T/JNBDA 0006-2025 Active Group standards

T/JNBDA 0006-2025 Medical data annotation specifications

Publish Date: 2025-11-13 Implement Date: 2025-11-13 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/JNBDA 0006-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Medical and Health Technology (Vocabulary)

Publish Date: 2025-11-13

Implement Date: 2025-11-13

Scope

This document stipulates the compliance framework, core principles, data classification, annotation objects, subject access, personnel management, process requirements, responsibilities of relevant parties, and supervision measures for the annotation of medical and health data. This document applies to all participants in medical and health data annotation 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 annotation (including annotation objects, rules, and results); defines applicable data objects (by associated objects, classification by form, and special data for minors), activity phases (the entire lifecycle of annotation), application scenarios, and applicable boundaries; covers the entire process of annotation implementation, involving preliminary preparation (data preprocessing, preparation of rules and tools, and personnel training), process execution (trial annotation, formal annotation), review and acceptance (three-level review), and archiving and retention (archiving of data and documents); specifies general principles of annotation (five principles of compliance and accuracy, and four annotation objectives) and core requirements (rule formulation, process control, and results management); stipulates quality control (quality indicator system and multi-dimensional inspection mechanisms) and problem rectification processes; clarifies annotation safety management (personnel control, protection for data transmission/storage/use/destruction, and process supervision); establishes supervision and evaluation mechanisms (daily supervision, regular evaluation, and continuous improvement); and includes informative appendices such as annotation exception feedback forms and process logs,