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FDA regulation of predictive clinical decision-support tools: What does it mean for hospitals?

Journal of Hospital Medicine April 1, 2021

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PAIR Center Research Team


Recent experiences in the transportation industry highlight the importance of getting right the regulation of decision-support systems in high-stakes environments. Two tragic plane crashes resulted in 346 deaths and were deemed, in part, to be related to a cockpit alert system that overwhelmed pilots with multiple notifications.Similarly, a driverless car struck and killed a pedestrian in the street, in part because the car was not programmed to look for humans outside of a crosswalk.These two bellwether events offer poignant lessons for healthcare, an industry in which human lives also depend on decision-support systems.

Clinical decision-support (CDS) systems are computerized applications, often embedded in an electronic health record (EHR), that provide information to clinicians to inform care. Although CDS systems have been used for many years,they have never been subjected to any enforcement of formal testing requirements. However, a draft guidance document released in 2019 from the US Food and Drug Administration (FDA) outlined new directions for the regulation of CDS systems.Although the FDA has thus far focused regulatory efforts on predictive systems developed by private manufacturers,this new document provides examples of software that would require regulation for CDS systems that hospitals are already using. Thus, this new guidance raises critical questions—will hospitals themselves be evaluated like private manufacturers, be exempted from federal regulation, or require their own specialized regulation? The FDA has not yet clarified its approach to hospitals or hospital-developed CDS systems, which leaves open numerous possibilities in a rapidly evolving regulatory environment.


National Heart,Lung,and Blood Institute (NHLBI)