Most health AI tools in use today fall outside the oversight framework patients and executives might expect, according to a Bipartisan Policy Center report.
Here are five notes from the report, which maps which agencies oversee health AI, as discussed by Maya Sandalow, associate director of the center’s health program, on Federal News Network‘s “The Federal Drive,” published June 12:
1. The most common health AI applications are administrative — ambient scribes that record patient conversations and tools insurers use for prior authorization — rather than FDA-regulated clinical devices, Ms. Sandalow said.
2. “The same AI may be regulated by different entities depending on where it is used, the data that it’s trained on,” she said. The FDA, CMS, HHS’ Office for Civil Rights, Federal Trade Commission and ONC each oversee different slices of the landscape, and state rules vary on top of that.
3. The regulatory complexity and unclear payment pathways are creating a chilling effect on clinical AI applications such as early disease detection and diagnosis, Ms. Sandalow said.
4. Developers currently have an incentive to argue their products are not medical devices to avoid FDA review, she said, meaning users may not realize a chatbot is unregulated and not intended for diagnosis or treatment.
5. The new administration proposed in early January to roll back ONC’s “nutrition label” transparency policy for AI embedded in EHRs — a move some providers worry will limit the information they need to evaluate AI tools and increase their liability exposure, Ms. Sandalow said.
She said bipartisan agreement exists on the need for a federal framework to replace the state patchwork, but consensus on the details remains elusive.
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