T/JNBDA 0007-2025 医疗健康数据标注合规指引

T/SJNBTD/JANBDA

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/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

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）..................