The "Hainan Model" for childhood autism achieves 94% effectiveness! When will the whole country follow suit?
Children with autism have hope!
On September 4, the website of the National Health Commission released a response to the proposal of the third session of the 14th National People's Congress, detailing China's policies and current treatment status for childhood autism. It mentioned the next step of providing free standardized health check-up services for children aged 0-6 in urban and rural areas across the country.
The reply directly addresses the recent social hotspots involving several unfortunate incidents of children with autism spectrum disorder (hereinafter referred to as ASD). In mid-August, a child with ASD went missing in Dali and was tragically found deceased several days later. At the end of August, the Xi'an police issued an announcement stating that criminal control measures were taken against staff members of a rehabilitation center for assaulting children with ASD.
The plight faced by children with ASD and other neurodevelopmental disorders has aroused high public concern. To avoid the recurrence of tragedy, it is extremely urgent to provide timely and effective medical intervention for children with ASD.
At the southernmost tip of our country, children with ASD have received care from the local government and have started using digital therapy for home-based rehabilitation training. At the 2025 Digital Therapy Conference not long ago, relevant institutions in Hainan Province also announced the results of the nearly one-year operation of the "Digital Therapy Intervention for Children with Autism Spectrum Disorder Aged 0-6". The results showed that digital therapy intervention for children with ASD has achieved good outcomes and gained recognition from all parties.
Perhaps, the "Hainan Solution" has reached the point of being widely promoted nationwide.
Childhood ASD is a type of neurodevelopmental disorder, with core characteristics including significantly impaired social skills, as well as restricted, repetitive stereotyped behaviors and narrow interests. Its incidence has significantly increased in recent years. The prevalence of ASD in Chinese children aged 6-12 reached 7/1000 from 2017 to 2020, which is a marked increase compared to the incidence of 2.65/1000 before 2017.
Currently, the medical community has yet to pinpoint the exact cause of autism. "Unknown etiology, no cure available" is the consensus in the field regarding this condition. Coupled with a late start (ASD was first identified and diagnosed in mainland China in 1982), and a lack of resource support, intervention for children with ASD in our country has long faced numerous challenges, such as difficulties in standardizing the quantification and datafication of diagnoses, and corresponding medical resources being extremely scarce and unevenly distributed.
During the rehabilitation training phase, children face numerous challenges: medical resources for pediatric ASD are extremely scarce and unevenly distributed, while intensive intervention is required as early as possible for autism rehabilitation. This means high costs and exhausting commutes for the families. Moreover, the rehabilitation process for pediatric ASD is lengthy, and there is a significant chance of minimal progress or even regression in some cases.
Besides, although there are currently no medications specifically for children with ASD, doctors may incorporate drug treatments to alleviate complications based on the condition and treatment plan. These medications inevitably come with some side effects, which can also lead to hesitation among parents.
Under multiple pressures, it is not uncommon for parents of children with autism to seek alternative solutions. Some unqualified and unethical institutions take advantage of this situation, and the tragedy that occurred in August is a typical case in point.
In fact, there are solutions to address the aforementioned challenges in the field of childhood ASD. Digital therapeutics, an emerging intervention method, has already demonstrated tremendous potential in the area of childhood ASD rehabilitation training and has been validated. Zhang Zhiguang, founder of ALSOLIFE, who has been deeply involved in this field, believes that compared to traditional intervention methods, digital therapeutics for childhood ASD offers three main advantages: high efficiency, low cost, and high service accessibility.
He stated that the characteristics of digital therapeutics determine their high intervention efficiency: "Digital therapeutics introduces a standardized intervention process, so therapists no longer need to design topics or prepare various intervention materials. At the same time, it is less constrained by location and time, allowing sessions to be conducted anytime, anywhere. Our statistics show that its intervention efficiency is more than three times that of traditional manual intervention, demonstrating clear advantages."
High efficiency naturally leads to lower costs. Zhang Zhiguang introduced to Artery Network the situation of their practice in Hainan Province — under the same quality of intervention, the cost of digital therapy intervention is only one-tenth or even less than that of manual intervention: "A session of manual service for children with ASD typically costs around 150-500 yuan, while our digital therapy intervention in Hainan costs only over 30 yuan per day, with two sessions a day, meaning each session costs only about 18 yuan."
For childhood ASD, a condition with limited and unevenly distributed medical resources, the improvement in service accessibility brought by digital therapeutics is clearly visible. Zhang Zhiguang noted that in several remote counties and cities of Hainan Province, such as Ledong, Wuzhishan, Lingao, and Baoting, rehabilitation resources are severely lacking, especially teaching staff. Most parents can only choose to travel long distances to the Hainan Provincial Women and Children's Medical Center in Haikou for intervention. However, this center also cannot accommodate all ASD children from across the province, leading to severe waiting lists.
"Many young patients have to wait for half a year or even a full year before they can enter the hospital to receive intervention, which makes it highly likely that they will miss the optimal time for treatment. Since the introduction of digital therapeutics services, children in various parts of Hainan no longer need to endure exhausting journeys; they can now receive excellent intervention services locally, greatly improving service accessibility."
"Digital therapeutics generate a large amount of data during use. This data also supports local maternal and child institutions, accelerates the training process for rehabilitation therapists, thereby helping to build a rehabilitation system from scratch locally, which is of great significance," he added.
Not only in children with ASD, but also in the field most commonly associated with childhood ASD—Attention Deficit Hyperactivity Disorder (hereinafter referred to as ADHD)—digital therapeutics have been clinically proven effective. As the first digital therapeutic for childhood ADHD approved by the FDA, Akili's EndeavorRx enrolled over 600 children with ADHD across five clinical trials, all of which confirmed the significant effect of digital therapeutics in improving symptoms of childhood ADHD.
Unfortunately, this emerging intervention faces the "last mile" bottleneck in the country. As a medical device, digital therapeutics need to be included in the medical insurance billing directory for hospitals to charge for their use and thus purchase the corresponding products. However, based on the current price review system in our country, it is extremely difficult to add new billing codes.
Some companies have turned to collaborate with private hospitals or even directly adopt a B2C approach in the hope of overcoming obstacles. However, considering that parents tend to be more conservative and cautious regarding children's disease interventions, these methods clearly cannot match the endorsement effect of services provided by public pediatric hospitals.
On one side, there is an extreme lack of medical resources and intervention methods for children with ASD, leaving families no choice but to seek alternative solutions, often falling prey to unscrupulous organizations out of desperation. On the other side, digital therapeutics, which have the potential to solve these problems, remain unable to reach patients due to existing bottlenecks despite their capabilities.
Clearly, addressing this "last mile" is imperative.
Across the country, Hainan Province, which has paid high attention to digital therapeutics in recent years, is paving an effective path for the whole nation.
As early as 2022, Hainan listed "exploring the pilot use of digital therapeutics" as one of the main tasks for the province's 14th Five-Year Plan for digital health development. This marked the first time that digital therapeutics was included in a provincial plan.
Subsequently, Hainan Province identified the pain points in the development of the digital therapeutics industry through intensive research and introduced the "Several Measures to Accelerate the Development of the Digital Therapeutics Industry in Hainan Province." These 21 measures directly address the critical issues in the development of the digital therapeutics industry, providing clear support and encouragement in research, clinical applications, promotion, and payment. This policy marks the first full-cycle support for the digital therapeutics industry introduced domestically and globally.
Taking regulation as an example, at that time, many products had not yet met the attributes of medical devices, and "obtaining certification" was the top priority. The Hainan Drug Administration also actively responded to provincial planning by incorporating the registration and approval of digital therapy products into the priority approval process for medical devices in October 2022. It innovatively launched the country’s first special consultation channel for digital therapies, providing full-chain guidance services for digital therapy products. Regulatory requirements were embedded in the product development process in advance, offering technical guidance to registrants on core aspects such as product classification, testing-related confirmation, selection of clinical evaluation pathways, and design of clinical trial protocols.
Hainan Medical Products Administration's Director of the Medical Device Department, Pan Juenan, introduced the progress of the bureau’s approval work to VCBeat: "Since the opening of the special consultation channel for digital therapeutics, our bureau has provided 65 special coaching sessions to 43 companies, helping them avoid 'detours' in product registration. As of August this year, our bureau has approved the listing of 10 digital therapeutic products managed as Class II medical devices, with an average review and approval time of only 29 working days, placing the speed of product registration and approval among the top in the country. Currently, nine products are still under development in our province, covering areas such as chronic disease management, sports rehabilitation, and cognitive disorders, laying a solid foundation for the diversified development of Hainan's digital therapeutics industry."
He stated that most digital therapeutics companies are transformed from internet enterprises, software companies, or pharmaceutical companies. Their unfamiliarity with medical device regulatory policies and relevant regulations results in registration application materials and quality systems failing to meet regulatory requirements. This increases the cost of product registration approval for companies and extends the time cycle.
"We recommend that companies make full use of Hainan Province's special consultation channel for digital therapeutics, and strengthen communication with the evaluation and approval departments in the early stage of product registration. For any difficult issues arising during the R&D and registration process, timely consultation with the technical evaluation department is advised to resolve problems before the formal commencement of the registration process, thereby improving the success rate of registration. Meanwhile, we also suggest that companies actively participate in industry exchange activities to learn from peers’ successful experiences in the registration, application, and promotion of digital therapeutics products."
Beyond the approval process, Hainan has also conducted intensive research to understand the bottlenecks of digital therapeutics entering hospitals. Measures have been proposed to establish clinical trial centers for digital therapeutics in local hospitals. This approach allows frontline doctors to directly engage with digital therapeutics and gain a clear understanding of their effects, paving the way for further implementation.
Recalling the situation at the time, Zhang Zhiguang remembered it vividly: "Hainan communicated intensively with more than 100 digital therapeutics companies at that time, with extremely high efficiency. In May 2022, we had our first exchange with the local Health Commission, and we felt that they were well-prepared, very knowledgeable about digital therapeutics, and asked highly professional questions regarding functionality, significance, clinical evidence, and key metrics. Subsequently, Hainan quickly initiated clinical pilot programs. In October, we began discussions with the Hainan Women and Children's Medical Center for cooperation, and by December, we started serving the first group of pediatric patients for clinical validation."
"Throughout the 2022-2023 period, the reputation and clinical outcomes of the validation projects across 10 clinical centers gradually emerged, including parent satisfaction, user adherence, rehabilitation effectiveness, expert opinions, and clinical research evidence. The digital therapeutic solution for children with ASD served a total of 500 patients across three hospitals, with a very low dropout rate, high frequency of use among parents, and excellent rehabilitation outcomes, indicating highly positive feedback."
"At that time, to evaluate the clinical outcomes, the hospital gave us a group of children with relatively severe conditions. One child left a particularly deep impression on me. During the initial assessment, he could recognize fewer than 20 objects and had no perception of the outside world. I remember it took him an average of seven seconds to respond to each instruction. From a professional perspective, there were hardly any signs of previous interventions, nor much visible progress," he added.
"Fortunately, the child's parents never gave up, and the child himself was not averse to digital therapy, allowing the training to continue. From initially being able to recognize only one target per day, by day 20, he was averaging 4-6 targets per day and was able to engage in various generalization exercises. By day 60, the child had made significant progress, recognizing around 100 items and gradually beginning to distinguish between things to eat and things to drink, showing some initial functional awareness."
Zhang Zhiguang stated that through practical applications on the clinical front line, doctors have truly understood the effects of digital therapeutics. Subsequently, with increased confidence, the hospital gradually expanded the scope of digital therapeutic services.
Li Ling, Chief Expert of Pediatric Rehabilitation at the Hainan Women and Children's Medical Center and head of Hainan's first Digital Therapeutics Clinical Trial Center (focusing on mental health, cognitive, and behavioral disorders), also expressed affirmation regarding the role played by the clinical trial center: "The preliminary digital therapeutics clinical trial center has indeed played a positive role. During this clinical validation process, while collecting clinical data to assist in product refinement and localization, we have also deepened our understanding of digital therapeutics products. After a year of actual use, significant results have been achieved."
Establishing clinical trial centers to help digital therapeutics integrate into clinical practice is just the first step. After completing the planning and policy foundation, Hainan Province began specific implementation and scenario expansion of digital therapeutics in 2023. One initiative was including the "Pilot Program for Digital Therapeutics in Cognitive Rehabilitation for the Elderly" in the 2023 list of practical projects for the people's welfare in Hainan Province. The other was incorporating diabetes digital therapeutics into the "2+3" health service package.
On the one hand, the promotion and application are crucial in the development of digital therapeutics; on the other hand, the medical standards and resources in Hainan are limited, and the high-quality development of health in the new era urgently requires the support and promotion of new productive forces such as digital therapeutics.
By government-led planning and designing innovative application scenarios, and integrating these innovative scenarios with digital therapeutics and the ongoing healthcare initiatives, as well as aligning them with the functional requirements of medical institutions at all levels and types, it not only enables valuable digital therapeutics to be more widely applied but also leverages digital therapeutics to promote faster, better, and more efficient completion of various healthcare tasks, thereby achieving a win-win situation.
Digital therapy for children with ASD has been included in the 2024 Hainan Province's initiatives for the people under such a background.
Li Ling told VcBeat that the inclusion of childhood autism into the livelihood projects fully reflected the care, love, and attention from leaders at all levels towards the autism community. She pointed out: “The incidence of childhood autism continues to rise, while high-quality rehabilitation resources are insufficient and unevenly distributed. This social challenge directly translates into a real pain point for parents—they have to bear the exorbitant costs of living, transportation, and medical expenses brought by long-term cross-regional medical treatment and rehabilitation training.”
"Our hospital's rehabilitation department has 60 staff members responsible for autism rehabilitation training, making it the largest autism rehabilitation center in the national medical system with the most international certification certificates. Currently, the department trains over 400 children daily, but after diagnosis, children still need to wait at least half a year to receive rehabilitation training. Due to unknown causes, there is still no effective drug treatment for autism, and the only way to significantly improve prognosis is early diagnosis and early intervention. Having to queue for six months to a year after diagnosis will render early detection meaningless and affect the child’s prognosis, which must be addressed."
She further added: "One of the long-term goals of the health system adhering to the 'strengthening grassroots' initiative is that minor illnesses should not require patients to leave their local communities. The training of rehabilitation therapists for children with ASD cannot be achieved overnight, and it is extremely challenging to accumulate high-quality resources at the grassroots level in a short period of time. Early pilot programs of digital therapeutics have already shown clear positive results: compared to manual interventions, they are more efficient, accurate, and standardized, and their algorithms based on big data can quickly calculate shorter rehabilitation paths for children and provide more precise training objectives. They significantly reduce the difficulty of developing and implementing rehabilitation plans, improve the efficiency of grassroots rehabilitation workers, and enhance the standardization of rehabilitation services. Digital therapeutics are also replicable, easy to promote, and low-cost, making them an ideal solution to expand service coverage by supporting grassroots efforts and addressing the need for nearby rehabilitation services for children with autism. However, the bottleneck restricting its promotion was the lack of chargeable programs. To address the key challenges and bottlenecks in autism rehabilitation in our province as soon as possible, and to genuinely alleviate public concerns, the leading officials of the Health Commission and the Department of Maternal and Child Health decided to apply for a private-sector initiative project."
Zhang Zhiguang mentioned that the undersupply of digital therapeutics during the clinical testing phase also provided significant momentum for their eventual inclusion in the government's list of practical initiatives: "Many families signed up to participate during the clinical validation, but there were limited spots available. Considering this situation, the local Health Commission also included pediatric ASD digital therapeutics in the list of practical initiatives for the public the following year, forming a pattern of one large and one small initiative with the previous year’s elderly Alzheimer's digital therapeutic intervention."
After being included in the "Doing Practical Things for the People" initiatives, Hainan Province will provide substantial financial support for local children with ASD. According to the announcement released by the Hainan Provincial Department of Finance, Hainan Province will allocate a budget of 2.3399 million yuan for the entire project. Of this amount, 1.98 million yuan will be used to purchase 1,200 sets of digital therapeutic intervention devices to be provided free of charge to children diagnosed with autism for home-based digital rehabilitation therapy. An additional 359,900 yuan will be allocated for service expenditures related to purchasing rehabilitation training.
According to further information from Vcbeat, Hainan provides a subsidy of 36 yuan for each rehabilitation training session for young patients to complete a total of 120 sessions. These 120 sessions will be distributed over 6 months, with no fewer than 15 sessions per month.
At the 2025 Digital Therapeutics Conference, the results of this project were showcased. As of June 2025, the project has completed interventions for 1,100 children, with a completion rate of 115%, an effective intervention rate of 94%, and a satisfaction rate of 91.5% among the families of the patients. The outcomes have exceeded expectations.
Moreover, statistical surveys show that the dropout rate for digital therapeutics is very low, less than 5% in a year. In contrast, the dropout rate for psychiatric medications can reach 15-20% within three months. According to the survey, 98.5% of parents hope to continue using it next year.
Zhang Zhiguang stated that the implementation of this people-oriented initiative not only enabled local ASD children to receive timely and high-quality rehabilitation training but also reduced the difficulty of subsequent digital therapies entering hospitals: "With good clinical outcomes, we have currently entered 14 hospitals and 3 rehabilitation institutions in Hainan. The government will provide subsidies for each child, averaging about 3,000 yuan per person on our end. Although we still face the issue of being included in the official catalog, it is much better than other fields due to the proven clinical effectiveness."
In May this year, the Hainan Provincial Medical Insurance Bureau and the Hainan Provincial Health Commission issued the "Notice of the Hainan Provincial Medical Insurance Bureau and the Hainan Provincial Health Commission on Doing a Good Job in the Charge Management of Digital Therapeutics" (hereinafter referred to as the "Notice"), which stipulates and arranges the charging for digital therapeutics. It not only clarifies the legality of continuing to use the current charge code format, eliminating concerns from the industry, but also explicitly allows medical institutions to apply for additional or extended charges for digital therapeutics based on actual circumstances, and handle them according to the method of "self-determined formulation, filing for implementation," further granting medical institutions certain pricing authority and flexibility.
"Compared with the past, we have seen hope," Zhang Zhiguang exclaimed.
According to reports from VCBeat, some regions in China have also begun to adopt Hainan's model. Zhang Zhiguang mentioned during an exchange that Chaoyang District in Beijing is also focusing on the development of digital therapeutics: "We are currently collaborating with the Capital Medical University Children's Research Institute to explore the adoption of Hainan’s model, aiming to replicate the screening and intervention process for digital therapies targeting childhood autism locally."
More notably, this model has drawn strong interest not only domestically but also overseas. According to reports, relevant departments in Malaysia are particularly interested in Hainan's model and also hope to leverage digital therapeutics to address the challenges of rehabilitation training for children with autism in their region.
The Hainan Model, which has already achieved phased results, might be at the stage of nationwide promotion, with the hope that every "star child" will eventually become the brightest star in the night sky.