Looming Confrontation over FDA Oversight of Health IT

March 5, 2014 | Strategic Insights for Health System


Health information technology (IT) vendors are preparing to lobby aggressively against anticipated recommendations that products such as electronic health records (EHRs) be subject to U.S. Food and Drug Administration (FDA) oversight, according to a February 25, 2014, Boston Globe article. Proponents of regulation note that EHRs have been implicated in a host of adverse events (such as those described in ECRI Institute PSO’s ECRI Institute PSO Deep Dive™: Health Information Technology). Opponents, including both health IT vendors and healthcare providers, fear that such regulation could stifle the pace of innovation and make software upgrades, all of which would require FDA review, difficult.

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