The Centers for Medicare & Medicaid Services is seeking comment on a proposed rule to amend regulations from the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that would allow digital access to laboratory data.
The proposed rule would amend CLIA to permit virtual access to remotely review clinical laboratory data, results, live imaging, and digital images under the CLIA certificate of the primary testing laboratory that generated the data. For digital gynecologic cytology proficiency testing, the proposed rule would allow digital images of glass slides to be used.
Additionally, the rule proposes changes to personnel qualification requirements, SARS-CoV-2 reporting requirements, certificate requirements, test reporting requirements, enforcement requirements, public consultation requirements, and editorial and technical updates.
Public comment is open for a 60-day comment period, until Dec. 7, 2026.
Source:
https://www.cap.org/advocacy-update/cms-cdc-propose-changes-to-clia-regulations/