{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T13:17:55Z","timestamp":1784899075042,"version":"3.55.0"},"reference-count":50,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2026,5,23]],"date-time":"2026-05-23T00:00:00Z","timestamp":1779494400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,5,23]],"date-time":"2026-05-23T00:00:00Z","timestamp":1779494400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"NIH","award":["R01 CA276301"],"award-info":[{"award-number":["R01 CA276301"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["AI Ethics"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Artificial intelligence (AI) is increasingly deployed in oncology and pathology to support diagnosis, prognosis, molecular subtyping, and clinical documentation. Although these systems often achieve high predictive accuracy, their integration into clinical workflows exposes a structural mismatch with existing legal frameworks. U.S. medical law is organized around accountable, reason-giving clinicians, yet many clinically deployed AI systems operate as opaque decision engines that cannot articulate the rationale underlying their outputs. This article argues that treating such systems as mere \u201ctools\u201d obscures a growing justification gap resulting from poor explainability and lack of reasoning of AI models: predictive and prognostic artificial intelligence increasingly shapes clinical outcomes without bearing legal responsibility or providing explanations required for malpractice defense, insurance coverage determinations, or regulatory review. Drawing on malpractice doctrine, insurance law, FDA regulation, and professional licensure regimes, this article demonstrates that clinicians cannot fully delegate diagnostic justification to AI systems, even when those systems materially influence clinical decisions. As a result, clinicians remain legally accountable for decisions they do not entirely control. The article reframes clinical autonomy not as an ethical preference, but as a legal necessity arising from justification-centered accountability structures. It concludes by outlining regulatory and institutional approaches for clarifying responsibility in AI-mediated oncology and pathology without undermining clinical judgment.<\/jats:p>","DOI":"10.1007\/s43681-026-01184-2","type":"journal-article","created":{"date-parts":[[2026,5,23]],"date-time":"2026-05-23T04:25:53Z","timestamp":1779510353000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Artificial intelligence and the limits of delegated clinical judgment"],"prefix":"10.1007","volume":"6","author":[{"given":"Alejandro","family":"Leyva","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muhammad Khalid Khan","family":"Niazi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,5,23]]},"reference":[{"key":"1184_CR1","doi-asserted-by":"publisher","unstructured":"Cerrone, M., et al.: An Update of AI and radiomics in precision oncology: insights from liver tumors as case models. Technol. Cancer Res. Treatment (2025). https:\/\/doi.org\/10.1177\/15330338251387928. Accessed 16 Dec. 2025","DOI":"10.1177\/15330338251387928"},{"key":"1184_CR2","unstructured":"Bono, M.J., Wermuth, H.R., Hipskind, J.E.: Medical Malpractice: [Updated 2022 Oct 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025.Available from: https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK470573\/"},{"key":"1184_CR3","doi-asserted-by":"publisher","unstructured":"Price, I.I.W.N., Gerke, S., Cohen, I.G.: Liability for use of artificial intelligence in medicine. In: Solaiman B, Cohen IG, editors. Research Handbook on Health, AI and the Law. Cheltenham, UK: Edward Elgar Publishing Ltd; Jul 16. Chapter 9 (2024). https:\/\/doi.org\/10.4337\/9781802205657.ch09","DOI":"10.4337\/9781802205657.ch09"},{"key":"1184_CR4","doi-asserted-by":"publisher","unstructured":"Bal, B., Sonny, Brenner, L.H.: The judgment defense in medical malpractice. Clin. Orthopaed. Relat. Res. 11, 3405\u20133408. (2013). https:\/\/doi.org\/10.1007\/s11999-013-3223-0","DOI":"10.1007\/s11999-013-3223-0"},{"key":"1184_CR5","doi-asserted-by":"publisher","unstructured":"Bal, S.B., Brenner, L.H.: Medicolegal sidebar: the law and social values: conformity to norms. Clin. Orthop. Relat. Res. 473(5), 1555\u20131559 (2015). https:\/\/doi.org\/10.1007\/s11999-015-4177-1","DOI":"10.1007\/s11999-015-4177-1"},{"key":"1184_CR6","doi-asserted-by":"crossref","unstructured":"Hall v. Hilbun, 466 So.2d 856: (1985)","DOI":"10.1097\/00000542-198510000-00030"},{"key":"1184_CR7","doi-asserted-by":"publisher","unstructured":"Gerke, S., et al.: Ethical and legal challenges of artificial intelligence-driven healthcare. Artific. Intell. Healthcare 1(1), 295\u2013336. pmc.ncbi.nlm.nih.gov\/articles\/PMC7332220\/, (2020). https:\/\/doi.org\/10.1016\/B978-0-12-818438-7.00012-5","DOI":"10.1016\/B978-0-12-818438-7.00012-5"},{"key":"1184_CR8","unstructured":"Institute of Medicine (US) Committee on the Public Health Effectiveness of the FDA 510(k): 2, Legislative History of the Medical Device Amendments of 1976. (2010). https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK209793\/"},{"key":"1184_CR9","doi-asserted-by":"publisher","unstructured":"Eldakak, A., et al.: Civil liability for the actions of autonomous AI in healthcare: an invitation to further contemplation. Human. Soc. Sci. Commun. 11(1), 1\u20138. www.nature.com\/articles\/s41599-024-02806-y, (2024). https:\/\/doi.org\/10.1057\/s41599-024-02806-y","DOI":"10.1057\/s41599-024-02806-y"},{"key":"1184_CR10","doi-asserted-by":"publisher","unstructured":"Aldhafeeri, F.M.: Governing artificial intelligence in radiology: a systematic review of ethical, legal, and regulatory frameworks. Diagnostics 15(18), 2300, (2025). https:\/\/doi.org\/10.3390\/diagnostics15182300","DOI":"10.3390\/diagnostics15182300"},{"key":"1184_CR11","doi-asserted-by":"publisher","unstructured":"Froicu, E.-M., et al.: Artificial intelligence and decision-making in oncology: a review of ethical, legal, and informed consent challenges. Curr. Oncol. Rep. (2025). https:\/\/doi.org\/10.1007\/s11912-02501698-8. http:\/\/pubmed.ncbi.nlm.nih.gov\/40526332\/","DOI":"10.1007\/s11912-02501698-8"},{"key":"1184_CR12","doi-asserted-by":"publisher","DOI":"10.1111\/bioe.13222","author":"H Smith","year":"2023","unstructured":"Smith, H., et al.: Artificial intelligence in clinical decision-making: rethinking personal moral responsibility. Bioethics (2023). https:\/\/doi.org\/10.1111\/bioe.13222","journal-title":"Bioethics"},{"key":"1184_CR13","doi-asserted-by":"publisher","unstructured":"Hinostroza Fuentes, V., Gerardo, et al.: AI with agency: a vision for adaptive, efficient, and ethical healthcare. Front. Digital Health 7, 7 (2025). https:\/\/doi.org\/10.3389\/fdgth.2025.1600216","DOI":"10.3389\/fdgth.2025.1600216"},{"key":"1184_CR14","doi-asserted-by":"publisher","unstructured":"Abulibdeh, R., et al.: June. The illusion of safety: a report to the FDA on AI healthcare product approvals. PLOS Digital Health 4(6), e0000866, (2025). https:\/\/doi.org\/10.1371\/journal.pdig.0000866","DOI":"10.1371\/journal.pdig.0000866"},{"key":"1184_CR15","doi-asserted-by":"publisher","unstructured":"Ansari, S., et al.: Challenges in the postmarket surveillance of clinical prediction models. NEJM AI 2(5), 24 (2025). https:\/\/doi.org\/10.1056\/aip2401116. Accessed 23 May 2025","DOI":"10.1056\/aip2401116"},{"key":"1184_CR16","doi-asserted-by":"publisher","unstructured":"Trimble, M.: The thinking doctor: clinical decision making in contemporary medicine. Clin. Med. 16(4), 343\u2013346 (2016). https:\/\/doi.org\/10.7861\/clinmedicine.16-4-343","DOI":"10.7861\/clinmedicine.16-4-343"},{"key":"1184_CR17","unstructured":"Walker, H.K.: The origins of the history and physical examination. In: Walker, H.K., Hall. W.D., Hurst, J.W. (ed)s. Clinical methods: the history, physical, and laboratory examinations. 3rd edition. Boston: Butterworths; Chapter 1. (1990). Available from: https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK458\/"},{"key":"1184_CR18","doi-asserted-by":"publisher","unstructured":"Van Norman, G.A.: Drugs, Devices, and the FDA: Part 2. JACC: Basic Trans. Sci. 1(4), 277\u2013287. (2016). https:\/\/doi.org\/10.1016\/j.jacbts.2016.03.009","DOI":"10.1016\/j.jacbts.2016.03.009"},{"key":"1184_CR19","doi-asserted-by":"publisher","unstructured":"Sepideh, H., et al.: Ovarian cancer beyond imaging: integration of AI and multiomics biomarkers. Eur. Radiol. Exp. 7(1), 13 (2023). https:\/\/doi.org\/10.1186\/s41747-023-00364-7","DOI":"10.1186\/s41747-023-00364-7"},{"key":"1184_CR20","doi-asserted-by":"publisher","unstructured":"Sadr, H., et al.: Unveiling the potential of artificial intelligence in revolutionizing disease diagnosis and prediction: a comprehensive review of machine learning and deep learning approaches. Eur. J. Med. Res 30(1), 26 (2025). https:\/\/doi.org\/10.1186\/s40001-025-02680-7","DOI":"10.1186\/s40001-025-02680-7"},{"key":"1184_CR21","doi-asserted-by":"publisher","unstructured":"Zhang, X., et al.: Clinical research on artificial intelligence medical diagnostic devices: a scoping review. EngMedicine 3(1), 100120 (2026). https:\/\/doi.org\/10.1016\/j.engmed.2026.100120","DOI":"10.1016\/j.engmed.2026.100120"},{"key":"1184_CR22","doi-asserted-by":"publisher","unstructured":"Tikhomirov, L., et al.: A scoping review of silent trials for medical artificial intelligence. Nat. Health (2026). https:\/\/doi.org\/10.1038\/s44360-025-00048-z. Accessed 17 Feb. 2026","DOI":"10.1038\/s44360-025-00048-z"},{"key":"1184_CR23","unstructured":"National Academy of Medicine; The Learning Health System Series; Whicher D, Ahmed M, Israni ST, et al. (eds) Artificial intelligence in health care: the hope, the hype, the promise, the Peril. Washington (DC): National Academies Press (US), et al.: Aug 2. 7, Health care artificial intelligence: law, regulation, and policy. (2023). Available from: https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK605945\/"},{"key":"1184_CR24","doi-asserted-by":"publisher","unstructured":"Xu H, Michael K.: Medical artificial intellegence and the black box problem\u2014a view based on the ethical principle of do no harm. Intelligent Med. 4(1), (2023). https:\/\/doi.org\/10.1016\/j.imed.2023.08.001","DOI":"10.1016\/j.imed.2023.08.001"},{"key":"1184_CR25","unstructured":"Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. No. 108\u2013173, 117 Stat. (2066) (2003)"},{"key":"1184_CR26","doi-asserted-by":"publisher","unstructured":".Social Security Act \u00a7 1862(a)(1)(A), codified at 42 U.S.C. \u00a7 1395y(a)(1)(A), Mello MM, Trotsyuk AA, Jalil A, Char D.: The AI arms race in health insurance utilization review: promises of efficiency and risks of supercharged flaws. Health Affairs 45(1), 6\u201313 (2026). https:\/\/doi.org\/10.1377\/hlthaff.2025.00897","DOI":"10.1377\/hlthaff.2025.00897"},{"key":"1184_CR27","doi-asserted-by":"publisher","unstructured":"Medicare Program Integrity Manual, CMS Pub. 100-08, ch. 3, \u00a7 3.2.3.3 (Clinical Review Judgment), available at https:\/\/www.cms.gov\/Regulations-and-Guidance\/Guidance\/Manuals\/Downloads\/pim83c03.pdf. Centers for Medicare & Medicaid Services, Mello, M.M., Trotsyuk, A.A., Jalil, A., Char, D.: The AI arms race in health insurance utilization review: promises of efficiency and risks of supercharged flaws. Health Affairs. 45(1), 6\u201313. (2026). https:\/\/doi.org\/10.1377\/hlthaff.2025.00897","DOI":"10.1377\/hlthaff.2025.00897"},{"key":"1184_CR28","doi-asserted-by":"crossref","unstructured":"Ye, J., et al.: The role of artificial intelligence for the application of integrating electronic health records and patient-generated data in clinical decision support. AMIA Summ. Transl. Sci. Proc 31, 459 (2024).","DOI":"10.1101\/2024.05.01.24306690"},{"key":"1184_CR29","doi-asserted-by":"publisher","unstructured":"Lee, C., et al.: Prospects for AI clinical summarization to reduce the burden of patient chart review. Front Digit Health 6, 7 (2024). https:\/\/doi.org\/10.3389\/fdgth.2024.1475092","DOI":"10.3389\/fdgth.2024.1475092"},{"key":"1184_CR30","doi-asserted-by":"publisher","first-page":"53","DOI":"10.1186\/s12962-025-00640-w","volume":"23","author":"M Ramezani-a","year":"2025","unstructured":"Ramezani-a, M., Bakhtiari, A., Mobinizadeh, M., et al.: Artificial intelligence applications in health insurances: a scoping review. Cost Eff. Resour. Alloc. 23, 53 (2025). https:\/\/doi.org\/10.1186\/s12962-025-00640-w","journal-title":"Cost Eff. Resour. Alloc"},{"key":"1184_CR31","unstructured":"Institute of Medicine (US) Committee on Utilization Management by Third Parties; Gray BH, Field MJ (eds) Controlling costs and changing patient care? The role of utilization management. Washington (DC): National Academies Press (US): Appendix A, Legal Implications of Utilization Review. (1989). Available from: https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK234991\/"},{"key":"1184_CR32","doi-asserted-by":"publisher","unstructured":"Hendrix, N., et al.: Assessing the economic value of clinical artificial intelligence: challenges and opportunities. Value Health. 25(3) (2021). https:\/\/doi.org\/10.1016\/j.jval.2021.08.015","DOI":"10.1016\/j.jval.2021.08.015"},{"key":"1184_CR33","unstructured":"Centers for Medicare & Medicaid Services: Medicare Program Integrity Manual, CMS Pub. 100-08, ch. 3, \u00a7 3.5.1 (Automated Review)"},{"key":"1184_CR34","unstructured":"Wilson v: Blue Cross of Southern California, 222 Cal. App. 3d 660 (Cal. Ct App (1990)"},{"key":"1184_CR35","doi-asserted-by":"crossref","unstructured":"Wickline v. State, 192 Cal. App. 3d 1630: (1986)","DOI":"10.1007\/978-1-349-18269-5_8"},{"key":"1184_CR36","unstructured":"Social Security Act \u00a7: 1902(a)(42)(B), 42 U.S.C. \u00a7 1396a(a)(42)(B)"},{"key":"1184_CR37","unstructured":"Social Security Act \u00a7: 1893, 42 U.S.C. \u00a7 1395ddd (Medicare Integrity Program)"},{"key":"1184_CR38","unstructured":"Shannon v. McNulty, 718 A.2d 828: (1998)"},{"key":"1184_CR39","doi-asserted-by":"publisher","unstructured":"Teo, W.Z.W., et al.: Medicolegal sidebar: (mis)informed consent in medical negligence lawsuits. Clin. Orthopaed. Relat. Res 475(11), 2643\u20132646, (2017). https:\/\/doi.org\/10.1007\/s11999-017-5493-4","DOI":"10.1007\/s11999-017-5493-4"},{"key":"1184_CR40","unstructured":"Vanderpool, D.: The standard of care. Innovat. Clin. Neurosci. 18(7\u20139), 50 (2021)."},{"key":"1184_CR41","doi-asserted-by":"publisher","unstructured":"Cyr, M.E., et al.: Access to specialty healthcare in urban versus rural us populations: a systematic literature review. BMC Health Serv. Res. 19(1) (2020). https:\/\/doi.org\/10.1186\/s12913-019-4815-5","DOI":"10.1186\/s12913-019-4815-5"},{"key":"1184_CR42","unstructured":"Restatement: (Second) of Torts \u00a7 299A (1965)"},{"key":"1184_CR43","doi-asserted-by":"publisher","unstructured":"Bal, B., Sonny: The expert witness in medical malpractice litigation. Clin. Orthopaed. Relat. Res. 467(2), 383\u2013391 (2008). https:\/\/doi.org\/10.1007\/s11999-008-0634-4","DOI":"10.1007\/s11999-008-0634-4"},{"key":"1184_CR44","doi-asserted-by":"crossref","unstructured":"Brune v. Belinkoff, 354 Mass. 102, 235\u00a0N.E.2d 793: (1968)","DOI":"10.1007\/BF00503392"},{"key":"1184_CR45","unstructured":"Johnson v. Kokemoor, 199 Wis. 2d 615, 545\u00a0N.W.2d 495: (1996)"},{"key":"1184_CR46","doi-asserted-by":"publisher","unstructured":"Rowland, S.P., et al.: Digital health technology-specific risks for medical malpractice liability. NPJ Digital Med. 5(1), 1\u20136 (2022). https:\/\/doi.org\/10.1038\/s41746-022-00698-3","DOI":"10.1038\/s41746-022-00698-3"},{"key":"1184_CR47","unstructured":"Medtronic: Inc v Lohr 518 U S 470 (1996)"},{"key":"1184_CR48","unstructured":"Hunsaker v. Surgidev Corp., 818 F.2d 744: (1987)"},{"key":"1184_CR49","unstructured":"Riegel v, Medtronic: Inc 552 U S 312 (2008)"},{"key":"1184_CR50","doi-asserted-by":"publisher","unstructured":"Schneider, F., et al.: International organization for standardization (ISO) 15189. Ann. Lab. Med 37(5), 365 (2017). https:\/\/doi.org\/10.3343\/alm.2017.37.5.365","DOI":"10.3343\/alm.2017.37.5.365"}],"container-title":["AI and Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43681-026-01184-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s43681-026-01184-2","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43681-026-01184-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T12:06:35Z","timestamp":1782129995000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s43681-026-01184-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,23]]},"references-count":50,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,6]]}},"alternative-id":["1184"],"URL":"https:\/\/doi.org\/10.1007\/s43681-026-01184-2","relation":{},"ISSN":["2730-5953","2730-5961"],"issn-type":[{"value":"2730-5953","type":"print"},{"value":"2730-5961","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,23]]},"assertion":[{"value":"17 March 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 May 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 May 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"318"}}