Digital therapeutics (DTx) are reshaping the healthcare landscape with software-driven interventions that aim to treat, manage or prevent diseases. Recognised for their potential to deliver safe, personalised care at scale, DTx solutions have gained traction worldwide, accelerated by the COVID-19 pandemic and rising demand for non-contact treatment options. Yet their regulatory approval, adoption and use vary widely. A comparative look at China, the United States, Germany and Belgium reveals distinct national approaches, clinical priorities and technological preferences that shape how DTx is developed, approved and used
Different Regulatory Approaches, Shared Aspirations
The evolution of DTx across these four countries has been shaped by each system’s regulatory maturity and strategic health priorities. The US Food and Drug Administration (FDA) pioneered DTx regulation, approving its first product in 2017 and establishing pathways like De Novo and 510(k) for software-based medical devices. Germany followed with the 2019 Digital Healthcare Act, which enabled DTx prescription apps to be covered by insurance. Belgium launched the mHealthBelgium platform in 2018, implementing a tiered approval framework. China, although a later entrant, has rapidly accelerated its efforts, especially via local pilot policies in Hunan and Hainan provinces.
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Despite these differences, all four countries have built mechanisms to vet DTx for safety and efficacy. The US and China regulate DTx within their broader medical device frameworks, while Germany and Belgium have created more specialised pathways. As of the end of 2024, China had approved the most DTx (235), surpassing the US (192), Germany (55) and Belgium (25), underlining the impact of government-led initiatives in shaping digital health policy.
Varying Clinical Priorities and Technological Focus
Countries also differ in their therapeutic focus and preferred technologies. In China, 88% of DTx address disease treatment, with a strong emphasis on neurological and ophthalmic disorders. This aligns with demographic trends such as population ageing and the need for early intervention in vision-related issues. In contrast, the US and Belgium prioritise disease management, focusing on chronic conditions like diabetes and cardiovascular disease. Germany mainly targets mental and behavioural disorders, with 47% of its DTx falling under this category.
Technological implementation reflects these therapeutic goals. China favours online healthcare platforms and cognitive correction therapies, often used for cognitive decline and visual impairments. The US and Belgium lean heavily on mobile health applications, which facilitate remote monitoring and chronic disease management. Germany focuses on cognitive behavioural therapy delivered through structured software interventions. Across the board, most approved products are medium to low risk, reflecting a shared preference for safety in software-based health interventions.
Challenges and Opportunities in Adoption and Scaling
While regulatory frameworks and clinical needs shape the supply side of DTx, their long-term success depends on clinical validation, physician trust and patient engagement. The US, Germany and Belgium have seen recent slowdowns in DTx approvals, possibly due to challenges such as high validation costs, limited academic research and uncertainty around reimbursement. The financial instability of leading DTx companies has further underscored the volatility of this market.
China presents a contrasting picture, with a surge in approvals driven by provincial support and reduced regulatory timelines. However, questions remain about the long-term sustainability of this government-led model, particularly around evidence generation and patient confidence. As countries seek to balance innovation with oversight, economic incentives such as reimbursement policies and insurance coverage will be pivotal. For instance, Germany's and France’s models for DTx reimbursement, as well the US use of CPT codes, offer templates for incentivising adoption.
Equally important is building acceptance among healthcare professionals. In Europe and the US, medical associations support DTx but call for more clinical evidence and data security. Patients are gradually embracing DTx, especially in mental health, where digital platforms reduce stigma and improve adherence. Nonetheless, concerns around privacy, slow therapeutic effect and blurred boundaries with other digital health tools continue to impede widespread adoption.
Digital therapeutics hold considerable promise in transforming patient care, particularly for chronic and mental health conditions. Yet global adoption remains uneven, shaped by each country’s regulatory architecture, clinical priorities and economic levers. China’s rapid expansion offers lessons in scalability, while the US, Germany and Belgium demonstrate the importance of clinical validation, reimbursement structures and technological diversity. A shared challenge across all four countries is ensuring physician and patient trust through rigorous evidence and user-centred design.
To fulfil their potential, DTx must move beyond regulatory approval towards integration into clinical pathways, supported by robust policy, education and data infrastructure. Collaboration between regulators, clinicians, manufacturers and academics will be essential to translate digital promise into measurable health outcomes. The lessons drawn from these four early adopters can guide global efforts in making digital therapeutics a cornerstone of modern medicine.
Source: npj digital medicine
Image Credit: iStock
