PCOR Privacy and Security Research Scenario Initiative and Legal
Analysis and Ethics Framework Development
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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
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Background and Context
Prashila Dullabh
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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
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
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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.
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Project Overview
Prashila Dullabh and GWU
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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
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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 15-20 research data use scenarios in collaboration with the
PCOR stakeholder group
• Produce a report highlighting priority research scenarios, lessons
learned, and next steps
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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
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Project Milestones
Phase 1
Public Kick-off
Meeting
Dec. 1
12 bi-weekly
meetings
December to
March 2016
Submit 15-20 draft
research data use
scenarios
Submit 15-20 final
research data use
scenarios
February 2016
March-April 2016
Phase 2
Legal and ethical framework development
Early 2016 to Sep. 2017
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Process for Developing Research Data Use Scenarios
Ioana Singureanu and Daniella Meeker
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High Level Process
Business Process Methodology S&I Lite Process
Draft Project
Project Charter
Reach out to subject
matter experts
Project kick-off
Finalize Project
Charter
Update the charter
based on stakeholder
input.
Proposed Research
Data Use Scenarios
«BusinessProcess»
Use Case Analysis
Research data
use case
analysis
document
Existing policy and
legal frameworks
Define legal requirements
and ethical principles
based on current research
data use scenarios/use
cases
Requirements
Input for
Phase2
Describes whether an organization
needs to meet specific law, policy, or
ethical considerations. It may require
the development of a new legal
framework that can evolve and adapt.
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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
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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.
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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
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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
email)
• Method of collection (e.g., paper, EHR, PHR, mobile, wearable, implanted
device)
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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?
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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
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Sample Site Page
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Next Steps
Prashila Dullabh
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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
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Next Steps
• Determine level of commitment
• Confirm meeting schedule
Meeting 1 (kickoff)
Meeting 2
Meeting 3
Upcoming Meetings
Tuesday, December 1, 2015
Wednesday, December 16, 2015
1:00pm EST
Wednesday, January 6, 2016
1:00pm EST
Schedule will be finalized by December 16
• Review and refine project charter
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Key Contacts
• Prashila Dullabh, Project Director: dullabh-prashila@norc.org
• Ioana Singureanu, Data Scenario Analysis and Facilitator:
ioana@eversolve.com
• Daniella Meeker, PCOR Research Lead: dmeeker@usc.edu
• Helen Caton-Peters, ONC Staff Lead: helen.caton-peters@hhs.gov
• Katherine Donaldson, Stakeholder Liaison : donaldson-katherine@norc.org
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Thank You
@ONC_HealthIT
@HHSONC