1. PCOR Privacy and Security Research Scenario Initiative and Legal Analysis and Ethics Framework Development Welcome and Please Sign In »Please sign into the WebEx using your name and affiliation and/or record your name on the conference line after the prompt. »If you are not signing on to the WebEx, signing on anonymously, or did not record your name on the conference line, please email Donaldson- Katherine@norc.org to let us know you are on the phone.Donaldson- Katherine@norc.org Participation »Please keep your own line muted throughout. »If you have a question, please raise your hand via the web and we will call upon you. »If you are not signed in to the web conference, please state your full name before speaking on the phone. »You may also e-mail questions or comments to Katherine Donaldson. 1

2. Patient Centered Outcomes Research (PCOR) Privacy and Security Research Scenario Initiative and Legal Analysis and Ethics Framework Development Stakeholder Work Group Meeting #6 February 17, 2016 NORC at the University of Chicago The George Washington University

3. Meeting Agenda Welcome Working through Research Data Use Scenarios »Key Questions »Research Consent for Special Populations: Prisoners; Decisionally Disabled »Linking Data across Institutions via a Research Identifier Scenarios Under Development Wrap-Up and Next Steps 3

4. Working through Research Data Use Scenarios Ioana Singureanu, Daniella Meeker 4

5. Key Questions Who/what are the sources of the data? Who is requesting the data? For what purpose(s) is the data being requested? Are there any fees associated with either obtaining the data and/or combining the data? Is the data being combined with other sources of data? If so, by whom and how? What is done with the data once the research is complete? Is it available for secondary use? Why were data originally collected? What parties participate in agreements in the scenario? What specifications are relevant for data security? Is the data individually identifiable? Is the data partially de-identified (e.g., limited data set)? If not, how was it de-identified? Can it/will it be re-identified? 5

6. Working through Scenarios Prison Populations »http://confluence.siframework.org/pages/viewpage.action?pageId=51807140http://confluence.siframework.org/pages/viewpage.action?pageId=51807140 Individuals with Decisional Disabilities »http://confluence.siframework.org/display/PSRSI/Use+Case+%238+Special+Pop ulation%3A+Consenting+Individuals+with+Decisional+Impairmentshttp://confluence.siframework.org/display/PSRSI/Use+Case+%238+Special+Pop ulation%3A+Consenting+Individuals+with+Decisional+Impairments Linking Data across Entities via a Research Identifier »http://confluence.siframework.org/display/PSRSI/Use+Case+%239+Implementi ng+Multisite+Research+Unique+Identifiershttp://confluence.siframework.org/display/PSRSI/Use+Case+%239+Implementi ng+Multisite+Research+Unique+Identifiers 6

7. Scenarios Under Development & Generating Scenarios for Future Meetings Prashila Dullabh and Ioana Singureanu 7

8. Other Possible Research Data Use Scenario Topics Combining Data: Clinical Data and Birth Records; Clinical, Claims, and Social Services Information Precision Medicine: Managing Privacy Related to Genetic Data and Precision Medicine; Use of Genetic Biomarkers for Research; Disclosure of Genomic Data to a Minor; Non-Genetic Precision Medicine Research Re-identification Risks: Longitudinal Research; Risks to Family Members Research on Small Sub-Populations Research on Under-Represented Populations Collecting Patient-Generated Health Data: Patient Reported Outcomes; Patient-Mediated Exchange 8

9. Other Possible Research Data Use Scenario Topics Other Ideas, Gaps to Address, Comments? Template link: »http://confluence.siframework.org/display/PSRSI/Research+Data+Use+ Scenario+Templatehttp://confluence.siframework.org/display/PSRSI/Research+Data+Use+ Scenario+Template Please suggest scenarios or topic areas that should be included. 9

10. Wrap-up and Next Steps Prashila Dullabh 10

11. Review of Progress Summary of major decision points »Research data use scenarios Materials will be posted on Confluence »You will receive links to relevant documents via email »We will revise and post the updated versions for our next meeting Next meeting: Wednesday, March 2, 2016 at 1:00pm (ET) 11

12. Update on Previous Scenarios Based on your input in previous meetings, we have updated: Combining Data Scenario »http://confluence.siframework.org/display/PSRSI/Use+Case+%231+Combining+ data+setshttp://confluence.siframework.org/display/PSRSI/Use+Case+%231+Combining+ data+sets Behavioral Health Scenarios »http://confluence.siframework.org/display/PSRSI/Use+Case+%232+Integration+ of+Behavioral+Health+Data+with+Physical+Health+Datahttp://confluence.siframework.org/display/PSRSI/Use+Case+%232+Integration+ of+Behavioral+Health+Data+with+Physical+Health+Data »http://confluence.siframework.org/display/PSRSI/Use+Case+%233+Secondary+ Analysis+of+Administrative+Data+on+Substance+Use+Treatment+CERhttp://confluence.siframework.org/display/PSRSI/Use+Case+%233+Secondary+ Analysis+of+Administrative+Data+on+Substance+Use+Treatment+CER Consent of Children and Adolescents »http://confluence.siframework.org/display/PSRSI/Use+Case+%234+Consenting+ Children+and+Adolescentshttp://confluence.siframework.org/display/PSRSI/Use+Case+%234+Consenting+ Children+and+Adolescents 12

13. Confluence Please access the Confluence site for this initiative using this link: »http://confluence.siframework.org/display/PSRSI/PCOR+Privacy+and+Security+ Research+Scenario+Initiative+and+Legal+Analysis+and+Ethics+Framework+Dev elopment+Homehttp://confluence.siframework.org/display/PSRSI/PCOR+Privacy+and+Security+ Research+Scenario+Initiative+and+Legal+Analysis+and+Ethics+Framework+Dev elopment+Home All notes and slides from previous meetings are available: »http://confluence.siframework.org/display/PSRSI/Meeting+Materialshttp://confluence.siframework.org/display/PSRSI/Meeting+Materials If you are interested in the Patient Choice project, you can access their project page via Confluence: »http://confluence.siframework.org/display/PATCH/Patient+Choice+Homehttp://confluence.siframework.org/display/PATCH/Patient+Choice+Home 13

14. Meeting Schedule Meetings will be held biweekly from 1-2pm ET on the following dates: 14 Meeting 1 (kickoff)Tuesday, December 1, 2015 Meeting 2Wednesday, December 16, 2015 Meeting 3Wednesday, January 6, 2016 Meeting 4Wednesday, January 20, 2016 Meeting 5Wednesday, February 3, 2016 Meeting 6Wednesday, February 17, 2016 Meeting 7Wednesday, March 2, 2016 Meeting 8Wednesday, March 16, 2016 Meeting 9Wednesday, March 30, 2016 Meeting 10Wednesday, April 6, 2016 Meeting 11Wednesday, April 20, 2016 Meeting 12Wednesday, April 27, 2016

15. @ONC_HealthIT@HHSONC Thank You