Artificial intelligence tools in health care should be safe and effective. They should be fair to people of different races, genders, and geographies. And they should be monitored to ensure they are improving outcomes in the real world.
Most participants agreed on those goals in a Food and Drug Administration workshop on the regulation of artificial intelligence late last week. But how to accomplish them remained a source of considerable debate.
Some medical device makers and their trade groups called for a light regulatory touch, arguing that devices that rely on AI do not necessarily pose novel challenges or require special treatment from the FDA.
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