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As the use of artificial intelligence in medicine increases, the CAP notes that pathologists' current responsibilities are analogous to the work required to monitor the performance of AI-enabled medical devices.
On December 1, the CAP submitted comments in response to the FDA's request on evaluating AI-enabled medical devices.
- The FDA's initiative focuses on identifying effective strategies to detect, assess, and mitigate performance changes over time and ensuring that such technologies remain safe, effective, and trustworthy throughout their life cycle.
What we're saying: Our response highlights the unique insights from pathologists and laboratory medicine that the FDA should consider in its assessment of measuring and evaluating AI-enabled medical device performance in the real world
- The CAP underscores that AI systems should enhance, not replace, human expertise in diagnostics.
- The CAP’s experience, including that of our members as CLIA laboratory directors, section directors, and peer reviewers for CAP's Laboratory Accreditation Program, provides valuable insight into successful strategies and potential challenges for measuring and evaluating real-world performance of AI-enabled medical devices.
What's next: The CAP is committed to working with the FDA to develop frameworks for measuring AI performance in clinical diagnostics.