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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 Kick-off Meeting December 1, 2015 NORC at the University of Chicago The George Washington University

Kickoff Meeting Agenda Introductions from the NORC and ONC Teams Background and Context Project Overview Process for Developing Research Data Use Scenarios Next Steps 3

Background and Context Prashila Dullabh 4

The Learning Health System and PCOR Sharing data across the health IT ecosystem is a major federal priority, as articulated in ONC’s 2014 report on its 10-year vision and the Interoperability Roadmap v.1.0. This data contributes to PCOR and the Learning Health System but raises privacy-related concerns 5 A Learning Health System: “…will improve the health of individuals and populations. The learning health system will accomplish this by generating information and knowledge from data captured and updated over time – as an ongoing and natural by-product of contributions by individuals, care delivery systems, public health programs, and clinical research…” -The Learning Health Community’s Preamble

6 Source: The Office of the National Coordinator for Health Information Technology. Connecting Health and Care for the Nation: A Ten Year Vision to Achieve Interoperable Health IT Infrastructure.

Project Overview Prashila Dullabh and GWU 7

Project Description Determining how health information from a variety of data sources can be used for PCOR/CER, consistent with principles of bioethics and the legal requirements governing privacy of health information, including patient consent Phase 1: »Develop research data use scenarios with the stakeholder group Phase 2: »Assess the legal, regulatory, and policy environment governing the use of health information for PCOR/CER »Develop a legal and ethics framework for protecting patient privacy during conduct of PCOR/CER 8

PHASE 1 Recruit and engage PCOR stakeholders »Including researchers, patients, providers, health IT technologists, and legal experts that have experience relevant to PCOR data Develop research data use scenarios in collaboration with the PCOR stakeholder group Produce a report highlighting priority research scenarios, lessons learned, and next steps 9

PHASE 2 Identify and define data types Identify relevant ethical principles and legal requirements related to privacy and security Map privacy and security legal requirements to the potential flow of data for PCOR, identify gaps where applicable Develop a legal framework for PCOR that addresses privacy and security requirements and ethical principles Develop a Privacy and Security Conceptual Enterprise Architecture for PCOR 10

Public Kick-off Meeting Dec bi-weekly meetings December to March 2016 Submit draft research data use scenarios February 2016 Submit final research data use scenarios March-April 2016 Phase 2 Legal and ethical framework development Early 2016 to Sep Project Milestones 11 Phase 1 November 2015 December 2015 January 2016 February 2016 March 2016 April 2016

Process for Developing Research Data Use Scenarios Ioana Singureanu and Daniella Meeker 12

High Level Process 13 Input for Phase2

Goals of the Multi-Stakeholder Process Identify practical research needs of the PCOR community Ensure research data use scenarios are representative of industry-wide needs and valuable for solving real-world PCOR challenges Provide an understanding of how users and systems interact and identify the data sharing and system interactions and requirements Leverage federal and private sector work in developing the scenarios Consider various operational elements, tasks, activities and information sharing necessary to support the PCOR community 14

Scope of the Research Data Use Scenarios Identifying the policy, legal, and ethical components and requirements to support data use in PCOR while protecting patient privacy. We will focus on: »Identifying research data use scenarios that are patient-centric »Identifying necessary policies and requirements to enable data use in research »Defining the gaps and needs »Identifying instances where technical components intersect policy requirements; referencing relevant technical specifications, as needed Out of scope: Identifying and developing solutions, technical or otherwise. This will be the work of other planned and future initiatives. 15

Examples of Possible Research Data Use Scenario Topics Research involving collections of data that may be used for multiple purposes Merging of large databases for research purposes Precision medicine Research performed across multiple entities/institutions Laboratory data for research purposes Patient-generated data for research purposes Familial/community implications of research data collection and use 16

Possible Questions/Issues for Consideration Characteristics of the Data? Data identifiability (e.g., identifiable, de-identified, limited data set) Data type (e.g., genomic, clinical, HIV, mental health, substance use, biospecimens) Data source (e.g., clinical, registry, administrative, claims, patient-generated data) Data Handling? Data storage method (e.g., paper, local secure server, cloud) Method of data transmission (e.g., paper, fax, cloud service provider, secure ) Method of collection (e.g., paper, EHR, PHR, mobile, wearable, implanted device) 17

Possible Questions/Issues for Consideration Data Uses? Purpose (e.g., clinical treatment, research, public health, quality improvement) Scope of consent (e.g., for single purpose, multiple purposes, secondary use, given by patient/subject vs surrogate) Users/Facilities Interacting with Data? Collector of data (e.g., provider, researcher, public health agency, business associate) Data user (e.g., provider, researcher, public health agency, business associate) Location of collection/use (e.g., federally-funded substance use facility, single institution, multiple institutions in several states) Other Issues? 18

Project Collaboration Space Web-based collaboration space for reviewing and commenting on research data use scenarios Other purposes: sharing resources, viewing the meeting calendar, posting meeting materials and minutes Project team will administer the content Stakeholders will weigh in and occasionally the larger research community as well There is a dedicated URL we will share 19

Sample Site Page 20

Next Steps Prashila Dullabh 21

Stakeholder Levels of Commitment Committed contributors »18-22 hours of meetings over 6 months (12-15 meetings, 90 minutes each) »Ad hoc review of project documents on discussion on wiki site Secondary contributors »Roughly 3 hours per month »Feedback on key deliverables Web-based contributors »Review materials, contribute to web-based discussions »No formal commitment 22

Next Steps Determine level of commitment Confirm meeting schedule Review and refine project charter 23 Meeting 1 (kickoff)Tuesday, December 1, 2015 Meeting 2 Wednesday, December 16, :00pm EST Meeting 3 Wednesday, January 6, :00pm EST Upcoming MeetingsSchedule will be finalized by December 16

Key Contacts Prashila Dullabh, Project Director: Ioana Singureanu, Data Scenario Analysis and Facilitator: Daniella Meeker, PCOR Research Lead: Helen Caton-Peters, ONC Staff Lead: Katherine Donaldson, Stakeholder Liaison : 24

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