The FDA is pushing for continuous monitoring of artificial intelligence tools used in healthcare. The agency warns that unmonitored AI systems could pose risks to patient safety.
They outlines several challenges, including balancing financial optimization with patient outcomes and evaluating large language models in clinical settings. The FDA also highlighted the importance of maintaining workforce expertise to review increasingly complex AI applications.
The agency advocates for a “total product life cycle” approach, requiring ongoing evaluation of AI tools’ safety and effectiveness after deployment, similar to monitoring patients in intensive care units.
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