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

ObjectiveTo investigate the governance requirements for real world data (RWD) in China's medical standards and specifications, summarize key technical aspects of data governance, and provide references for RWD governance-related research.MethodsComputerized searches were conducted in CNKI, Wanfang Data, VIP, and SinoMed, as well as the official websites of 29 national medical societies and the National Standard Information Public Service Platform, covering all records from inception to December 12, 2023. A data extraction form was developed, and the included standards and specifications were categorized according to the first six RWD governance processes outlined in the Guidelines for Real World Data Used to Generate Real-World Evidence (Trial) issued by the National Medical Products Administration: data security, data extraction, data cleaning, data transformation, data transmission and storage, and quality control. Relevant content on data governance was systematically summarized and comparatively analyzed.ResultsA total of 32 standards and specifications were included, comprising 15 foundational medical data standards and 17 data governance technical specifications. Among these, 6 addressed data security, 6 covered data extraction, 5 focused on data cleaning, 5 involved data transformation, 6 pertained to data transmission and storage, and 4 discussed quality control. Foundational medical data standards included data description elements, terminology, and format standards, broadly covering essential data elements and meeting basic standardization needs. Data governance technical specifications primarily provided general guidelines for medical data governance, emphasizing requirements and recommendations. While requirements for data security and extraction were relatively well-defined, technical guidance on data transformation and quality control remained limited, and implementation pathways for data cleaning, transmission, and storage were insufficiently detailed.ConclusionsAs real-world evidence plays an increasingly critical role in healthcare decision-making, China's medical standards and specifications have established a preliminary governance framework for RWD. However, technical details and practical implementation of RWD governance still require further refinement.