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

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.