Study: HealthCore’s Data Partnership Helped Drive the FDA’ Sentinel Initiative

The US Food and Drug Administration’s Sentinel Initiative tracks the safety of drugs, medical devices, and biologics on the market using claims data and electronic health records (EHR). In a new study, HealthCore outlines its essential role in advancing the program. HealthCore collaborated with the Harvard Pilgrim Healthcare Institute, which houses and runs the Sentinel Operations Center, from 2009-2014 on the Mini-Sentinel pilot program.

According to HealthCore, “the pilot program yielded hundreds of queries annually during its five-year span, and produced studies on a variety of immunizations, biologics, and drugs that have made a significant impact on healthcare. From the Mini-Sentinel program, HealthCore, among other organizations, was able to help determine what data, methods, and operations the larger Sentinel Initiative would require.”

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(Source: HealthCore, March 2022)