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Medical News & Perspectives
May 10, 2016

FDA’s Foray Into Big Data Still Maturing

JAMA. 2016;315(18):1934-1936. doi:10.1001/jama.2016.2752

With access to claims data on about 200 million patients and 5.5 billion patient encounters across the United States, the US Food and Drug Administration’s (FDA’s) Sentinel Initiative has grown into a juggernaut of patient experience since its pilot program launched in 2008 (Kuehn BM. JAMA. 2008;300[2]:156-157).

The pilot phase, Mini Sentinel, met a Food and Drug Administration Amendments Act (FDAAA) requirement to create an active drug safety monitoring system. Created as a public-private partnership, the system would give the FDA the ability to query patient data while still protecting patient privacy. The FDA contracted the Harvard Pilgrim Health Care Institute to be the initiative’s operating center, which interacts directly with Sentinel’s 18 data partners, predominantly major health insurers recruited to provide access to data on large swaths of US patients. The center has also worked to develop and refine the methods for querying partners’ data.