1. HIT Policy Committee Consumer Empowerment Workgroup September 26, 2013 10:00 -11:00AM Eastern

2. Consumer Empowerment Workgroup (WG) Members WG Members Christine Bechtel, National Partnership for Women & Families (Chair) Korey Capozza, HealthInsight James Cartreine, Brigham and Women's Hospital/Harvard Medical School Scott Fannin, Greenway Medical Technologies Leslie Kelly Hall, Healthwise Katherine Kim, San Francisco State University Sarah Krug, Society for Participatory Medicine Rita Kukafka, Columbia University Patricia MacTaggart, George Washington University Beth Morrow, Children’s Partnership Jan Oldenburg, Aetna Casey Quinlan, Mighty Casey Media LLC Clarke Ross, Consortium for Citizens with Disabilities Mark Savage, Consumers Union MaryAnne Sterling, Sterling Health IT Consulting, LLC Ann Waldo, Wittie, Letsche & Waldo LLP Ryan Witt, drchrono inc Ex Officio Members Terry Adirim, HRSA Cynthia Baur, CDC Bradford Hesse, NIH Kim Nazi, Veterans Health Administration Danielle Tarino, SAMHSA Teresa Zayas Caban, AHRQ 1

3. CE Workgroup Charter Charge: Provide recommendations on policy issues and opportunities for strengthening the ability of consumers, patients, and lay caregivers to manage health and health care. Scope: – Examples of policy issues the WG may engage in include patient generation of their health data, co-managing and sharing care plans, patient reconciliation of medical records from various sources, and new types & sources of patient data. – Important touch points with other workgroups: HITPC Meaningful Use WG HITPC Privacy & Security Tiger Team WG HITPC Quality Measures WG HITSC Consumer Technology WG 2

4. Agenda Review and Finalize Key Takeaways from the 7/18 Patient Generated Health Data Listening Session Review and Finalize Revised Recommendations on Patient Generated Health Data Public comment 3

5. July 18 Patient Generated Health Data Listening Session Purpose: To provide input into the Meaningful Use Stage 3 recommendation for Patient Generated Health Data (PGHD) and to identify any policy issues we need to address to facilitate more widespread use of PGHD. 4

6. Key Takeaways Patient Generated Health Data Definition – “PGHD are health-related data—including health history, symptoms, biometric data, treatment history, lifestyle choices, environmental factors and other information—created, recorded, gathered, or inferred by or from patients or their designees (i.e., care partners or those who assist them) to help address a health concern. – PGHD are distinct from data generated in clinical settings and through encounters with providers in two important ways. First, patients, not providers, are primarily responsible for capturing or recording these data. Second, patients direct the sharing or distributing of these data to health care providers and other stakeholders. In these ways, PGHD complement provider- directed capture and flow of health-related data across the health care system.” Source: Patient-Generated Health Data White Paper. Prepared for ONC by RTI, International, April 2012. 5

7. Key Takeaways PGHD is not new; it’s already valued and incorporated into the record today (e.g. patient reported outcomes) Providers under MU 3 draft recommendations can work with patients to choose what PGHD is most meaningful and useful to their care delivery/outcomes There are several mechanisms for incorporating PGHD: Primary methods include: – secure messaging, surveys (structured and semi- structured), biometric/device data in cloud, etc. There are four things providers need to be able to do with PGHD: receive, review, respond and record. 6

8. Key Takeaways, ctd. MU Stage 3 sets up receive and record “When PGHD is implemented appropriately, concerns are addressed and PGHD use becomes routine.” Appropriate implementation means developing workflows and clear policies/procedures for clinicians and patients that help set mutual expectations around PGHD. – Including communicating policies and expectations to patients and families 7

9. Key Takeaways, ctd. Liability is reduced or eliminated when there is a mutually agreed upon set of information to be shared and clear policies/procedures for handling it. HIPAA: Sets a floor, not a ceiling. Establishes rights around corrections. Providers and patients are aligned around wanting information to be high quality and accurate. – We just need to make it easier. 8

10. Group Discussion: Revise and Finalize Key Takeaways from PGHD Hearing Any additions or corrections to the key takeaways? 9

11. Former Objective PGHD Recommendation - 204B* Stage 2Stage 3 Recommendations NewEP/EH MENU Objective: Patients have the ability to electronically submit patient-generated health (PGH) information. EP/EH MENU Measure: Provide the ability to electronically submit PGH information through structured or semi-structured questionnaires (e.g., screening questionnaires, intake forms, risk assessment, functional status) for more than 10 percent of all unique patients seen by the EP during the EHR reporting period. Standards work needed to incorporate and acknowledge PGHD – feedback from Health IT Standards Committee needed. Certification criteria for devices, continue to work with the Health IT Standards Committee. Consumer Technology WG will have information by the end of the August. 10 * As of September 23, 2013

12. Engaging patients and families in their care: Patient Generated Health Data* 11 Stage 3 Functionality Goals Provide patient and caregivers online access to health information Provide ability to contribute information in the record, including PRO Patient preferences recorded and used Examples of Functionality Needed to Achieve Goals Eligible Providers and Hospitals provide the capability for patients to electronically submit patient-generated health information through structured or semi- structured questionnaires (e.g., screening questionnaires, intake forms, risk assessment, functional status) using CEHRT Recommended as a Menu item Former Objective EP/EH MENU Objective: Patients have the ability to electronically submit PGH information EP/EH MENU Measure: Provide the ability to electronically submit PGH information through structured or semi-structured questionnaires (e.g., screening questionnaires, intake forms, risk assessment, functional status) for more than 10 % of all unique patients seen by the EP during the EHR reporting period. Standards work needed: Certification criteria for devices, continue to work with HITSC. Placeholder: Awaiting feedback from Consumer Engagement and Consumer Technology Workgroups *as of September 23, 2013

13. Proposed Recommendation – Amendments 204D* 12 Stage 2 Final RuleStage 3 Recommendations NewProvide patients with an easy way to request an amendment to their record online (e.g., offer corrections, additions, or updates to the record) *As of September 23, 2013

14. REVISED PGHD Recommendations 1.For provider organizations that choose the menu item for PGHD in Stage 3, they should establish policies and procedures for handling PGHD in advance of or during implementation of Stage 3, including, but not limited to, the content to be received; the mechanisms by which it can be submitted/received; and how it will be received, reviewed, acknowledged, and recorded (including but not limited to provenance). 2.In achieving the above, providers should collaborate with patients to ensure PGHD collection and use works for both parties. 3.ONC should work through its own channels and with federal partners to educate providers about the need to establish clear PGHD policies/procedures, and how best to communicate those to patients and families, including understanding and exercising their rights under HIPAA to amendments and corrections. – Website, RECs, HITRC, etc. 4.Under Meaningful Use Stage 3, PGHD will be reflected in the record, and HIPAA should govern that data as it does other data in the record. But for the future, ONC and the Office for Civil Rights should undertake work to address data sharing by consumer apps that providers may also use in clinical care. 5.Work is also needed in the medium term to examine policy, workflow and liability issues around unsolicited PGHD. 13

15. REVISED PGHD Recommendations 6.Direct email addresses should be made available to patients in order to open up more options for efficient and effective collection of PGHD. 7.Meaningful Use Stage 3 requirements should address the capacity for EHRs to accept amendments/corrections. 8.We should gain experience in Stage 3 with PGHD and in future stages, explore whether secure messaging content has the capacity in the future to be used as a mechanism to ingest PGHD. 9.Additional work is needed to explore how to summarize and aggregate biometric/device data to show trends to providers. 14

16. Requests for the HIT Standards Committee 1.Ask Consumer Technology WG to examine standards/market re: feasibility of including consumer device data in MU Stage 3 2.Ask Consumer Technology WG to ensure receipt, acknowledge, review, record for PGHD 3.The Consumer Technology WG should identify necessary standards to support PGHD –including but not limited to evaluating standards for incorporating biometric/device data in a summary form for inclusion in Stage 3 15

17. Group Discussion: Revise and Finalize PGHD Recommendations Any additions or corrections to the existing recommendations before we present to the Consumer Technology WG in October? 16

18. Public Comment 17