Mariana Lenharo in Nature:
Artificial intelligence (AI) already helps clinicians to make diagnoses, triage critical cases and transcribe clinical notes in hospitals across the United States. But regulation of medical AI products has not kept up with the rapid pace of their adoption, argue researchers in a report published on 5 June in PLOS Digital Health1. The authors point to limitations in how the US Food and Drug Administration (FDA) approves these devices, and propose broader strategies that extend beyond the agency to help ensure that medical AI tools are safe and effective.
More than 1,000 medical AI products have been cleared by the FDA, and hospitals are rapidly adopting them. Unlike most other FDA-regulated products, AI tools continue to evolve after approval as they are updated or retrained on new data. This raises the need for continuous oversight, which current regulations have limited capacity to ensure.
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