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- FDA publishes guidance on AI and clinical support software
The FDA has released updated guidance on Clinical Decision Support Software to outline its oversight of software intended for health care professionals. It affects how physicians can integrate AI into their practices.
Clinical decision support tools are software systems intended to support the diagnosis, treatment, prevention, cure, or mitigation of diseases.
Zoom in: With this new guidance, the FDA aims to reduce regulatory burdens and foster innovation in digital health care. The updates also clarify which clinical decision support tools are regulated as devices.
Yes, but: Certain clinical decision support tools are not regulated as devices if they meet specific criteria, including:
- They should not process or analyze medical images or signals.
- They must provide recommendations that a health care professional can independently review.
Relevance for pathology: Most predictive AI applications in pathology will remain under FDA oversight due to the ways in which medical images are classified.
- However, generative AI applications that don’t analyze images but provide single recommendations might see reduced enforcement.
Go deeper: View the FDA's full guidance update.