials or publications and by speakers and moderators at HHS-sponsored conferences do not necessarily reflect the official policies of HHS; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.