STAT September 29, 2022
Mario Aguilar

FDA’s new AI guidelines create uncertain future

The Food and Drug Administration roared into the week with a handful of dense documents that hold big implications for how it will oversee technology in health care. The most significant is the agency’s final guidance on what kinds of decision support software it intends to regulate, spelling out four criteria, pictured above, that determine whether things like AI software that flags medical conditions for doctors are considered diagnostic devices that must be reviewed by the agency.

The guidelines specifically call out tools that alert clinicians of sepsis as requiring agency review. The mention feels hardly accidental. Sepsis kills more than 200,000 people in the United States each year and is notoriously difficult to detect. STAT has published multiple investigations detailing the shortcomings of a widely-used tool developed by Epic.


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Topics: AI (Artificial Intelligence), Digital Health, Equity/SDOH, FDA, Govt Agencies, Healthcare System, Medical Devices, Technology
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