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.
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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. LI Qing, QIU Ying-peng, WU Di, et al.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]. CHINESE HEALTH ECONOMICS,2023,42(5):5-8.