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In the Final Days of Trump Administration, Agencies Clashed Over How to Regulate Medical AI, MedCity News

January 21, 2021

Morgan Lewis partner Michele Buenafe spoke with MedCity News about proposed exemptions issued by the US Department of Health and Human Services in the final days of the Trump administration regarding machine-learning-based software. In the article, she discussed the conflicts between the proposal and previous FDA guidance. “For software in general, there isn’t one clear overarching guidance saying this is when software’s regulated and when software is not regulated,” said Michele. “It’s unclear how it’s going to shake out, how it may impact developers of AI or machine learning technology, or patients who may be treated or diagnosed by this technology.”

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