April 6, 2018: Legal and Ethical Architecture for PCOR Data

Speakers

Jane Hyatt Thorpe, JD
Associate Professor
Department of Health Policy and Management
Milken Institute School of Public Health
George Washington University

Lara Cartwright-Smith, JD, MPH
Associate Research Professor
Department of Health Policy and Management
Milken Institute School of Public Health
George Washington University

Elizabeth Gray, JD, MHA
Research Scientist
Department of Health Policy and Management
Milken Institute School of Public Health
George Washington University

Topic

Legal and Ethical Architecture for PCOR Data

Keywords

Patient-centered outcomes research; PCOR; Data privacy and security; Research ethics

Key Points

  • The patient-centered outcomes research (PCOR) Privacy and Security Research Scenario Initiative supports the development of a legal, ethical architecture to enable robust and secure PCOR data.
  • The legal and ethical framework was created to foster stakeholder trust through compliance with federal and state privacy laws.
  • The framework is a visual decision tool highlighting key characteristics and considerations associated with the spectrum of data used for PCOR and the nature of the relationships between researchers and other stakeholders.
  • The framework directs stakeholders through considerations organized into relevant legal provisions according to 6 key data characteristics:
    • Identifiability and Content
    • Subject
    • Source
    • Access and Use/Purpose
    • Consent/Authorization
    • Security

Discussion Themes

While the PCOR framework is not intended to replace a conversation with individual counsel, it should provide guidance to researchers on the types of questions to ask about their data.

The framework’s appendix was created to organize issues that may have ambiguous or overlapping legal authority.

Ethical considerations were embedded in the document, rather than being broken out separately apart from legal considerations, as they often go hand in hand (e.g., informed consent considerations).

 

To see the full framework documents, visitHealthIT.gov https://bit.ly/2H2RLke 

For more about regulatory frameworks, visit The Living Textbook  https://bit.ly/2GG3sOr

Tags

@PCORI, @ @ONC_HealthIT, @HHSONC, @GWtweets, #PCOR, #stakeholderengagment, #pctGR