我国医学人工智能监管沙盒模式构建思路  

The Construction Approach for a Regulatory Sandbox Model of Medical Artificial Intelligence in China

作　　者：邱英鹏 姚涵 任平 田雪晴 游茂 QIU Yingpeng;YAO Han;REN Ping;TIAN Xueqing;YOU Mao(China National Health Development Research Center,Beijing 100044,China)

机构地区：[1]国家卫生健康委卫生发展研究中心,北京市100044 [2]中国医学科学院北京协和医学院卫生健康管理政策学院,北京市100730

出　　处：《中国卫生信息管理杂志》2025年第2期262-268,共7页Chinese Journal of Health Informatics and Management

基　　金：北京市科技计划—“人工智能医疗技术应用价值评估体系及示范验证研究”(Z241100007724003);科技创新2030—“新一代人工智能”重大项目(项目编号:2020AAA0105000,课题编号:2020AAA0105001)。

摘　　要：形成包容审慎的新型监管体系,是当下医学人工智能监管方面的发展需求。本研究结合国内外监管沙盒在金融科技、人工智能和卫生健康领域的建设特点和运作模式,从释放医疗健康数据要素价值的角度出发,探析了监管沙盒在医学人工智能领域的作用机制。此外,从制度、技术、环境等层面探讨了监管沙盒在数据要素治理中的监管框架、监管流程、准入机制、动态监管机制和退出机制的可行性,以期为我国医疗健康数据治理、医学人工智能创新发展之间的平衡与协调提供新的思路。Formulating a comprehensive and cautious regulatory framework is a pressing need amidst the rapid advancements in medical artificial intelligence.This article examines the unique features and operational models of domestic and international regulatory sandboxes within the realms of financial technology,artificial intelligence,and healthcare.It scrutinizes the regulatory sandbox mechanism specifically within the domain of medical artificial intelligence,focusing on unlocking the value of medical and health data elements.The article further deliberates on the viability of its regulatory framework,including regulatory procedures,access protocols,dynamic regulatory mechanisms,and exit strategies,in governing data elements across institutional,technical,and environmental dimensions.The aim is to provide fresh insights for harmonizing China’s governance of medical and health data with the innovative strides in medical artificial intelligence.

关 键 词：监管沙盒 医疗健康 人工智能 数据要素 价值释放 

分 类 号：R197.323[医药卫生—卫生事业管理] R319[医药卫生—公共卫生与预防医学]