{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,9]],"date-time":"2026-05-09T02:49:13Z","timestamp":1778294953464,"version":"3.51.4"},"reference-count":15,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2024,12,6]],"date-time":"2024-12-06T00:00:00Z","timestamp":1733443200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Informatics Review LLC"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,2,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To assess the potential to adapt an existing technology regulatory model, namely the Clinical Laboratory Improvement Amendments (CLIA), for clinical artificial intelligence (AI).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Materials and Methods<\/jats:title>\n                  <jats:p>We identify overlap in the quality management requirements for laboratory testing and clinical AI.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We propose modifications to the CLIA model that could make it suitable for oversight of clinical AI.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Discussion<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>A 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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jamia\/ocae296","type":"journal-article","created":{"date-parts":[[2024,12,10]],"date-time":"2024-12-10T22:22:56Z","timestamp":1733869376000},"page":"404-407","source":"Crossref","is-referenced-by-count":10,"title":["Regulation of artificial intelligence in healthcare: Clinical Laboratory Improvement Amendments (CLIA) as a model"],"prefix":"10.1093","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7902-3990","authenticated-orcid":false,"given":"Brian R","family":"Jackson","sequence":"first","affiliation":[{"name":"Department of Pathology, University of Utah , Salt Lake City, UT 84112,","place":["United States"]},{"name":"Department of Biomedical Informatics, University of Utah , Salt Lake City, UT 84108,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5828-4497","authenticated-orcid":false,"given":"Mark P","family":"Sendak","sequence":"additional","affiliation":[{"name":"Duke Institute for Health Innovation , Duke University, Durham, NC 27701,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2117-2461","authenticated-orcid":false,"given":"Anthony","family":"Solomonides","sequence":"additional","affiliation":[{"name":"Research Institute, Endeavor Health , Evanston, IL 60210,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suresh","family":"Balu","sequence":"additional","affiliation":[{"name":"Duke Institute for Health Innovation , Duke University, Durham, NC 27701,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dean F","family":"Sittig","sequence":"additional","affiliation":[{"name":"Department of Clinical and Health Informatics, University of Texas Health Science Center at Houston , Houston, TX 77030,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2024,12,6]]},"reference":[{"key":"2025012119040722600_ocae296-B1","doi-asserted-by":"publisher","first-page":"722","DOI":"10.1038\/d41586-024-02675-0","article-title":"How do you test AI in Medicine?","volume":"632","author":"Lenharo","year":"2024","journal-title":"Nature"},{"key":"2025012119040722600_ocae296-B2","doi-asserted-by":"publisher","first-page":"361","DOI":"10.1093\/jamia\/ocac218","article-title":"Diachronic and synchronic variation in the performance of adaptive machine learning systems: the ethical challenges","volume":"30","author":"Hatherley","year":"2023","journal-title":"J Am Med Inform Assoc"},{"key":"2025012119040722600_ocae296-B3","doi-asserted-by":"crossref","first-page":"245","DOI":"10.1001\/jama.2023.26930","article-title":"A nationwide network of health AI assurance laboratories","volume":"331","author":"Shah","year":"2024","journal-title":"JAMA"},{"key":"2025012119040722600_ocae296-B4","doi-asserted-by":"publisher","first-page":"e241369","DOI":"10.1001\/jamahealthforum.2024.1369","article-title":"Artificial intelligence can be regulated using current patient safety procedures and infrastructure in hospitals","volume":"5","author":"Fleisher","year":"2024","journal-title":"JAMA Health Forum"},{"key":"2025012119040722600_ocae296-B5","doi-asserted-by":"crossref","first-page":"821","DOI":"10.1038\/s42256-023-00699-1","article-title":"Enabling collaborative governance of medical AI","volume":"5","author":"Price","year":"2023","journal-title":"Nat Mach Intell"},{"key":"2025012119040722600_ocae296-B6","doi-asserted-by":"publisher","author":"Warraich","year":"2024","DOI":"10.1001\/jama.2024.21451"},{"key":"2025012119040722600_ocae296-B7","doi-asserted-by":"publisher","first-page":"2686","DOI":"10.1038\/s41591-023-02540-z","article-title":"External validation of AI models in health should be replaced with recurring local validation","volume":"29","author":"Youssef","year":"2023","journal-title":"Nat Med"},{"key":"2025012119040722600_ocae296-B8","author":"U.S. Food and Drug Administration","year":"2024"},{"key":"2025012119040722600_ocae296-B9","doi-asserted-by":"crossref","first-page":"130","DOI":"10.1373\/jalm.2016.021832","article-title":"FDA-cleared versus laboratory developed tests: why start from scratch when kits are available?","volume":"2","author":"Snozek","year":"2017","journal-title":"J Appl Lab Med"},{"key":"2025012119040722600_ocae296-B10","doi-asserted-by":"publisher","first-page":"122","DOI":"10.1093\/ajcp\/aqz096","article-title":"Regulation of laboratory-developed tests","volume":"152","author":"Genzen","year":"2019","journal-title":"Am J Clin Pathol"},{"key":"2025012119040722600_ocae296-B11","author":"42 CFR Part 493\u2014Laboratory Requirements","year":"2024"},{"key":"2025012119040722600_ocae296-B12","doi-asserted-by":"publisher","DOI":"10.1056\/AIp2400109","article-title":"The chief health AI officer\u2014an emerging role for an emerging technology","volume":"1","author":"Beecy","year":"2024","journal-title":"NEJM AI"},{"key":"2025012119040722600_ocae296-B13","doi-asserted-by":"crossref","first-page":"ocae119","DOI":"10.1093\/jamia\/ocae119","article-title":"Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety","volume":"31","author":"Sendak","year":"2024","journal-title":"J Am Med Inform Assoc"},{"key":"2025012119040722600_ocae296-B14","doi-asserted-by":"publisher","DOI":"10.1056\/AIp2300048","article-title":"How academic medical centers govern AI prediction tools in the context of uncertainty and evolving regulation","volume":"1","author":"Nong","year":"2024","journal-title":"NEJM AI"},{"key":"2025012119040722600_ocae296-B15","doi-asserted-by":"publisher","author":"Kim","year":"2023","DOI":"10.1145\/3593013.3594089"}],"container-title":["Journal of the American Medical Informatics Association"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jamia\/article-pdf\/32\/2\/404\/60971846\/ocae296.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jamia\/article-pdf\/32\/2\/404\/60971846\/ocae296.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,21]],"date-time":"2025-01-21T19:04:16Z","timestamp":1737486256000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jamia\/article\/32\/2\/404\/7918300"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12,6]]},"references-count":15,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2024,12,6]]},"published-print":{"date-parts":[[2025,2,1]]}},"URL":"https:\/\/doi.org\/10.1093\/jamia\/ocae296","relation":{},"ISSN":["1067-5027","1527-974X"],"issn-type":[{"value":"1067-5027","type":"print"},{"value":"1527-974X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,2]]},"published":{"date-parts":[[2024,12,6]]}}}