Joe Lennerz, Medical Director, Pathology Innovations at Natera, shared on LinkedIn:
“CLIA modernization is no longer about updating laboratory regulations – it is about redefining what constitutes a clinical laboratory in the era of artificial intelligence and computational medicine.
The recently released Request for Information (RFI) from the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) marks the first broad solicitation of stakeholder input on how the ‘Clinical Laboratory Improvement Amendments‘ (CLIA) should evolve to meet the realities of modern laboratory medicine. An RFI is NOT a proposed regulation; rather, it is an early-stage policy instrument used by federal agencies to gather evidence, identify emerging challenges, and assess stakeholder perspectives before considering future regulatory action. So this is your time to speak up.
The RFI spans a broad range of modernization topics, including expansion of CLIA oversight, tissue stewardship, preanalytic processes, specimen quality, validation of advanced testing, calibration verification, artificial intelligence, computational laboratories, remote operations, laboratory resilience, and emerging testing specialties. Collectively, these themes outline a roadmap for how laboratory regulation may evolve over the coming decade.
One particularly notable aspect of the RFI is its substantial attention to computational pathology and software-driven diagnostics. The dedicated sections on artificial intelligence, data-only facilities, advanced performance specifications, and molecular testing specialties suggest that CMS and CDC are actively considering how CLIA should evolve for laboratories whose primary value lies in software, algorithms, digital pathology, and advanced genomic interpretation – not solely in traditional wet-laboratory testing. This shift signals an important evolution in regulatory thinking, recognizing that future laboratory quality and oversight will increasingly encompass computational workflows alongside conventional analytical processes.
RFI period is open until September 14th 2026.
RFI source.”
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