As FDA has noted, artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform healthcare. These technologies could be used at the agency, by other agencies involved in healthcare regulation and finance, by private participants in the healthcare delivery system, and by medical device manufacturers. They can also be embedded in conventional medical devices or, indeed, serve as standalone medical devices. For several years now, FDA has been exploring how its existing medical device framework applies, or should be adapted to apply to, software “as” a medical device as well as software “in” a medical device. In this post, I review four recent law review articles exploring legal and policy issues presented by the emergence of artificial intelligence and machine learning in medical devices and the healthcare setting more generally.
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