数智时代医疗人工智能的潜在法律风险及规制措施

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Abstract The emergence of medical artificial intelligence has triggered the digital transformation of physician diagnosis and treatment activities.The policy documents at the normative level demonstrate an attitude of encouraging innovation while regulating risks,which,accompanied with the dual characteristics of advantages and disadvantages of medical AI in practice,arouses the internal demand of medical AI risk regulation.The practical risks caused by medical AI in the current technical stage mainly include the judgment deviation of image recognition system,the calculation distortion of medical expert system and the out of control of medical robot behavior.The affirmation theory of medical AI subject qualification,which attempts to regulate risks on the grounds that independent consciousness will inevitably emerge in the future,is too early and has no practical significance.The principle of proportionality should be introduced into the risk regulation of medical AI,and the binary standard of the principle of appropriateness should be set according to the informed consent of patients.The dual structure of the principle of minimum infringement and the differentiated review mechanism of the principle of proportionality should be constructed by the division of medical diseases.At the same time,the analytic hierarchy process was used to quantitatively analyze the impact of AI type,disease severity,informed consent of patients,and profit and loss of AI on the limit of medical artificial intelligence application,so as to determine the feasibility and risk of AI application in a quantitative form.

Key words： Medical artificial intelligence Risk regulation Principle of proportionality Informed consent of patients Analytic hierarchy process

Received: 07 June 2023

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D912.1

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	You Junzhe
	Ding Dairui

Cite this article:

You Junzhe,Ding Dairui. Potential Legal Risks and Regulatory of Medical Artificial Intelligence in the Era of Digital Intelligence[J]. , 2025, 6(3): 129-140.

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http://www.zgkjlt.org.cn/EN/ OR http://www.zgkjlt.org.cn/EN/Y2025/V6/I3/129

[1]中国政府网.全国医师数量逾428万人[EB/OL].(2022-08-26)[2023-03-17].https://www.gov.cn/xinwen/2022-08/26/content_5706887.htm.
[2]郝晨幸,周娜,张晓春.人工智能——开启医学新时代[J].精准医学杂志,2021,36(5):465.
[3]KIM G R,LEE E,KIM H R,et al.Convolutional neural network to stratify the malignancy risk of thyroid nodules:Diagnostic performance compared with the American college of radiology thyroid imaging reporting and data system implemented by experienced radiologists[J].American Journal of Neuroradiology,2021,42(8):1513-1519.
[4]BUDA M,WILDMAN-TOBRINER B,HOANG J K,et al.Management of thyroid nodules seen on US images:Deep learning may match performance of radiologists[J].Radiology,2019,292(3):695-701.
[5]MADANI A,ARNAOUT R,MOFRAD M,et al.Fast and accurate view classification of echocardiograms using deep learning[J].Nature Partner Journals:Digital Medicine,2018(1):6.
[6]周泊阳,石一磊,郭乐杭,等.人工智能技术赋能超声影像用于肝脏疾病精准诊疗[J].中国血吸虫病防治杂志,2022,34(5):461.
[7]刘再毅,石镇维.医学影像人工智能:进展和未来[J].国际医学放射学杂志,2023,46(1):2.
[8]陈闻天,黄鹤,于汉杰,等.甲型流感病毒基因组的进化与变异[J].中国病毒病杂志,2018,8(5):411.
[9]卢培佩,胡建安.计算机专家系统在疾病诊疗中应用和发展[J].实用预防医学,2011,18(6):1169.
[10]胡春雷,侯佳宁,靳枫,等.沃森肿瘤解决方案系统在我国结肠癌综合治疗决策中的应用价值评估[J].中国医学前沿杂志,2018,10(10):116.
[11]陈毅德,高应勤,郑文慧,等.沃森肿瘤学治疗中国食管癌患者与厦门市肿瘤中心的一致性及适用性检验评价[J].中国当代医药,2021,28(30):96.
[12]刘虎,包楚阳,向丽娟,等.应用沃森肿瘤解决方案评价胃癌术后辅助治疗获益的研究[J].安徽医科大学学报,2019,54(8):1321.
[13]陈小平.跨学科视野下医疗机器人的进展与挑战[J].生命科学,2022,34(8):966.
[14]宋学民,徐君毅,以敏,等.达芬奇手术机器人系统对胃癌根治性切除术患者胃肠功能恢复及免疫功能的影响[J].中国医学装备,2022,19(7):91.
[15]谢京茂,易波.不同类型手术机器人全直肠系膜切除术短期疗效的比较[J].中国临床医学,2022,29(4):630.
[16]杜亚丽,李鹰,马锦琪,等.达芬奇手术机器人与常规腹腔镜手术治疗子宫内膜癌的比较研究[J].中国现代手术学杂志,2022,26(5):398.
[17]张剑宁,刘嘉霖.手术机器人推动神经外科进入新时代[J].四川大学学报(医学版),2022,53(4):556.
[18]夏兵,王新茹,马雪皎,等.基于FDA MAUDE数据库的手术机器人不良事件数据的智能化分析[J].医疗卫生装备,2023,44(2):77.
[19]郭剑平.制度变迁史视域下人工智能法律主体地位的法理诠释[J].北方法学,2020,14(6):123.
[20]骁克.论人工智能法律主体的法哲学基础[J].政治与法律,2021(4):109.
[21]彭诚信,陈吉栋.论人工智能体法律人格的考量要素[J].当代法学,2019,33(2):52.
[22]袁曾.基于功能性视角的人工智能法律人格再审视[J].上海大学学报(社会科学版),2020,37(1):16.
[23]刘云.论人工智能的法律人格制度需求与多层应对[J].东方法学,2021(1):61.
[24]郭少飞.人工智能“电子人”权利能力的法构造[J].甘肃社会科学,2019(4):108.
[25]王春梅,冯源.技术性人格:人工智能主体资格的私法构设[J].华东政法大学学报,2021,24(5):69.
[26]杨清望,张磊.论人工智能的拟制法律人格[J].湖南科技大学学报(社会科学版),2018,21(6):91.
[27]冯洁.人工智能体法律主体地位的法理反思[J].东方法学,2019(4):43.
[28]龙敏.自动驾驶交通肇事刑事责任的认定与分配[J].华东政法大学学报,2018,21(6):82.
[29]赵申豪.自动驾驶汽车侵权责任研究[J].江西社会科学,2018,38(7):211.
[30]司晓,曹建峰.论人工智能的民事责任:以自动驾驶汽车和智能机器人为切入点[J].法律科学,2017,35(5):173.
[31]刘练军.人工智能法律主体论的法理反思[J].现代法学,2021,43(4):73.
[32]马治国,徐济宽.人工智能发展的潜在风险及法律防控监管[J].北京工业大学学报(社会科学版),2018,18(6):65.
[33]张善根.人工智能从属法律主体论的理论基础与技术甄别[J].求索,2021(6):169.
[34]赵万一.机器人的法律主体地位辨析——兼谈对机器人进行法律规制的基本要求[J].贵州民族大学学报(哲学社会科学版),2018(3):158.
[35]李润生.论医疗人工智能的法律规制——从近期方案到远期设想[J].行政法学研究,2020(4):50.
[36]谈在祥,蒋雨彤.医疗人工智能侵权行为法律规制研究[J].医学与哲学,2022,43(14):64.
[37]王素芳,孙爱青,张新华.人工智能在临床应用中的侵权责任探析[J].医学与法学,2021,13(5):72.
[38]梅扬.比例原则的立法适用与展开[J].甘肃政法大学学报,2022(4):11.
[39]汤晓华,毕伊,陈霞,等.我院抗肿瘤药物临床试验知情同意书伦理审查问题分析[J].中国药房,2023,34(6):649.
[40]袁江帆,陈伟,刘诗卉,等.《民法典》背景下我国医疗知情同意履行方式探究[J].中国医院,2023,27(3):80.
[41]中国保险行业协会.重大疾病保险的疾病定义使用规范[EB/OL].(2020-11-05)[2023-05-09].http://www.iachina.cn/art/2020/11/5/art_8616_104704.html.