by
Barbara Kram, Editor | August 06, 2007
Two agencies will
protect patients' health
information and the
products they use
(click to enlarge)
Data from the U.S. Military Health System will soon help FDA make decisions affecting the safety and use of FDA-regulated products for all Americans.
FDA, part of the U.S. Department of Health and Human Services, and the Department of Defense have announced a partnership to share data and expertise related to the review and use of FDA-regulated drugs, biologics, and medical devices.
General patient data such as prescriptions, lab results, and patient weight will be used by FDA to spot trends, which may identify potential concerns as well as recognize benefits of products.
The two agencies will protect all personal health information exchanged under the agreement, in accordance with federal law.
"FDA is privileged to collaborate with DoD to protect the health of all Americans," says FDA Commissioner Andrew C. von Eschenbach, MD, "The opportunity to create systems to monitor the safety of products should directly benefit those cared for by the armed services as well as many others."
The partnership is part of FDA's Sentinel Network, a medical product safety initiative first announced in January 2007. This initiative is intended to explore linking private sector and public sector information to create a virtual, integrated, electronic network.
Among the DoD programs involved in the agreement is TRICARE, the agency that administers the healthcare plan serving 9.1 million members of the uniformed services, retirees and their families. The first data shared will most likely be TRICARE prescription information.
The DoD and FDA will meet later this year to establish specific procedures and safeguards necessary to implement the program. Long range plans for the Sentinel Network call for a seamless national electronic information network that will include everything from new medical product information and patient care records to adverse event reports, and domestic and foreign clinical trials.
For more information, view the FDA-DoD Memorandum of Understanding:
http://www.fda.gov/oc/mous/domestic/FDA-DOD-INFO.html
