Hainan Launches International Innovative Medical Products and Devices 'Tri-Medical Synergy' Trusted Data Space to Enhance Healthcare Data Circulation and Application Efficiency

Real-world data is a core element for conducting high-quality real-world studies. However, compared with overseas markets, although China leads in policy frameworks and academic achievements in the field of real-world research, it faces challenges such as insufficient accessibility to real-world data resources, inadequate data quality, lack of coordinated platforms, and inability to perform compliant traceability and verification, which hinder the conduct of real-world studies.

To better promote the implementation of the “International Innovative Drugs and Medical Devices ‘Three-Medical Synergy’ Trusted Data Space” project and accelerate the conduct of real-world studies, on September 23,Organized by the Hainan Provincial Development and Reform Commission (Provincial Data Bureau), Hainan Provincial Health Commission, Hainan Provincial Healthcare Security Administration, Hainan Provincial Medical Products Administration, Hainan Big Data Development Center, and Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration; undertaken by the Statistical Information Center of Hainan Provincial Health Commission, Hainan Boao Lecheng Digital Technology Development Co., Ltd., and Hainan Lecheng Real World Research Institute2025 Hainan · International Innovative Drugs and Medical Devices “Three-Medical Coordination” Trusted Data Space Co-construction Launch Conference Held in Boao, Hainan

Themed “Empowering Through Digitalization, Unlocking Health with Data,” the conference provided a comprehensive overview of the core capabilities, application scenarios, and collaboration models of the trusted data space for “three-sector coordination” (healthcare, medical insurance, and pharmaceuticals) in Hainan’s international innovative drugs and medical devices sector. The event brought together representatives from government agencies, healthcare institutions, regional data centers, health and medical big data enterprises, pharmaceutical companies, technology firms, law firms, and other organizations to jointly explore how to better support the co-construction of this trusted data space and address current industry challenges.

In July 2025, the National Data Administration officially announced the list of pilot projects for the innovative development of trusted data spaces in various industries. The “Three-Medical Coordination” Trusted Data Space Project for International Innovative Drugs and Medical Devices, led by Hainan Boao Lecheng, was successfully selected as a pilot project for the innovative development of trusted data spaces in the “Imported Drugs and Medical Devices” industry.

As the conference moderator,Deputy Director of the Hainan Provincial Health Commission, Zhang GuangpengIt was emphasized that Hainan Province is currently implementing the strategic deployment of the Provincial Party Committee and the Provincial Government to strengthen itself through digitalization. By leveraging data elements as a key driver, the province is comprehensively promoting the digital, intelligent, and international development of its healthcare sector and industry. The launch of the trusted data space for “Three-Medical Coordination” in innovative international pharmaceuticals and medical devices represents a concrete measure by Hainan Province to implement the Digital China and Healthy China strategies. It stands as another landmark achievement, serves as the latest practice in the integrated institutional innovation of the Hainan Free Trade Port, and best exemplifies the province’s long-standing commitment to “Three-Medical Coordination.”

Hainan’s accumulated experience and advantages are effectively facilitating the implementation of a trusted data space for the “Three-Medical Coordination.”Zhou Changqiang, Secretary of the Qionghai Municipal Party Committee and Secretary of the Boao Lecheng International Medical Tourism Pilot Zone Administration Party CommitteeAttended the conference and delivered a speech. He pointed out that after more than ten years of exploration and development, the Boao Lecheng International Medical Tourism Pilot Zone has achieved a leapfrog breakthrough from a “policy testing ground” to a “new industrial highland.” Relying on the core policy of “pilot implementation” for specially permitted drugs and medical devices, the zone has cumulatively introduced over 510 types of innovative global drugs and medical devices, established collaborations with more than 180 pharmaceutical and medical device companies from 20 countries, and truly realized the “triple synchronization” of medical technologies, equipment, and pharmaceuticals with international standards. Leveraging the pilot application of real-world data as an “engine,” it has accelerated the domestic market approval of 21 innovative drugs and medical devices, becoming a fast track for global innovative drugs and medical devices to enter China. Currently, the digital economy has become a core driver of global development, with digital health emerging as the most promising new sector. The newly released “Three-Medical Synergy” Trusted Data Space not only fully leverages the dual advantages of Hainan Free Trade Port policies and Lecheng’s medical industry foundation to provide compliant data support for the research and development of digital therapeutics, cross-border multi-center clinical trials, and international remote consultations; but also strives to address key pain points in the application of specially permitted drugs and medical devices, enhance the completeness and application value of real-world data, and provide a scientific and reliable basis for high-quality corporate research and regulatory assessment by authorities. The Administration Bureau of Boao Lecheng International Medical Tourism Pilot Zone will join hands with all parties to better promote the implementation of the “Three-Medical Synergy” Trusted Data Space project for international innovative drugs and medical devices, with “Three-Medical Synergy” as the core, the digital health industry as the goal, and data security as the bottom line.

Amid the wave of digitalization, the construction of trusted data spaces cannot be achieved without institutional innovation and safeguards.Li Wenxiu, Party Secretary and Director of the Hainan Provincial Health CommissionAttending the meeting, he stated that Hainan Province has consistently implemented the decisions and deployments of the CPC Central Committee. Since 2020, it has promoted the coordinated reform of medical care, health insurance, and pharmaceuticals (the “Three-Medical” linkage), establishing China’s first integrated network for this coordinated approach. In July and August this year, Boao Lecheng and the Hainan Provincial Health Commission were respectively approved by the National Data Administration as pilot sites for the “Industry Trusted Data Space” and the “High-Quality Three-Medical Health Dataset.” This recognition not only affirms Hainan’s earlier efforts but also marks a new starting point for the province to seize opportunities in the emerging fields of digital health and medical artificial intelligence. It signifies that Hainan has taken an important step toward being the first in the province to implement the construction of the National Comprehensive Pilot Zone for Data Elements.At this new starting point, Hainan will focus on three areas: First, proactively embracing the digital wave to unlock the value of data elements. Second, leveraging the advantages of the Free Trade Port to advance integrated institutional innovation. Third, adhering to safety baselines while exploring compliant and sustainable development models.

As the manager and holder of data resources, the Big Data Development Center’s accumulated expertise and exploratory efforts are increasingly facilitating the construction of trusted data spaces.Wang Yan, Director of the Hainan Provincial Big Data Development CenterIt is pointed out that medical and health data harbor immense scientific research, industrial, and social value, urgently requiring in-depth exploration and efficient application. As the implementing agency for public data management across the province, the Hainan Provincial Big Data Development Center can further facilitate the joint construction of a trusted data space for the “coordination of medical care, health insurance, and pharmaceutical services.” First, it possesses abundant data resources. It has established a unified provincial data middle platform, aggregating over 100 billion data records, and built a reliable and extensive data resource system, providing robust data support for the future development of the trusted data space for the “three-medical coordination.” Second, by continuously exploring mechanisms for authorized data operations, it has innovatively created the “Hainan Data Product Supermarket,” which has been successfully replicated in eight other provinces and municipalities nationwide, creating greater potential for future collaborative development. Third, it has developed numerous demonstration cases related to the “three-medical coordination” and will actively collaborate with departments such as Health Commission, Medical Insurance Administration, Drug Administration, and the Boao Lecheng International Medical Tourism Pilot Zone Administration to explore secure data authorization models in the medical and health sector. By creating a batch of replicable and scalable demonstration cases, these efforts aim to jointly cultivate and strengthen the data element industry ecosystem in Hainan Province.

How Can We Better Facilitate the Completion of Pilot Programs?Huang Peng, Deputy Director of the Hainan Provincial Development and Reform Commission (Provincial Data Bureau)stated that data, as a new factor of production, is beginning to take effect and empower industries across the board. The CPC Central Committee and the State Council attach great importance to the construction of data infrastructure. Trusted data spaces are an important component of critical infrastructure; their essence lies in providing a secure and trustworthy environment for the generation, circulation, sharing, and use of data that is “controllable,” “manageable,” and “measurable.” This year, the National Data Administration launched the first batch of pilot projects, marking a rapid transition in the development of China’s core data spaces from proof-of-concept to large-scale promotion. Going forward, under the guidance and support of the provincial party committee, the provincial government, and the National Data Administration, we will treat the construction of trusted data spaces as a key lever for promoting data development and utilization, cultivating the data industry, and building a market system for data factors. We will collaborate with relevant industry regulatory authorities, strengthen overall coordination and policy support, and ensure the high-quality completion of the pilot work.

Innovative synergy will help better leverage the value of the trusted data space for the “collaboration among medical care, health insurance, and pharmaceuticals.”Zhou Jun, Party Secretary and Director of the Hainan Provincial Healthcare Security AdministrationIt was pointed out that this project represents a significant achievement in Hainan’s deepening reforms in the healthcare sector and its promotion of data element circulation. It also marks a crucial step for the medical care, health insurance, and pharmaceutical systems to proactively embrace the digital age and explore new models of governance. To advance the application of real-world data (RWD) in the health insurance sector, the Hainan Provincial People’s Government and the National Healthcare Security Administration signed a strategic cooperation agreement in April 2023. This collaboration aims to establish a policy framework, guiding principles, and technical standards for RWD applications in health insurance, thereby making RWD a key policy tool for value-based purchasing services—such as drug value assessment, evaluation of health insurance service quality, and pharmaceutical price management—as well as for big data-driven regulatory oversight. As a pivotal vehicle for implementing the cooperation agreement, the project to construct a real-world database for health insurance research and applications passed preliminary acceptance on June 11 this year and is currently in its trial operation phase, with final acceptance scheduled for November this year. The newly launched initiative to build a trusted data space for the coordinated development of medical care, health insurance, and pharmaceuticals (“Three-Medical Coordination”) will create synergies with the provincial-level RWD project for health insurance. Together, they will fully unlock the application value and empowering potential of health insurance data as a new factor of production in technological innovation, economic development, and government governance.

Enhancing Strategic Awareness of Data Factorization to Jointly Promote the Coordinated Development of Trusted Data Spaces.Ji Tiejun, Director of the Hainan Provincial Medical Products AdministrationHe attended the conference and shared his insights on trusted data spaces. He stated that, first, this represents the “Hainan Answer” to empowering pharmaceutical innovation through data elements, serving as a vivid practice of the deep integration between the digital economy and the real economy. The Hainan Provincial Medical Products Administration, in collaboration with departments including Health, Healthcare Security, and the Boao Lecheng International Medical Tourism Pilot Zone Administration, has explored innovative pathways for leveraging real-world data (RWD) from clinical applications in Lecheng to support product registration and regulatory decision-making for特许 drugs and medical devices. In doing so, they have established an ecological system integrating four key components: institutional frameworks, technical standards, data platforms, and expert think tanks. Second, this serves as the “future engine” for reconstructing the pharmaceutical ecosystem and unlocking data value, representing a breakthrough move under the opportunities presented by the customs closure operations of the Hainan Free Trade Port. With the trusted data space as the “central hub,” efforts are being made to thoroughly reconstruct the pharmaceutical innovation ecosystem, break down data barriers among healthcare, health insurance, and pharmaceuticals, and achieve full-chain data integration and standardized governance. This approach allows dispersed data to “accumulate like sand into a tower” and collaborative applications to “link up like beads into a chain,” thereby shortening the R&D and launch cycles for pharmaceutical products. By leveraging the triple advantages of policies, ecosystem, and data in Lecheng, it aims to build a global highland for the aggregation of innovative drugs and medical devices. Third, this constitutes a community of shared responsibility based on co-construction, co-governance, and sharing, reflecting a united commitment to safeguarding public health and creating global value together.

The “Launch Ceremony for the Joint Development of the Trusted Data Space for International Innovative Drugs and Medical Devices with ‘Three-Medical Coordination’ in Hainan Province” was held at the conference, marking the official commencement of construction and the entry into a phase of substantive advancement for this trusted data space.

Currently, regions across China are accelerating the circulation and application of healthcare data elements. As an innovative pilot project, the “Three-Medical Coordination” trusted data space implemented in Boao Lecheng, Hainan, holds unique value and significance.

Fu Sheng, Director of the Hainan Boao Lecheng International Medical Tourism Pilot Zone AdministrationIn an interview, he stated that Boao Lecheng has been successfully approved as one of the first pilot projects for the innovative development of trusted data spaces in the pharmaceutical industry by the National Data Administration. It is the only pilot project for a trusted data space in the national health sector, marking a high level of national recognition for Lecheng’s applications in medical data. He pointed out that Hainan Province’s International Innovative Drugs and Medical Devices “Three-Medical Coordination” Trusted Data Space possesses four core differentiated advantages: unified data catalogs, integrated data resources, traceable data verification, and low-cost secure computing. In the future, it will expand into a series of high-value, differentiated, and strictly regulated medical data application scenarios, including registration and market launch of innovative drugs and medical devices, post-market evaluation, and comprehensive value assessment for medical insurance coverage.

The Boao Lecheng International Medical Tourism Pilot Zone in Hainan is poised to leverage innovative application scenarios under pilot policies to explore a replicable, scalable, and economically impactful new model for the circulation and application of medical data elements. This initiative aims to break down data silos among healthcare services, health insurance, and pharmaceuticals, achieve end-to-end data integration and standardized governance, and contribute Lecheng’s strength to Hainan Free Trade Port’s strategy of “strengthening through digitalization.”

The Hainan Boao Lecheng International Medical Tourism Pilot Zone also hopes that more industry practitioners will join the co-construction of the trusted data space for the “three-medical coordination” of international innovative drugs and medical devices in Hainan Province, thereby supporting the innovative transformation of the pharmaceutical industry.

The conference unveiled several major achievements, laying the foundation for the open utilization of data resources and the further development of a trusted data space for “collaborative integration of healthcare, medical insurance, and pharmaceuticals.”

Wang Cunku, Director of the Planning and Information Division, Hainan Provincial Health CommissionHainan Province has publicly released the Catalog of Healthcare Data Resources for the “Three Medicals” (medical care, health insurance, and pharmaceuticals), Certificates of Ownership Registration for Healthcare Data Products in the “Three Medicals” sector, and a high-quality healthcare dataset for the “Three Medicals” as part of a pilot project by the National Data Bureau. Centered on the “Three Medicals” platform, the Catalog of Healthcare Data Resources achieves comprehensive interoperability and sharing, aggregating data that is complete, real-time, and case-based, thereby ensuring rich and comprehensive data resources. Through data governance, the value of these data assets has been multiplied. As the Trusted Data Space project progresses, the Hainan Provincial Health Commission will further open access to the data resource catalog for society, research institutions, and pharmaceutical companies, enabling data resources to be searchable, viewable, and usable within a secure environment. Meanwhile, high-quality development in the field of artificial intelligence relies heavily on excellent datasets. The Statistical Information Center of the Hainan Provincial Health Commission was approved in August this year to undertake the pilot project for high-quality healthcare datasets in the “Three Medicals” sector. Currently, Hainan Province is promoting the ownership registration of related data products, among which the clinical dataset for interstitial pneumonia has already obtained a registration certificate. Several other datasets have been established and are applying for ownership registration, including the digital therapeutic intervention dataset for children aged 0–6 with autism spectrum disorder, and the dataset for adult and pediatric patients (aged 8 and above) with type 1 diabetes.

Yang Yanxiang, Deputy Director of the Hainan Real-World Data Health Insurance Innovation Application CenterKey highlights were presented on the Hainan Real-World Data Innovation Application Center for Medical Insurance. Construction of this platform commenced on November 11, 2024, and has since achieved phased milestones. By governing multi-source heterogeneous data from healthcare, pharmaceuticals, and medical insurance into a unified, high-quality scientific database suitable for real-world studies, the platform provides robust data support for conducting real-world research, leveraging real-world data to facilitate value-based purchasing in medical insurance, and enabling big data-driven non-contact supervision. Currently, it has established a unified data aggregation standard system, a high-quality foundational layer for real-world study data, a rigorous security management system, an efficient suite of data analysis tools, and a standardized project management process for real-world studies, thereby solidifying the data foundation for such research. Based on this platform, multiple research projects are underway, including comprehensive clinical evaluations of dominant Traditional Chinese Medicine (TCM) conditions in Hainan Province using real-world data, investigations into healthcare-seeking preferences and consultation characteristics of populations from specific regions in Hainan, and studies on chronic myeloid leukemia. Notably, case studies from the Real-World Study Database project, recommended by the National Healthcare Security Administration, have been successfully selected as typical examples of data infrastructure construction by the National Data Bureau. Looking ahead, the platform will further develop a patient follow-up system based on real-world data research applications and a real-world study service platform powered by DeepSeek.

Deputy Director Yuan Weihong, Department of Medical Capacity Building, Boao Lecheng International Medical Tourism Pilot Zone AdministrationA comprehensive introduction was provided to the Trusted Data Space for International Innovative Drugs and Medical Devices under the “Three-Medical Coordination” framework. She pointed out that the development of this Trusted Data Space aims to address existing challenges, including insufficient accessibility of real-world data, the absence of a unified data platform supporting regulatory services, and the lack of data circulation mechanisms for high-value application scenarios. By constructing a data resource catalog, establishing a data integration mechanism across medical care, health insurance, and pharmaceuticals, exploring evaluation standards for regulatory verification data, and deploying cost-effective high-performance homomorphic encrypted computing capabilities, the initiative seeks to streamline data circulation mechanisms. This will effectively support various aspects such as the registration and market launch of innovative drugs and medical devices, as well as their inclusion in medical insurance coverage.

Meanwhile, the conference is also pooling industrial strength to build an open, collaborative, and win-win ecosystem for data elements. Representatives from multiple parties, including data providers, three types of data service providers (data technology services, data management, statistical and analytical services, and data compliance and security services), and data users, gathered at the event.

To better address the pain points of various stakeholders and meet industry demands, the conference invited numerous guests to discuss the theme, “How Multi-Stakeholder Entities Can Build a Trusted Data Space Ecosystem for ‘Three-Medical Coordination’ Based on Co-Construction, Win-Win Cooperation, and Shared Benefits.” Industry experts pointed out that the sector currently faces several key challenges: the contradiction between rising demands for data quality and the high costs of data governance; how to determine the benefits for all parties during data circulation; how to promote the adoption of data products by users through efficient regulation; and how to address data ethics issues in future development. With the ongoing construction of trusted data spaces, these issues are expected to be gradually resolved.