FDA developing new rules for artificial intelligence in medicine - STAT

The Food and Drug Administration announced Tuesday that it is developing a framework for regulating artificial intelligence products used in medicine that continually adapt based on new data. The agency's outgoing commissioner, Scott Gottlieb, released a white paper that sets forth the broad outlines of the FDA's proposed approach to establishing greater oversight over this rapidly evolving segment of AI products. It is the most forceful step the FDA has taken to assert the need to regulate a category of artificial intelligence systems whose performance constantly changes based on exposure to new patients and data in clinical settings. These machine-learning systems present a particularly thorny problem for the FDA, because the agency is essentially trying to hit a moving target in regulating them. The white paper describes criteria the agency proposes to use to determine when medical products that rely on artificial intelligence will require FDA review before being commercialized.