White House Releases Precision Medicine Privacy Principles

While promoting a personalized approach to medicine, which involves more sharing of data, the Obama administration isn't neglecting the need to protect privacy of health information. The White House released July 8 Proposed Privacy and Trust Principles as part of the Precision Medicine Initiative. These principles provide guidance on access to, sharing and use of data as well as data quality, integrity and security. "The principles articulate a set of core values and responsible strategies for engendering public trust and maximizing the possible benefits of a large national research cohort, while minimizing the risks inherent in large-scale data collection, analysis, and sharing," according to the proposed guidance.

The principles were developed by a working group spearheaded by the Department of Health and Human Services Office for Civil Rights (which enforces HIPAA's privacy and security rules), the National Institutes of Health and the White House Office of Science and Technology Policy. The group consulted experts and reviewed bioethics literature and biobank and research privacy policies. Their efforts yielded 10 fundamental assumptions about the Precision Medicine Initiative, data sharing and privacy. Those fundamentals include recognition that those who contribute their data to precision medicine related research will come from different backgrounds and have different "preferences and risk tolerances with respect to privacy" and that the sources of data contributed will be numerous and varied. The document also addresses reciprocal access for patients who contribute data to the initiative.

The guidance calls for centralized management of communication with participants, and governance that involves participation from all stakeholders and holds users of the PMI data accountable for maintaining privacy and appropriate use of data. It also recognizes that research under the PMI can involve risks and benefits not just for individual patients but families and communities as well and cautions against social stigmatization based on data collected. Addressing transparency, the guidance recommends participants be informed about data usage at "the point of initial engagement and periodically thereafter" and be "clearly and conspicuously" informed about "how, when, and what information and specimens will be collected and stored; generally how their data will be used, accessed, and shared"; the efforts to protect their data, and ability to withdraw from participation. It also suggests researchers should have to publish their research findings "regardless of the outcomes, as a condition of data use." The principles also discuss access, use and sharing of data, protection against unauthorized re-identification of participants, and disclosure in civil, criminal and other legal proceedings. Finally, state-of-the-art security measures that are easily implemented and periodically tested were recommended.

The group also suggested a similar set of principles be developed for data security and be periodically updated to "keep pace with an ever-advancing technological environment." Public comments are due by August 7, 2015.

Takeaway: While precision medicine calls for sharing of data, privacy and security of data remains paramount.