In a 107-page report, released last week, the White House set forth its plan to create and manage a database containing 1 million or more Americans’ medical records in furtherance of the Precision Medicine Initiative. As announced by President Obama during his 2015 State of the Union Address, the Precision Medicine Initiative was launched “to bring us closer to curing diseases like cancer and diabetes, and give all of us access to the personalized information we need to keep ourselves and our families healthier.”
To achieve this goal, the Precision Medicine Initiative Cohort Program (“PMI-CP”) will build a “research cohort” of at least 1 million volunteers, which will provide the “platform” for improved understanding and knowledge of precision medicine approaches. As explained in the report, “[p]recision medicine is an approach to disease treatment and prevention that seeks to maximize effectiveness by taking into account individual variability in genes, environment, and lifestyle.”
The report explains that assembly, evaluation, and analysis of a research cohort of this size has been made possible by technological advances, including the development and wide implementation of electronic health records, and the increased usage of mobile health technologies.
The report acknowledges that, as is true with any collection of personal health information, data security and privacy are important. On the issue of privacy, the report outlines a two-mode approach to allow communications with study participants, while “respecting participant preferences and terms of consent.” “The ‘fully identified’ mode of operations will be needed for messaging, study appointment reminders, phone interactions, etc.” On the other hand, “[a]ggregate data assembled for analysis will need to be de-identified by removal of standard classes of personal identifiers.” In addition, because “the proliferation of data mining methods and potential naming sources . . . means that technology alone will be insufficient to address issues of data privacy,” the report states that “[a]cceptable use policies with substantial enforceable sanctions will need to be developed or adapted . . . to complement the technical approaches to de-identification of data.” Further, educational materials will be needed to explain to study participants the risks associated with the publication of personal information via social media and how they can “reduce the likelihood that their identity could be discovered by data mining of publically accessible data resources.”
As illustrated by the issue of privacy, the creation and management of the PMI cohort will present many challenges, but, as described throughout the report, the PMI-CP may provide invaluable insights into the factors contributing to individual health and disease.