ICS11.020.10 CCSC00 团体标准 T/BRACDCHE003-2026 医疗人工智能应用的伦理风险评估 操作指引 Guidelinesforethicalriskassessmentoperationsofmedicalartificial intelligenceapplications 2026-01-08发布 2026-01-08实施 北京慢性病防治与健康教育研究会 发布 全国团体标准信息平台 T/BRACDCHE003-2026 I目次 前 言...........................................................................................................................................................II 引 言.........................................................................................................................................................III 1范围.....................................................................................................................................................................1 2规范性引用文件.................................................................................................................................................1 3术语和定义.........................................................................................................................................................1 4伦理评估准则.....................................................................................................................................................1 4.1以人为本.....................................................................................................................................................1 4.2自主性.........................................................................................................................................................1 4.3透明性.........................................................................................................................................................1 4.4不伤害.........................................................................................................................................................1 4.5隐私和信息保护.........................................................................................................................................2 4.6负责任.........................................................................................................................................................2 4.7公平公正.....................................................................................................................................................2 5评估流程.............................................................................................................................................................2 5.1组建风险评估团队.....................................................................................................................................2 5.2开展风险评估.............................................................................................................................................2 6风险评估结果应用.............................................................................................................................................2 6.1最小风险项目.............................................................................................................................................2 6.2低风险项目.................................................................................................................................................2 6.3高风险项目.................................................................................................................................................2 6.4不可接受风险项目.....................................................................................................................................2 7风险持续监控.....................................................................................................................................................3 附录A（资料性）A1.1医疗人工智能应用伦理风险评估表........................................................4 附录B（资料性）医疗人工智能风险分级表.................................................................................7 参考文献..........................................................................................................................