SLIDE 1
2
Development of Research Data Use Scenarios to Inform a Legal and - - PowerPoint PPT Presentation
Development of Research Data Use Scenarios to Inform a Legal and - - PowerPoint PPT Presentation
Development of Research Data Use Scenarios to Inform a Legal and Ethics Framework for PCOR Prashila Dullabh September 13, 2016 Acknowledgements Funded by the Office of the National Coordinator for Health IT Project team members
SLIDE 2
SLIDE 3
3
Agenda
Introduction
Project goals Background
Methods Principal findings Lessons learned
SLIDE 4
4
Introduction to the project
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
SLIDE 5
5
Related ONC-funded PCORTF Projects
Patient Choice Project Conceptualizing a Data Infrastructure for the Capture and Use of Patient-Generated Health Data Structured Data Capture Data Access Framework Patient Aggregation Matching and Linkage Project
SLIDE 6
6
Project Goals
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 and use cases with a multi- 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
SLIDE 7
7
Phase 1
Identify practical research needs of PCOR community Ensure research data use scenarios representative of industry-wide needs Provide an understanding of how users and systems interact and identify data sharing and system interactions and requirements Leverage federal and private sector work Consider operational elements, tasks, activities and information sharing necessary to support the PCOR community
SLIDE 8
8
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
SLIDE 9
9
Phase 1: Approach for Research Data Use Scenario Development
SLIDE 10
10
Key Questions for Developing Scenarios
- 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?
SLIDE 11
Principal Findings
SLIDE 12
12
Research Data Use Scenarios, Thematic Areas, and Use Cases
Use Case Thematic Area Scenario Use Case 1: Combine Data for PCOR Combining Independently Managed Data for PCOR Combining Clinical and Claims Data Combining Claims and Birth Records Secondary Analysis of Administrative Data on Substance Use Treatment CER Use Case 2: Consent Management Research and Age-Related Consent Considerations Related to Consent and Transitions from Minor to Adult Research Data Use Scenarios on Special Populations and Protection Status Obtaining Consent from Incarcerated HIV-Positive Research Participants Consenting Individuals with Impaired Decision-Making Capacity Use Case 3: Use of Sensitive Data Accessing Sensitive Behavioral Health Data for PCOR Combining Mental Health Data with Physical Health Data Precision Medicine Consent to Disclose Genomic Data that Affects Family Members Genomic Testing and Disclosure to Minors Use of Genetic Bio-Markers data for PCOR Individual and Population-Level Research Related to Sub- Populations Privacy Concerns for American Indian/Alaska Native Individuals and/or Populations Use Case 4: Identification and Re-Identification of PCOR Data Research Use Scenarios Related to Cumulative Re-identification Risks Reidentification Risk from the Mosaic Effect Variations in Linkage Mechanisms/Availability of Unique Identifiers Creating A Multi-Institutional Unique Identifier for Research Use Case 5: Patient-Generated Health Data Patient-Generated Health Data Creating A Registry That Includes Patient Reported Outcomes Use a Registry that includes Patient Reported Outcomes for PCOR Use Sensor Data fro PCOR
SLIDE 13
13
Process for Analyzing Scenarios Several scenarios shared a common goal Use Case
Involving same entities Actors
Scenarios involved specific policies Thematic Area
SLIDE 14
14
Use Case Overview Diagram
SLIDE 15
15
Workflow Diagrams
SLIDE 16
16
Cross-Cutting Themes
Complexities and variations in institutional and IRB policies and understanding of technical safeguards have exposed the need for standardized contractual agreements and implementation guides (protocols) for data management, transfer, and record linkage Compliance professionals need better standardized protocols and agreements that are coupled with implementation specifications that can be used by IT professionals to implement appropriate safeguards, information flows, and access control systems
SLIDE 17
17
Cross Cutting Themes
Gaps relating to emerging data types including PGHD and genetic data highlights the need for policies to protect both patients and family members from risks related to privacy, confidentiality, and security Mosaic Effect: New analytic techniques and availability of diverse data have implications for unauthorized reidentification of deidentified health data
SLIDE 18
18