ADLM Calls for CLIA Rules to Cover AI in Laboratory Medicine

Association for Diagnostics & Laboratory Medicine (ADLM) submitted comments on potential updates to the Clinical Laboratory Improvement Amendments (CLIA), recommending that AI tools used in laboratory medicine remain subject to the professional expertise, quality systems, validation requirements and monitoring standards that apply to traditional laboratory testing.

ADLM identified risks including errors that vary by case, unsupported generative AI outputs, omitted clinical information and changes in behavior after updates to models, prompts or knowledge bases. It recommends coordinated oversight by the Centers for Medicare and Medicaid Services, Centers for Disease Control and Prevention and Food and Drug Administration.

The recommendations call for regulators to distinguish conventional software from AI models and adopt a risk based, technology appropriate approach with clear quality expectations. ADLM also says facilities that independently analyze patient data or provide specialized interpretations should receive appropriate CLIA oversight, and that AI should be evaluated as part of the total testing process under the existing CLIA framework rather than regulated as standalone software. ADLM says it represents more than 70,000 laboratory professionals, physicians, research scientists and business leaders in 110 countries.