FDA taps VUMC, Duke, others to lead medical product safety innovation center

Nashville, Tenn.-based Vanderbilt University Medical Center will serve as one of four co-leaders of the FDA's new Sentinel Innovation Center, part of the FDA's national electronic safety surveillance program.

Joining VUMC as a co-leaders are groups from Brigham and Women's Hospital in Boston, Duke Clinical Research Institute in Durham, N.C., and Kaiser Permanente Washington Health Research Institute in Seattle. The innovation center will focus on leveraging de-identified data from EHRs and publicly available data sources to enhance medical product safety surveillance. The center comprises more than 50 academic centers and healthcare payers.

"The Innovation Center will support VUMC and its other member organizations in the development of new tools to efficiently unlock the safety information in these records — tools in areas like natural language processing, machine learning and safety signal detection," said Michael Matheny, MD, associate bioinformatics professor at VUMC and a member of the Innovation Center executive committee, according to the report.

The FDA launched Sentinel in 2009 to oversee surveillance of medical products after they have reached market. Products include drugs, medical devices, vaccines and biologicals.

Boston-based Harvard Pilgrim Health Care Institute oversees Sentinel operations. The institute recently partnered with Veradigm, Allscripts' payer and life sciences division, to extract and structure information from EHRs for the Sentinel drug safety database.

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