On Monday, the White House released its Privacy and Trust Principles (the “Principles”) for the Precision Medicine Initiative (“PMI”).  PMI is a federal initiative announced in the 2015 State of the Union to support research, technology, and policies to empower all parts of the healthcare community to enable the development of individualized treatments.  The PMI was launched to accelerate “biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.”  The Principles establish core values and strategies to minimize precision medicine risks inherent in data collection, analysis, and sharing.

Precision Medicine is “an emerging approach for disease treatment and prevent that takes into account individual variability in genes, environment, and lifestyle for each person.”  This approach is intended to allow physicians and researchers to predict with more accuracy which treatments and prevention strategies for particular diseases will work for particular groups of people.  The President has called for $215 million in fiscal year 2016 to support the PMI.

With the increased focus on genetic information and the sensitivity of that information, the PMI sought to provide guidance about how best to protect the privacy of individuals involved in precision medicine.   Following the unveiling of the 2015 announcement of the PMI, the White House convened experts to discuss privacy challenges in this area which resulted in a draft set of Principles released for comment and review in July of 2015.  After receiving more than 100 comments, the Principles were revised and this final draft was released.

The Principles outline a set of core values and strategies for protecting the privacy of individuals and maintaining trust in the PMI.  The Principles provide broad guidance for future PMI activities in the following areas:

  • Creating a Governance Structure;
  • Trust and Accountability Through Transparency;
  • Respecting Participant Preferences;
  • Participant Empowerment through  Access to Information;
  • Responsible Data Sharing,
  • Access, and Use; and Data Quality and Integrity.

In addition to the Principles, PMI also intends to develop a Security Policy Framework that will draw on industry best practices in identifying strong administrative, technical, and physical safeguards to ensure the confidentiality and integrity of specimens and data.