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It was a brave thing for the Food and Drug Administration to do. Earlier this week, the agency put one of its regulatory officers in front of a room full of scientists clamoring for answers on how the agency intends to regulate artificial intelligence in medicine.

Regina Barzilay, a professor of computer science at at the Massachusetts Institute of Technology and an organizer of the university event, cut right to the chase: Why does the FDA regulate AI algorithms that rely on medical imaging data, but largely ignore those that analyze other forms of clinical data — such as information in electronic medical records — to answer the same sorts of questions?


Amir Khan, a senior staff fellow at the agency, did what the FDA has largely done for years. He demurred.

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