ADLM Tells Regulators AI Lab Tools Must Meet Existing CLIA Standards
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Washington – September 18, 2026 -- The Association for Diagnostics & Laboratory Medicine (ADLM) has formally recommended that artificial intelligence tools used in clinical laboratories remain subject to the same validation, quality-system, and monitoring requirements that govern traditional laboratory testing under the Clinical Laboratory Improvement Amendments (CLIA). The recommendation was submitted in a comment letter responding to a federal request for information on potential updates to CLIA, the regulatory framework that has governed U.S. clinical laboratory testing since 1992.