Healthcare AI regulation needs nuance, balance: Research review

AI in Healthcare December 16, 2024
Dave Pearson

When regulating AI-equipped medical devices, the FDA might take a page from the Department of Transportation’s playbook for overseeing AI-equipped vehicles. These run the gamut from assisting human drivers to fully taking the wheel.

This would make particular sense when machine learning in medical software can make the products ever “smarter” over time.

The recommendation comes from Paragon Health Institute, a D.C.-based think tank focused on promoting innovation while encouraging competition and flagging cuttable costs.

“Regulation must protect the incentives for software improvement, including but not limited to feature enhancements and the remediation of known software anomalies that do not impair the system’s safety or effectiveness,” Paragon suggests in a new review of the relevant literature. “Regulators...

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