A landmark longitudinal research study involving one million or more U.S volunteers will help researchers to better understand how to improve health and treat disease. The goal is to enroll 79,000 cohort participants in the NIH Precision Medicine Initiative (PMI) Cohort program by the end of 2016 and reach one million by the end of 2019.
Initially, the program will begin with Vanderbilt University working in collaboration with advisors from Verily (formerly Google Life Sciences) to find the best way to engage, enroll, and retrain participants from across the U.S into the PMI cohort Program.
NIH www.nih.gov will be working with the Office of the National Coordinator for Health IT (ONC) www.healthit.gov on a program called “Sync for Science (S4S) that will pilot the use of open, standardized applications to give individuals enrolled in the PMI Cohort program the ability to contribute their data to research.
NIH will coordinate S4S pilots through an open standards development process with EHR developers Allscripts, athenahealth, Cerner, drchrono, Epic, and Mckesson. These pilots will enable participants to access their EHRs, control and manage their data, and coordinate their care with healthcare providers and researchers if they choose. The EHR vendors will design, build, test, and help implement a platform based on open standards including FHIR, OAuth 2.0, and OpenID Connect.
Also, ONC in collaboration with the National Institute of Standards and Technology (NIST) by the end of December will develop a precision medicine guide specific to the NIST Cybersecurity Framework.
HRSA www.hrsa.gov, has plans to establish partnerships with several Federally Qualified Health Centers to develop, pilot, and refine approaches so that underserved individuals, families, and communities can take part in the PMI Cohort Program especially participants underrepresented in biomedical research.
In addition, NIH plans to establish a central PMI Cohort Program Institutional Review Board (IRB) experienced in mHealth, bioinformatics, health disparities, epidemiology, genomics, and environmental health to review the research conducted in the program.
As the PMI project moves on, a coordinating center will be established to manage the overall projects. A network of healthcare provider organizations will engage, enroll, and support data collection for a large segment of the program’s participants. Eventually, a participant technologies center will be available to harness the latest opportunities in mobile phone and sensor technologies.
Go to www.nih.gov/precision-medicine-initiative-cohort-program for more information on PMI.
Go to www.healthit.gov/FACAS/calendar/2016/02/26/standards-precision-medicine-task-force to view information on S4S.