В США инициирован пересмотр правил CLIA для охвата цифровых лабораторий и кибербезопасности

- within Food, Drugs, Healthcare and Life Sciences topic(s) - in United States - with readers working within the Business & Consumer Services, Healthcare and Retail & Leisure industries - within Food, Drugs, Healthcare, Life Sciences, Law Practice Management and Intellectual Property topic(s) It seems that Clinical Laboratory Improvement Amendments of 1988 (CLIA) may be undergoing a facelift. A potential regulatory shift of this magnitude warrants some context. The CLIA, codified at 42 CFR Part 493, require laboratories that test human specimens for diagnosis, treatment, prevention of disease or health assessment to be appropriately certified and to meet federal quality standards that ensure test results are accurate, reliable and timely. Many of the technologies now central to clinical laboratory practice either did not exist or were not widely used when CLIA was implemented. The Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC) are evaluating whether the current regulations are sufficient for today's testing environment and, if not, what changes may be needed. Accordingly, on July 16, 2026, the CMS and CDC together issued a Request for Information (RFI)1 that could lay the groundwork for the most significant update to CLIA since its enactment in 1988. Although the RFI does not change any requirement today, it signals that agencies believe CLIA may no longer fully address modern laboratory technologies and operations. CMS and CDC are seeking stakeholder input by Sept. 14, 2026, on whether CLIA should be updated to reflect developments, such as laboratory-developed tests (LDT), artificial intelligence (AI), digital laboratory operations, cybersecurity and next-generation sequencing (NGS). The feedback received will help inform potential future rulemaking. The RFI offers a clear signal from federal regulators: modernization is on the horizon. Laboratories – including those operating under the auspices of Bond clients – should view this RFI as an important opportunity to shape any future CLIA reforms and prepare for emerging compliance expectations. Key Areas Under Review The RFI seeks input on four broad categories: (1) breath testing, (2) laboratory processes and procedures, (3) emergency preparedness, biosafety, biosecurity and cybersecurity, and (4) specialty testing areas. Several topics stand out as candidates for future regulatory attention: - LDTs and Test Validation. CMS and CDC are seeking detailed feedback on how laboratories establish and document performance specifications for non-FDA-cleared and modified FDA-cleared tests. More prescriptive requirements for LDT validation, verification and documentation may follow. - AI and Software-Assisted Interpretation. The agencies are examining how laboratories use AI and software tools in pathology, genetic testing and result interpretation, as well as how those tools are validated and monitored. The RFI specifically asks about AI use in NGS, histocompatibility, pharmacogenomics testing and histopathology slide interpretation. New requirements for AI governance, oversight and performance monitoring may be considered. - Data-Only Laboratories. CMS and CDC are exploring whether entities that analyze laboratory data or provide diagnostic interpretations—without performing traditional wet-lab testing—should fall within CLIA's scope. The agencies have received inquiries focused on facilities that review and interpret genetic data, digital images and perform calculations of risk factors. This could expand CLIA oversight to certain digital-health, analytics and data-interpretation operations. - Cybersecurity and Operational Resilience. Recognizing laboratories' increasing reliance on LIS, EHR integration, remote access capabilities, and interconnected digital systems, the agencies are considering whether CLIA should include explicit cybersecurity disaster preparedness, and business continuity requirements. A 2025 Department of Health and Human Services’ Office of Inspector General report2 recommended emergency preparedness plans for independent laboratories. Compliance obligations may extend beyond traditional laboratory quality systems. - Emerging Technologies. The RFI also addresses newer testing modalities and practices, including NGS, breath testing for clinical use (such as for cancer diagnosis, microbial identification and gastrointestinal disorders), cloud-based analytics and remote competency assessments. The Clinical Laboratory Improvement Advisory Committee (CLIAC) has recommended that CMS allow remote technology for direct observation competency assessments, particularly benefiting rural facilities. New standards tailored to technologies and testing models that did not exist when CLIA was originally implemented may be developed. Key Takeaways Laboratories should focus on these immediate action items: - Submit a comment by Sept. 14, 2026. Submit a comment on the Federal Register website here responding to the RFI’s questions and support your answers with real-world data. - Confirm your policies are current. Ensure your procedures for LDT validation, AI use, and cybersecurity meet today’s expectations and are well documented. - Evaluate “data-only” services. If you provide interpretations without wet-lab testing, prepare for possible CLIA oversight. - Plan for tougher oversight. Anticipate future rules on new technologies, cybersecurity and business continuity. Footnotes 1. Request for Information: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations, 91 Fed. Reg. 32097 (July 16, 2026), https://www.federalregister.gov/documents/2026/07/16/2026-14358/request-for-information-clinical-laboratory-improvement-amendments-of-1988-clia-regulations. 2. CMS’s emergency preparedness related to clinical laboratories during a public health emergency. Office of Inspector General | Government Oversight | U.S. Department of Health and Human Services. (January 16, 2026). https://oig.hhs.gov/reports/work-plan/browse-work-plan-projects/cmss-emergency-preparedness-related-to-clinical-laboratories-during-a-public-health-emergency/ The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. [View Source]