Authorized by the State Council, the medical institutions at Hainan Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as Lecheng Pilot Zone) can use the clinically urgently needed imported medical products that have been marketed abroad, but still not marketed in China and access the precious clinical use data of such medical products. The Hainan Real-world Data Platform collects, governs and manages the use data of specially approved medical products from the systems of Lecheng Pilot Zone such as medical institution informationization system and Traceability Management Platform for Specially Approved Medical Products , on the basis of which real-world data necessary for the registration and research of medical products will be formed to support the real-world studies in Lecheng Pilot Zone for the registration of medical products. The platform boasts good extensibility. In the future, it will support the connection with real-world data platforms of Hainan Province and key regions nationwide to expand the sources and scope of data and realize data exchange and sharing.

The platform is the first regional real-world data platform established according to the relevant guidance of the National Medical Products Administration (NMPA) on real-world studies in China, which consists of six modules, namely data collection and governance, real-world studies and applications, disease-specific data management, business supervision and regulation, data security and privacy protection, and basic support. It has applied innovative information technologies such as blockchain, artificial intelligence, big data and cloud computing to achieve information-based supervision and regulation on the entire life cycle of medical products from registration to the post-marketing monitoring of adverse reactions, and innovate the mechanisms, technologies, regulation and services, providing a referential model for the collection, governance and application of real-world data in China.