Mission statement:
To enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care.
The future of precision medicine will enable health care providers to tailor treatment and prevention strategies to people’s unique characteristics, including their genome sequence, microbiome composition, health history, lifestyle, and diet. To get there, we need to incorporate many different types of data, from metabolomics (the chemicals in the body at a certain point in time), the microbiome (the collection of microorganisms in or on the body), and data about the patient collected by health care providers and the patients themselves. Success will require that health data is portable, that it can be easily shared between providers, researchers, and most importantly, patients and research participants.
Agencies across the Federal government are doing important work to support the President’s vision. This is an “all of government” effort, leveraging the unique expertise and history of each agency to carry forward the President’s vision of individualized treatments for every American. Here’s how each participating agency is moving ahead to implement PMI:
- NIH is building the Precision Medicine Initiative (PMI) Cohort Program, with the goal of collecting data from one million or more U.S. volunteers who are engaged as partners in a longitudinal, long-term effort to transform our understanding of health and disease.
- NCI, a second PMI effort housed in the NIH National Cancer Institute, seeks to expand cancer precision medicine clinical trials, examine mechanisms of drug resistance in cancer patients, develop new cancer pre-clinical models, and establish a national cancer knowledge system.
- FDA is developing new regulatory approaches for evaluating next-generation genomic sequencing technologies. In addition, the agency launched precisionFDA in December 2015, a crowd-sourced, cloud-based platform where the community can test, develop, and validate Next Generation Sequencing software and methods.
- ONC is accelerating opportunities for innovative collaboration around pilots and testing of standards that support health IT interoperability for research, encouraging adoption of policies and standards to support privacy and security, and advancing standards that support a participant-driven approach to patient data contribution.
- OCR is developing regulatory guidance and other tools to ensure that individuals and HIPAA covered entities understand the patient’s right to access their health information, enabling them to donate it for research.
Department of Health and Human Services (HHS)
Department of Veterans Affairs
VA continues to expand the Million Veteran Program through enrollment of Veteran volunteers and planned collaborations with DOD. In addition, VA has funded eight scientific projects that will utilize the MVP resource.
Department of Defense
DoD is partnering with VA to facilitate the enrollment of active duty men and women into MVP. This collaboration will enhance the quality of data available to both VA and DoD, as well as the natural progression from active duty military to veteran status.