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Why the FDA Regulating Medical AI Products Would Be Good for Everyone

February 15, 2021

The recently published FDA Action Plan for Software as a Medical Device (SaMD) has sparked a flurry of opinions and market activity. This piece lays out a lucid argument for the greater good that AI will do for medical products if it is properly managed, governed, and standardized across developers. The background, however, is illuminating: only 7 of approved products provide race and only 13 provide gender in the makeup of their datasets.

In related news, 3 industry groups for radiologists are calling on the US HHS to throw out a midnight rule from the outgoing Trump appointees that would exempt developers from oversight and presents outsized risks to patient safety. The Consumer Technology Association (CTA), consisting of 52 companies working in healthtech, announced an initiative to define a common lexicon for AI so industry stakeholders can understand, communicate, and further development. "Transparency and a common language will be key to enable the proper and safe functioning of AI," said Pat Baird, regulatory head of global software standards at Philips and co-chair of the working group.

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AI Governance & Assurance
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Regulation & Legislation