HIT Policy Committee Consumer Empowerment Workgroup June 17, :00 -5:00PM Eastern

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

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

Agenda Roll Call Overview of two work streams – Policy framework for Patient Generated Health Data – Shared Care Plans Discussion of Policy Framework for Patient Generated Health Data – Do we have what we need? What are key policy issues? Public comment 3

PGHD: Context & Related ONC Activities 1.Definition of PGHD 2.Draft Stage 3 MU Criteria 3.PGHD Technical Expert Panel 4

1. PGHD Definition “PGHD are health-related data—including health history, symptoms, biometric data, treatment history, lifestyle choices, 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

2. Meaningful Use Stage 3 Draft Objective Provide 10% of patients with the ability to electronically submit patient-generated health information that can be reviewed and selectively incorporated by EPs and EHs into CEHRT (e.g. pre-visit information, problem history questionnaires, home medication updates, functional status, patient created health goals, advance directives, etc.) to allow patients to contribute information needed for visits, improve performance on high priority health conditions, and improve patient engagement in care. This could be accomplished through a variety of channels, such as structured or semi-structured questionnaires, (e.g., problem resolution, change in medication dosing) or secure , with EPs and EHs choosing information to verify in the record that is most relevant for their patients and their health conditions. 6

3. ONC’s PGHD Technical Expert Panel National eHealth Collaborative (NeHC) convening a Technical Expert (TEP) Panel to: – provide input on how to successfully implement patient generated health data (PGHD) – identify use cases and best practices for integrating PGHD into clinical workflows Goal: establish a policy framework through guidelines or standards of behavior to: – Reduce concerns – Enable this information to flow more easily – Appropriately set expectations for providers and patients Output: aggregation and summary of good practices 7

Key Questions Do we need a policy framework for PGHD? Is the policy framework for amend/correct applicable to PGHD? 8

Right to view their records on request Right to request an amendment to a record BUT – Having rights and exercising rights are not the same – Technology can make rights easier to exercise or more difficult HIPAA Gives Patients Rights 9

Definition The HIPAA Privacy Rule provides individuals with the right to have their protected health information (PHI) amended in a manner that is fully consistent with the Correction Principle in the National Privacy and Security Framework. See 45 C.F.R. § Correction Principle: “Individuals should be provided with a timely means to dispute the accuracy or integrity of their individually identifiable health information, and to have erroneous information corrected or to have a dispute documented if their requests are denied.” Definition 10

Your Right to Amend/Correct Your Record* You have a right to request that a health care provider or health plan amend your health information—either change wrong information or add information to your file that is missing or incomplete 11 *Source: 1-pager titled “YOUR HEALTH INFORMATION PRIVACY RIGHTS”, Produced by the Office for Civil Rights

Meaningful Use Stage 3 Draft Recommendation on Amending EHR SGRP 204D Provide patients with the ability to request an amendment to their record online (e.g., offer corrections, additions, or updates to the record) through VDT in an obvious manner. 12

Discussion Are there additional policy issues that emerge in an electronic environment w/ respect to PGHD? For example: – Timeliness of provider response/ acknowledgement – Does data from patients need to be flagged as PGHD? – Can consumers exercise their rights electronically? – Is technology ready to facilitate this? – Other? 13

Wrap Up Next Steps Public Comment 14