Record: Policy Interpretation Press Conference of  "Several Measures to Accelerate the Development of the Digital Therapy Industry in Hainan Province"

(October 14, 2022)

Ru Yingying, a fourth-level researcher of the Press Release Office of the Publicity Department of the CPC Hainan Provincial Committee:

Ladies and gentlemen, friends from the press, good afternoon! Welcome to the press conference of the Information Officeof Hainan Province.

On October 10, 2022, the General Office of the Provincial Government issued the "Several Measures to Promote the Development of the Digital Therapy Industry in Hainan Province" (Qiong Fu Office [2022] No. 46, hereinafter referred to as "Measures"). These "Measures" are the first policy document in the nation and even the world to provide support and guarantees for the full cycle of digital therapy. We are holding this press conference on policy interpretation today in order to keep everyone informed about the policy. Attending today's press conference are: Mr. Zhang Yuhui, a Member of the Party Committee and Deputy Director of the Hainan Provincial Department of Health; Mr. Liu Zuokai, a Member of the Party Group and Deputy Director of the Department of Science and Technology of Hainan Province; Mr. Zhu Yongfeng, Member of the Party Group of the Medical Security Bureau of Hainan Province; Mr. Wang Gang, member of the party group and deputy director of the Hainan Provincial Medicine Administration; Ms. Zhou Li, director of the Personal Insurance Supervision Department of Hainan Banking and Insurance Regulatory Bureau; and Ms. Yi Hua, deputy director of the Innovation and High-tech Development Department of the Hainan Development and Reform Commission.

Next, I would like to ask Zhang Yuhui, deputy director of the Hainan Provincial Department of Health, to introduce the relevant aspects of the "Measures".

Zhang Yuhui, Member of the Party Committee and Deputy Director of the Hainan Provincial Department of Health:

Dear friends from the media, good afternoon! Welcome to the press conference on "Several Measures to Promote the Development of the Digital Therapy Industry in Hainan Province" (hereinafter referred to as "Several Measures"). Thank you, friends from the media, for your concern and support for the development of the digital therapy industry in Hainan Province.

The central government emphasized that "Hainan should deepen supply-side structural reform, give full play to its advantages, gather its innovative elements, and actively cultivate a new era in the information technology industry and digital economy." Digital therapy organically combines the wave of the fourth industrial revolution and new progress in the understanding of life and health. It represents the direction of global technological innovation and the primary development trend of the healthcare industry, and is the key intersection of Hainan’s developmental direction in the digital economy, modern service industry, and high-tech industry, as well as digital service trade. At the same time, the development of Hainan’s digital therapy industry can foster the intelligent growth of medical and health systems in this free trade port, promote the quality and improvement of Hainan's online medical industry, and help deepen reforms in the fields of medicine and healthcare and the cultivation of better health on the island.

In order to seize this major opportunity, after in-depth research, the Provincial Health Commission drafted the "Report on Seizing Opportunities to Promote the Development of the Digital Therapy Industry in Hainan" in early January this year. The report was affirmed by the leaders of the Provincial Party Committee and Provincial Government. On January 25, Hainan Provincial Department of Health and Health Commission issued the "14th Five-Year Plan for Digital Health in Hainan Province", which clearly listed "exploring digital therapy for trial use" as one of its 24 main tasks. This is the first time digital therapy has been implemented in the country. Inclusion in the provincial plan has attracted widespread attention from all parties and formed the "flagship" effect of Hainan. This time, under the leadership of the Provincial Party Committee and the Provincial Government, and with the support and cooperation of various departments, relevant units and enterprises, the Provincial Health and Health Commission conducted extensive research and formulated the "Several Measures" document, and has repeatedly solicited relevant opinions during this process. It was issued by the General Office of the Provincial Government on the 10th. This is the first full-cycle support policy for digital therapy nationwide and even globally.

The "Several Measures" will provide all-round support for the construction of digital therapy clinical research demonstration bases, product registration and approval, product promotion and application, exploration of payment methods, publicity and industrial cluster construction, standardized development and guarantees, etc., which will play a significant role in the development of the digital therapy industry. The goal is to build Hainan into the world's digital therapy innovation island, an innovation resource gathering area and industrial highland, through 2 or 3 years of effort: to build digital therapy into a new engine for the high-quality development of Hainan's health industry, and to promote Hainan's health and health-related undertakings by leaps and bounds. This includes the development and realization of the goal of increasing average life expectancy by two years during the "14th Five-Year Plan" period, and accelerating the construction of a higher level of health on the island.

Below I will introduce to you the main contents of the "Several Measures". The "Several Measures" have a total of 21 articles, which are divided into 6 parts.

The first is to build a national leading digital therapy clinical research demonstration base. As a result of building a digital therapy clinical trial center, supporting technical research and clinical transformation, and building a public service and management platform, we will create an excellent environment for digital therapy research and service support.

The second is to speed up the registration and approval of digital therapy products. By formulating the classification supervision and registration approval guidance documents of digital therapy products, setting up a special channel for product registration guidance, establishing a green approval channel, exploring the digital therapy filing system, and encouraging the application of real-world data, the rapid registration and approval of digital therapy products can be achieved.

The third is to actively promote the application of digital therapy products. This includes efforts to promote the application of digital therapy products in a comprehensive way by building a digital therapy application promotion base, as well as promoting the integrated development of digital therapy and internet hospitals, building a demonstration area for digital therapy applications, and encouraging all sectors of society to increase the application of digital therapy products.

Fourth, encourage exploration of multiple payment methods. Relevant aspects include commercial insurance innovation, pricing charges, medical insurance payments, etc. This also entails encouraging the exploration of "digital therapy + commercial insurance" product innovation, exploring digital therapy price formation mechanisms and medical insurance payment models, etc., to provide payment guarantees for the promotion and application of digital therapy.

The fifth is to strengthen the promotion of digital therapy and construction of industrial clusters. This will be done through the implementation of precise investment strategies and promotion of the entire industry chain, the active introduction of outstanding digital therapy innovation enterprises at home and abroad, the planning and holding of the World Digital Therapy Conference, and the creation of Hainan's "World Digital Therapy Innovation Island" brand, etc., to promote the aggregation of the digital therapy industry in Hainan.

Sixth, standardize development and other guarantees. This can be achieved by formulating industry standards, strengthening data security supervision, strengthening the use of data resources, strengthening talent protection, and giving play to the role of the free trade port industrial fund. Multiple measures have been taken to ensure the high-quality development of the digital therapy industry.

The above is the main content of the "Several Measures". You may have noticed that among the 21 specific measures, 18 are to be completed before December 31 this year. Digital therapy is an emerging industry that requires extensive institutional innovation and policy exploration, which is highly challenging. However, we can still set this demanding goal despite the time limit. This is the result of various departments resolutely implementing the work deployment of the provincial party committee and the provincial government and actively applying pressure to themselves. The results also fully demonstrate Hainan's determination to promote the development of its digital therapy industry, and also fully demonstrate the unique developmental acceleration of the Hainan Free Trade Port.

As our the next step, we will take the "Several Measures" as our foundation, give full play to the integrated innovation advantages of the Hainan Free Trade Port system, and work together with various departments to accelerate the implementation of various specific policies. This forms an excellent chance for Hainan's digital therapy policy to attract innovative elements, accelerate the development of the digital therapy industry, build a smart healthcare system with the characteristics of a free trade port, and promote a productive, coordinated development of the island’s health care and industries. Finally, I wish everyone good health and productive work. Thank you!

Ru Yingying:

Thank you Deputy Director Zhang Yuhui for your professional and inspiring introduction. Next, we will allow reporters to ask questions. Please inform the media organizations you represent before asking questions. Questioners may now raise your hand.

Q&A session

Health News reporter:

What is the special background of Hainan's introduction of 21 measures to accelerate the development of the digital therapy industry?

Zhang Yuhui:

Hainan's development of the digital therapy industry is firstly in line with the central government's requirements for innovation and high-quality development in Hainan. In his speech to celebrate the 30th anniversary of Hainan's establishment as a special economic zone, General Secretary Xi Jinping emphasized that Hainan should "deepen supply-side structural reform, give full play to its advantages, gather its innovative elements, and actively develop a new generation of the information technology industry and digital economy."

Digital therapy uses data as its means of production, and uses information technology and big data algorithms as production tools. It is an important content and frontier field for the digital economy. Second, the development of "digital therapy" is an important way for Hainan to innovatively implement its healthcare policy in the new era, accelerate the construction of a health service system centered on people's health, and accelerate the improvement of the health and well-being of the people of Hainan.

The Eighth Provincial Congress has proposed a plan to build a higher level of health on the island. During the "14th Five-Year Plan" period, Hainan aims to achieve the goal of increasing average life expectancy by two years. To achieve this extremely challenging goal, the support of digital therapy as a "new increment" and "new power" is needed. Digital therapy combines the latest advances in life science and information technology, and can provide innovative treatment approaches for some diseases, such as mental disorders, autism, etc. It can be combined with medicine and devices to improve medication compliance and treatment and rehabilitation effects, such as significantly improving the effective control rate of chronic diseases such as diabetes. It can empower medical staff to treat and serve more patients at the same time, as well as playing a role in disease screening and preventive intervention.

Third, the development of "digital therapy" is in line with Hainan's unique policies and resource endowments. Digital therapy uses data as its means of production, information technology and big data algorithms as production tools. It is less constrained by the basic conditions of the upstream and downstream industrial chains of Hainan's health industry. It can form an effective connection with the registration access policy of the clinical real-world data application pilot in the Boao Hope City and the Internet medical industry cluster in Hainan Ecological Software Park. Thus, it is conducive to taking advantage of Hainan's innovations in system integration, as well as the advantages of "facilitation" and a "safe and orderly flow of data", and quickly forming policies to promote the rapid development of the industry.

Fourth, the development of "digital therapy" is conducive to creating a new engine for the high-quality coordinated development of health and industry. The characteristics of digital therapy are naturally in line with Internet medical care, and can achieve the dual-core drives of "Internet medical treatment + digital therapy" in the fields of disease treatment and health management, which will lead to the aggregation and reconstruction of the trillion-level digital medical industry. At the same time, it can effectively improve the accessibility and continuity of services, reduce the burden of cost, and promote the high-quality coordinated development and progress of healthcare and industry.

Fifth, the development of "digital therapy" is conducive to attracting overseas digital therapy innovation resources and helping to improve Hainan's level of internationalization. Digital therapy is the intersection of the most active areas of innovation in the life sciences and information technology. Hainan is backed by a large market of 1.4 billion people on the mainland, and has advantages such as its system integration and innovation, a strong attraction to global innovative companies. Hainan has accelerated the development of its digital therapy industry through system integration innovation, which is conducive to attracting and introducing global innovation elements. This includes international talents, technology, capital, and rising standards that help improve the internationalization level of Hainan's health industry and free trade port.

Reporter:

In what ways will the Provincial Department of Science and Technology support the development and application of digital therapy?

Liu Zuokai, member of the party group and deputy director of the Department of Science and Technology of Hainan Province:

Digital therapy is a cutting-edge technology that combines information technology, artificial intelligence, etc. with medical technology. The Provincial Department of Science and Technology actively supports the development of digital therapy scientific research and technological innovation in many ways:

The first is to encourage all units to apply for provincial science and technology special projects such as the Provincial Natural Science Foundation and the Provincial Key R&D Special Projects. Next, they are to organize teams of high-level talents to carry out basic research, applied research and product development, with a special emphasis on key technology research and clinical translation research of related products combined with the diagnosis and treatment of key diseases in our province.

The second is to support the construction of relevant innovation platforms and encourage qualified enterprises and institutions to establish key scientific research platforms such as provincial key laboratories and technology innovation centers. This supports scientific and technological innovation cooperation with industry-leading scientists and key enterprises, establishes scientific and technological cooperation platforms, and supports the introduction of high-level scientific research institutions.

The third is to support the development of related technology enterprises, increase the cultivation of high-tech enterprises and technology-based small and medium-sized enterprises in the field of digital therapy, and encourage the park to establish public technical service platforms, incubators, maker spaces and other platforms to support the accelerated development of relevant small, medium and micro enterprises. This includes encouraging enterprises to increase investment in scientific and technological innovation through scientific and technological financial means.

China News Service reporter:

How will digital therapy be billed? Will it be included in medical insurance reimbursement, and how will it be integrated with the ongoing reform of medical payment methods?

Zhu Yongfeng, a member of the party group of the Medical Security Bureau of Hainan Province.

First, our province is deepening its reform of medical service prices and accelerating the establishment of a scientifically determined and dynamically adjusted medical service price formation mechanism. As a new form of business, digital therapy will also be included in the scope of medical service price reform. Based on the requirements of the "Several Measures for Improving the Development of the Digital Therapy Industry in Hainan Province", our bureau will actively explore price formation mechanisms for the clinical use of digital therapy according to the actual diagnosis and treatment needs of patients and specific diseases, and reasonably formulate digital therapy billing methods and standards. For digital therapy that is a medical service item, medical institutions can apply to the Provincial Medical Insurance Bureau, and after organizing demonstrations and performing relevant procedures, the price and billing policies will be clarified and released for implementation.

Second, according to the characteristics and clinical application of digital therapy, we will study the inclusion of digital therapeutic products or digital medical services that have high clinical value. We will do this according to the medical insurance strategic purchase principle, based on the premise of adapting appropriately to the level of economic development, in addition to being guided by the social fairness of medical insurance while remaining centered on enhancing value. The result will be an excellent economic evaluation, one which is affordable by medical insurance funds and insured in the scope of medical insurance payments.

The third is to select medical institutions that have carried out digital therapy and accumulated relevant data based on the progress of the reform of medical insurance payment methods in the province. The includes conducting data analysis, research and demonstration, and supporting the application of digital therapy in medical cost control. Other important aspects include service quality improvement and health management; exploring an effective form of digital therapy combined with the promotion of payments by disease; and promoting the formation of a payment mechanism based on value and data-efficient use.

Hainan Daily reporter:

What specific measures does the Hainan Provincial Medical Products Administration take to support the development of the digital therapy industry in our province?

Wang Gang, member of the party group and deputy director of the Hainan Provincial Medical Products Administration:

Thank you for your question! The Hainan Provincial Medical Products Administration attaches great importance to promoting its digital therapy industry, and we have four specific measures to speed up the registration and approval of digital therapy products.

The first is to publish policy and regulatory documents on digital therapy products. A column for digital therapy products will be set up on the website of the provincial bureau, and important content such as policies and regulations, guidance documents, classification definitions, and precautions related to digital therapy products will be published in the column and updated promptly.

The second is to strengthen digital therapy product registration coaching training; publicize the digital therapy policy consultation hotline and mailbox on the provincial bureau website; establish a special counseling mechanism for second-class medical device digital therapy products; arrange a special person to be responsible for product technical consultation; carry out digital therapy product registration application and policy training; and improve enterprise application standards and quality.

The third is to unblock the priority approval channel for digital therapy products and include the registration approval of the second category of digital therapy products into the provincial bureau's priority approval process for medical devices. This will unblock the priority approval channel, support the application of digital therapy products on a basis of solid evidence, a high level of technology maturity, and key development in our province. This services to reinforce the vitality of the development of the digital therapy industry.

The fourth is to encourage real-world data to be used for post-market clinical validation, encourage real-world research, give play to the leading role of real-world research institutions, and promote the use of real-world data for post-market clinical validation of digital therapy products.

At the same time, the Hainan ProvincialMedical Products Administration will also actively cooperate with the Provincial Health Commission and other departments to carry out the construction of a digital therapy clinical trial center and a digital therapy public service and management platform. Thanks!

Youth Channel reporter:

What hurdles need to be overcome for commercial insurance to play a role in digital therapeutics?

Zhou Li, Director of the Personal Insurance Supervision Division of the Hainan Banking and Insurance Regulatory Bureau:

"Digital therapy" is a relatively new concept in this country and even in the world. Hainan's promotion and development of "digital medicine" will be a milestone across the ages. In order to help promote the popularization and high-quality development of digital therapy, the Hainan Banking and Insurance Regulatory Bureau will support insurance institutions within its jurisdiction to actively research and learn about digital therapy, and actively participate in digital therapy training organized by medical authorities to enhance awareness of digital therapy. This will guide insurance institutions within the jurisdiction to explore the incorporation of digital therapy into the insurance product design system, or also to utilize it as a health management service tool to help people maintain a higher level of health and ease people's worries about using new technologies.

At the same time, "digital therapy" is still in the exploratory stage, and a complete commercial system has not yet been formed. Further development is required in the realms of technology, supervision, and existing upstream and downstream industrial chains. For commercial insurance to play a role in digital therapy, we require strong support from the medical and health authorities and a sound digital therapy ecosystem as support. It is necessary to clarify the positioning of commercial insurance in digital therapy and what kind of risk protection it provides. The algorithm of insurance products under "digital therapy" will also change as technology advances. The new technology will have an impact on the actuarial and pricing foundation of insurance products because it lacks historical data support. All of these new concerns require further research, including how to preserve sustainable development and how to regulate insurance products beyond iteration. As the next step, the Hainan Bureau of Banking and Insurance Regulatory Commission will cooperate with relevant departments to jointly promote "digital therapy" as a "new engine" for the high-quality development of Hainan's health industry, and help in the construction of a free trade port!

Haikou Daily reporter:

What are the considerations for building a high-quality digital therapy industry cluster and introducing overseas digital therapy companies?

Yi Hua, Deputy Director of the Innovation and High-Tech Development Division of the Hainan Development and Reform Commission:

Thanks for asking. We will mainly work on the following aspects.

The first is to focus on policy advantages and innovate the mode of industrial linkage. Together with relevant departments in the province, we will make full use of the Hainan Free Trade Port policy and the special policy advantages of the Boao Lecheng. We will also promote joint investment promotion between the Lecheng and the Haikou National High-tech Zone, and jointly build an economic cooperation demonstration park to promote resource integration, complementary functions and overlapping advantages. This will attract prospective companies to use the Lecheng policy to quickly introduce more high-quality overseas digital therapy products to Lecheng, promote real-world research pilot approved products to be produced in Haikou High-tech Zone, and form a "front area and rear factory" industry.

At the same time, combined with the existing industrial foundation of key parks such as Haikou National High-tech Zone, Hainan Ecological Software Park, and Haikou Fuxing City Internet Information Industrial Park, overseas scientific and technological talents and digital therapy companies are encouraged to carry out achievement incubation and commissioned production in relevant parks. We will attract overseas R&D institutions and technology transfer centers to set up regional centers in Hainan, drive the improvement of the overall R&D level of digital therapy, and create a highland for the province's digital therapy industry.

The second is to strengthen policy support such as capital elements. In order to promote the construction of Smart Hainan, starting in 2022, our province will allocate 1 billion yuan of financial funds every year to set up subsidy funds for the construction of Smart Hainan, and issue the "Interim Measures for the Management of Subsidy Funds for the Construction of Smart Hainan". This will guide social capital to plan and package projects around digital industry application scenarios such as digital therapy, support project construction through loan discounts, substitute awards for subsidies, etc., while boosting the implementation of projects and aiding in the development of the digital therapy industry.

Ru Yingying:

Do any other reporters want to ask questions? If not, this is the end of today's reporter questioning session. Thanks again to all the publishers for a very detailed and professional introduction and interpretation of the relevant content of "Several Measures to Accelerate the Development of the Digital Therapy Industry in Hainan Province". If you still need interviews after the meeting, you can contact the staff of the Provincial Information Office.

This press conference ends here. Thank you all!

Source: Hainan Provincial Information Office

Photography: Liu Yang

Editor: Zhang Liuyang, Li Wencui

Proofreading: Fan Xueling