引用本文: 李清,邱英鹏,吴迪,等.基于利益相关者理论的人工智能医疗技术临床应用评估需求分析[J].中国卫生经济,2023,42(5):5-8.[点击复制] LI Qing,QIU Ying-peng,WU Di,et al.Requirements Analysis of Clinical Application Evaluation of Artificial Intelligence Medical Technology Based on Stakeholder Theory[J].CHINESE HEALTH ECONOMICS,2023,42(5):5-8.[点击复制]
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基于利益相关者理论的人工智能医疗技术临床应用评估需求分析
李清,邱英鹏,吴迪,王健,史黎炜,刘克军,肖月
0
(国家卫生健康委卫生发展研究中心 北 京 100191;国家卫生健康委卫生发展研究中心暨国家药品和卫生技术综合评估中心 北 京 100191;哈尔滨医科大学卫生管理学院卫生经济学教研室哈尔滨 150081)
摘要:
目的:对人工智能(AI)医疗技术的临床应用评估需求进行研究,了解研发生产方、决策管理方和临床应用方对评估的需求,助力技术研发与推广。方法:通过文献综述和专家咨询方法了解AI医疗技术临床使用的利益相关者,并使用问卷调查法获取利益相关者对AI医疗技术临床应用价值和评估需求的反馈。结果:利益相关者主要是人工智能医疗器械生产企业、国家药品监督管理局、卫生健康委、医保局、医疗机构和患者;利益相关者普遍认为人工智能医疗技术具有较好的应用前景,并认为应关注对于安全性、临床需求和有效性的评估。结论:虽然AI医疗技术的应用范围仍较局限,但利益相关者对人工智能医疗技术临床应用评估需求旺盛。
关键词:  人工智能医疗技术  临床应用  评估  需求分析  利益相关者理论
DOI:
投稿时间:2023-03-31
基金项目:
Requirements Analysis of Clinical Application Evaluation of Artificial Intelligence Medical Technology Based on Stakeholder Theory
LI Qing,QIU Ying-peng,WU Di,WANG Jian,SHI Li-wei,LIU Ke-jun,XIAO Ye
()
Abstract:
Objective: To investigate the evaluation needs of clinical applications of artificial intelligence (AI) medical technology,understand the evaluation needs of research and development,decision-making,management,and clinical application stakeholders,and assist in the development and promotion of technology. Methods: Methods of literature review and expert consultation were applied to identify the stakeholders of AI medical device products in clinical use,and a questionnaire survey was used to obtain feedbacks on the clinical application value and evaluation needs of AI medical device products. Results: The stakeholders were mainly AI medical device manufacturers,the National Medical Products Administration,the Health Commission,the Medical Insurance Bureau,medical institutions,and patients. They generally believed that AI medical technology has good application prospects and should focus on safety,clinical needs and effectiveness evaluation. Conclusion: Although the application scope of AI medical technology is still limited,stakeholders have a strong demand for the evaluation of AI medical device products in clinical settings.
Key words:  artificial intelligence medical technology  clinical application  evaluation  requirement analysis  stakeholder analysis

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