ArticleJournal of the American Medical Informatics Association : JAMIA2025
Regulation of artificial intelligence in healthcare: Clinical Laboratory Improvement Amendments (CLIA) as a model.
Article in Journal of the American Medical Informatics Association : JAMIA, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed.
- Integrating Generative AI Into Patient-Centered Clinical Decision Support: Viewpoint on Research and Practice Considerations.Journal of medical Internet research · 2026Article
- Foundation models in computational pathology: methods, applications and clinical implications.BMJ oncology · 2026Review
- An overview of CRISPR-artificial intelligence theranostics: Current and emerging applications.Biomaterials translational · 2026Review
- Evaluation and Regulation of Artificial Intelligence Medical Devices for Clinical Decision Support.Annual review of biomedical data science · 2025Review
- Hot topics in artificial intelligence.Journal of the American Medical Informatics Association : JAMIA · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
objectivesTo assess the potential to adapt an existing technology regulatory model, namely the Clinical Laboratory Improvement Amendments (CLIA), for clinical artificial intelligence (AI). MATERIALS AND
methodsWe identify overlap in the quality management requirements for laboratory testing and clinical AI.
resultsWe propose modifications to the CLIA model that could make it suitable for oversight of clinical AI. DISCUSSION: In national discussions of clinical AI, there has been surprisingly little consideration of this longstanding model for local technology oversight. While CLIA was specifically designed for laboratory testing, most of its principles are applicable to other technologies in patient care.
conclusionA CLIA-like approach to regulating clinical AI would be complementary to the more centralized schemes currently under consideration, and it would ensure institutional and professional accountability for the longitudinal quality management of clinical AI.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.