The General Office of the Provincial Government issued Several Measures for Accelerating the Development of the Digital Therapy Industry in Hainan Province (

Hainan Government Office [2022] No. 46

To all municipal, county, and autonomous county people's governments, and all units directly under the provincial government:

The "Several Measures for Hainan Province to Accelerate the Development of Digital Therapy Industry" has been approved by the provincial government and is now issued to you. Please implement it conscientiously.

Office of the People's Government of Hainan Province

September 29, 2022

(This document is disclosed voluntarily)

Several measures for Hainan Province to accelerate the development of digital therapy industry

In order to implement the spirit of General Secretary Xi Jinping's speech at the conference celebrating the 30th anniversary of Hainan's establishment as a province and a special economic zone, that "Hainan should deepen supply-side structural reforms, give full play to its advantages, gather innovative elements, and actively develop a new generation of information technology industry and digital economy", seize the historical opportunity, and through 2-3 years of efforts, build Hainan into a global digital therapy innovation island, innovation resource gathering area and industrial highland, and make digital therapy a "new engine" for the high-quality development of Hainan's health industry, promote the leapfrog development of Hainan's health and the realization of the goal of increasing life expectancy by two years during the "14th Five-Year Plan", the following measures are specially formulated:

1. Build a national leading digital therapy clinical research demonstration base

(I) Build a number of digital therapy clinical trial centers. A number of tertiary hospitals with advantageous disciplines will be selected throughout the province to establish digital therapy clinical trial centers, such as the Boao Lecheng International Medical Tourism Pilot Zone Digital Therapy Clinical Research and Transformation Base, the Mental Disorder Digital Therapy Clinical Trial Center, the Children's Attention Deficit Hyperactivity Disorder and Autism Digital Therapy Clinical Trial Center, the Tumor Digital Therapy Clinical Trial Center, the Ophthalmology Digital Therapy Clinical Trial Center, and the Sleep Digital Therapy Clinical Trial Center. (Responsible units: Provincial Health Commission, Provincial Drug Administration, Boao Lecheng International Medical Tourism Pilot Zone Management Bureau; Implementation deadline: before October 31, 2022)

(II) Encourage the development of digital therapy technology research and clinical transformation. Encourage medical institutions and colleges and universities to conduct scientific research on digital therapy and promote clinical transformation. Actively organize the application of provincial key R&D projects, provincial natural science funds and other science and technology special funds, and explore ways to attract superior forces to carry out key technology research in the digital therapy industry through "unveiling the list and taking charge". Encourage international scientific research cooperation and develop a global scientific research project cooperation platform for digital therapy. Support the R&D and innovation of digital therapy products. The provincial biomedical industry R&D vouchers and other R&D and innovation support policies in the province can be used to provide corresponding subsidies and rewards to enterprises, universities and medical institutions in stages according to the different phases of digital therapy product R&D and industrialization results. Support medical institutions to give certain preferences to personnel who actively carry out and undertake digital therapy clinical research in terms of job setting, job promotion, and award recommendation. When distributing performance within public hospitals, appropriately increase the preference for digital therapy clinical researchers, and allow digital therapy job technology achievements to be included in the total performance salary of the unit in the year, without being subject to total restrictions, not included in the total base, and not used as the social insurance payment base. (Responsible units: Provincial Department of Science and Technology, Provincial Department of Industry and Information Technology, Provincial Health Commission, Provincial Talent Development Bureau, Provincial Department of Human Resources and Social Security, Provincial Department of Education; Implementation deadline: before December 31, 2022)

(III) Accelerate the construction of digital therapy public service and management platform. Establish a special channel for digital therapy industry development on the websites of relevant departments to support digital therapy participants such as enterprises, medical institutions, and clinicians to submit clinical trial needs, and help all parties quickly connect and match resources. Establish a digital therapy clinical trial disclosure system, and digital therapy companies shall promptly report the specific circumstances and results of clinical trials, and relevant information can be used as the basis for the approval department. Introduce a number of digital therapy CRO and CDMO companies to settle in Hainan, support the construction of Hainan digital therapy CDMO platform, and support CDMO and other platforms to conduct clinical trials and market-oriented cooperation with Hainan physical hospitals and Internet hospitals. (Responsible units: Provincial Health Commission, Provincial Drug Administration, Provincial Department of Industry and Information Technology; Implementation period: before October 31, 2022)

2. Accelerate the registration and approval of digital therapy products

(IV) Formulate guidance documents on the classification supervision and registration and approval of digital therapy products. Set up a digital therapy column on the department website to list regulatory policies and guidance documents related to the registration and approval of digital therapy. According to the National Medical Products Administration's guidance principles for the classification of medical device software products, the guidance principles for the registration and technical review of mobile medical devices, and the classification and definition results of the National Standards Management Center, form opinions on the classification and definition of digital therapy and publish them in the column; classify and explain the regulatory policies, regulatory documents and operating guidelines that can be applied to digital therapy products in key links such as clinical trials, registration review and approval, and updates and iterations. (Responsible unit: Provincial Drug Administration; Implementation deadline: before December 31, 2022)

(V) Establish a special channel for registration guidance for digital therapy products of Class II medical devices. Publicize the digital therapy regulatory policy consultation hotline and email address on the website of the relevant department, establish a special guidance and rapid response mechanism for digital therapy products of Class II medical devices, and assign a dedicated person to be responsible for technical consultation on digital therapy products. In principle, a reply will be given within 10 working days after receiving the consultation. Carry out training on the registration process and policies for digital therapy products applied by enterprises, improve the application standards and quality of enterprises, and increase the approval rate. (Responsible unit: Provincial Drug Administration; Implementation deadline: before October 31, 2022)

(VI) Issue a catalogue of digital therapy encouragement and establish a green approval channel for specific types of digital therapy. Priority will be given to encouraging the development of a number of digital therapy products with solid evidence-based basis, high technical maturity, urgent clinical needs in Hainan, and broad development prospects, and establish a priority approval channel. Formulate a digital therapy priority approval procedure, clarify the conditions and work procedures to be met for the priority approval procedure, and complete the review and approval within 3 months after the enterprise submits the digital therapy product registration application in accordance with the medical device registration application materials requirements. The enterprise's supplementary materials and expert technical review are not included in the time limit requirements. For those that are not approved, inform the applicant of the reasons for failure and suggestions. (Responsible unit: Provincial Drug Administration; Implementation deadline: before October 31, 2022)

(VII) Explore the digital therapy filing system and encourage the use of real-world data in product registration and approval and clinical validation for marketing. For digital therapy products with low risks and suitable for screening, intervention and other public health fields, explore rapid promotion and application through filing on the premise of meeting the relevant national review and approval requirements. Encourage real-world research, give full play to the leading role of the National Medical Products Administration's Drug and Medical Device Regulatory Science Research Base and the National Medical Products Administration's Hainan Real-World Data Research and Evaluation Key Laboratory, as well as the experience of licensed medical device products being approved for marketing through real-world research policies, and promote the use of real-world data for digital therapy product registration basis and digital therapy product regulatory decision-making and post-marketing clinical validation. (Responsible unit: Provincial Drug Administration; Implementation period: long-term promotion)

III. Actively promote the application of digital therapy products

(VIII) Build a digital therapy promotion base. Select qualified medical institutions as the first batch of digital therapy diagnosis and treatment centers, and gradually incorporate digital therapy into the routine diagnosis and treatment pathways of all qualified medical institutions. Combined with Hainan Province's "2'3" health service package and other work, rely on digital therapy to improve the medical service supply capacity of primary medical institutions and the disease management capacity of patients and families. Encourage medical institutions to promote digital therapy in hospitals and improve patients' and the public's awareness and use of digital therapy. (Responsible unit: Provincial Health Commission; Implementation period: before December 31, 2022)

(IX) Promote the integrated development of digital therapy and Internet hospitals. Encourage medical institutions to integrate digital therapy with Internet hospital platforms and give doctors the authority to prescribe digital therapy in Internet hospitals. Promote Internet hospitals to increase the application of digital therapy products and enhance service functions in the fields of special disease prevention and health intervention. Doctors are encouraged to use digital therapy as a tool for outpatient patient management, and to combine it with the functions of Internet hospitals such as follow-up prescription renewal, prescription circulation, and medicine distribution to achieve all-round outpatient patient management. Operational supervision of digital therapy is achieved through the Hainan Internet Hospital Supervision Platform. (Responsible unit: Provincial Health Commission; Implementation deadline: before December 31, 2022)

(10) Build a national leading digital therapy application demonstration area. Introduce digital therapy into the entire process of Hainan's medical and health reform and development, coordinate the reform and development work such as the construction of Hainan's tiered diagnosis and treatment system and the construction of diagnosis and treatment centers, and support the promotion and application of digital therapy products with urgent clinical needs and outstanding clinical value in five major centers such as urban medical groups, county medical communities, and chest pain centers. Encourage the use of patient data generated by digital therapy to support doctors in secondary and tertiary hospitals in diagnosing difficult and serious diseases, and support medical staff in primary medical institutions to complete the management of chronic disease patients and disease tracking. Promote the construction of regional medical informatization, and open up the interface between digital therapy and regional electronic medical record database and electronic health record database. Relying on Hainan Province's "Three Medical Linkages and One Network" platform, realize comprehensive supervision of digital therapy. (Responsible unit: Provincial Health Commission; Implementation deadline: before December 31, 2022)

(XI) Encourage all aspects of society to increase the application of digital therapy products. Encourage relevant departments, public welfare foundations and other institutions and organizations to purchase digital therapy products, focus on key populations, diseases and diversified and multi-level digital health needs, and use digital therapy products for the treatment of mental health and behavioral cognition on a larger scale, effectively improve the intervention and screening effects of chronic diseases, empower community family doctors through digital therapy technology, innovate service forms, and improve residents' health intervention capabilities. (Responsible unit: Provincial Health Commission, Provincial Disabled Persons' Federation; Implementation deadline: before December 31, 2022)

IV. Encourage the exploration of multiple payment methods

(XII) Encourage the exploration of "digital therapy ' commercial insurance" product innovation. Pilot the use of digital therapy as a health management service for special drug insurance in the Boao Lecheng International Medical Tourism Pilot Zone. Encourage insurance companies to use digital therapy as a user health management service tool in accordance with the law and regulations, and reasonably price it according to relevant regulations based on the real-world data collected by digital therapy. Explore the development of an upgraded version of Hainan Huiminbao, and include some digital therapy products as health management services in the coverage of insurance products. Encourage the inclusion of digital therapy products in the insurance product design system of insurance institutions. Support product developers of insurance institutions to participate in digital therapy training organized by medical authorities to enhance their understanding of digital therapy. (Responsible units: Hainan Regulatory Bureau of the China Banking and Insurance Regulatory Commission, Provincial Department of Finance, Provincial Medical Insurance Bureau, Provincial Health Commission, Provincial Taxation Bureau, Boao Lecheng International Medical Tourism Pilot Zone Management Bureau; Implementation period: before December 31, 2025)

(Thirteen) Encourage the inclusion of digital therapy in the technical specifications and charging scope of medical service items. Explore the price formation mechanism and medical insurance payment model for digital therapy. According to the actual diagnosis and treatment needs of specific diseases, actively explore the price formation mechanism for clinical use of digital therapy, reasonably formulate digital therapy charging standards, and the medical service price project of digital therapy shall be applied by medical institutions to the Provincial Medical Insurance Bureau, and announced and implemented after organizational demonstration and fulfillment of relevant procedures; in accordance with the medical insurance strategic purchase principle based on the premise of adapting to the level of economic development, guided by reflecting the social fairness of medical insurance, and centered on enhancing value, research on the inclusion of digital therapy products or medical services with high clinical value, excellent economic evaluation, and affordable to medical insurance funds and insured persons into the medical insurance payment scope. Include digital therapy products used by medical institutions in the scope of medical service income. (Responsible units: Provincial Medical Insurance Bureau, Provincial Health Commission; Implementation deadline: before December 31, 2022)

(XIV) Support the exploration of combining digital therapy with medical insurance payment reform. In combination with the progress of medical insurance payment reform in the province, select medical institutions that have carried out digital therapy and accumulated relevant data, support the application of digital therapy in medical cost control and health management, explore effective forms of combining digital therapy with the promotion of payment by disease type, and promote the formation of an efficient and effective payment mechanism based on value and data. (Responsible units: Provincial Medical Insurance Bureau, Provincial Health Commission; Implementation deadline: before December 31, 2022)

V. Strengthen the promotion of digital therapy and the construction of industrial clusters

(XV) Create a high-quality digital therapy industrial cluster. Sort out domestic and foreign digital therapy companies and potential intention companies, form a list of companies, and implement precise investment promotion for the entire industry chain. Relying on the policy advantages of Hainan Free Trade Port and the policy support system for the entire cycle of digital therapy, as well as high-level data platforms such as the electronic prescription center, we will gather innovative resources and combine the industrial foundations of key parks such as the Boao Lecheng International Medical Tourism Pilot Zone, Hainan Ecological Software Park, Haikou National High-tech Development Zone, and Haikou Fuxing City Internet Information Industry Park to create several innovation highlands and industrial clusters for digital therapy in Hainan Free Trade Port. (Responsible units: Provincial Health Commission, Provincial Development and Reform Commission, Boao Lecheng International Medical Tourism Pilot Zone Administration, Hainan Ecological Software Park Administration, Haikou National High-tech Industrial Development Zone Management Committee, Haikou Fuxing City Internet Information Industry Park, Hainan International Economic Development Bureau, etc.; Implementation deadline: before December 31, 2023)

(XVI) Actively introduce overseas digital therapy companies. Take targeted policy measures for different types of overseas digital therapy companies, actively guide overseas digital therapy companies to cooperate with local medical institutions, and achieve in-depth integration of overseas digital therapy and local industrial chains. Relying on the advantages of the real-world data research and application pilot project in the Boao Lecheng International Medical Tourism Pilot Zone, a batch of high-quality overseas digital therapy products will be introduced for trial in China, and their real-world research data will be supported for product approval. (Responsible units: Provincial Health Commission, Provincial Development and Reform Commission, Boao Lecheng International Medical Tourism Pilot Zone Administration; Implementation deadline: before December 31, 2022)

(XVII) Accelerate the creation of the Hainan Digital Therapy Innovation Island brand. Hold the World Digital Therapy Conference in Hainan, and gather government policies, leading enterprises, capital power, innovative technologies, talents and other resources through the conference. Release the annual World Digital Therapy Report (multilingual), establish a digital therapy display and experience center, and create a digital therapy exhibition hall with a certain scale and distinctive characteristics through virtual reality, holographic projection, digital large screen, physical display and other technologies and means. (Responsible units: Provincial Health Commission, Provincial Department of Commerce, Provincial Development and Reform Commission, Hainan Ecological Software Park Administration, Boao Lecheng International Medical Tourism Pilot Zone Administration; Implementation deadline: before December 31, 2022)

VI. Standardized development and other guarantees

(XVIII) Attract digital therapy-related associations or branches to settle down, formulate industry standards, and establish information exchange platforms. Establish a digital therapy expert committee or related organizations to study and formulate digital therapy industry standards; regularly hold digital therapy training and academic discussion meetings to enhance the understanding of digital therapy by clinicians and other parties, and gradually promote the inclusion of digital therapy in the diagnosis, treatment and management of various specialized diseases. Expert consensus. Support the establishment of an international digital therapy industry alliance, organize domestic and foreign companies to carry out discussions in the fields of digital therapy policies and regulations, review and approval, medical value and medical insurance payment, and provide international cutting-edge theoretical guidance and practical experience for building innovative business models. (Responsible unit: Provincial Health Commission; Implementation deadline: before December 31, 2022)

(XIX) Strengthen data security supervision and enhance the use of data resources. Formulate policy guidelines on digital therapy data security. Encourage the use of the provincial government information sharing and exchange platform to strengthen security and protection in accordance with the law.

Under the premise of ensuring the safety and privacy of users, the health data collected by digital therapy products will be gathered in the "Three Medical Big Data Resource Centers" of the province, and the orderly opening of health and medical data resources will be steadily promoted. Special guidance will be strengthened on the technical review of user information protection for digital therapy products, and strict accountability will be pursued for data leaks. User complaint channels and regular inspections and spot checks will be established to promptly discover and deal with related illegal and irregular behaviors in accordance with the law. (Responsible units: Provincial Cyberspace Administration, Provincial Big Data Management Bureau, Provincial Health Commission; Implementation deadline: before December 31, 2022)

(Twenty) Strengthen the guarantee of digital therapy talents. Encourage relevant colleges and universities in Hainan to add digital therapy courses and majors, support the development of related interdisciplinary disciplines, increase the training of interdisciplinary talents such as the Internet, big data, artificial intelligence, and bioinformatics, and provide talent support for the development of the digital therapy industry. Relying on Hainan Medical College, the Provincial Digital Therapy Research Institute was established. Implement the service guarantee policies for talent settlement, car purchase, housing, medical care, etc. in our province, and encourage and support scientific research institutions and enterprises to actively introduce middle and high-level talents from home and abroad. Actively organize digital therapy industry talents to apply for talent projects at all levels, and support high-end and scarce digital therapy talents to enjoy the personal income tax preferential policies of Hainan Free Trade Port in accordance with relevant regulations. (Responsible units: Provincial Department of Education, Provincial Health Commission, Provincial Department of Finance, Provincial Talent Development Bureau, Provincial Department of Industry and Information Technology, Hainan International Economic Development Bureau, Hainan University, Hainan Medical College; Implementation deadline: before December 31, 2022)

(Twenty-one) Give full play to the role of the Free Trade Port Fund and adopt equity investment to support the development of the digital therapy industry. Give full play to the leverage role of the Hainan Free Trade Port Construction Investment Fund, cooperate with industrial capital and financial capital in a government-guided, market-oriented manner, promote the establishment of sub-funds in the medical and health field, invest in the digital therapy industry, and support the development of Hainan digital therapy companies. (Responsible units: Provincial Department of Finance, Provincial Health Commission; Implementation deadline: before December 31, 2022)