HealthInfoLaw team members Jane Hyatt Thorpe, Lara Cartwright-Smith, Elizabeth Gray, and Marie Mongeon authored the Legal and Ethical Architecture for patient-centered outcomes research (PCOR) Data, published by the Office of the National Coordinator for Health Information Technology (ONC). The full brief is available through the Health Information & the Law website here and through ONC's website here; access to each individual chapters is available here and through the links listed below.
The Architecture is a collection of tools and resources that help researchers and others navigate an overview of the legal requirements related to data use, sharing, and disclosure for patient-centered outcomes research (PCOR). Specifically, the Architecture:
- Provides a common structure and model for the analysis of legal requirements and ethical consideration and responsibilities in research, particularly PCOR;
- Supports PCOR by illustrating pathways to collect and share data for research that is in compliance with relevant federal laws and regulations and in consideration of state law; and
- Supports a culture of trust among stakeholders by applying meaningful and appropriate privacy and security parameters.
The Architecture consists of the following five chapters and five appendices:
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Chapter 1: Overview of Legal and Ethical Architecture for PCOR Data
- Provides background information on the project, an overview of the key legal and ethical issues relevant to PCOR data and an overview of the Architecture.
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Chapter 2: Legal and Ethical Significance of Data for PCOR
- Explores fundamental concepts to help readers understand the features of the data they are working with and any privacy, security, consent, and ethics issues that may arise while conducting PCOR.
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Chapter 3: Linking Legal and Ethical Requirements to PCOR Data
- Helps readers identify what specific laws may be triggered by the data they are working with for a particular research project.
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Chapter 4: Framework for Navigating Legal and Ethical Requirements for PCOR
- Visual decision tool that groups and color-codes key data characteristics to guide readers through the factors that determine whether a statute or regulation applies to a given data type. The Framework also includes information regarding how a reader should navigate statutes and/or regulations and whether there are case-specific determinations relating to the collection and use of data within the context of a particular research project.
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Chapter 5: Mapping Research Data Flows to Legal Requirements
- Provides example data use scenarios and data flow maps that identify decision or trigger points that note specific laws and explain why those points are legally significant.
- Appendix A: Statutes and Regulations Relevant to PCOR
- Appendix B: Assessing Potential Barriers and Ambiguity in the Legal Landscape
- Appendix C: Selected Federal Initiatives
- Appendix D: Selected Federal Resources
- Appendix E: Glossary
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