Jia Jinrun, Zhao Shiqiao
School of Law, Xi'an Jiaotong University, Xi'an, Shaanxi Province, People's Republic of China.
J Multidiscip Healthc. 2025 Sep 1;18:5405-5419. doi: 10.2147/JMDH.S541271. eCollection 2025.
The application of generative artificial intelligence (AI) technology in the healthcare sector can significantly enhance the efficiency of China's healthcare services. However, risks persist in terms of accuracy, transparency, data privacy, ethics, and bias. These risks are manifested in three key areas: first, the potential erosion of human agency; second, issues of fairness and justice; and third, questions of liability and responsibility. This study reviews and analyzes the legal and regulatory frameworks established in China for the application of generative AI in healthcare, as well as relevant academic literature. Our research findings indicate that while China is actively constructing an ethical and legal governance framework in this field, the regulatory system remains inadequate and faces numerous challenges. These challenges include lagging regulatory rules; an unclear legal status of AI in laws such as the Civil Code; immature standards and regulatory schemes for medical AI training data; and the lack of a coordinated regulatory mechanism among different government departments. In response, this study attempts to establish a governance framework for generative AI in the medical field in China from both legal and ethical perspectives, yielding relevant research findings. Given the latest developments in generative AI in China, it is necessary to address the challenges of its application in the medical field from both ethical and legal perspectives. This includes enhancing algorithm transparency, standardizing medical data management, and promoting AI legislation. As AI technology continues to evolve, more diverse technical models will emerge in the future. This study also proposes that to address potential risks associated with medical AI, efforts should be made to establish a global AI ethics review committee to promote the formation of internationally unified ethical and legal review mechanisms.
生成式人工智能（AI）技术在医疗保健领域的应用能够显著提高中国医疗服务的效率。然而，在准确性、透明度、数据隐私、伦理和偏差方面，风险依然存在。这些风险体现在三个关键领域：其一，人类自主性可能受到侵蚀；其二，公平与正义问题；其三，责任归属问题。本研究回顾并分析了中国针对生成式AI在医疗保健领域应用所建立的法律法规框架以及相关学术文献。我们的研究结果表明，尽管中国正在积极构建该领域的伦理和法律治理框架，但监管体系仍不完善，面临诸多挑战。这些挑战包括监管规则滞后；在《民法典》等法律中AI的法律地位不明确；医疗AI训练数据的标准和监管方案不成熟；以及不同政府部门之间缺乏协调的监管机制。对此，本研究试图从法律和伦理两个角度为中国医疗领域的生成式AI建立一个治理框架，并得出相关研究结果。鉴于中国生成式AI的最新发展情况，有必要从伦理和法律两个角度应对其在医疗领域应用所带来的挑战。这包括提高算法透明度、规范医疗数据管理以及推动AI立法。随着AI技术不断发展，未来将会出现更多样化的技术模型。本研究还提议，为应对与医疗AI相关的潜在风险，应努力建立一个全球AI伦理审查委员会，以促进形成国际统一的伦理和法律审查机制。
