参考文献/References:
.计算机科学与技术:人工智能[M].崔良沂,赵永昌,译.北京:清华大学出版社,2005:1-5.
[3]HAMET P, TREMBLAY J. Artificial intelligence in medicine [J]. Metabolism: Clinical and Experimental, 2017, 69: 36-40.
[4]蔡丽萍. 达芬奇手术机器人[A]//江西第十五次妇产科学学术年会论文集[C]. 南昌:江西省医学会,2016.
[5]魏东海, STEVEN S, LOUIS R, 等. 从远程医疗到互联网+人工智能(AI)医疗看医疗数字化的演进[J]. 中国研究型医院, 2022, 9(5): 64-76.
[6]孟岩,孙雪梅,王雪,等.人工智能技术应用于电子病历质控的研究与思考[J].中国卫生质量管理,2021,28(12):63-65.
[7]国家药品监督管理局. 关于政协十三届全国委员会第三次会议第4356号(医疗体育类581号)提案答复的函 [Z].2020.
[8]国家标准化管理委员会,中央网信办,国家发展改革委,等.关于印发《国家新一代人工智能标准体系建设指南》的通知:国标委联〔2020〕35号[EB/OL].(2020-07-27).http://www.thepaper.cn/newaDetail_ forward_ 8660010.
[9]国家医疗保障局,国家卫生健康委,国家发展改革委,等. 关于印发《深化医疗服务价格改革试点方案》的通知 :医保发〔2021〕41号[EB/OL].(2021-08-31).http://www.nhsa.gov.cn/art/2021/8/31/art_104_6542.html.
[10]国家医疗保障局. 关于完善骨科手术机器人“3D打印”等辅助操作价格及相关政策的指南(征求意见稿) [Z]. 2022.
[11]AGENCY MAHPR. Government response to consultation on the future regulation of medical devices in the United Kingdom[Z]. 2022.
[12]UNSWORTH H, DILLON B, COLLINSON L, et al. The NICE evidence standards framework for digital health and care technologies - developing and maintaining an innovative evidence framework with global impact [J]. Digital Health, 2021(7): 20-55.
[13]张世庆, 邓洁,章金刚.美国医疗器械监管模式概述[J].中国医疗器械信息,2009, 15(10): 62-66,82.
[14]ADMINISTRATION FAD. Proposed regulatory framework for modifications to Artificial Intelligence/Machine Learning (AI/ML)-based software as a medical device (SaMD) - discussion paper and request for feedback[Z]. 2021.
[15]ADMINISTRATION FAD. Digital health software precertification (Pre-Cert) program [Z].2019.
[16]EUROPEAN C.On artificial intelligence— a European approach to excellence and trust [Z].2020.
[17]EUROPEAN C.Intelligence high-level expert group on artificial,ethics guidelines for trustworthy AI[Z]. 2019.
[18]CASE W. Regulation of artificial intelligence in Europe and Japan[Z]. 2020.
[19][日]医薬·生活衛生局. AI技術を利用した医療機器の医薬品医療機器法上の取扱にかかる対応について [Z].厚生労働省,2019.