摘要
目的:解析世界卫生组织(WHO)《为基于人工智能的医疗设备生成证据:训练、验证和评估框架》(简称“WHO AIMD框架”),讨论对我国医学装备行业的启示。方法:分析WHO文本的基本要素,检索我国相关政策文件、期刊文献,进行文献评阅和比较研究。结果:WHO从软件研发(评估的框架、临床评估模型研发和训练、数据集管理、内部验证和数据管理)、软件验证与报告(外部验证和报告、数据管理、证据生成标准、证据报告)、配置部署与上市后监管(可用性评估、临床影响评估、实施过程的证据)3个部分并以人工智能医疗器械软件(AI-SaMD)宫颈癌筛查为用例分别进行了系统阐述,强调在全球医疗健康背景下对在AI医疗设备(AIMD)产品生命周期内的验证、生成证据和报告等方面生成证据的方法、原则、标准、基本路径和实施要点;文献复习和比较研究表明,国际医疗器械监管者论坛(IMDRF)、国际标准化组织(ISO)等国际组织和包括我国在内的一些国家相关机构前期开展了大量工作,发布有系列指导性文本,对规范AIMD的研发和应用尤其是上市前的监管环节发挥了重要作用;我国医疗设备监管与临床医学学者从AIMD安全有效主题出发,开展文献解读分析和基于真实世界数据的实证研究,文献数量呈逐年上升趋势。结论:“WHO AIMD框架”是一部基于生命周期管理对AIMD研发、训练、验证、临床评估生成证据及其标准要求的系统性文本,是WHO在全面总结了有关国际组织和各国前期工作经验的基础上面向全球医疗健康领域发出的工作倡议,对我国医学装备行业进一步推动AIMD发展具有重要启示作用,提出在我国医学装备行业需要加强AIMD生命周期管理(LCM)、生成证据、提升证据标准和质量、完善生成证据方法学和评估架构、建立AIMD应用证据与评估文献数据资源库等建议。
Objective: To analyze the World Health Organization(WHO) “Generating evidence for artificial intelligence based medical devices: a framework for training, validation and evaluation”(hereinafter referred to as "WHO AIMD framework") and discuss the enlightenments for China’s medical equipment industry. Methods: The WHO texts were analyzed and reviewed, and the relevant policy documents and research literatures in China were reviewed and compared. Results: WHO started from software development, software validation and reporting,deployment and post marketing supervision are systematically described with AI software medical device(AI-SaMD)cervical cancer screening as the use-case, emphasizing the methods, principles, basic pathway and implementation elements of generating evidence in the verification, evidence generation and reporting of AI medical device(AIMD)products in the life cycle under the global healthcare background;Relevant documents were mined and acquired for literature review and comparative research. It is shown that international organizations such as the International Medical Device Regulator Forum(IMDRF), the International Standardization Organization(ISO) and some national institutions, including China, have carried out a lot of work in the early stage and issued a series of guiding texts,which has played an important role in standardizing the development and application of AIMD, especially the premarketing supervision. Chinese regulators and clinical medicine scholars started from the subjects of AIMD safety and effectiveness, carried out literature interpretation and analysis and empirical research based on the real world,and the literatures showed an upward trend year by year. Conclusion: "WHO AIMD framework" is a systematic text based on life cycle management to generate evidence and standard requirements for AIMD development, training,verification and clinical evaluation. It is a work initiative issued by WHO to the global healthcare field on the basis of a comprehensive summary of the pre
作者
李志勇
邱晓岚
杨建龙
谢子归
彭雄俊
崔泽实
LI Zhi-yong;QIU Xiao-lan;YANG Jian-long(不详;China Association of Medical Equipment,Beijing 100086,China)
出处
《中国医学装备》
2022年第7期157-167,共11页
China Medical Equipment
