T/JNBDA 0007-2025 Compliance medical guidelines for medical data annotation

Scope

This document specifies the compliance framework, core principles, data classification, labeling objects, subject access, personnel management, process requirements, responsibilities of relevant parties, and regulatory measures for medical and health data labeling. This document applies to all participants in medical and health data labeling across the country, including but not limited to medical institutions, medical technology companies, third-party evaluation agencies, and medical research institutions; regulatory authorities may refer to this document when conducting compliance supervision. It clarifies relevant terms and definitions of medical and health data labeling (including data classification, third-party agencies, etc.); defines applicable data objects (A/B/C classification, special data for minors), participating subjects, and applicable boundaries; covers the entire labeling process, involving preliminary preparation (data review, tool verification, personnel training), process execution (classification operations, anonymization processing), review and acceptance (compliance assessment, rework of non-compliant items), and post-labeling management (storage, retention, destruction); clarifies the general principles of labeling (four major principles), core requirements (subject access, personnel/tool compliance); stipulates quality control (multi-dimensional evaluation indicators, result disposal mechanisms) and problem rectification; clarifies security management (confidentiality agreements, environmental isolation, data protection); establishes a compliance supervision mechanism (graded supervision, violation handling, social supervision); and includes informative appendices such as quality evaluation and anonymization guidelines, providing a full-process compliance guide for medical and health data labeling.

Development Information

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