医疗人工智能技术评估与监管的国际经验及启示

International Experience and Implications of Medical Artificial Intelligence Technology Evaluation and Regulation

人工智能技术在生物技术、医学影像识别、药物研发、辅助诊断等领域发挥了重要作用。介绍了国际上关于医疗人工智能技术的评估与监管框架,包括英国的《数字卫生技术的证据标准框架》、美国的医疗器械独立软件预认证试点项目、欧盟的《可信赖人工智能道德准则》等,指出有效性与安全性是医疗人工智能技术评估与监管的前提,需制订符合我国国情的医疗人工智能设备分类标准,注重医疗人工智能产品的持续监管与风险控制。

Artificial intelligence(AI)technology has played an important role in biotechnology,medical image recognition,drug research and development,assisted diagnosis and other fields.This paper introduced the international evaluation and regulatory frameworks for medical AI technology,including the UK's Evidence Standard Framework for Digital Health Technology,the US's independent software precertification pilot project for medical devices,and the European Union's Code of Ethics for Trusted AI.It pointed out that effectiveness and safety are the preconditions for the evaluation and regulation of medical AI technology.It was necessary to draw up the classification standards of medical AI equipment according to our own characteristics,and pay attention to the continuous supervision and risk control of medical AI products.