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題名：系統性規範人工智慧醫療器材軟體之必要性
書刊名：月旦醫事法報告
作者：Gerke, Sara／Babic, Boris／Evgeniou, Theodoros／Cohen, I. Glenn／陳怡君
作者(外文)：Chen, Yi-chun
出版日期：2022
卷期：64
頁次：頁111-125
主題關鍵詞：人工智慧；機器學習；醫療器材軟體；AI；ML
原始連結：連回原系統網址new window
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  • 點閱點閱:1
期刊論文
1.Danziger, Shai、Levav, Jonathan、Avnaim-Pesso, Liora(2011)。Extraneous Factors in Judicial Decisions。Proceedings of the National Academy of Sciences of the United States of America，108(17)，6889-6892。  new window
2.Abràmoff, Michael D.、Lavin, Philip T.、Birch, Michele、Shah, Nilay、Folk, James C.(2018)。Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices。Npj Digital Medicine，1，(39)1-(39)8。  new window
3.Babic, Boris、Gerke, Sara、Evgeniou, Theodoros、Cohen, I. Glenn(2019)。Algorithms on Regulatory Lockdown in Medicine。Science，366，1202-1204。  new window
4.Lehman, Constance D.、Wellman, Robert D.、Buist, Diana S. M.、Kerlikowske, Karla、Tosteson, Anna N. A.、Miglioretti, Diana L.、The Breast Cancer Surveillance Consortium(2015)。Diagnostic Accuracy of Digital Screening Mammography with and without Computer-Aided Detection。JAMA Internal Medicine，175(11)，1828-1837。  new window
5.Emanuel, Ezekiel J.、Wachter, Robert M.(2019)。Artificial Intelligence in Health Care: Will the Value Match the Hype?。The Journal of American Medical Association，321(23)，2281-2282。  new window
6.Shah, Pratik、Kendall, Francis、Khozin, Sean、Goosen, Ryan、Hu, Jianying、Laramie, Jason、Ringel, Michael、Schork, Nicholas(2019)。Artificial Intelligence and Machine Learning in Clinical Development: A Translational Perspective。Npj Digital Medicine，2。  new window
7.Brynjolfsson, Erik、Hitt, Lorin M.(2000)。Beyond Computation: Information Technology, Organizational Transformation and Business Performance。The Journal of Economic Perspectives，14(4)，23-48。  new window
8.Tversky, Amos、Kahneman, Daniel(1974)。Judgment under Uncertainty: Heuristics and Biases: Biases in judgments reveal some heuristics of thinking under uncertainty。Science，185(4157)，1124-1131。  new window
圖書
1.Kasparov, Garry(2017)。Deep Thinking: Where Machine Intelligence Ends And Human Creativity Begins。  new window
2.FDA(2019)。Developing a Software Precertification Program: A Working Model。  new window
單篇論文
1.FDA(2018)。De Novo Classification Request for IDx-DR，https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180001.pdf。  new window
2.UK Statutory Instruments。Explanatory memorandum to the UK Human Fertilisation and Embryology (Mitochondrial Donation) Regulations，https://www.legislation.gov.uk/uksi/2015/572/memorandum/contents。  new window
其他
1.IDx Technologies Inc.。Autonomous AI that Instantly Detects Disease，https://www.eyediagnosis.net。  new window
2.FDA。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，https://www.fda.gov/media/122535/download。  new window
3.FDA。Software as a Medical Device (SaMD)，https://www.fda.gov/medical-devices/digital-health/software-medical-device-samd。  new window
4.IMDRF SaMD Working Group(2013)。Software as a Medical Device (SaMD): Key Definitions，http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-keydefinitions-140901.pdf。  new window
5.FDA's Sentinel Initiative，https://www.fda.gov/safety/fdassentinel-initiative。  new window
 
 
 
 
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