FDA, DOD Share Medical Data to Address Medical Product Safety

August 20, 2007 // Published as a news service by IHS

General patient data such as prescriptions, lab results and patient weight will be used by the FDA to spot trends, which may identify potential concerns as well as recognize benefits of products, said the FDA.

The two agencies will protect all personal health information exchanged under the agreement in accordance with federal law.

The partnership is part of the FDA's Sentinel Network, a medical product safety initiative announced in January 2007. This initiative is intended to explore linking private sector and public sector information to create a virtual, integrated electronic network, said the FDA.

Among the DOD programs involved in the agreement is TRICARE, the agency that administers the health care 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, said the FDA.

The DOD and the 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 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, said the FDA.

More information about the FDA-DOD Memorandum of Understanding can be found at http://www.fda.gov/oc/mous/domestic/FDA-DOD-INFO.html.

Source: Association for the Advancement of Medical Instrumentation (AAMI).