Politico January 31, 2024
Did federal regulators give artificial intelligence developers a roadmap to avoid their oversight?
In a limited way, they did, according to University of Maryland researchers.
In a new paper in JAMA, the researchers say the FDA inadvertently revealed a loophole when it said that some AI products, such as those that summarize doctors’ notes, wouldn’t be considered medical devices subject to FDA rules. The loophole was included in the FDA’s guidance for “clinical decision support software,” which it issued in September 2022.
The guidance, released just two months before ChatGPT revolutionized AI, suggested that the agency didn’t consider note-taking AI within its purview because such technology doesn’t make specific predictions or disease estimates.
That’s too bad, the researchers argue, because...
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