Today, the White House is releasing the Privacy and Trust Principles for the President’s Precision Medicine Initiative (PMI). These principles are a foundation for protecting participant privacy and building trust in activities within PMI.
PMI is a bold new research effort to transform how we characterize health and treat disease. PMI will pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients. The initiative includes development of a new voluntary research cohort by the National Institutes of Health (NIH), a novel regulatory approach to genomic technologies by the Food and Drug Administration, and new cancer clinical trials by the National Cancer Institute at NIH. In addition, PMI includes aligned efforts by the Federal government and private sector collaborators to pioneer a new approach for health research and healthcare delivery that prioritizes patient empowerment through access to information and policies that enable safe, effective, and innovative technologies to be tested and made available to the public.
Following President Obama’s launch of PMI in January 2015, the White House Office of Science and Technology Policy worked with an interagency group to develop the Privacy and Trust Principles that will guide the Precision Medicine effort. The White House convened experts from within and outside of government over the course of many months to discuss their individual viewpoints on the unique privacy challenges associated with large-scale health data collection, analysis, and sharing. This group reviewed the bioethics literature, analyzed privacy policies for large biobanks and research cohorts, and released a draft set of Principles for public comment in July 2015.
More than 100 comments were submitted by individuals, groups, academic research institutions, and advocacy organizations. The public comments informed the discussions leading to the release of the final PMI Privacy and Trust Principles today. Overall, the comments supported the emphasis in the principles on engaging participants as collaborators in PMI. Commenters strongly reinforced the need to ensure a robust data security framework. In response to these comments, the White House is leading an interagency group to develop a security policy principles framework over the coming months. Commenters also focused on the communications participants would receive from PMI and encouraged the governance body to ensure that communications were appropriate, responsible, and inclusive of linguistic and cultural differences. The principles were updated to reflect that suggestion. Commenters also encouraged special considerations for engaging with the diverse populations that PMI hopes to include. The principles maintained this idea as a priority. All the public comments informed the discussions leading to the release of the final PMI Privacy and Trust Principles today.
The Privacy and Trust Principles are organized into 6 broad categories:
- Governance that is inclusive, collaborative, and adaptable;
- Transparency to participants and the public;
- Respecting participant preferences;
- Empowering participants through access to information;
- Ensuring appropriate data sharing, access, and use;
- Maintaining data quality and integrity.
These Principles are intended to establish a foundation for future PMI activities to ensure that privacy has been built into the core of the Initiative and that privacy is maintained as a central priority of PMI throughout all components. The tenets of privacy and trust should underlie every activity launched within PMI and mechanisms to promote these values should be built into every step to ensure that PMI best serves the American public.
Jo Handelsman is Associate Director for Science at the White House Office of Science and Technology Policy.
DJ Patil is Chief Data Scientist at the White House Office of Science and Technology Policy.