FDA contracts with Harvard Pilgrim to bolster safety surveillance
The Food and Drug Administration awarded a $72 million contract to Harvard Pilgrim Health Care to develop a test version of the FDA's Sentinel system, an electronic network designed to sift health data for threats to medical product safety.
Sentinel, which has been under development since 2008, enables the FDA to track potential adverse events involving the introduction of drugs, biological products and medical devices after they have been introduced into the health marketplace.
The Harvard Pilgrim pilot would extend the data stream Sentinel filters into the realm of everyday, practice-level healthcare. Data from electronic health record systems, administrative and insurance claims databases and medical registries would be culled.
"Once operational, the Sentinel system will help us find answers to important drug safety questions, leading to stronger safeguards for public health while still protecting the privacy and security of individual health information," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
Currently, the FDA relies on reports filed by hospitals, healthcare professionals and industry officials for much of the raw information it uses to evaluate the safety of medical products. However, such reports may be incomplete or not filed in a timely manner, Woodcock said.
Over the five-year contract, Harvard Pilgrim, based in Wellesley, Mass., will establish a coordinating center that will operate as a scaled-down version of the Sentinel system. This center, or "mini-Sentinel," will identify appropriate databases to search, develop a scientific framework for obtaining real-time data and assure data quality.
To protect personal information, only summary results will be sent to the coordinating center, the agency said. The data itself will remain within its database.
The Harvard Pilgrim contract is one of many projects that have contributed to building the Sentinel system, including 10 small contracts that tackle scientific operations, data and infrastructure, privacy and working with a variety of organizations.