Federal regulators are reconsidering how a set of lab-testing rules written in 1992 should handle artificial intelligence, and the group representing the country’s clinical lab professionals just weighed in. The outcome could matter for investors well beyond any one company: the two largest publicly traded U.S. commercial labs, plus at least one AI-native diagnostics company, already operate under the very rules now up for review.
What ADLM Told Regulators
The Association for Diagnostics & Laboratory Medicine (ADLM), a nonprofit professional group formerly known as the American Association for Clinical Chemistry, submitted a comment letter on September 15 responding to a federal request for information on updating the Clinical Laboratory Improvement Amendments (CLIA). ADLM’s core position: AI-based tools used in lab testing should be held to the same professional oversight, quality-system, validation, and monitoring standards that already apply to traditional testing, rather than getting a separate regulatory track of their own.
The letter makes several specific recommendations. It asks the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC), the two agencies that administer CLIA, to coordinate with the FDA so AI oversight doesn’t duplicate existing device regulation. It calls for CLIA to formally distinguish AI models from conventional software, since the two tend to fail in different ways. It recommends a risk-based approach that sets clear quality expectations without dictating exactly how labs meet them. And it argues that when a facility interprets patient data or helps generate a result using AI, even without touching a physical specimen, that work should still count as part of the regulated testing process.
“Laboratories have the expertise and quality systems needed to evaluate, implement, and continuously monitor AI tools,” ADLM President Dr. Stanley F. Lo said in the release, calling continued laboratory oversight essential to the responsible use of AI in patient testing.
The Regulation Behind the Letter
ADLM’s comment isn’t a standalone event. CMS and CDC jointly published the underlying request for information on July 16, 2026, marking the first broad public review of CLIA’s technical standards since the regulations took effect in 1992. The request, filed under code CMS-3485-NC and docket CMS-2026-2345, covers four areas: breath testing, laboratory processes and procedures, emergency preparedness and cybersecurity, and specialty testing. AI-assisted interpretation falls under the second category, alongside a related question of whether “data-only facilities,” businesses that interpret genetic data, digital images, or other lab output without ever handling a physical specimen, need a CLIA certificate at all.
Comments closed on September 14, one day before ADLM’s release went out. It’s worth being precise about what this document actually is: a request for information, not a proposed rule. CMS and CDC have not committed to any rulemaking, and the agencies say the responses will simply help them decide whether and how to update the existing framework. Nothing about laboratories’ current obligations changes as a result of the comment period itself.
Where the FDA Already Fits In
ADLM’s call to avoid duplicating oversight points to a regulatory system that already exists elsewhere. The FDA separately regulates AI tools built into medical devices and diagnostic software through its Software as a Medical Device framework, using a risk-based mix of 510(k) clearance, De Novo classification, and premarket approval. By early 2026, the agency had authorized more than 1,350 AI-enabled devices, roughly double the count from 2022, and it now lets companies pre-clear a plan for future algorithm updates rather than resubmitting for every change. That framework governs the AI tool itself. CLIA separately governs how a laboratory uses any tool, AI or not, to produce a reliable patient result. ADLM’s letter is essentially asking regulators to keep that division clean as AI use grows across the industry.
Why This Reaches Beyond One Company
Neither ADLM’s release nor its comment letter names a single company, which is typical for a professional association weighing in on regulatory policy rather than promoting a product. But the “data-only facility” question sits squarely inside the operations of some of the largest public companies in diagnostics. Labcorp Holdings Inc. (NYSE: LH) and Quest Diagnostics Incorporated (NYSE: DGX), the two biggest commercial lab operators in the U.S., both run CLIA-certified digital pathology programs that let pathologists review slides and interpret cases remotely. Tempus AI, Inc. (Nasdaq: TEM), a newer public company built around AI-driven test interpretation, sits even more directly in the territory the RFI is asking about. How CMS and CDC eventually answer the data-only-facility question could affect the compliance obligations of all three, though none of that is spelled out anywhere in ADLM’s release; it was identified independently by cross-referencing the RFI’s language against how these companies currently describe their own operations.
What Comes Next
The comment period has closed, but CMS and CDC have given no indication of a timeline for further action, and an RFI carries no built-in deadline requiring the agencies to act at all. ADLM’s letter is one of an unknown number of responses; the release doesn’t say how many other organizations, companies, or individuals submitted comments, or whether any diagnostics companies filed their own letters. Any eventual rule change would likely go through standard notice-and-comment rulemaking, a process that typically runs months to years from here. This article covers regulatory policy and is not medical or investment advice.
Sources
Association for Diagnostics & Laboratory Medicine: ADLM calls for CLIA updates to help ensure safe and reliable use of AI in laboratory medicine, PRNewswire, September 15, 2026. Primary source release.
ADLM Comment Letter: CLIA Request for Information, cited for the full text of ADLM’s specific recommendations.
Federal Register / Regulations.gov: Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations (CMS-3485-NC), cited for the underlying RFI’s publication date, scope, docket number, and comment deadline, none of which appeared in ADLM’s release.
FDA: Artificial Intelligence in Software as a Medical Device, cited for the FDA’s separate AI/ML device oversight framework referenced by ADLM’s comment letter.
Editorial Disclosure
This article is based on a press release issued by the Association for Diagnostics & Laboratory Medicine (ADLM) on September 15, 2026, regarding a comment letter ADLM submitted to the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC). BioTech Stocks Daily was not compensated for this coverage. Labcorp Holdings Inc. (NYSE: LH), Quest Diagnostics Incorporated (NYSE: DGX), and Tempus AI, Inc. (Nasdaq: TEM) are discussed for investor context regarding companies whose operations could be affected by the underlying regulatory review; none of these companies were named in ADLM’s release or comment letter, and this context was independently researched. No staff member, principal, or affiliate of BioTech Stocks Daily holds a position, option, or financial interest in any security mentioned as of the date of publication. Statements regarding future CLIA rulemaking, regulatory timelines, and the scope of any eventual rule change are forward-looking; the underlying request for information does not itself amend any current regulation, and CMS and CDC may take limited action or none at all. This article is for informational and educational purposes only, does not constitute investment advice, and is not medical advice.
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