CEO SUMMARY: Clinical AI is advancing faster than regulation, creating risk for medical labs. An expert discusses using CLIA to oversee development and ensure safety, performance, and accountability while complementing FDA oversight. Lab leaders face regulatory uncertainty and vendor pushback, making up-front engagement and internal accountability critical for adopting AI while maintaining competitive advantage. Clinical […]
Could AI Oversight in Labs Fall Under a CLIA Model?
A CLIA-style system might allow labs to develop artificial intelligence tools internally
- By Scott Wallask
- > From the Volume XXXII, No. 14 - October 6, 2025 Issue
- Tags: AI, artificial intelligence, arup laboratories, Brian Jackson, CAIIA, Centers for Medicare and Medicaid, clia, CLIAC, Clinical AI Improvement Act, Clinical Laboratory Improvement Advisory Committee, Clinical Laboratory Improvements Amendments of 1988, CMS, Coalition for Health AI, Department of Health and Human Services, FDA oversight, Food and Drug Administration, HHS, lab risk & compliance, laboratory-developed test, ldt, University of Utah School of Medicine
