FDA awarded a contract to Harvard Pilgrim Health Care Inc. to develop a pilot for FDA’s Sentinel System that will use automated healthcare data to evaluate medical product safety. The Sentinel System will help FDA monitor product safety by analyzing information collected during the course of routine healthcare such as the data obtained from EHR systems, administrative and insurance claims databases, and from medical registries.
The one year contract with Harvard Pilgrim includes four renewable years for a total of $72 million. Harvard Pilgrim will establish a coordinating center to operate as a scaled down version of the Sentinel System. This “Mini Sentinel” center will identify appropriate databases, develop a scientific framework for obtaining real-time data, and work to ensure data quality. To protect personal information only summary results will be sent to the coordinating center.
The Harvard Pilgrim contract is just one of the activities contributing to building the Sentinel System. FDA has also awarded ten small contracts addressing scientific operations, data and infrastructure, privacy, and stakeholder engagement.
The reports resulting from these contracts are contain information on safety signal identification, how to engage patients, consumers and healthcare professionals, finding potential data sources for a National Network of Orthopedic Device implant registries, how to evaluate possible database models, develop a governance and operations structure, evaluate the timeliness of medical updates, and how to evaluate potential network data sources for blood and tissue product safety surveillance and studies.
On January 11th, Brookings Institution’s Engelberg Center held the 2nd Annual “Sentinel Initiative Public Workshop” to explore many issues and also to discuss the issues included in the completed FDA contracts. Discussion is also taking place on developing not only a multi-purpose distributed system to conduct safety surveillance work, but also how to use the system to collect comparative effectiveness research data and perform product quality assessments.
Go to www.fda.gov/Safety/FDAsSentinelInitiative/default.htm for more information.