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Research Assistant
Artificial Intelligence (AI) and Machine Learning (ML) algorithms have been integrated into FDA-approved medical devices and are starting to be used in clinical care. The laws that govern this rapidly innovative field are often playing catchup: for example, the 21st Century Cures Act of 2016 made several statutory changes in an attempt to define the scope of FDA's regulatory authority over software (including AI). Specifically, it carved out 5 functions or uses of software that would be exempted from review as a medical device: administrative support, healthy lifestyle/wellness, electronic patient records, transfer/storage of medical device data, and clinical support. The last category, termed Clinical Decision Support Software (CDS) was further interpreted by the FDA in a Sept.
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