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On October 11, Hainan Province issued the "Several Measures for Hainan Province to Accelerate the Development of the Digital Therapy Industry" (hereinafter referred to as the "Measures"), which put forward several policy details for the development of the digital therapy industry in Hainan Province, and planned to build Hainan into a global digital therapy innovation island, innovation resource gathering area and industrial highland through 2-3 years of efforts; It is proposed to build digital therapy into a "new engine" for the high-quality development of Hainan's health industry, and promote the leapfrog development of
Hainan's health care.
This is the first time in China and even the world to launch a full-cycle digital therapy industry support policy, which is of great significance! The Measures also echo Hainan's previous policies – at the end of January this year, the 14th Five-Year Plan for Digital Health in Hainan Province released by the Hainan Provincial Health Commission listed "exploring digital therapy pilot trials" as one of the main tasks of
Hainan's 14th Five-Year Plan for digital health development.
This is also the first time that digital therapeutics have been included in provincial planning, which has attracted widespread attention from the industry and formed a demonstration effect, and local governments in many places have begun to pay attention to digital therapeutics
.
For the digital therapeutics industry, this is another major positive news in the short term - just before the National Day holiday, the digital therapeutics industry has just ushered in a wave of favorable policies (for details, see: "Digital Therapeutics Make Great Progress!").
NMPA Classification Definition Guidelines and IEEE Standards Development Work Initiation").
The biggest highlight of Hainan's policy is the world's first full-cycle digital therapy industry support policy
The biggest highlight of Hainan's policy is the world's first full-cycle digital therapy industry support policy The biggest highlight of the Measures is that targeted measures
are proposed around product research and development, registration and approval, application, payment, industrial agglomeration, data security, talent protection and capital support in the digital therapy industry.
Earlier, some regions have explored targeted policies on a single item, but the Measures are the first to propose a full-process, systematic and operable full-cycle digital therapy industry support policy
.
Zhang Yuhui, deputy director of the Health Commission of Hainan Province, said that the Measures closely follow the central government's requirements for Hainan to deepen supply-side structural reform and actively develop the digital economy, rely on Hainan's resource endowment and system integration innovation advantages, and comprehensively support and empower the development of
the digital therapy industry from a full-cycle perspective.
The Measures give clear encouragement and support policy directions in the key links of the whole cycle such as scientific research and clinical transformation, registration and approval, promotion and application, innovative payment, standardization and guarantee, and are committed to truly solving the practical problems
faced by digital therapy enterprises.
"Hainan Province has proposed to increase life expectancy by two years during the 14th Five-Year Plan period, which is a very challenging goal
.
Digital therapeutics can provide innovative treatment pathways for a wide range of diseases; It can be combined with drugs, devices, etc.
to improve medication compliance and treatment and rehabilitation effects; It can also play the role of disease screening and prevention, and provide innovative digital solutions for solving difficult problems in health reform and development, such as accessibility, affordability, and service homogeneity, which will help Hainan Province to manage health care more scientifically, business more intelligently, and residents to benefit more, which we pay the most attention to
.
He introduced
.
"During the formulation of the Measures, we conducted extensive and in-depth research to understand the pain points and needs of digital health innovation enterprises, and held 6 conferences in the 'Hainan Digital Therapy Innovation Week' alone, and digital therapy innovative enterprises gathered in Hainan to discuss the key issues
of digital therapy development.
We hope to accelerate the development of digital therapeutics enterprises in Hainan through 21 measures, and build Hainan into a global digital therapeutics innovation island, innovation resource gathering area and industrial highland
through 2-3 years of efforts.
We believe that digital therapeutics have great prospects, which can realize the dual-core drive of 'Internet medical + digital therapeutics' around disease treatment and health management, and give birth to the aggregation and reconstruction
of the trillion-level digital medical industry.
" Zhang Yuhui further added
.
As an active promoter of digital therapeutics in China, Arterial Network and Eggshell Research Institute have played an important role as an industry think tank in the promotion of digital therapeutics: Arterial Network was the first to pay attention to the innovative exploration of digital therapeutics in Hainan and continued to track it; As a think tank, the Eggshell Research Institute undertook the digital therapy research project commissioned by the Hainan Health Commission, and played an important consulting and decision-making support role
in the formulation of the Measures.
Jiang Tianjiao, president of the Eggshell Research Institute, said that digital therapeutics is the most important innovative medical and health industry track
in addition to medicine and devices.
At the beginning of 2021, the global and domestic digital therapy industry has ushered in rapid growth, and many overseas companies have been listed on
IPOs.
The development of China's digital therapy industry is basically synchronized with the global leading level, but it also encounters many challenges, especially in clinical trials and business models
.
"The introduction of Hainan's "Measures" is very timely, directly hitting the current pain points of the development of the digital therapy industry, especially in scientific research, clinical, promotion, payment and other aspects to give clear support and encouragement
.
We believe and expect that after the introduction of the Measures, Hainan will become a global digital therapeutics industry highland and the core engine
for the development of China's digital therapeutics industry.
He said he was very optimistic about the future development of
digital therapeutics.
As Jiang Tianjiao said, since 2021, digital therapeutics have attracted widespread attention in the industry, and many local governments in China have begun to explore industrial promotion policies
for the launch of digital therapeutics.
In July 2021, the General Office of the People's Government of Hangzhou Municipality issued Several Opinions on Accelerating the High-quality Development of the Biomedical Industry
.
Among them, Article 18 mentions "encouraging the application of medical artificial intelligence and new digital health services, and supporting local medical institutions to participate in the pilot of digital therapy product purchase services"
.
This is also the first policy
in China to explicitly encourage the procurement of digital therapeutics.
Hunan Province is more prominent
in approval.
In December 2021, Hunan issued the Announcement of Hunan Provincial Drug Administration on Releasing the Business Process of Registration of Class II Medical Devices/In Vitro Diagnostic Reagents, taking the lead in significantly shortening the time from the original 80 working days to the final collection of Class II certificates from the original legal time limit of 80 working days to 40 working days, and increasing the speed of approval by 50%.
The effect of this policy was quickly felt - at present, among the digital therapeutics that have been approved by the NMPA, "Xiangji Precision" accounts for about
40%.
On January 25, 2022, the Health Commission of Hainan Province released the 14th Five-Year Plan for Digital Health in Hainan Province, which is the first time that digital therapeutics have been included in the provincial planning in China, representing that it has been valued and promoted
at the provincial level.
Article 22 mentions, "Explore digital therapeutics for trial first
.
" Increase the publicity and promotion of digital therapeutics, actively introduce digital therapeutics products that have been approved for marketing at home and abroad, and promote their use in eligible institutions and populations throughout the province to further meet the needs of
residents' disease treatment and health management.
Relying on the policy advantages and industrial foundation of Hainan Free Trade Port, we will promote the application demonstration of digital therapy in Hainan step by step, and explore the construction of relevant policy support systems
for digital therapeutics.
Take multiple measures to strengthen investment attraction, form a number of digital therapy innovation highlands and industrial clusters, build Hainan into a global digital therapy innovation island, promote the aggregation and reconstruction of 'digital therapy + Internet healthcare', and create a new engine
for the high-quality development of Hainan's health industry.
”
In June 2022, the 2022·6th Future Healthcare Top 100 Digital Therapy Innovation Practice Forum was set up in the Digital Medical and Health Industrial Park of Binzhou High-tech Zone, and participants participated in the Binzhou High-tech Zone Digital Healthcare Industry Development Roundtable to discuss how to accelerate the innovation of Binzhou's digital therapy industry and accelerate the development of
digital healthcare industry 。 Based on the focus of the Digital Medical and Health Industrial Park of Binzhou High-tech Zone in the fields of sleep, chronic diseases and rehabilitation, Binzhou hopes to use digital therapy thinking to promote the rapid development of the "medical health care" and "research, education and production" industrial chain, improve the medical concentration of the park and the height of digital technology innovation, and build Binzhou into a coordinate city
for China's digital therapy application and integrated innovation in 3-5 years.
The "Measures" issued by Hainan Province this month give specific landing measures for the direction of the "14th Five-Year Plan for Digital Health in Hainan Province" at the beginning of the year, and implement them to the specific implementation departments and the completion time
.
This is the most comprehensive of
the enabling policies for digital therapeutics to date.
In particular, the completion time frame of all measures is very tight, most of which will be implemented by the end of this year, and the time limit for some measures is the end
of October.
This fully reflects the determination of Hainan Province to promote the development of the digital therapy industry, and also fully demonstrates the unique development acceleration of Hainan Free Trade Port!
.
This is the most comprehensive of
the enabling policies for digital therapeutics to date.
Most of the measures will be implemented by the end of this year, with a few measures set by the end
of October.
This fully reflects the determination of Hainan Province to promote the development of the digital therapy industry, and also fully demonstrates the unique development acceleration of Hainan Free Trade Port!
21 articles in 6 categories, what impact will it have on the industry?
21 articles in 6 categories, what impact will it have on the industry? There are 21 articles in the Measures, which can be divided into six aspects
: building a leading national digital therapy clinical research demonstration base, accelerating the registration and approval of digital therapy products, actively promoting the application of digital therapy products, encouraging the exploration of multiple payment methods, strengthening digital therapy publicity and industrial cluster construction and standardized development and other guarantees.
: building a leading national digital therapy clinical research demonstration base, accelerating the registration and approval of digital therapy products, actively promoting the application of digital therapy products, encouraging the exploration of multiple payment methods, strengthening digital therapy publicity and industrial cluster construction and standardized development and other guarantees.
The first is the R&D phase
.
In terms of building a leading digital therapy clinical research demonstration base in China, the Measures plan to establish a digital therapy clinical trial center in tertiary hospitals with advantageous disciplines in Hainan Province, provide preferential support to digital therapy clinical researchers in universities and hospitals in project application and performance, and strengthen the construction of public services and management platforms including digital therapy CDMO and unified clinical platform, so as to help digital therapy enterprises connect with clinical and scientific research
.
As a representative of digital therapy CDMO, Zhilan Health is the earliest enterprise in the field of digital therapy in China, and has established a mature DTx-CDMO and full-process incubation system
.
Its person in charge told Arterial Network that Hainan's series of measures such as supporting the construction of digital therapy CDMO platform and building a high-quality digital therapy industry cluster have well solved the current pain points
in the digital therapy industry chain.
Building a digital therapy industry cluster requires the introduction or incubation of a large number of digital therapy products, and the development of digital therapy products needs to establish a complete chain from scratch, and most domestic enterprises currently lack mature experience and resources
in key links such as digital therapy product mechanism discovery, design and development, effectiveness verification, clinical trials, registration review and approval, and listing operation.
CDMO full-process services can help it quickly achieve product development and landing
.
Hainan conducted intensive research on digital therapeutics-related companies in the early stage of formulating relevant policies, and Zhilan Health also participated in them and experienced Hainan's determination and confidence
in developing the digital therapeutics industry.
Under the guidance of the full-cycle policy, the development of digital therapeutics will also open a new chapter
.
One of the most interesting parts of the Measures is the proposal to speed up the registration and approval
of digital therapeutics products.
Hainan Province plans to accelerate the approval process
of digital therapeutics in Hainan by formulating guidance documents for the classification supervision and registration approval of digital therapeutics products, establishing a special channel for registration and counseling of Class II medical device digital therapeutics, establishing a green approval channel for specific digital therapeutics, exploring a low-risk public health digital therapeutics record-filing system and encouraging the application of real-world data.
A highlight of this part is that the idea of a record-filing system for digital therapeutics is proposed for the first time in China, which will facilitate the rapid launch of low-risk digital therapeutics products and strongly promote the application
of real-world data in medical device approval.
Especially in the key aspects of digital therapy supervision, the Measures draw on foreign experience and propose for the first time that the regulatory policies, regulatory documents and operational guidelines required for each regulatory link will be classified and explained
.
This will greatly reduce confusion
when it comes to registration for digital therapeutics businesses.
In addition, the Measures propose to provide green approval channels for specific digital therapeutics and specify the time limit
for completing the review and approval within 3 months after submitting the registration application.
This timeframe is comparable
to the time required for the world's only green channel for digital therapeutics currently in operation, the German DiGA Green Approval Channel.
As for which digital therapeutics can enter the green channel, the Measures clearly meet the requirements
of "solid evidence-based evidence, high technological maturity, urgent clinical needs and broad development prospects in Hainan".
It is of reference to the clinical trial centers mentioned in Article 1 of the Measures - which mention mental disorders, children's attention deficit and hyperactivity disorder, autism, oncology, ophthalmology and sleep and other types of digital therapy
.
In the application of real-world data, Hainan has the advantage of
institutional integration and innovation.
As early as 2019, the "Implementation Plan for the Pilot Work of Clinical Real-World Data Application in Hainan Boao Lecheng International Medical Tourism Pilot Zone" was released, and it took the lead in carrying out clinical real-world data research
on imported drugs and medical devices urgently needed for clinical use in the Boao Lecheng Medical Tourism Pilot Zone.
Due to their natural properties, digital therapeutics products are often considered to have a unique advantage
in collecting real-world data.
Therefore, Hainan's policy advantages in real-world research are undoubtedly quite attractive
to the digital therapeutics industry.
In terms of the application of digital therapeutics, the Measures propose to promote the application
of digital therapeutics products by building promotion bases and promoting their integrated development with Internet hospitals.
Hainan Province is a highland for the construction of domestic Internet hospitals, which has formed a certain industrial agglomeration, and the integration of digital therapeutics will also help the mutual promotion
of Internet medical treatment and digital therapeutics.
of digital therapeutics products by building promotion bases and promoting their integrated development with Internet hospitals.
It is worth mentioning that the Measures also mention that the construction of regional medical informatization will be promoted, and the interface between digital therapeutics and regional electronic medical record databases and electronic health record databases will be opened, and relevant departments and public welfare organizations will be encouraged to purchase digital therapeutics products and other measures to help promote the local application of
digital therapeutics.
Yang Leigang, general manager of Micropulse Whole Course Management and Digital Therapeutics Center, believes that the current development of the domestic digital therapeutics industry has entered a new stage, and many digital therapeutics companies have encountered practical core problems
in the development process.
The promulgation of the Measures gives clear guidance and pragmatic supporting policies
.
Among them, the Measures mention encouraging medical institutions to integrate digital therapeutics with Internet hospital platforms, and for the first time propose to give doctors the authority
to prescribe digital therapeutics in Internet hospitals.
The introduction of this policy is undoubtedly very important for enterprises engaged in the research and application of digital therapeutics, which will accelerate the transformation
of scientific and technological achievements in the fields of out-of-hospital management of patients and patient rehabilitation treatment.
"This allows Internet hospitals to have the ability to
meet the multi-level and diversified medical and health services of the people.
" It is believed that under the leadership and guidance of the Hainan Provincial Party Committee and the Hainan Provincial Health Commission, digital therapy companies will be able to develop
rapidly by relying on the opportunity of the promulgation of this policy and measure.
Yang Lei just said
to the arterial network.
Encouraging the exploration of multiple payment methods is another highlight
of the Measures.
Payment has long been considered a major challenge
in the development of digital therapeutics.
Both start-ups and listed industry giants have encountered certain problems
in payments.
Based on the first and first trial of policies, Hainan has always been at the forefront
of the country in the exploration of payment innovation.
For example, Lecheng Global Special Drug Insurance, guided by the Development and Reform Commission of Hainan Province, the Medical Security Bureau of Hainan Province, the Hainan Regulatory Bureau of the China Banking and Insurance Regulatory Commission, the Health Commission of Hainan Province, and the Administration of Boao Lecheng International Medical Tourism Pilot Zone, is a very important innovation in health insurance, providing innovative ideas
for insurance payment in the pharmaceutical field.
This innovative approach has significant
implications for digital therapeutics.
Digital therapeutics are a good enabler for actuarial applications for commercial insurance products
.
It can help commercial insurance companies achieve cost control through health management and achieve accurate pricing
through customer screening.
The Measures also continue these innovative ideas, proposing to explore product innovation of "digital therapy + commercial insurance", including exploring the use of digital therapy as a health management service for special drug insurance in the Boao Lecheng International Medical Tourism Pilot Zone, and developing an upgraded version of Hainan Huimin Insurance
.
.
At the same time, the Measures also encourage the inclusion of digital therapeutics in the technical specifications and charging scope of medical service projects, and explore the price formation mechanism and medical insurance payment mode
of digital therapeutics.
Digital therapeutics products or medical services with high clinical value, excellent economic evaluation, and affordable for health insurance funds and insured persons will benefit
from this.
In addition, Hainan also plans to further explore the application of digital therapeutics in medical cost control and health management, and explore effective forms
of combining digital therapeutics with the promotion of payment by disease.
of digital therapeutics.
Digital therapeutics products or medical services with high clinical value, excellent economic evaluation, and affordable for health insurance funds and insured persons will benefit
from this.
In addition, Hainan also plans to further explore the application of digital therapeutics in medical cost control and health management, and explore effective forms
of combining digital therapeutics with the promotion of payment by disease.
As a pioneer in the combination of digital therapeutics and insurance in China, Bosten Technology not only took the lead in launching dementia protection insurance in China, but also reached the cooperation
between digital therapeutics and urban Huimin Insurance for the first time.
Regarding the exploration of the "Measures" in payment, Qiu Yan, partner of Bosten Technology, believes that the "Measures" cover a three-layer system of commercial insurance payment, personal self-payment and medical insurance payment in terms of payment, each of which can provide correct names and guidance for digital therapy enterprises and solve the problem
of revenue generation.
He said that the Measures not only absorb the world's leading practices, but also highlight a number of innovative directions such as special drug insurance, Huimin insurance, hospital charge catalogue, and DRGs for the domestic medical insurance pattern and Hainan characteristics, which are highly targeted and will be welcomed
by the digital therapy industry.
"We expect that under the guidance of this policy, digital therapeutics can empower medical institutions and primary doctors with the core of serious medical care and friendly interaction, and empower patients themselves
.
" It is hoped that digital therapeutics can be fully covered in Hainan as soon as possible, and support the construction of the Hainan model of digital medical care and the national benchmark
.
Qiu Yan said
.
The Measures also propose to build industrial agglomeration, strengthen promotion by holding conferences, releasing research reports, building exhibition halls, etc.
, and attract domestic and foreign digital therapy enterprises to land
in combination with policy inclination.
Especially in the introduction of overseas digital therapy products, Hainan Province can rely on the pilot advantages of real-world data research and application in the Boao Lecheng International Medical Tourism Pilot Zone to realize the pilot trial of overseas products in China, and support its real-world research data for product approval
.
, and attract domestic and foreign digital therapy enterprises to land
in combination with policy inclination.
According to Arterial Network, a number of digital therapy companies have settled or will soon settle in the local area, and the initial industrial agglomeration is taking
shape.
More than 20 head digital therapies, including the world's top 500 Huizhi Pharmaceutical, Zhilan Health, Luming Health Technology (a digital therapy company incubated by Takeda China), Micropulse, Liangyihui, Zhiyun Health, etc.
, have been deployed in advance and landed in Hainan
.
According to Arterial Network, a number of digital therapy companies have settled or will soon settle in the local area, and the initial industrial agglomeration is taking
shape.
More than 20 head digital therapy companies, including the world's top 500 Huizhi Pharmaceutical, Zhilan Health, Luming Health Technology (a digital therapy company incubated by Takeda China), Micropulse, Liangyihui, Zhiyun Health, etc.
, have been deployed in advance and landed in Hainan
.
In terms of industry supporting development, the Measures give detailed supporting measures from the aspects of association alliances, industry standards, data security supervision, talent protection and capital support to support the development of
the local digital therapy industry.
the local digital therapy industry.
Especially in the digital therapeutics industry, the Hainan Free Trade Port has policy advantages
.
At present, Hainan is implementing a pilot data security assessment, and enterprises with data export needs can declare relevant data export in accordance with the issued norms and procedures, and the data can be exported in compliance after approval, which can greatly reduce enterprise risks
.
At present, the relevant evaluation specifications, evaluation methods and evaluation processes have been implemented
.
At the same time, the Hainan Free Trade Port can provide convenience
for Hainan enterprises to access the overseas Internet for business exchanges.
This is a major advantage
for attracting global digital therapeutics companies, or digital therapeutics companies with international intentions.
It is worth mentioning that the Measures also specify the implementation and completion dates of specific measures, from which we can get a glimpse of the steps promoted by
the policy.
Among the 21 policies, four measures need to be completed by October 31: building a number of digital therapeutics clinical trial centers; Accelerate the construction of a public service and management platform for digital therapeutics; Establish a special channel for registration and counseling of Class II medical device digital therapy products; Introduce a catalogue to encourage the development of digital therapeutics and establish green approval channels
for specific types of digital therapeutics.
In addition, there are 14 policies that need to be completed by December 31; 1 policy needs to be completed by the end of 2023; 1 policy needs to be completed by the end of 2025; Only "exploring the digital therapeutics filing system and encouraging the application of real-world data in product registration approval and marketing clinical validation" is classified as "long-term advancement"
.
This means that most of the Measures need to be fully implemented
within more than two months.
It is not too difficult, but the sincerity of Hainan Province to promote the development of the digital therapy industry is self-evident
.
Write at the end
Write at the end Artery.
com believes that the release of the Measures is of great
significance to the promotion of digital therapeutics.
As the first full-cycle industry support policy for digital therapeutics, the Measures held intensive industry research in the early stage of formulation, widely understood the ideas of digital therapeutics stakeholders, and themselves have a global vision, clear positioning and clear
goals.
The Measures are highly targeted and operable, and will also be used as a reference by other local governments, thereby promoting the development of digital therapeutics nationwide and helping China's digital economy become stronger, better and bigger
.
However, from another perspective, for Hainan, after the introduction of the Measures, it is necessary to accelerate the implementation in order to continue to maintain Hainan's leading position
in the regional competition for the development of the digital therapy industry.
With a series of recent favorable policies, digital therapeutics are expected to gain greater momentum and usher in a new development situation
.
Arterial Network will also continue to pay attention to the industry dynamics, so stay tuned
.
