RSNA and ACR call for patient safety and ongoing monitoring as the FDA considers regulations for generative AI in radiology.
Key Details
- 1FDA recently sought public feedback on generative AI regulation, receiving over 300 responses.
- 2Both American College of Radiology (ACR) and Radiological Society of North America (RSNA) submitted comments.
- 3Societies stressed patient safety as the foremost priority in any regulatory framework.
- 4RSNA urged continuous real-world monitoring and safeguards for AI models after deployment, not just premarket review.
- 5Responsibility for safety and effectiveness should rest with AI manufacturers, not radiologists.
Why It Matters
Input from prominent radiology organizations will shape how generative AI is governed in medical imaging, potentially impacting workflow, accountability, and patient outcomes. Ongoing surveillance of AI models could set new precedents for medical device regulation.
Source
Radiology Business
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