Global DTx Landscape: Navigating Country-Specific Regulation Frameworks

Digital Therapeutics (DTx) have been gaining recognition and have proved their evidence-based nature and potential to address unmet medical needs, becoming a pillar of national healthcare frameworks in countries such as Germany and France as a way to improve patient care and outcomes. Recognizing this, several other countries have long been working on establishing the foundations and standards to facilitate the inclusion and adoption of digital therapies, while ensuring these solutions are safe for patients and serve a clear therapeutic purpose.

While some countries have established dedicated regulatory pathways for DTx, these approaches are tailored to the unique characteristics of each national healthcare system, reflecting local needs and priorities. Therefore, the landscape remains fragmented, with significant variations in approaches and maturity across geographies. Due to the lack of global harmonization in regulating these products, companies seeking to enter different local markets have to navigate diverse requirements for evidence generation, certification, and reimbursement. 

Six years after the launch of the first regulation of its kind in Germany, there is now enough historical data to assess its impact. However, very few products have actually successfully progressed through DiGA and other similar frameworks, raising the question: Is this actually a pathway to success or does it, instead, create unnecessary market access barriers? Given the numerous advantages of AI, is this technology effectively being leveraged to enhance access, or is it evolving too fast for a system still rooted in the traditional approach to drug validation?

Comparison of DTx Regulations and Adoption

The DiGA (Digitale Gesundheitsanwendungen) framework, introduced in Germany in 2019, is the world's first dedicated regulatory and reimbursement pathway. It allows certified digital health applications to be prescribed by physicians and reimbursed by statutory health insurance (a specific prescription is not required; however, access depends upon approval from the health insurance). DiGA establishes clear requirements for product safety, data privacy, and clinical evidence, enabling faster market access while ensuring patient benefit. As of today, the Federal Institute for Drugs and Medical Devices (BfArM) has listed 69 DiGAs in its registry. Starting January 1, 2025, all new and existing DiGA will be subject to heightened data security requirements introduced by the Federal Office for Information Security (BSI). 

Since 2019, Belgium’s National Institute for Health and Disability Insurance (NIHDI) has prioritized prescription and reimbursement over a strict and formal regulation of DTx. It is based on a tiered mHealth ‘pyramid process’ to ensure that solutions CE marked as a medical device comply with the EU General Data Protection Regulation and provide clinical evaluations proving both feasibility and value to national healthcare. As of today, 30 mHealth apps have been approved within the Belgian pyramid, with details publicly available on the Belgium mHealth website.  

The government of South Korea launched its regulatory framework for DTx in 2020 and is currently working on establishing reimbursement policies to facilitate the adoption within the national healthcare system. A prescription is required for reimbursement by public health insurance. As of October 2024, they have approved four DTx products, focusing on chronic disease management and mental health. 

The Health Sciences Authority (HSA) of Singapore introduced a regulatory framework for software-based medical devices, including DTx, in 2020. At present, there is no specific pathway for the reimbursement of digital health technologies (DHTs). The HSA has not publicly disclosed a comprehensive list of approved DTx products yet. 

The PECAN framework for DTx in France was launched in 2023, introducing a fast-track market access pathway for digital health applications and notably telemonitoring systems. The regulation aspires to provide access to DTx for 60 million French citizens covered by mandatory health insurance (prescription is required). At the end of April 2024, 23 files had been submitted: 3 were certified as compliant, 13 were not admissible due to incomplete documentation, and the remaining submissions were undergoing evidence analysis. 

The U.S. Food and Drug Administration (FDA) regulates DTx primarily through the 510(k) premarket notification process under the categories of Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). The framework, revised in 2020, requires companies to provide evidence of a robust quality management system and the ability to maintain data security. Medicare generally does not pay for software-only products due to the absence of an appropriate benefit category. Medicaid-managed care plans can consider fee-for-service pathways on a state-by-state basis. As of early 2025, numerous DTx products have received FDA 510(k) clearance, including recent approvals for treatments primarily targeting mental health conditions such as PTSD and major depressive disorders. 

The NICE Evidence Standards Framework for DTx in the UK was launched in 2019. DTx products in England are primarily regulated as medical devices. While there is no formal mechanism for prescribing DTx, products procured by NHS commissioners or trusts may be offered to eligible patients either as standalone interventions or as part of a wider care package.

Japan's Ministry of Health, Labour and Welfare (MHLW) approved the first DTx product in 2020; since then, it has been proactively integrating DTx into its healthcare system. DTx products in Japan are recognized as medical devices (SaMD) and following regulatory approval, MHLW evaluates products for potential reimbursement (a prescription is required for public insurance coverage). As of early 2023, three DTx applications have been approved. 

Regarding China, guidelines are determined on a case-by-case basis by China's National Medical Products Administration (NMPA). Their approach to DTx has been evolving over the last few years, a specific framework is still under development. However, several pilot programs have been initiated to evaluate DTx products, particularly in areas such as chronic disease management and rehabilitation. As of early 2023, no DTx products had received formal approval. 

In Australia, since updating its regulatory framework in 2021, the Australian Therapeutic Goods Administration (TGA) oversees the regulation of DTx as SaMD, categorizing them based on risk levels. There is no defined pathway for reimbursement for most digital health products and services at the moment, and specific figures on approved DTx in Australia are not readily available. 

Key Challenges

• The lack of harmonization and alignment of regulatory frameworks creates market entry barriers, making it difficult for companies to scale solutions internationally.

• RCTs (randomized controlled trials) have traditionally been the gold standard for regulatory approval. However, DTx operates differently, with its effectiveness being continuously measured in real-world settings (through wearables, patient-reported outcomes, etc.). This alternative measurement still raises concerns regarding data security and quality, potential technological bias, etc. 

• Regulatory frameworks typically assess medical products at a fixed point in time, but many DTx solutions - especially the AI-powered solutions- evolve over time,  learning from user data to improve their effectiveness. Thus the question: How should software that evolves over time be regulated?

• In terms of data privacy and security standards, achieving compliance across multiple jurisdictions is particularly challenging for global DTx companies as they must navigate various requirements, such as GDPR, HIPAA, China’s PIPL, etc.

Considerations and Future Outlook 

As DTx solutions continue to demonstrate their value in improving health outcomes, the regulatory landscape must evolve to ensure timely patient access while safeguarding quality, safety, and efficacy. The growing acceptance of real-world evidence represents a significant shift in regulatory thinking, while data privacy and cybersecurity standards remain crucial in building trust and confidence in DTx solutions. 

The majority of currently approved DTx solutions are concentrated in mental health (insomnia, depression, anxiety, and substance use disorders), chronic condition management (chronic pain, diabetes and hypertension), and rehabilitation (cognitive and physical recovery). These are areas where digital interventions have provided scalable, evidence-based treatments. 

Despite existing frameworks and tools designed to streamline regulation and market access, challenges remain, particularly in terms of speed and complexity. Many questions remain unanswered, but as the industry moves forward, collaboration among stakeholders — including regulators, developers and healthcare providers — will be essential to striking a balance between safety and innovation. Ultimately, ensuring that DTx solutions remain accessible will contribute to a healthier, more connected future for patients worldwide.