Precision Medicine Initiative Sets Privacy Principles

In mid-November the White House released the Privacy and Trust Principles for the Precision Medicine Initiative (PMI). The principles provide a framework for protecting the data of individuals participating in the initiative, while accelerating biomedical research and breaking new ground in providing participants data access.

“PMI includes aligned efforts by the Federal government and private sector collaborators to pioneer a new approach for health research and health care delivery that prioritizes patient empowerment through access to information,” said Jo Handelsman,

associate director for science at the White House Office of Science and Technology Policy, in a blog post. “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.”

Earlier in the year, President Obama asked for $215 million in funding for the initiative. The largest line item in the proposed budget—$130 million—was for the creation of a massive database containing the genetic data of at least one million volunteer participants. Given the increasing number of health care-related data breaches and the inherent sensitivity of genetic data, privacy must be ensured and trust must be built to ensure recruitment of the large cohort.

An interagency working group, initially convened in March, helped to provide guidance for the principles. The working group that was co-led by the White House Office of Science and Technology Policy, the Department of Health and Human Services Office for Civil Rights, and the National Institutes of Health. The principles were developed following expert roundtables, review of the bioethics literature, an analysis of privacy policies and frameworks used by existing biobanks and large research cohorts, and public comment this summer.

An interagency working group, initially convened in March, helped to provide guidance for the principles. The working group that was co-led by the White House Office of Science and Technology Policy, the Department of Health and Human Services Office for Civil Rights, and the National Institutes of Health. The principles were developed following expert roundtables, review of the bioethics literature, an analysis of privacy policies and frameworks used by existing biobanks and large research cohorts, and public comment this summer.

Central to trust is transparent communication. The principles outline that information should be communicated to participants “clearly and conspicuously” regarding how their data will be used, accessed, and shared; types of studies for which the individual’s data may be used; the goals, potential benefits, and risks of participation. Furthermore, the principles outline that data sharing expressly prohibits the sale or use of participant data for targeted advertising. Hand in hand with privacy principles is development of data security safeguards.

The PMI is taking steps to build sound security practices from the beginning of the initiative to ensure the confidentiality and integrity of all PMI participant data. The Security Policy Framework will draw on industry’s best practices in identifying strong administrative, technical, and physical safeguards, but will require regular reevaluation as practices evolve.

Takeaway: The PMI offers a new model of patient empowerment throughout the research process. Given the scope of the PMI endeavor, that patients will have access to their own data, and the number of anticipated participants, elaboration of guiding trust and privacy principles is an important step.