On May 22, 2008, the Food and Drug Administration (“FDA”) announced plans for what it is calling the “Sentinel System” — a new, national electronic health information surveillance system to track the performance and safety of medical products once they are on the market. According to the FDA, the Sentinel System will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort. A Reed Smith bulletin discussing this initiative in greater detail is posted here.
