MedCity News January 21, 2021
The agency published its first action plan last week for how it plans to regulate machine learning-based software as a medical device. To start, the FDA said it will issue guidance on how changes to algorithms should be regulated as they “learn.”
In the final days of the Trump Administration, two agencies clashed over how AI tools should be regulated in healthcare. The Food and Drug Administration had just mapped out a plan for how it would regulate changes to AI-based medical software in the future, when the Department of Health and Human Services proposed that the FDA should cease to review some software tools altogether.
The sudden about-face took many by surprise, and seemed to fly in the face...
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