As AI technology advances, the FDA is navigating the challenge of regulating AI tools in healthcare to ensure innovation while prioritizing patient safety. A special communication in JAMA examines the FDA’s regulation of AI in healthcare, focusing on key areas for adaptation, including effectiveness, safety, postmarket performance, and accountability. The FDA has approved numerous AI medical devices, particularly in radiology and cardiology, and is adapting regulatory frameworks to keep pace with AI’s rapid evolution. A five-point plan aims to foster innovation while ensuring the safety and effectiveness of AI products, highlighting the need for continuous monitoring throughout the entire life cycle of AI tools in clinical settings.
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FDA strengthens AI regulation to ensure patient safety and innovation in healthcare
