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 Donaldson- to let us know you are on the phone.Donaldson- 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 questions or comments to Katherine Donaldson. 1

Patient Centered Outcomes Research (PCOR) Privacy and Security Research Scenario Initiative and Legal Analysis and Ethics Framework Development Stakeholder Work Group Meeting #4 February 3, 2016 NORC at the University of Chicago The George Washington University

Meeting Agenda Welcome Working through Research Data Use Scenarios »Key Questions »Consenting Children and Adolescents »Vulnerable Populations Update on Previous Scenarios »Combining Data, Behavioral Health Scenarios Scenarios Under Development & Generating Scenarios for Future Meetings »Scenario Ideas »Discuss New Confluence Submission Wrap-Up and Next Steps 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 Consenting Children and Adolescents (Scenario 4) » onsent+for+Children+and+Adolescentshttp://confluence.siframework.org/display/PSRSI/Use+Case+%234+PMI+and+C onsent+for+Children+and+Adolescents Vulnerable Populations (Scenario 5) » ulnerable+Populationshttp://confluence.siframework.org/display/PSRSI/Use+Case+%235+PMI+and+V ulnerable+Populations 6

Update on Previous Scenarios Based on your input in previous meetings, we have updated: Combining Data Scenario » ing+data+setshttp://confluence.siframework.org/display/PSRSI/Use+Case+%231%3A+Combin ing+data+sets Behavioral Health Scenarios » 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 » 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 7

Scenarios Under Development & Generating Scenarios for Future Meetings Prashila Dullabh and Ioana Singureanu 8

Other Possible Research Data Use Scenario Topics Newly Under Development »Research Unique Identifiers »Assessing Re-identification Risk-Mosaic Effect »Collecting Patient Reported Outcomes We are looking for new ideas on the following topics: »Patient-Generated Health Data »Specific Examples related to the Precision Medicine Initiative 9

For Discussion: Combining Claims Data and Birth Records Max Researcher at Advanced Research Institute would like to conduct patient-centered outcomes research in pregnant women using several administrative claims databases from insurers that provide care in multiple states. A well-recognized limitation of claims databases is their lack of gestational information (e.g., gestational age) critical for pregnancy research. Therefore, Max Researcher will combine the claims databases with birth certificate files obtained from the states. In this scenario, the claims databases are owned by the insurers while the birth certificate data are managed by the states. 10

For Discussion: Combining Claims Data and Birth Records The following barriers are identified: Certain states will only grant access to the birth certificate data for one study at a time. If Max Researcher wants to conduct another study, he will have to repeat the same IRB approval process again. Certain states will only let their Departments of Health staff perform linkage, introducing significant delay. Some claims databases are not willing to share identifiable information with the states for such purposes. Certain states will only allow linkages to be done by Max or his team members, but only at their Department of Health's facilities, also introducing delays. Other considerations around use of APCDs as data sources? 11

For Discussion: Combining Claims Data and Birth Records Questions To Consider Level of Data Identifiability: Which of the following apply to this scenario? De-Identified Data determined by HIPAA Safe-Harbor Criteria Original Purpose of Data Capture: Why were data originally collected? Public health surveillance Parties Involved in Agreements: What parties participate in agreements in the scenario? Academic or Non-Profit Researcher Terms of Data Release: Which of the following apply to this scenario? Data was obtained under a Waiver of Authorization/Consent (IRB) Terms of Data Security: What specifications are relevant for Data Security? Defined in IRB approvals What are the limitations, barriers, and/or challenges related to collecting or combining data that prevent certain research? To be discussed 12

Other Possible Research Data Use Scenario Topics Other Ideas? Template link: » Scenario+Templatehttp://confluence.siframework.org/display/PSRSI/Research+Data+Use+ Scenario+Template Please suggest scenarios or topic areas that should be included. 13

Wrap-up and Next Steps Prashila Dullabh 14

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 17, 2016 at 1:00pm(ET) »We will discuss two new scenarios related to research unique identifiers and assessing re-identification risk (Mosaic Effect) that are currently under development. 15

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: » 16

Meeting Schedule Meetings will be held biweekly from 1-2pm ET on the following dates: 17 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