{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T12:34:17Z","timestamp":1793277257459,"version":"4.5.0"},"reference-count":45,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T00:00:00Z","timestamp":1793232000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Public Health"],"abstract":"<jats:p>With the deep integration of artificial intelligence (AI) technologies into public health and clinical care, challenges including dynamic algorithm iteration, data security risks, and ambiguous liability allocation pose multifaceted threats to traditional regulatory frameworks. Among these challenges, this study focuses specifically on the tension between static pre-market approval and the continuous iteration of AI-enabled medical systems. Globally, the European Union (EU), the United States (US), and Japan have developed distinct regulatory models that offer valuable lessons for China. This paper conducts a comparative analysis of medical AI regulatory logics and institutional practices across jurisdictions, with particular attention to algorithm modification, lifecycle oversight, and continuous post-market evaluation. Building on international experience, we propose an optimized institutional pathway for China that centers on differentiated algorithm-change control, continuous lifecycle evaluation, and risk-based regulatory adjustment, while treating liability allocation, risk classification, and data governance as supporting dimensions. This framework provides theoretical support and practical guidance for improving China's medical AI regulatory system, promoting standardized technology development, and supporting the orderly development of public health services in the digital health era.<\/jats:p>","DOI":"10.3389\/fpubh.2026.1962331","type":"journal-article","created":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T11:59:35Z","timestamp":1793275175000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Regulation of medical artificial intelligence in public health: governance lessons and implications for China"],"prefix":"10.3389","volume":"14","author":[{"given":"Jiayun","family":"Zhao","sequence":"first","affiliation":[{"name":"School of Health Economics and Management, Nanjing University of Chinese Medicine","place":["Nanjing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qing","family":"Chen","sequence":"additional","affiliation":[{"name":"School of Health Economics and Management, Nanjing University of Chinese Medicine","place":["Nanjing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,10,29]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.13723\/j.yxysh.2026.04.010","article-title":"Research on risk identification and regulation of the application of generative artificial intelligence algorithm in the medical field","author":"Chen","year":"2026","journal-title":"Med Soc"},{"key":"B2","doi-asserted-by":"publisher","first-page":"203","DOI":"10.14111\/j.cnki.zgfx.2023.01.011","article-title":"Medical damage liability of diagnostic artificial intelligence","author":"Zheng","year":"2023","journal-title":"China Legal Sci"},{"key":"B3","doi-asserted-by":"publisher","first-page":"151","DOI":"10.3969\/j.issn.2097-0749.2025.05.03","article-title":"Applying medical malpractice liability to clinical AI: dilemmas and solutions","volume":"49","author":"Wei","year":"2025","journal-title":"Human Rights Law Rev"},{"key":"B4","doi-asserted-by":"publisher","first-page":"9","DOI":"10.13723\/j.yxysh.2025.03.002","article-title":"Risks and regulations in the development of smart healthcare empowered by generative artificial intelligence technologies","volume":"38","author":"Wu","year":"2025","journal-title":"Med Soc."},{"key":"B5","doi-asserted-by":"publisher","first-page":"1630408","DOI":"10.3389\/fmed.2025.1630408","article-title":"A decade of review in global regulation and research of artificial intelligence medical devices (2015\u20132025)","volume":"12","author":"Zhang","year":"2025","journal-title":"Front Med."},{"key":"B6","unstructured":"Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations. IMDRF\/SaMD WG\/N12FINAL:2014\n          \n          2014"},{"key":"B7","volume-title":"Guiding Principles for Classification and Definition of Artificial Intelligence Medical Software Products (NMPA Announcement No. 47 of 2021).","year":"2021"},{"key":"B8","doi-asserted-by":"publisher","first-page":"27","DOI":"10.13723\/j.yxysh.2025.02.005","article-title":"Current status and improvement of the full process supervision system for artificial intelligence medical devices in China","volume":"38","author":"Tang","year":"2025","journal-title":"Med Soc."},{"key":"B9","volume-title":"Personal Information Protection Law of the People's Republic of China","year":"2021"},{"key":"B10","volume-title":"Data Security Law of the People's Republic of China","year":"2021"},{"key":"B11","volume-title":"Cybersecurity Law of the People's Republic of China","year":"2016"},{"key":"B12","doi-asserted-by":"publisher","first-page":"442","DOI":"10.1016\/j.imed.2026.05.001","article-title":"Expert consensus on the application and governance of artificial intelligence in medical institutions","volume":"6","author":"Cao","year":"2026","journal-title":"Intell Med."},{"key":"B13","doi-asserted-by":"publisher","first-page":"112","DOI":"10.12120\/bjutskxb202501112","article-title":"Dynamic risks and adaptive governance of generative artificial intelligence","volume":"25","author":"Xie","year":"2025","journal-title":"J Beijing Univ Technol."},{"key":"B14","doi-asserted-by":"publisher","first-page":"58","DOI":"10.13912\/j.cnki.chqm.2023.30.7.13","article-title":"International experience and implications of medical artificial intelligence technology evaluation and regulation","volume":"30","author":"Xiao","year":"2023","journal-title":"Chinese Health Qual Manag."},{"key":"B15","unstructured":"MDCG 2020-3 Rev.1: Guidance on Significant Changes Regarding the Transitional Provision Under Article 120 of the MDR With Regard to Devices Covered by Certificates According to MDD or AIMDD\n          \n          2023"},{"key":"B16","unstructured":"Regulation (EU) 2017\/745 on medical devices (MDR). Official Journal of the European Union, L117\/1\n          \n          2017"},{"key":"B17","doi-asserted-by":"publisher","first-page":"7261","DOI":"10.34172\/ijhpm.2022.7261","article-title":"The challenges of regulating artificial intelligence in healthcare","volume":"12","author":"McKee","year":"2023","journal-title":"Int J Health Policy Manag."},{"key":"B18","unstructured":"Food\n            \n            \n              U\n            \n          \n          Artificial Intelligence\/Machine Learning (AI\/ML)-Based Software as a Medical Device Action Plan\n          \n          2021"},{"key":"B19","unstructured":"United\n              States Congress\n            \n          \n          Food and Drug Omnibus Reform Act of 2022, \u00a7 3308, codified at 21 U.S.C. \u00a7 360e-4\n          \n          2022"},{"key":"B20","unstructured":"Food\n            \n            \n              U\n            \n          \n          Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions\n          \n          2025"},{"key":"B21","doi-asserted-by":"publisher","first-page":"e58080","DOI":"10.2196\/58080","article-title":"Exploring impediments imposed by the medical device regulation EU 2017\/745 on software as a medical device","volume":"12","author":"Svempe","year":"2024","journal-title":"JMIR Medical Informatics."},{"key":"B22","unstructured":"Delivering on the Promise of Medical AI: Can Japan's Regulators Keep Pace?\n          \n          2022"},{"key":"B23","doi-asserted-by":"publisher","first-page":"383","DOI":"10.3760\/cma.j.cn111325-20221203-01037","article-title":"Analysis of the application risks and legal strategies of intelligent medical algorithms","volume":"39","author":"Yue","year":"2023","journal-title":"Chinese J Hospital Adm."},{"key":"B24","doi-asserted-by":"crossref","first-page":"2254","DOI":"10.1145\/3630106.3659037","article-title":"Black-box access is insufficient for rigorous AI audits","volume-title":"Proceedings of the 2024 ACM Conference on Fairness, Accountability, and Transparency","author":"Casper","year":"2024"},{"key":"B25","unstructured":"Regulation (EU) 2024\/1689 on Artificial Intelligence (Artificial Intelligence Act)\n          \n          2024"},{"key":"B26","unstructured":"MDCG 2025-6: FAQ on Interplay between the Medical Devices Regulation (MDR) In Vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)\n          \n          2025"},{"key":"B27","doi-asserted-by":"publisher","first-page":"1","DOI":"10.5281\/zenodo.10078490","article-title":"Decoding U","volume":"27","author":"Duffourc","year":"2024","journal-title":"Stanford Technol Law Rev"},{"key":"B28","doi-asserted-by":"publisher","first-page":"456","DOI":"10.16507\/j.issn.1006-6055.2024.07.007","article-title":"International comparison and inspiration of artificial intelligence regulatory policies and measures","volume":"46","author":"Wang","year":"2024","journal-title":"World Sci-Tech RD."},{"key":"B29","volume-title":"Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc. (Act No. 145 of 1960)","year":"1960"},{"key":"B30","unstructured":"United\n              States Congress\n            \n          \n          United States Code, Title 21, Section 360c"},{"key":"B31","unstructured":"State of AI Governance Regulations in the United States\n          \n          2026"},{"key":"B32","unstructured":"Regulation (EU) 2016\/679 on the Protection of Natural Persons with Regard to the Processing of Personal Data (General Data Protection Regulation). Official Journal of the European Union, L119\/1\n          \n          2016"},{"key":"B33","volume-title":"Act on the Promotion of Research, Development, and Utilization of AI-Related Technology (Act No. 53 of 2025)","year":"2025"},{"key":"B34","unstructured":"Principles on Approval Review of SaMD\n          \n          2025"},{"key":"B35","doi-asserted-by":"publisher","first-page":"87","DOI":"10.16326\/j.cnki.1008-7168.2021.04.009","article-title":"Japan's medical care cooperation: operation mechanism and model enlightenment","volume":"23","author":"Ren","year":"2021","journal-title":"J Tianjin Adm Institute."},{"key":"B36","unstructured":"Policy adaptation of the \u201cregulatory state\u201d: the logic of EU artificial intelligence governance\n          \n          166\n          7\n          \n            \n              Yang\n              Z\n            \n          \n          Euro Stud\n          78\n          2025"},{"key":"B37","doi-asserted-by":"publisher","first-page":"127","DOI":"10.14180\/j.cnki.1004-0544.2023.08.014","article-title":"Public law regulation of artificial intelligence: U","author":"Shi","year":"2023","journal-title":"Theoretical Monthly"},{"key":"B38","doi-asserted-by":"publisher","first-page":"78","DOI":"10.16123\/j.cnki.issn.1000-355x.2026.01.006","article-title":"Governance of ethical risks in Japan's adaptive AI healthcare systems","volume":"45","author":"Chen","year":"2026","journal-title":"Contemp Econ Japan."},{"key":"B39","volume-title":"Recommendation on the Ethics of Artificial Intelligence","year":"2021"},{"key":"B40","doi-asserted-by":"publisher","first-page":"82","DOI":"10.12379\/j.issn.2096-1057.2026.01.10","article-title":"The EU artificial intelligence regulatory sandbox system and its enlightenment","volume":"12","author":"Xu","year":"2026","journal-title":"J Inf Security Res."},{"key":"B41","doi-asserted-by":"publisher","first-page":"24644","DOI":"10.48084\/etasr.11442","article-title":"Metrics and quality attributes of AI-based software as a medical device","volume":"15","author":"Ebad","year":"2025","journal-title":"Eng Technol Appl Sci Res"},{"key":"B42","doi-asserted-by":"publisher","first-page":"180","DOI":"10.13580\/j.cnki.fstc.2025.10.015","article-title":"Optimization of safety supervision system of generative artificial intelligence: European and American experience and its enlightenment","author":"He","year":"2025","journal-title":"Forum Sci Technol China"},{"key":"B43","doi-asserted-by":"publisher","first-page":"890","DOI":"10.1093\/jamia\/ocaa268","article-title":"Trust and medical AI: the challenges we face and the expertise needed to overcome them","volume":"28","author":"Quinn","year":"2021","journal-title":"J Am Med Inform Assoc."},{"key":"B44","volume-title":"Ethics and Governance of Artificial Intelligence for Health.","year":"2021"},{"key":"B45","unstructured":"United\n              States Congress\n            \n          \n          Federal Food, Drug, and Cosmetic Act, 21 U.S.C. \u00a7 301 et seq\n          \n          1938"}],"container-title":["Frontiers in Public Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2026.1962331\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T11:59:52Z","timestamp":1793275192000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2026.1962331\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,29]]},"references-count":45,"alternative-id":["10.3389\/fpubh.2026.1962331"],"URL":"https:\/\/doi.org\/10.3389\/fpubh.2026.1962331","relation":{},"ISSN":["2296-2565"],"issn-type":[{"value":"2296-2565","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,29]]},"article-number":"1962331"}}