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ADLM Calls for CLIA Updates to Help Ensure Safe and Reliable Use of AI in Laboratory Medicine

The Association for Diagnostics & Laboratory Medicine (ADLM) has submitted comments in response to a federal request for information regarding potential updates to the Clinical Laboratory Improvement Amendments (CLIA), which are a set of regulatory standards that govern all clinical laboratory testing in the U.S. In the comment letter, ADLM recommends that, under CLIA, emerging artificial intelligence (AI) tools should remain subject to the same professional expertise, quality systems, validation requirements, and monitoring standards that apply to traditional laboratory testing.

September 16, 2026


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