|
[1]
|
张鑫, 孙腾. 关于医疗器械可用性工程的探讨[J]. 中国仪器仪表, 2022(7): 31-33.
|
|
[2]
|
彭亮, 刘枭寅. 人工智能医疗器械典型产品注册情况分析[J]. 中国食品药品监管, 2024(2): 16-23.
|
|
[3]
|
张守营, 杜壮. 我国正式全面启动“人工智能+”新时代——八位权威专家全面解读《关于深入实施“人工智能+”行动的意见》[J]. 新型城镇化, 2025(10): 46-47.
|
|
[4]
|
赵阳, 边旭, 杜惠琴. 2024年我国人工智能医疗器械注册管理状况及产业发展趋势[M]//中国药品监督管理研究会. 中国医疗器械行业发展报告. 北京: 社会科学文献出版社, 2025: 49-59.
|
|
[5]
|
王世敏. 人工智能医疗器械的现状及发展趋势[J]. 张江科技评论, 2025(7): 150-152.
|
|
[6]
|
国家食品药品监督管理总局. YY/T 1474-2016医疗器械 可用性工程对医疗器械的应用[S]. 北京: 中国标准出版社, 2016.
|
|
[7]
|
国家药品监督管理局. YY/T 9706.106-2021医用电气设备 第1-6部分: 基本安全和基本性能的通用要求 并列标准: 可用性[S]. 北京: 中国标准出版社, 2021.
|
|
[8]
|
樊琳. YY/T 9706.106-2021《医用电气设备 第1-6部分: 基本安全和基本性能的通用要求 并列标准: 可用性》标准要求分析与探讨[J]. 中国医疗器械信息, 2024, 30(21): 35-37, 47.
|
|
[9]
|
聂艳艳, 郭大为, 刘东岩, 等. 基于人因工程学的761例医疗器械召回事件分析与探讨[J]. 医疗卫生装备, 2021,4 2(11): 80-82, 108.
|
|
[10]
|
卢岩, 陈娟, 张婷, 等. 全球人工智能医疗器械临床试验注册现状分析[J]. 生物医学工程学杂志, 2025, 42(3): 512-519.
|
|
[11]
|
Tjoa, E. and Guan, C. (2021) A Survey on Explainable Artificial Intelligence (XAI): Toward Medical Xai. IEEE Transactions on Neural Networks and Learning Systems, 32, 4793-4813. https://doi.org/10.1109/tnnls.2020.3027314
|
|
[12]
|
Barredo Arrieta, A., Díaz-Rodríguez, N., Del Ser, J., Bennetot, A., Tabik, S., Barbado, A., et al. (2020) Explainable Artificial Intelligence (XAI): Concepts, Taxonomies, Opportunities and Challenges toward Responsible AI. Information Fusion, 58, 82-115. https://doi.org/10.1016/j.inffus.2019.12.012
|
|
[13]
|
Markus, A.F., Kors, J.A. and Rijnbeek, P.R. (2021) The Role of Explainability in Creating Trustworthy Artificial Intelligence for Health Care: A Comprehensive Survey of the Terminology, Design Choices, and Evaluation Strategies. Journal of Biomedical Informatics, 113, Article ID: 103655. https://doi.org/10.1016/j.jbi.2020.103655
|
|
[14]
|
Endsley, M.R. (1995) Toward a Theory of Situation Awareness in Dynamic Systems. Human Factors: The Journal of the Human Factors and Ergonomics Society, 37, 32-64. https://doi.org/10.1518/001872095779049543
|
|
[15]
|
MacNamee, K. (2020) Analysis: A Neurocognitive Approach to Developing Safer Medical Devices. Biomedical Instrumentation & Technology, 54, 28-36. https://doi.org/10.2345/0899-8205-54.1.28
|
|
[16]
|
Johnson-Laird, P.N. (1983) Mental Models: Towards a Cognitive Science of Language, Inference, and Consciousness. Harvard University Press.
|
|
[17]
|
Dietvorst, B.J., Simmons, J.P. and Massey, C. (2015) Algorithm Aversion: People Erroneously Avoid Algorithms after Seeing Them Err. Journal of Experimental Psychology: General, 144, 114-126. https://doi.org/10.1037/xge0000033
|
|
[18]
|
Egala, B. and Liang, D. (2024) Algorithm Aversion to Mobile Clinical Decision Support among Clinicians: A Choice-Based Conjoint Analysis. Journal of Information Systems, 20, 1-22.
|
|
[19]
|
Skitka, L.J., Mosier, K.L. and Burdick, M. (1999) Does Automation Bias Decision-Making? International Journal of Human-Computer Studies, 51, 991-1006. https://doi.org/10.1006/ijhc.1999.0252
|
|
[20]
|
Parasuraman, R. and Manzey, D.H. (2010) Complacency and Bias in Human Use of Automation: An Attentional Integration. Human Factors: The Journal of the Human Factors and Ergonomics Society, 52, 381-410. https://doi.org/10.1177/0018720810376055
|
|
[21]
|
Rezaeian, O., Bayrak, A.E. and Asan, O. (2025) Explainability and AI Confidence in Clinical Decision Support Systems: Effects on Trust, Diagnostic Performance, and Cognitive Load in Breast Cancer Care. International Journal of Human-Computer Interaction, 42, 4477-4497. https://doi.org/10.1080/10447318.2025.2539458
|
|
[22]
|
Jussupow, E., Spohrer, K., Heinzl, A. and Gawlitza, J. (2021) Augmenting Medical Diagnosis Decisions? An Investigation into Physicians’ Decision-Making Process with Artificial Intelligence. Information Systems Research, 32, 713-735. https://doi.org/10.1287/isre.2020.0980
|
|
[23]
|
Tschandl, P., Rinner, C., Apalla, Z., Argenziano, G., Codella, N., Halpern, A., et al. (2020) Human-Computer Collaboration for Skin Cancer Recognition. Nature Medicine, 26, 1229-1234. https://doi.org/10.1038/s41591-020-0942-0
|
|
[24]
|
Xu, F., Sepúlveda, M., Jiang, Z., Wang, H., Li, J., Yin, Y., et al. (2019) Artificial Intelligence Treatment Decision Support for Complex Breast Cancer among Oncologists with Varying Expertise. JCO Clinical Cancer Informatics, 3, 1-15. https://doi.org/10.1200/cci.18.00159
|
|
[25]
|
Okada, Y., Ning, Y. and Ong, M.E.H. (2023) Explainable Artificial Intelligence in Emergency Medicine: An Overview. Clinical and Experimental Emergency Medicine, 10, 354-362. https://doi.org/10.15441/ceem.23.145
|
|
[26]
|
Croskerry, P. (2002) Achieving Quality in Clinical Decision Making: Cognitive Strategies and Detection of Bias. Academic Emergency Medicine, 9, 1184-1204. https://doi.org/10.1197/aemj.9.11.1184
|
|
[27]
|
Vearrier, L., Derse, A.R., Basford, J.B., Larkin, G.L. and Moskop, J.C. (2022) Artificial Intelligence in Emergency Medicine: Benefits, Risks, and Recommendations. The Journal of Emergency Medicine, 62, 492-499. https://doi.org/10.1016/j.jemermed.2022.01.001
|
|
[28]
|
Chenais, G., Lagarde, E. and Gil-Jardiné, C. (2023) Artificial Intelligence in Emergency Medicine: Viewpoint of Current Applications and Foreseeable Opportunities and Challenges. Journal of Medical Internet Research, 25, e40031. https://doi.org/10.2196/40031
|
|
[29]
|
Lyell, D., Wang, Y., Coiera, E. and Magrabi, F. (2023) More than Algorithms: An Analysis of Safety Events Involving ML-Enabled Medical Devices Reported to the FDA. Journal of the American Medical Informatics Association, 30, 1227-1236. https://doi.org/10.1093/jamia/ocad065
|
|
[30]
|
张建楠, 李莹莹, 周佳卉, 朱烨琳, 李兰娟. 人工智能独立医用软件监管研究[J]. 中国工程科学, 2022, 24(1): 198-204.
|
|
[31]
|
Asan, O. and Choudhury, A. (2021) Research Trends in Artificial Intelligence Applications in Human Factors Health Care: Mapping Review. JMIR Human Factors, 8, e28236. https://doi.org/10.2196/28236
|
|
[32]
|
Sujan, M., Pool, R. and Salmon, P. (2022) Eight Human Factors and Ergonomics Principles for Healthcare Artificial Intelligence. BMJ Health & Care Informatics, 29, e100516. https://doi.org/10.1136/bmjhci-2021-100516
|