White House Gets More Precise About Precision Medicine

July 09, 2015

July 20, 2015 — Editor's note: This article has been revised to reflect the correct August 7 deadline for submitting comments on the PMI principles (not August 27).

The White House yesterday proposed "privacy and trust principles" for its 6-month-old Precision Medicine Initiative (PMI) that set forth the sometimes clashing goals of safeguarding patient data while sharing it as freely as possible.

The centerpiece of the $215 million PMI will be a cohort of one million or more individuals who will share their health data so that researchers can develop targeted therapies for cancer and other diseases based on an individual's genetic and molecular profile. It represents a "new model of scientific research" in which patients are engaged partners, according to the draft principles released by the Obama administration. Accordingly, patients should take a leadership role in designing, implementing, and overseeing the work of the PMI cohort program.

The guidelines arose from the work of a series of expert roundtables, a bioethics literature review, and an analysis of how existing "biobanks" and other large research cohorts safeguard patient data.

In the name of transparency, participants should be told exactly what information and specimens of theirs will be collected; how their data will be used, accessed, and disseminated; and how it will be kept private, according to the proposed guidelines. The cohort program must allow participants to access the medical information they contribute, help them understand what it means, and explore how to share research findings with them. Participants should be able to drop out of the cohort at any time, although health information used in past or ongoing studies can't be withdrawn.

The White House expects all PMI cohort researchers to publish or post online a summary of their findings "regardless of the outcomes" as a condition of using the data.

More than anything, though, the PMI principles are concerned with with misuse and theft of patient information. They expressly forbid selling the data or using it for targeted advertising. Once participants are deidentified, they should not be reidentified and contacted without proper authorization. The White House recommends developing ways to protect individual as opposed to aggregate PMI data "from disclosure in criminal, administrative, legislative, or other proceedings."

The PMI program could give so-called ethical hackers some paying work. The White House recommends "penetration testing" for data safeguards put in place.

The importance of keeping patient information under wraps looms so large that the privacy and trust principles call for developing a separate data security framework in consultation with computer experts and ethicists. The security measures that emerge should be easy for data users to implement and maintain.

The White House said it wants public feedback on the PMI principles released yesterday. The deadline for submitting comments is August 7.

More information about the latest developments in the PMI is available on the White House website.

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