我国医疗标准及规范中真实世界数据治理要求及技术要点

Requirements and Technical Aspects of Real-world Data Governance in China's Medical Standards and Guidelines

  • 摘要: 目的 调查我国医疗标准、规范中关于真实世界数据(real-world data,RWD)的治理要求,总结数据治理技术要点,为开展RWD治理工作的相关研究提供参考。方法 计算机检索中国知网(CNKI)、万方数据(Wanfang data)、维普网(VIP)和中国生物医学文献数据库(SinoMed)以及中国29家医学一级学会官网、全国标准信息公共服务平台,检索时限均为建库至2023年12月12日。制定资料提取表,根据国家药监局发布的《用于产生真实世界证据的真实世界数据指导原则(试行)》中RWD治理6个环节(数据安全、数据提取、数据清洗、数据转化、数据传输与存储、质量控制)对纳入的标准、规范进行分类,对其数据治理相关内容进行汇总和比较分析。结果 共纳入标准、规范32部,其中医疗基础类数据标准15部,数据治理技术规范17部。涉及数据安全6部、数据提取6部、数据清洗5部、数据转化5部、数据传输与存储6部、质量控制4部。医疗基础类数据标准包含数据描述元素信息、术语、格式标准,整体覆盖了关键数据要素,能基本满足数据标准化的需求。数据治理技术规范主要为普适性医疗数据规范,内容以治理工作的要求与指导性建议为主,数据安全和提取方面的要求和方法相对明确,然而在数据转化和质量控制方面的规范技术指导较为有限,数据清洗、传输和存储环节则缺乏明确的实施路径。结论 随着真实世界证据在医疗卫生决策中的作用不断增强,我国医疗标准及规范中RWD治理框架逐渐清晰,然而,RWD的治理在技术细节和实施方面仍需完善。

     

    Abstract: Objectives: To investigate the current status of real-world data (RWD) governance in China's medical standards and guidelines, summarize the technical aspects of data governance, and provide references for researchers engaged in RWD governance work. Methods: Searches were conducted in CNKI, Wanfang Data, VIP, SinoMed and official websites of 29 first-tier Chinese medical societies, and the National Standard Information Public Service Platform, up to December 12, 2023. Data extraction forms were created to classify and analyze the data governance aspects of the included standards and guidelines based on the six RWD governance phases (data security, extraction, cleaning, transformation, transmission and storage, quality control) from the National Medical Products Administration's guidelines, and strategies were proposed. Results: A total of 32 standards and guidelines are included: medical data standards(15) and data governance technical specifications(17). The coverage includes data security (6), data extraction (6), data cleaning (5), data transformation (5), data transmission and storage (6), and quality control (4). Medical basic data standards address data description elements, terminology, and format standards, covering essential data elements data and standardization needs. Data governance technical guidelines primarily offer general requirements and recommendations for governance, with clear directives for data security and extraction but limited on data transformation and quality control. Data cleaning, transmission, and storage lack explicit implementation pathways. Conclusions: With the growing role of real-world evidence in medical decision-making, the RWD governance framework in China's medical standards is becoming clearer. However, technical details and implementation methods for RWD governance still need refinement.

     

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