济南市大数据协会团体标准 T/JNBDA0007-2025 医疗健康数据标注合规指引 Compliancemedicalguidelinesformedicaldataannotation 2025-11-13发布 2025-11-13实施 济南市大数据协会发布T/SJNBDAT/JNBDA 全国团体标准信息平台 T/JNBDA0007—2025 目录 前言..........................................................................Ⅱ 引言..........................................................................Ⅲ 1范围............................................................................1 2规范性引用文件..................................................................1 2.1引导语....................................................................1 2.2规范性引用文件列表........................................................1 3术语和定义.......................................................................1 3.1数据标注...................................................................1 3.2标注.......................................................................1 3.3数据分级（A／B／C级）.....................................................1 3.4第三方机构.................................................................2 3.5未成年人医疗数据...........................................................2 4数据分级.........................................................................2 4.1A级（高风险数据）........................................................2 4.2B级（中风险数据）........................................................2 4.3C级（低风险数据）........................................................2 5标注总则........................................................................2 5.1合规优先原则...............................................................2 5.2伦理审查原则...............................................................2 5.3分级管控原则...............................................................2 5.4全流程追溯原则.............................................................2 6标注对象........................................................................2 6.1个人类数据................................................................2 6.2疾病类数据................................................................2 6.3科室类数据................................................................3 7标注主体准入要求................................................................3 7.1数据提供方.................................................................3 7.2标注实施方.................................................................3 7.3第三方机构.................................................................3 8标注人员选拔与管理..............................................................3 全国团体标准信息平台 T/JNBDA0007—2025 8.1选拔要求..................................................................3 8.2培训管理..................................................................3 8.3保密管理..................................................................3 8.4入职与异动管理............................................................3 9标注工具合规性要求..............................................................3 9.1安全要求...................................................................3 9.2适配要求...................................................................4 9.3兼容性要求.................................................................4 10标注合规流程...................................................................4 10.1流程图....................................................................4 10.2各环节详细要求...........................................................4 11相关方合规要求.................................................................5 11.1甲方（数据提供方）.......................................................5 11.2乙方（标注实施方）.......................................................5 11.3丙方（第三方机构）.......................................................5 12合规监管.......................................................................5 12.1监管方向.................................................................5 12.2监管措施.................................................................5 13保密措施.......................................................................6 13.1保密审计扩展.............................................................6 13.2跨主体保密责任............................................