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CMS and CDC Consider Major Updates to CLIA Regulations

Agencies recognize ‘CLIA is lacking in areas,’ says attorney Christine Bump

CEO Summary: CMS and CDC are weighing updates to CLIA that could reshape oversight of laboratory developed tests, AI tools, molecular testing, and clinical laboratory compliance. A healthcare attorney notes that CLIA modernization is needed, but future changes could also bring added costs for labs. Clinical laboratories could face new requirements covering laboratory developed tests […]

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