On May 25, 2016, the White House released its much anticipated Data Security Policy Principles and Framework (Security Framework) for President Obama’s Precision Medicine Initiative (PMI). The PMI is aimed at pioneering a new model of patient-powered research to improve health and treat disease, which takes into account individual differences in people’s genes, environments, and lifestyles.
The Security Framework is based on the NIST framework for improving critical cybersecurity infrastructure and was developed through a collaborative interagency process involving the FTC, HHS-OCR, NIH, FDA, DoD, and other federal agencies. It covers data security amongst the precision medicine community which, under the PMI, involves the NIH, FDA, NCI, other health agencies. The Security Framework is likely to become an industry standard for all health care organizations conducting or participating in precision medicine activities.