WPF Report – Privacy, the Precision Medicine Initiative, & the All of Us Research Program: Will Any Legal Protections Apply?
Medical treatments tailored to each individual’s physiology and genetic history have long been a dream, but this dream is data-intensive. Until recently, the lack of a broad set of detailed health information from a wide variety of research subjects stymied medical research efforts. The most current effort to turn personalized, tailored medicine into a reality is the Precision Medicine Initiative (PMI), which now includes the All of Us research program. It is this full PMI/All of Us research program, begun in 2015, that hopes to gather an unprecedented amount of detailed biomedical data sets -- including biospecimens and detailed personal health information -- from over one million volunteers, the largest group of medical research volunteers that has been assembled thus far in the United States, if not the world.
Collecting, maintaining, reporting results back to research subjects/participants, and sharing biospecimens and health data from over a million volunteers for research requires meaningful privacy protections. This report analyzes those protections.