CMS published a proposed rule on October 8, 2026 that would update the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations for virtual and digital laboratory operations. Comments are open through December 7, 2026 (CMS docket CMS-3478-P).
The proposal would allow virtual access under the CLIA certificate of the primary testing laboratory that generated the data, with the exception of the cytology subspecialty, and would permit digital images for gynecologic cytology proficiency testing. CMS also proposes changes to personnel qualification requirements, plus certificate, test reporting, SARS-CoV-2 reporting, enforcement, and public consultation requirements.
CMS says the changes aim to strengthen federal oversight of clinical laboratories while adapting to modern technological capabilities and workforce shortages. The proposal follows the July 2026 CLIA request for information.
Source: federalregister.gov
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