The White House has released a set of privacy principles to govern the Precision Medicine Initiative.
The administration worked with experts from inside and outside government, who crafted the principles after analyzing bioethics literature and privacy policies for large biobanks and research cohorts as well as taking into account more than 100 comments on their draft suggestions.
The comments emphasized the importance of engaging participants as collaborators and the need for a robust data security framework, according to an announcement about the initiative.
The privacy principles are organized into six categories more fully detailed here:
- Governance that is inclusive, collaborative and adaptable
- Transparency to participants and the public
- Respect for participant preferences
- Participant empowerment through access to information
- Appropriate data sharing, access and use
- Data quality and integrity
In the upcoming months, the White House will work with an interagency group on a security framework for the initiative that includes strong administrative, technical and physical safeguards for the project data.
The initiative to find ways to customize treatment requires the National Institutes of Health (NIH) to recruit "a million or more" volunteers to share their health data in order for researchers to increase their understanding of health and disease. It also will rely on the Office of the National Coordinator for Health Information Technology to implement interoperability and privacy standards for the health data.
Kirk Nahra, partner at the law firm Wiley Rein LLP, told HealthcareInfoSecurity.com that the project shares the same privacy and security issues as any major research project, but the government wants to be very clear about how the data will be used.