“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…”
“The paper is the first step in a monthslong process in which the FDA will collect input from the public and a variety of stakeholders in medicine before finalizing a policy on regulating adaptive AI systems…” Read the full article here.
Source: FDA developing new rules for artificial intelligence in medicine – By Casey Ross, April 2, 2019. STAT.
