Jennifer S. Geetter and Chelsea M. Rutherford of McDermott Will & Emery write:
Six months after the Precision Medicine Initiative’s (Initiative’s) debut, the White House has released a working draft of proposed privacy and trust principles (the Principles) to govern future design and development efforts for the national research cohort envisioned by the Initiative. This cohort will be a sample population of one million or more Americans, all of whom will provide data for use in research studies. The national research cohort is just one of the Initiative’s efforts to use precision medicine—an approach to medical treatment which aims to harness patient-specific information to inform the patient’s diagnosis and treatment decisions—to help accelerate biomedical discoveries.
[…]
Data Sharing and Use
The Initiative aims to gather large amounts of data for research purposes while ensuring such data is used and shared appropriately. Various Principles reflect this approach:
- There will be multiple tiers of cohort data access, including access by participants, researchers, and the public.
- Certain data restrictions would apply:
- researchers would not be able to access participant data for future research without additional informed consent, and participants would have to authorize researchers to contact them in the future;
- cohort data could not be sold or used for directed advertising; and
- all cohort-related research findings must be published or summarized publicly, regardless of the outcome of the research.
Read the full article on National Law Review.