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Patient Centered Outcomes Research (PCOR) Privacy and Security Research Scenario Initiative and Legal Analysis and Ethics Framework Development Stakeholder Work Group Meeting #4 January 20, 2016 NORC at the University of Chicago The George Washington University

Meeting Agenda Welcome Working through Two Behavioral Health Scenarios »Key Questions »Integration of Behavioral Health Data with Physical Health Data »Secondary Analysis of Administrative Data on Substance Use Treatment CER Update on Combining Data Sets Scenario Generating Additional Research Data Use Scenarios »Other Possible Research Data Use Scenario Topics »Template for Additional Scenarios Next Steps »Review Progress »Confluence »Meeting Schedule 3

Working through Research Data Use Scenarios Ioana Singureanu, Daniella Meeker, and Eric Goplerud 4

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

Working through Scenarios Integration of Behavioral Health Data with Physical Health Data (Scenario 2) » ion+of+Behavioral+Health+Data+with+Physical+Health+Datahttp://confluence.siframework.org/display/PSRSI/Use+Case+%232%3A+Integrat ion+of+Behavioral+Health+Data+with+Physical+Health+Data Secondary Analysis of Administrative Data on Substance Use Treatment CER (Scenario 3) » ary+Analysis+of+Administrative+Data+on+Substance+Use+Treatment+CERhttp://confluence.siframework.org/display/PSRSI/Use+Case+%233%3A+Second ary+Analysis+of+Administrative+Data+on+Substance+Use+Treatment+CER We will refer to Confluence for this exercise 6

Working through Scenarios cont… Linkage of Behavioral Health Data with Physical Health Data Questions to Consider: The ethics of consent and release of data for seriously mentally ill patients Issues associated with adherence and maintenance of repeated consent (e.g. what happens if patient cannot be contacted) Issues associated with maintenance of consent and other access policies across multiple parties, each potentially with dynamically changing release policies that might change in the middle of a study 7

Update on Combining Clinical and Claims Data (Scenario 1) Based on your input in previous meetings, we have updated the Combining Data workflow » ing+data+setshttp://confluence.siframework.org/display/PSRSI/Use+Case+%231%3A+Combin ing+data+sets 8

Scenarios Under Development & Generating Scenarios for Future Meetings Prashila Dullabh and Ioana Singureanu 9

Other Possible Research Data Use Scenario Topics Currently Under Development »Combining Clinical and Claims Data »Behavioral Health (2) »Precision Medicine (TBD) »Research Unique Identifier »Mosaic Effect Other Ideas? »Patient-Generated Health Data Please discuss scenarios in these topic areas that should be included. 10

Template for Additional Scenarios Goal: »Capture additional ideas for scenarios »Build a roadmap of scenarios for our future meetings Based on initial ideas, the NORC team will follow up with a call to discuss in greater detail and build out the ideas »These scenarios will then be discussed with the full work group Template link: » enario+Templatehttp://confluence.siframework.org/display/PSRSI/Research+Data+Use+Sc enario+Template 11

Wrap-up and Next Steps Prashila Dullabh 12

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 »We will revise and post the updated versions for our next meeting Next meeting: Wednesday, February 3, 2016 at 1:00pm(ET) »We will discuss behavioral health scenarios and relevant use cases, based on information we have been gathering »We will discuss additional research data use scenarios under development 13

Confluence Please access the Confluence site for this initiative using this link: » 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: » If you are interested in the Patient Choice project, you can access their project page via Confluence: » 14

Meeting Schedule Meetings will be held biweekly from 1-2pm ET on the following dates: 15 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

Thank You