Hainan's Digital Therapeutics Policy Blitz: Achievements and Product Landscape in Just 21 Days

On October 31, with the launch and operation of the Hainan Digital Therapeutics Public Service Platform, Hainan Province successfully achieved its previously“Several Measures of Hainan Province to Accelerate the Development of the Digital Therapeutics Industry”The series of targets for the first phase mentioned in the “Measures” (hereinafter referred to as the “Measures”) fully demonstrate the unique development acceleration of the Hainan Free Trade Port, leaving a deep impression.

What goals has Hainan Province achieved in promoting digital therapeutics policies within the short span of 21 days, from October 10 to October 31? Where can one find the specific related policies and communication channels? VCBeat has compiled this information.

Hainan’s initial push to promote digital therapeutics began on January 30. On that day, the Hainan Provincial Health Commission (hereinafter referred to as the Hainan Health Commission) released the “Hainan Province Digital Health "14th Five-Year" Development Plan” (hereinafter referred to as the Plan), which lists “exploring pilot trials of digital therapeutics” as one of the key tasks for Hainan Province’s digital health development during the 14th Five-Year Plan period.

This marks the first time digital therapeutics have been included in a provincial-level plan, garnering attention and promotion at the provincial level. The industry has paid close attention to this development, creating a demonstration effect that has prompted local governments in multiple regions to begin focusing on digital therapeutics.

Nevertheless, at the time, many individuals raised questions regarding the specific implementation of the policy. Some industry insiders, in discussions with VCBeat, acknowledged that the plan was undoubtedly a significant boon to the sector, but they placed greater emphasis on the concrete implementation policies—after all, such an ambitious macro-level blueprint faces numerous challenges in practical execution.

Judging by subsequent developments, Hainan Province has not merely paid lip service but has taken concrete steps to drive implementation. According to VCBeat, after releasing the Plan, Hainan Province promptly launched intensive industry research to gain a comprehensive understanding of the pain points and needs of digital health innovators.

Taking the “Hainan Digital Therapeutics Innovation Week” as an example, six conferences were held during the event, bringing together leading digital therapeutics innovators in Hainan to engage in in-depth discussions with government officials on key issues surrounding the development of digital therapeutics. Over the past six months, Hainan has conducted extensive research and surveys in various forms and scales. Through these efforts, Hainan has gained insights into the current state of the industry and its pain points. By leveraging its own resource endowments and aligning with its development goals, Hainan is able to scientifically formulate concrete implementation measures.

On October 10, Hainan Province released the “Measures,” complementing the previously issued “Plan.” The 21 measures directly address current pain points in the digital therapeutics industry, providing clear support and incentives particularly in research, clinical application, promotion, and reimbursement. This makes it the first comprehensive, full-lifecycle industrial support policy for digital therapeutics introduced in China and globally.

“We aim to accelerate the establishment and development of digital therapeutics companies in Hainan through 21 measures, and strive to build Hainan into a global innovation hub for digital therapeutics, a cluster for innovative resources, and an industrial highland within two to three years. We believe that digital therapeutics hold significant promise; by centering on disease treatment and health management, we can achieve dual-core drive of ‘Internet healthcare + digital therapeutics,’ spur the aggregation and restructuring of a trillion-yuan digital healthcare industry, and promote the efficient and coordinated development of Hainan’s healthcare services and industry.” In a previous communication with VCBeat, Zhang Yuhui, Deputy Director of the Hainan Provincial Health Commission, outlined Hainan Province’s goals for developing digital therapeutics.

Impressively, without any delay, Hainan immediately began the intensive implementation of specific policies following the release of the Measures.

On October 14, Hainan Province held a special meetingInterdepartmental Press Conference, jointly interpreted the Measures and provided specialized responses to concerns of interest to the industry by the relevant departments involved in the Measures, including the Hainan Provincial Health Commission, the Hainan Provincial Department of Science and Technology, the Hainan Provincial Healthcare Security Administration, the Hainan Provincial Medical Products Administration, the Hainan Bureau of the China Banking and Insurance Regulatory Commission, and the Hainan Provincial Development and Reform Commission.

Later that day, the Hainan Provincial Health Commission released"Notice of the Hainan Provincial Health Commission on Organizing the Application for the Establishment of the Hainan Provincial Digital Therapeutics Clinical Trial Center", to apply for the establishment of the Hainan Provincial Digital Therapeutics Clinical Trial Center, focusing on key therapeutic areas such as respiratory diseases, nervous system disorders, endocrine, nutritional and metabolic diseases, circulatory system diseases, mental, behavioral and cognitive disorders (including sleep disorders, etc.), ophthalmic diseases, and oncological diseases.

Currently, the relevant clinical trial centers have completed the review and havePublic Notice。

On October 19, the Hainan Provincial Center for Drug and Medical Device Evaluation and Service released“Notice of the Hainan Provincial Center for Drug and Medical Device Evaluation Services on Summary Opinions Regarding the Classification Determination of ‘Digital Therapeutics’ Software Medical Devices”, in conjunction with the relevant classification guidance documents issued by the National Medical Products Administration (NMPA), the "Medical Device Classification Catalog" (No. 104 of 2017), the publicly available classification determination results from the National Standards Management Center, as well as national and industry standards, we have compiled a summary of opinions on the classification determination of software-based medical devices for "Digital Therapeutics."

In fact, since the initial proposal of the Plan in January 2021, the Hainan Provincial Medical Products Administration has launched external consulting services for the technical review of medical devices. By employing various communication channels, including email, telephone, and on-site consultations, the administration has provided targeted support to local “digital therapeutics” medical device enterprises and assigned dedicated personnel to handle technical inquiries related to “digital therapeutics” medical devices.

On October 21, the Hainan Provincial Center for Drug and Medical Device Evaluation and Services launched a dedicated section on its official website."Digital Therapeutics" ColumnandConsultation Services Column, publicly disclose policy regulations, guidance documents, national and industry standards, and other relevant information related to "digital therapeutics" medical devices.

On October 27, Hainan Province took another significant step forward in the implementation of digital therapeutics. First, the Health Commission of Hainan Province released"Notice of the Hainan Provincial Health Commission on Recommending the Inclusion of Digital Therapeutics Products in Commercial Insurance", initiating the application process for digital therapeutics products proposed for inclusion in commercial health insurance within the province. For the digital therapeutics industry, which urgently needs to resolve reimbursement issues, this exploration is nothing short of a bombshell.

Subsequently, the Hainan Provincial Center for Drug and Medical Device Evaluation and Review Services also issued a statement on the same day.Notice on the Establishment of a Special Consultation Channel for Class II Medical Devices in the “Digital Therapeutics” Category, establish a dedicated consultation channel for Class II medical devices in the “Digital Therapeutics” category (hereinafter referred to as “Digital Therapeutics” products), with designated personnel responsible for handling inquiries, so as to provide regulatory policy and registration consultation services to relevant applicants within the province.

On October 28, the Hainan Provincial Medical Products Administration and the Hainan Provincial Health Commission jointly held an online meeting"Key Points on Digital Therapeutics Registration and Approval under Hainan Province's New Policies: Sharing Session". The meeting introduced how Hainan Province is promoting the development of the digital therapeutics industry through 21 new measures, provided an interpretation of the newly released Priority Review Procedure for Class II Medical Devices in Hainan Province, and addressed several concerns raised by the industry.

On October 31, the Hainan Provincial Health Commission issued anotherAnnouncement，Hainan Digital Therapeutics Public Service PlatformOfficially launched as a special topic section on the official website of the Hainan Provincial Health Commission.

Hainan Digital Therapeutics Public Service Platform (Screenshot from Official Website)

Digital therapeutics companies and related stakeholders across China can submit requests for industry development support through this platform, including policy incentives for implementation, CDMO services, CRO services, matchmaking with medical institutions for clinical trials, and partnerships with healthcare providers for product deployment.

Overview of Hainan’s Related Measures Since the Release of the “Measures”

In just 21 days, Hainan rapidly established a comprehensive framework for the implementation of digital therapeutics from scratch through a “package of measures,” fully demonstrating the determination, speed, and execution capability of the Hainan Free Trade Port. A senior media professional who has long tracked government policies expressed deep impression: “Having covered government policy for over a decade, I find it extremely rare to see such specific, multi-departmental implementation measures rolled out in such a short timeframe. This level of efficiency is truly remarkable.”

The successful conclusion of the first phase has also laid a solid foundation for Hainan’s next steps in policy formulation. According to the Measures, 14 additional measures must be implemented by December 31, i.e., within just two months.

Currently, several future plans have come to light. One of them is that Hainan will host the “China Digital Therapeutics Development Summit Forum” under the framework of the “2022 6th Hainan International Health Industry Expo” (hereinafter referred to as the “Health Expo”), which will be held at the Hainan International Convention and Exhibition Center from November 18 to 20.(Click to register for the forum), inviting government leaders, experts, scholars, and industry pioneers to engage in in-depth exchanges and discussions on current hot topics and challenging issues, such as how to promote the development of the digital therapeutics industry.

The Health Expo is a major achievement in implementing the joint initiative by the Central Committee of the Chinese Peasants and Workers Democratic Party and the Hainan Provincial People’s Government to co-build “Healthy Hainan.” Since its inception in 2017, the expo has held five editions. By aggregating premium industry resources and establishing a high-quality platform for exchange within the health sector, the Health Expo has gradually evolved into an important window for global health brands to enter Hainan and for promoting “Healthy Hainan” to the international community.

The upcoming Health Expo will also feature a dedicated exhibition zone for digital therapeutics, and invitations are currently being extended to industry participants.

Scan the QR code to apply for the Health Expo “Digital Therapeutics Special Exhibition”

VCBeat will continue to track developments in digital therapeutics in Hainan as always. Stay tuned.

Let us look forward to the vast and promising future of digital therapeutics!