Abstract
Background
Digital health technologies have expanded access to healthcare services by improving disease management and reducing unnecessary hospitalizations. A major challenge, however, is designing appropriate reimbursement mechanisms for these technologies. Ensuring such mechanisms not only leverages their benefits but also maintains the financial sustainability of health systems.
Objective
This study aimed to identify reimbursement processes, classification methods, assessment frameworks and criteria used, pricing mechanisms, organizations involved in the digital health reimbursement process, and the technologies covered by health insurance in selected countries from each continent (Europe, North America, and Asia).
Methods
This study followed the Joanna Briggs Institute (JBI) framework. A systematic search was conducted in Web of Science, Scopus, PubMed, and grey literature sources (e.g. government reports and health organization websites), with no language restrictions, from 1 January 2000 to 9 February 2025. Data extraction focused on reimbursement processes, classification approaches, evaluation criteria, pricing mechanisms, key stakeholders, and insured digital health technologies.
Conclusion
Developing transparent reimbursement frameworks, coordinating stakeholders, and integrating digital technologies into insurance systems are essential. Learning from successful frameworks—such as Germany's DiGA, telemedicine in the USA and Canada, and China's digital health policies—can enhance equitable access and financial sustainability. Establishing digital health technology assessment (DHTA) guidelines, investing in digital health literacy and infrastructure, and implementing supportive regulatory policies are critical prerequisites.
Introduction
Digital transformations in the global health sector in recent decades have transformed healthcare systems, causing fundamental changes in service delivery methods, increased access, and improved quality of healthcare.1,2 These transformations, first introduced in 2000 by “Seth Frank” with a focus on internet-based programs and media to improve medical content, e-commerce, and communications, are now manifested in the concept of “digital health”—defined as the use of digital information and communication technologies in healthcare.3,4 Digital health encompasses a wide range of technologies, including telemedicine, mobile health apps, artificial intelligence (AI)-based diagnostic systems, wearable devices for remote monitoring, and electronic health records. 5 Evidence shows that these technologies have significant potential to improve access to healthcare services, especially in underserved areas, enhance care quality through standardization and decision support systems, and potentially reduce healthcare costs by optimizing processes and preventive interventions. 6 Despite these advantages, the widespread adoption and sustainable implementation of digital health solutions heavily depend on well-defined reimbursement mechanisms that provide appropriate incentives for healthcare providers and technology developers.7,8
The reimbursement of digital health technologies refers to the mechanisms and policies through which healthcare providers and patients receive payment for delivering and using digital health services. Establishing transparent and effective reimbursement frameworks is essential to ensure financial sustainability and widespread adoption of these innovative solutions in healthcare systems.9,10 Approaches to reimbursing digital health services vary significantly worldwide. European countries such as Germany, Belgium, and France have been pioneers in integrating digital health into their national healthcare systems, creating national reimbursement frameworks for digital health programs.11–14 These measures reflect the growing trend among European nations to formalize the role of digital therapeutics in national healthcare. 15
In countries like the USA and Australia, reimbursement for telemedicine services has expanded significantly, particularly through legal and regulatory changes implemented during the COVID-19 pandemic.16,17 These countries have also made progress in reimbursing certain telemedicine services, especially for patients in remote areas and those with chronic conditions. However, unlike European nations, they lack a unified national approach to digital health reimbursement, and the approval and licensing process for digital health technologies occurs at the local level in coordination with national regulatory bodies. 18 Despite these advancements, significant challenges remain in digital health reimbursement. Findings from Li et al. 19 indicate that to improve access to telemedicine services through insurance mechanisms, it is essential to determine appropriate and equitable insurance payment levels for digital health and redesign insurance payment systems to align with digital health technologies. Similarly, van Kessel et al.'s 20 study on digital health reimbursement strategies in eight European countries highlights the diversity in reimbursement approaches. It also points to the lack of value-based pricing frameworks, with countries such as France and Germany treating digital health as standalone products, while others like Belgium and Israel view it as part of traditional treatment processes. This study emphasizes the need for harmonized reimbursement policies, clear definitions of digital health, and value-based pricing mechanisms to facilitate equitable access across borders. These findings remark the importance of transparent eligibility and evaluation guidelines for digital health technologies to support their integration into insurance systems and ensure equitable access for diverse patient populations.21,22
Therefore, this scoping review aims to map the existing evidence on digital health reimbursement policies across multiple countries, focusing on six key components: reimbursement mechanisms and processes, classification systems for digital health technologies, assessment frameworks and decision-making criteria, pricing models and payment mechanisms, organizational structures and responsible institutions, and technologies covered by insurance. This comprehensive comparative review provides valuable insights into global best practices, identifies gaps in current knowledge, and highlights areas for future research, rather than assessing causal relationships or intervention effectiveness. The findings offer a robust scientific foundation for developing strategies and designing effective reimbursement systems for digital health.
Materials and methods
Study design
A scoping review is a type of evidence synthesis aimed at identifying and mapping the breadth of available evidence—often regardless of source (i.e. primary research, review articles, grey literature, guidelines, and non-empirical evidence)—on a specific topic, concept, or issue within or across defined contexts. 23 This type of study may also be used to develop “policy maps” by identifying and outlining operational guidelines from policy documents and reports in a particular field. 24 The scoping review framework was first proposed by Arksey and O'Malley, 25 later refined by Levac et al. 26 and subsequently detailed by the Joanna Briggs Institute (JBI), which provided clearer guidance on each stage of the review process, enhancing its rigor and precision. 27
We conducted a scoping review to systematically map the literature and grey sources related to digital health reimbursement, including policies, pricing mechanisms, and organizational frameworks. The scoping review approach was chosen because it allows a broad exploration of the field, identification of research gaps, and synthesis of heterogeneous evidence, which is not feasible with a conventional systematic review focused on narrowly defined causal questions. This study follows the JBI approach,26,28 with selection, screening, and reporting conducted in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines (Supplemental Appendix A—Table A1). 29 The study protocol has been registered on the Open Science Framework (OSF) at: https://osf.io/hy8xz/.
Formulation of the research questions
To identify frameworks, mechanisms, and reimbursement strategies for digital health, we set the following research questions:
What are the reimbursement processes for digital health technologies in selected countries from each continent (Europe, North America, and Asia)? How are digital health technologies evaluated for digital health reimbursement in selected countries from each continent (Europe, North America, and Asia) using classification, assessment frameworks, and criteria? What are the pricing mechanisms for digital health reimbursement in selected countries from each continent (Europe, North America, and Asia)? Which organizations participate in the licensing, approval, and reimbursement processes of digital health in selected countries from each continent (Europe, North America, and Asia)? Which digital health technologies are covered by insurance in selected countries from each continent (Europe, North America, and Asia)?
Source of Evidence Selection
This study employed a comprehensive search strategy consisting of four main components:
Systematic database search: We conducted searches in PubMed, Web of Science, and Scopus using precise combinations of predefined keywords and MeSH terms, covering the period from 1 January 2000 to 1 February 2025 (searches performed up to 1 February 2025). The search strategy with specific keywords and MeSH terms for each database is provided in Supplemental Appendix B (Supplemental Table B2). Advanced academic search engines: Targeted searches were performed in Google Scholar and Scilit using specialized key phrases related to digital health reimbursement (searches performed up to 8 February 2025) (Supplemental Appendix B3—Search strategy in search engines). Grey literature review: We systematically examined grey literature including technical reports, policy documents, and conference papers following standard protocols, covering the period from 1 January 2000 to 9 February 2025 (searches performed up to 9 February 2025). The grey literature extraction followed Godin et al.'s framework,
30
recording: organization name + URL, search date, keywords used, and number of retrieved documents (Supplemental Appendix B—Table B4). Official health organization websites: After extracting academic and grey literature, we identified and evaluated official healthcare websites of selected countries through Google searches (limited to first five results pages) using queries like “digital health reimbursement” + [country name] (Supplemental Appendix B—Table B5).
To ensure the comprehensive collection of all relevant studies and the validity of website sources, two additional quality control mechanisms were implemented. First, the reference lists of related articles were systematically checked by the authors through random sampling to enhance search completeness and prevent the omission of pertinent sources. Second, website information sources were evaluated for credibility using the AACODS checklist, which consists of six criteria: Authority, Accuracy, Coverage, Objectivity, Date, and Significance. Each criterion was assessed using a three-level response option (yes, no, or unclear). This checklist assessed key criteria including clear content ownership and accountability, explicit statement of purpose, transparent sourcing of information, quality and relevance of content, as well as timeliness and regular updating of information. 31 These rigorous quality control measures were implemented to ensure the reliability and validity of all data sources included in the study.
Study selection
The study selection process followed a rigorous multi-stage approach, with an independent dual review conducted at each phase. First, two independent authors (RR and SA) screened titles and abstracts, with any disagreements resolved through discussion and consensus. Subsequently, a full-text review was performed by two independent researchers (RR and MA), who assessed the articles against predetermined inclusion and exclusion criteria. Disagreements were again resolved through discussion and consensus, with the senior author (SA) providing adjudication when necessary. Finally, data extraction was carried out independently by two authors (RR and MA) using a standardized form based on the JBI framework. Extracted elements included reimbursement processes, classification approaches, evaluation criteria, pricing mechanisms, key stakeholders, and insured digital health technologies. Any discrepancies in the extracted data were discussed and resolved by consensus. To ensure data integrity, duplicate articles were identified and removed using The Automated Systematic Search Deduplicator (ASySD). 32 All selected articles were subsequently managed using EndNote 21, as illustrated in Figure 1.
Flow diagram of conducting searches, filtering, and paper selection.
Eligibility criteria
Inclusion criteria
We included studies that addressed digital health technologies with a focus on health insurance reimbursement policies for these technologies, including scope, licensing process for digital health technologies and reimbursement, pricing mechanisms and entities involved in health insurance reimbursement, and technologies covered.
With respect to the type of studies, we included all academic articles, and other grey literature including theses, research reports, government reports, conference papers and ongoing research, and websites of organizations in the selected countries without language restrictions.
The inclusion criteria for country selection focused on leading nations with either implemented reimbursement processes, processes under implementation, or at least established evaluation frameworks for digital health technologies, including European countries (Germany, France, England, Finland, Spain, Poland, Netherlands, and Belgium), Asian nations (South Korea, Australia, Singapore, Japan, and China), and countries in the USA and Canada.14,33–37 The literature search was conducted with a focus on studies published from 2000 onwards. 1
Exclusion criteria
We excluded studies that did not focus on digital health technologies or health insurance reimbursement, studies that focused on non-health related technologies or reimbursement in non-health sectors, and studies that discussed digital health technologies but did not address reimbursement or coverage policies.
Data Analysis and Presentation
Both descriptive and analytical approaches were applied to comprehensively explore the research findings. In the initial phase, we utilized descriptive statistics (frequency counts and percentages) to outline the fundamental characteristics of the included studies. The results were presented through an integrated approach combining detailed tables, visual charts, and narrative descriptions to ensure a thorough understanding of the outcomes. To systematically address the research questions, we conducted a narrative synthesis approach. This qualitative analysis technique that well-established in the literature 38 enabled us to effectively review and integrate findings across multiple studies. Our analytical process consisted of two key components: we initially conducted individual country-level analyses focusing on five critical dimensions: reimbursement processes, evaluation framework nomenclature, classification and assessment criteria, pricing mechanisms, involved organizations, and covered technologies (Tables 1 to 3) (see Supplemental Appendix C for detailed country-specific insights). In Table 4, the evidence was categorized based on the six dimensions mentioned above for each country, highlighting the strength and nature of evidence in these areas. This categorization aimed to provide a clear understanding of the research gaps and evidence depth across countries. The evidence was stratified into three levels: high-level evidence (e.g. guidelines and government/regulatory reports), medium-level evidence (e.g. websites), and low-level evidence (e.g. primary research articles). This approach helps to clarify the types of sources and their relevance in addressing key dimensions of digital health reimbursement. Subsequently, we performed comparative syntheses for each research question, examining patterns both across countries and continents. These cross-national comparisons were systematically presented in comparative tables to highlight key relationships and differences. This multi-layered analytical strategy enabled us to identify significant similarities, variations, and emerging patterns in digital health reimbursement policies at an international level. All analytical procedures strictly adhered to principles of transparency and reproducibility, with complete methodological details available in the relevant appendices.
Comparison of digital health reimbursement frameworks in European countries.
Comparison of digital health reimbursement frameworks in North American countries.
Comparison of digital health reimbursement frameworks in Asian countries.
Evidence matrix for digital health reimbursement across countries.
Results
Characteristics of included studies
Our comprehensive search strategy yielded an initial pool of 6313 records, comprising 5580 documents from scientific databases and 733 additional sources from supplementary searches. Following deduplication, 4871 records remained for preliminary screening. Through rigorous title and abstract screening, we narrowed this pool to 280 records for full-text evaluation. Ultimately, 132 records met all inclusion criteria and were selected for final analysis. The primary reason for exclusion of most documents was their lack of focus on digital health reimbursement pathways in the target countries (Figure 1).
The final documents included a diverse range of sources: 82 primary research articles, 45 websites, and five guidelines. In terms of geographical distribution, the documents were categorized according to the countries including: 22 from Germany, 19 from the USA, 16 from China, 11 each from Australia and England, nine from Finland, seven from South Korea, six each from Belgium, France and Canada, five from the Netherlands, four each from Japan and Singapore, and three each from Spain and Poland (Figure 2). Subsequently, we conducted a comparative analysis of each aspect (reimbursement processes, health software classification, evaluation frameworks and criteria, pricing mechanisms, participating organizations, and covered technologies) across the 15 selected countries. At the end of each section, we provided a continental-level comparative analysis of digital health reimbursement status. The comprehensive details of digital health reimbursement systems in different countries are presented in Supplemental Appendix B (Country-Specific Insight).
Characteristics of included studies.
Comparative analysis of key elements from selected countries
To enable a structured cross-country comparison, key elements of digital health reimbursement systems were systematically mapped and contrasted across countries in Tables 1 to 3, covering reimbursement processes, evaluation frameworks, pricing and reimbursement mechanisms, participating organizations, and types of technologies covered. Rather than presenting isolated country descriptions, the results are organized to highlight common patterns, differences, and emerging models across health systems.
Reimbursement processes for digital health technologies
European countries have established more centralized approaches and frameworks for digital health reimbursement compared to other countries.39,40 As summarized in Table 1, countries can be broadly grouped into those with dedicated national reimbursement pathways, those relying on pilot or transitional schemes, and those without explicit national frameworks. This observation is primarily supported by peer-reviewed studies and high-level national policy documents. Digital health applications (DiGA) and digital nursing applications in Germany, mHealthBelgium in Belgium, and several parallel pathways in France—including telemedicine tariffs, the ETAPES pilot, and the PECAN fast-track pathway for Software as a Medical Device (SaMD)—represent institutionalized, nationwide reimbursement models.7,41–43 Evidence for these centralized reimbursement pathways is consistently reported across peer-reviewed literature and official health authority publications. The UK follows a hybrid model, combining centralized assessment by NICE with decentralized implementation through the NHS, enabling national standards alongside local commissioning decisions. 44 This positions the UK between fully centralized systems (e.g., Germany) and more fragmented models (e.g., Spain or the USA).
In contrast, Spain, Finland, the Netherlands, and Poland lack comprehensive national reimbursement frameworks, with decisions largely delegated to insurers, regions, or market actors and not fully integrated into statutory insurance coverage.45–49 As shown in Table 1, these countries rely more heavily on ad hoc arrangements and limited telemedicine tariffs rather than dedicated digital health pathways. Findings related to these countries are largely derived from grey literature and official institutional websites, reflecting limited availability of peer-reviewed evaluative studies. Outside Europe, the USA and Canada primarily rely on existing medical device and service reimbursement structures rather than dedicated digital health pathways. In the USA, the absence of a unified national approach results in heterogeneous reimbursement models across payers, with FDA approval as a prerequisite but not a guarantee of coverage.50–52. In contrast, Canada, although it has a predominantly public system, shows significant provincial differences in reimbursement regulations due to its decentralized structure. Each province maintains its own health insurance program, codes, and tariffs, leading to inconsistent coverage of digital health services. Additionally, during the COVID-19 pandemic, several temporary/emergency measures were introduced in Canada, including provisional reimbursement codes and emergency telemedicine coverage. These measures were later reviewed for long-term integration into provincial frameworks. Virtual care programs in Canada (especially in Ontario) have improved access to health services and reduced costs for patients and the system using technologies like video visits and telephone consultations. The OTN network is the main infrastructure for these services, which are divided into two categories: comprehensive (for registered patients) and limited (for patients without prior visits), with each province having its specific programs (such as HealthLink BC in British Columbia or chronic patient monitoring in Alberta). 53 Evidence from North America is mainly based on regulatory documentation and descriptive grey literature rather than comparative reimbursement trials.
In Asia, reimbursement processes range from experimental and pilot-based systems (China) to nationally integrated insurance models (Australia, Japan, and South Korea). China evaluates and approves products through the National Medical Products Administration (NMPA) and has contributed to the development of this field in recent years with programs such as “Internet Plus Health Care” (IPHC), although the reimbursement system still operates regionally.54,55 However, during the pandemic, China implemented temporary measures that allowed for broader telemedicine reimbursement coverage, which is now transitioning to more permanent mechanisms. In contrast, Australia has a unified national system under Medicare that covers eligible services with a Medicare Benefits Schedule (MBS). 56 In China, decisions are often made at the local level, while Australia has centralized federal policymaking and has integrated many telehealth services into its insurance system permanently following the pandemic. 57 Australia's transition from temporary emergency coverage during COVID-19 to the inclusion of telemedicine into the permanent MBS framework highlights the shift from emergency measures to institutionalized reimbursement systems. Japan, South Korea, and Singapore exhibit a diverse range of reimbursement frameworks. Evidence from Asian countries is largely heterogeneous and derived from a mix of policy reports, pilot program descriptions, and regulatory documents. Both Japan and South Korea have developed national insurance systems that cover telemedicine services, with Japan focusing on chronic disease management and home care, while South Korea has facilitated regulations and is moving towards expanding coverage post-COVID-19. However, Singapore has a mixed approach, relying more on private sector participation and targeted government schemes. 58 In contrast, Australia, with its Medicare system, provides broader public coverage, with supplementary insurances playing a complementary role. Meanwhile, in Singapore, direct patient payments and personal savings accounts (MediSave) hold greater significance. Singapore evaluates products through the Health Sciences Authority (HSA) and reimburses through the public and private insurance systems, with a special emphasis on advanced technologies and artificial intelligence in health. 59 The transition from COVID-19 emergency measures to structured, long-term reimbursement policies is ongoing in several Asian countries, including Singapore and South Korea. This comparison shows that Japan and South Korea have national insurance coverage for selected digital services, whereas Singapore relies on targeted public schemes combined with private payments. All these countries seek to facilitate access to digital health technologies but have different methods to achieve this goal. In particular, several countries such as South Korea, China, and Singapore are shifting from temporary emergency measures used during the pandemic towards more stable, long-term reimbursement systems. Overall, European countries like Germany, Belgium, and France have more structured reimbursement pathways for digital treatments compared to other European countries, while the USA and Canada rely more on traditional medical device regulations and decentralized systems. Asian countries are also developing specific regulatory frameworks for digital technologies. Overall, Tables 1 to 3 highlight a spectrum of reimbursement models, ranging from fully institutionalized national pathways (e.g., Germany and France) to fragmented or pilot-based systems (e.g., China and Spain), illustrating distinct policy choices in managing uncertainty and innovation in digital health.
Comparative analysis across countries shows convergence around risk-based classification and HTA-informed evaluation, alongside substantial variation in evidentiary requirements and institutional maturity. To better integrate the rapidly expanding digital technologies into healthcare services, many countries have adapted their national frameworks and policies in recent years. The evaluation frameworks described in this subsection are based on both peer-reviewed methodological studies and official HTA and regulatory documents. Countries that have developed frameworks for evaluating digital health technologies include Belgium, with the three-tier mHealthBelgium validation pyramid; the UK's NICE model; DiGA in Germany42,43,62; the integration of connected medical devices (CMD/DMD) and remote monitoring programs under ETAPES in France63,64; the Digi-HTA framework in Spain 47 ; and Finland.65,66 These countries rely on structured HTA-based evidence for classification and evaluation.
The Netherlands and Poland lack dedicated digital health evaluation frameworks, instead applying general medical device or service assessment criteria through insurers or HTA agencies. 67 As summarized in Table 1, these countries exhibit lower standardization and greater reliance on market-driven adoption. In Poland, the Agency for Health Technology Assessment and Tariff System (AOTMiT) evaluates clinical effectiveness and safety, but a clear reimbursement pathway is still absent. Compared to Germany and France, these countries have less structured and more localized frameworks. 45
The classification of digital software in these countries is typically divided into four classes (I–IV) in Europe, with the UK and Spain using three levels (A, B, and C). Common evaluation criteria among European countries include CE certification according to Medical Device Regulation (MDR), data protection, clinical evidence, cost-effectiveness, usability and accessibility, interoperability, high quality, and innovativeness. Evidence for these countries is primarily descriptive and derived from grey literature sources
In the USA, there are two main frameworks for evaluating digital health technologies: the Digital Health Assessment Framework (DHAF), focusing on quality, privacy, security, and user-friendliness, and compliance with regulations such as HIPAA; and the Institute for Clinical and Economic Review-Peterson Health Technology Institute (ICER-PHTI), focusing on clinical effectiveness and economic impact for buyer and developer decision-making.68,69 The evaluation process may vary among payers, but it typically includes review by specialized committees, analysis of clinical and economic data, and stakeholder engagement. Each payer may assign different weights to these criteria, but the ultimate goal is evidence-based decision-making for insurance coverage of digital health technologies
In Canada, the Pan-Canadian framework—with three components (conceptual model, evaluation matrices, and toolkit)—is used to standardize evaluation at the national level. Virtual care programs must undergo rigorous regulatory processes
Asian countries generally apply risk-based medical device classifications, but the depth of evaluation varies. Japan and South Korea require strong clinical and economic evidence, whereas China focuses primarily on safety and regulatory compliance, with limited use of cost-effectiveness.57,72 In South Korea, the National Evidence-based Healthcare Collaborating Agency (NECA) and Health Insurance Review and Assessment (HIRA) conduct evaluations, emphasizing clinical and economic effectiveness. Recently, temporary insurance frameworks have been introduced for some technologies. South Korea mandates precise criteria, including clinical effectiveness (through trials) and cost-effectiveness comparisons for telemedicine and emerging products such as digital therapies (DTx), evaluated by MFDS and HIRA. 73
In Australia, the mHealth Apps evaluation framework, developed by the Digital Health Agency, is implemented voluntarily. Broader technology evaluations are conducted by the Therapeutic Goods Administration (TGA) and specialized committees. Australia distinguishes telehealth from SaMD, with TGA responsible for evaluating safety and performance.
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In Japan, there is no specific framework for digital health, but stricter criteria—including clinical effectiveness, cost-effectiveness, and real-world evidence (RWE)
In China, Health Technology Assessment (HTA) is used for insurance decisions and the national drug list, but a specific framework for non-drug technologies (e.g. digital) is still incomplete. The focus has been mainly on telemedicine and internet hospitals, with evaluation criteria centered on safety and compliance with NMPA regulations, and cost-effectiveness playing a minor role.
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Singapore employs a combination of health technology evaluation by ACE and HSA regulations for digital health, emphasizing effectiveness, affordability, and cybersecurity, gradually incorporating cost-effectiveness into decisions.
59
The maturity of evidence varies: Japan and South Korea rely on strong clinical and economic data, while China focuses primarily on safety and compliance. Overall, in Europe, countries utilize more structured frameworks, such as DiGA in Germany, NICE in the UK, and ETAPES in France
In North America, the USA relies on FDA approval, HIPAA privacy, and cost-benefit evaluation by payers, while Canada emphasizes provincial standards and cybersecurity. In Asia, Japan and South Korea focus on clinical evidence and cost-effectiveness, China remains telemedicine- and safety-focused
Mechanism of pricing and reimbursement for digital health
Pricing mechanisms across countries reflect different policy trade-offs between value-based negotiation, administratively fixed tariffs, and market-oriented pricing approaches. The evidence supporting these pricing models is derived primarily from policy documents, payer reports, and regulatory guidelines, with comparatively limited peer-reviewed economic evaluations. Germany's DiGA framework exemplifies a structured two-phase value-based pricing model. Following approval by the Federal Institute for Drugs and Medical Devices (BfArM), manufacturers may set a free price during the first 12 months to reflect development and market-entry costs. After real-world clinical evidence is generated, the price is negotiated with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband). If negotiations fail, an independent arbitration board determines the final reimbursement level.76–78
In Belgium, pricing is negotiated between the National Institute for Health Insurance and Disability and manufacturers and is explicitly linked to demonstrated clinical value, although it is typically embedded within broader healthcare budgets rather than governed by a standalone pricing framework. 79 In France, prices are set by the Economic Committee for Health Products (CEPS) following evaluation by the HAS. Pricing agreements generally last 5 years, while temporary programs such as ETAPES for remote monitoring operate under time-limited reimbursement arrangements. 80
The UK relies on recommendations from NICE combined with negotiations at the level of integrated care boards,49,81 reflecting a decentralized yet value-oriented structure. Spain lacks a dedicated pricing mechanism for digital health technologies, and telemedicine services are typically reimbursed at rates comparable to in-person consultations. 82 In the Netherlands, pricing decisions are coordinated between the Healthcare Regulatory Authority (NZa) and the National Health Institute (Zorginstituut Nederland). 83 Finland applies fixed reimbursement rates, whereas Poland has no formalized pricing pathway for digital health technologies, limiting reimbursement largely to digital emergency consultations. 84
In North America, pricing is predominantly payer-driven and negotiation-based, particularly in the United States. 85 Canada faces additional coordination challenges due to provincial autonomy, which results in heterogeneous pricing practices across jurisdictions. In Australia, telehealth services are primarily reimbursed under the MBS, while pricing of digital devices is influenced by private insurance arrangements. 86
In Asia, China and Japan determine prices through centralized tariff systems under the NHSA and NHI, respectively, 57 reflecting an emphasis on integration within universal coverage schemes. South Korea lacks a specific pricing mechanism for digital therapeutics, relying instead on general medical device pricing regulations.87,88 Singapore determines pricing through the Ministry of Health, supported by subsidy programs such as CHAS and MediSave. 89
Regionally, European systems tend to exhibit greater structural formalization and explicit linkage to clinical value assessment, particularly in Germany and the UK. France prioritizes price stability through centralized negotiation, albeit with comparatively less flexibility. In contrast, the United States adopts a market-oriented and innovation-driven approach, though at the cost of increased complexity and variability. Canada's provincial structure constrains national price harmonization. Asian systems, particularly in Japan and China, emphasize scalability and cost containment through centralized national insurance schemes. Australia and Singapore focus primarily on telehealth expansion, while South Korea remains in a transitional phase of framework development. Across regions, a common policy challenge is achieving an appropriate balance between incentivizing innovation and ensuring long-term affordability and equitable access. The evidentiary strength underpinning pricing decisions varies considerably and is generally stronger in countries with formalized value-based pricing frameworks and explicit evaluation criteria.
Participating organizations in the digital health authorization, approval, and reimbursement process
Cross-country comparison (Tables 1 to 3) indicates that organizational complexity tends to increase with the decentralization of health systems. This subsection is primarily based on institutional reports and official organizational documentation and therefore reflects predominantly descriptive evidence.
Germany, through the DiGA framework supervised by the Federal Institute for Drugs and Medical Devices (BfArM) and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), has established a clearly delineated pathway for approval, evidence generation, and pricing negotiation.90,91 Belgium integrates industry stakeholders via the participation of beMedTech and the National Institute for Health and Disability Insurance (NIHDI) within the structured mHealthBelgium validation system. 60 France relies on formal evaluation by the HAS and pricing negotiations conducted by CEPS, 63 while the UK utilizes NICE in conjunction with NHS England to support evidence-based integration of digital technologies. 61
In contrast, Spain and Poland operate within multi-actor and less centralized arrangements. In Spain, approval and reimbursement involve collaboration among the Ministry of Health, the Medicines Agency, national and regional HTA bodies, and autonomous governments, resulting in a multi-layered decision-making process. 82 In Poland, responsibility is distributed across the Ministry of Health (policy-making), the National Health Fund (financing), AOTMiT (technology assessment), and the eHealth Center (CeZ) for digital infrastructure, requiring coordination across multiple oversight entities.45,92 The Netherlands regulates pricing through NZa in combination with negotiations involving insurers, 93 while Finland—through Kela and the Ministry of Social Affairs and Health (MSAH)—does not maintain a dedicated digital health reimbursement pathway. 66
In North America, the United States operates under a highly fragmented public–private structure, involving the Centers for Medicare and Medicaid Services (CMS), the FDA, and numerous private insurers. Canada, by contrast, reflects provincial autonomy, leading to variability in implementation across jurisdictions. 94
Australia combines regulatory approval by the Therapeutic Goods Administration (TGA) with innovation initiatives led by the Australian Digital Health Agency (ADHA). China employs centralized reimbursement governance under the NHSA alongside regulatory oversight by the NMPA. 95 Japan integrates digital health within its universal National Health Insurance (NHI) system through coordination between MHLW and PMDA, 57 while South Korea continues to develop formalized pathways under MFDS and HIRA. 88 Singapore utilizes the Ministry of Health (MOH) and the Health Sciences Authority (HSA) to administer targeted subsidy schemes, particularly in telemedicine. 89
Overall, variation in organizational design reflects differing levels of institutional maturity in digital health reimbursement systems. Countries with specialized and clearly mandated entities—such as Germany, France, and Belgium—demonstrate greater procedural transparency and streamlined coordination, which may facilitate innovation and access. In contrast, countries with dispersed responsibilities—such as Spain, Poland, and Finland—exhibit institutional fragmentation that can complicate scaling and accountability. Hybrid systems, including those in the United States and Australia, provide flexibility but introduce administrative complexity. Centralized models, such as those in China and Japan, integrate digital health within universal coverage schemes; however, bureaucratic procedures may constrain responsiveness to rapidly evolving technologies.
Digital health technologies covered
Comparison across countries reveals marked differences in the breadth of technologies reimbursed. In Germany, the Digital Care Act 2019 introduced the DiGA framework for reimbursement of mobile and web applications in chronic disease management. 96 Coverage patterns are mainly identified through official reimbursement lists, policy documents, and regulatory websites, with peer-reviewed support where available. Wearable devices qualify alongside standard devices, but telemedicine is reimbursed separately. In Belgium, mHealthBelgium reimburses mobile applications, wearable devices, and telemedicine in care pathways. 97 Eligibility is closely linked to demonstrated clinical value and system-level efficiency gains. France reimburses telemedicine, remote monitoring applications, and connected medical devices through programs such as ETAPES and PECAN. 98 Priority is generally given to technologies with demonstrated therapeutic benefit and integration into existing care models. In the United Kingdom, the NHS covers telemedicine, digital therapeutics, and wearable devices following evaluation and recommendation by NICE.83,99 Mobile applications targeting mental health and chronic disease management are also included when supported by evidence.
In contrast, Spain primarily reimburses telemedicine services under tariffs comparable to in-person visits, while mobile applications and wearable devices are rarely publicly covered and are more commonly financed through private insurance. The Netherlands reimburses telemedicine, selected mobile applications, and wearable devices via statutory insurance, 84 with remote monitoring incorporated into Diagnosis-Related Group (DRG) payments for chronic conditions. Finland provides reimbursement for telemedicine services—particularly in private care settings through Kela 65 —while public coverage of mobile applications and wearables remains limited. Poland restricts public reimbursement largely to digital consultations and electronic prescriptions, primarily introduced under emergency arrangements, with no routine coverage of mobile applications or wearable devices. 92
In the USA, telemedicine, digital therapies, and remote monitoring devices are reimbursed through Medicare and private insurance. 100 Wearable devices with medical applications are covered. Canada reimburses telehealth and some remote monitoring devices on a provincial basis. Mobile applications and wearable devices are generally covered by private insurance. Australia reimburses telehealth through the MBS.101,102 Monitoring devices and mobile applications are rarely covered publicly and depend on private insurance. China reimburses telemedicine, online pharmacies, and AI devices through NHSA.53,103,104 Mobile applications and wearable devices are covered under specific programs. Japan reimburses telemedicine, digital therapies, and wearable devices through NHI.105,106 Mobile applications for patient education and AI diagnostics are eligible. South Korea still has no reimbursement for digital therapies or telemedicine. 73 Pilot programs for remote monitoring and AI tools are under consideration. Singapore reimburses telemedicine through CHAS and MediSave. Mobile applications and wearable devices are primarily covered by private insurance. 59
In Europe, countries like Germany, France, Belgium, the UK, and the Netherlands with advanced frameworks such as Germany's DiGA and Belgium's mHealthBelgium reimburse a wide range of digital health technologies, including telemedicine, mobile applications, and wearable devices, while Spain, Finland, and Poland are largely limited to telemedicine due to the lack of dedicated frameworks. In North America and the Pacific, the USA and Canada have mixed systems with extensive coverage for telemedicine and digital therapies. In Asia, Japan and China integrate multiple categories of digital technologies within national insurance systems, whereas Australia and Singapore focus primarily on telemedicine, and South Korea remains in a transitional phase. These differences reflect varying degrees of regulatory institutionalization, evidentiary requirements, and fiscal risk tolerance across health systems.
Discussion
Digital health technologies have transformed healthcare delivery worldwide. However, our cross-country comparison indicates that adoption speed and sustainability depend less on technological maturity and more on the design, regulation, and governance of reimbursement systems. A critical factor is the presence of clear, predictable, and evidence-informed pathways, which reduce uncertainty for developers, providers, and payers while safeguarding public resources. 107 The observed variation reflects distinct policy models shaped by health system architecture, regulatory centralization, and payer structure rather than random divergence.
In Europe, countries such as Germany and Belgium have established formalized, nationwide reimbursement frameworks covering digital therapeutics, remote monitoring, and other services. These centralized and structured systems facilitate transparent evaluation, consistent evidence requirements, and smoother integration of new technologies. Evidence supporting these approaches comes primarily from peer-reviewed literature and high-level national policy documents, providing relatively strong support for the effectiveness of centralized frameworks in promoting equitable access and sustainable adoption.
North America and the Asia-Pacific region show more heterogeneous and evolving patterns. In the USA and Canada, reimbursement is largely payer-driven and fragmented, with telemedicine widely covered but digital therapeutics evaluated through initiatives like the Digital Health Assessment Framework (DHAF) in the USA. The evidentiary base in these countries remains largely descriptive, derived from regulatory documents and gray literature rather than comparative effectiveness studies. Similarly, in Asia-Pacific, China and Australia have focused on expanding telemedicine, Australia has implemented an mHealth evaluation framework, and South Korea has begun institutionalizing mobile health assessment via nHTA. In most countries of this region, digital health reimbursement is still transitioning from pilot or emergency schemes toward more stable long-term frameworks, with evidence primarily from policy reports and institutional documentation rather than consolidated evaluations.
Reimbursement processes for digital health technologies
Global comparison of digital health reimbursement processes highlights substantial heterogeneity, primarily shaped by structural and institutional factors rather than random variation. Key determinants include the concentration of health insurance (single- vs. multi-payer), the degree of regulatory centralization, the share of private markets and providers, historical policy trajectories, and prevailing provider payment arrangements. Countries with centralized public payers and robust national HTA bodies—such as Germany (DiGA), France (ETAPES/PECAN), and the UK (NICE–NHS)—demonstrate more coherent, scalable, and predictable reimbursement pathways. These systems benefit from uniform evidentiary standards, clear timelines, and streamlined contracting mechanisms, facilitating smoother adoption of digital health technologies. Conversely, fragmented or weakly coordinated systems generate uncertainty for innovators, slow the institutionalization of new technologies, and hinder consistent evaluation and reimbursement. Viewing cross-country differences through this institutional lens helps explain why some countries achieve rapid and sustainable digital health integration while others remain limited by structural and governance constraints.
In European countries such as Germany, the United Kingdom, and France, structured frameworks—including DiGA (Germany), NICE (UK), and ETAPES (France)—provide clear guidance for the evaluation and reimbursement of digital health technologies. These frameworks typically assess clinical effectiveness, safety, and cost-effectiveness within well-defined procedural pathways. Centralized public payers and national HTA bodies, such as the German statutory insurance system or the NHS/NICE model, enable the adoption of uniform fast-track mechanisms by ensuring consistent evidentiary requirements and coordinated contracting. This institutional clarity facilitates predictable and scalable integration of digital technologies, as supported by HTA reports and peer-reviewed policy analyses. In contrast, countries with fragmented payer systems and a strong private sector presence, such as the United States, exhibit heterogeneous, payer-specific reimbursement arrangements. While such environments may foster experimentation and selective rapid adoption, they often hinder equitable access and limit national scalability. Similarly, in many North American and Asian contexts, hybrid and decentralized approaches predominate, with private insurers and providers playing significant roles. These observations are largely based on regulatory documentation and institutional grey literature.
Our comparative analysis shows that centralized decision-making reduces transaction costs for developers by providing clear evidentiary requirements and well-defined contracting pathways. This clarity facilitates predictable and scalable integration of digital health technologies. In contrast, fragmented payer systems, such as in the United States, generate variability in coverage decisions. While this can foster rapid innovation in niche markets, it often limits harmonization and equitable access at the national level. Similarly, decentralized or federal systems, such as those in Canada, Spain, and China, tend to rely heavily on pilot programs and regional initiatives, which can result in uneven implementation and delays in integrating digital health technologies into routine reimbursement. This pattern suggests that pilot initiatives alone are insufficient unless accompanied by explicit transition mechanisms toward permanent coverage.
Evidence from Essén et al. 108 further highlights the value of structured institutional frameworks. The experiences of Germany and Belgium—through the DiGA fast-track pathway and the mHealthBelgium validation pyramid—show that centralized, transparent systems can build stakeholder trust and facilitate integration with broader digital infrastructures, including compliance with data protection standards and interoperability with electronic health records. A comparative study of reimbursement policies across five leading countries (the USA, Germany, Japan, the UK, and South Korea) identifies three key principles for successful integration of digital technologies into insurance systems: first, multidimensional evaluation that incorporates both clinical and economic criteria before coverage; second, tariff-setting mechanisms aligned with the characteristics of the technology and service; and third, continuous post-implementation monitoring of effectiveness and budget impact. 35 These principles are consistently supported by cross-country peer-reviewed evidence and underscore how structured institutional design can promote predictable, scalable, and sustainable adoption of digital health technologies. Taken together, the heterogeneity observed in this review reflects underlying institutional configurations rather than isolated policy choices. Future research should explicitly model these institutional variables—such as payer concentration, regulatory centralization, and provider payment structures—to move beyond descriptive mapping toward explanatory and potentially causal analysis of digital health reimbursement performance.
Classification and evaluation criteria for digital health technologies
Comparative analysis reveals a broad convergence toward risk-based classification and HTA-informed evaluation, yet substantial differences remain in methodological rigor and institutional maturity. Countries with dedicated digital HTA frameworks—such as DiGA, ETAPES, mHealthBelgium, NICE, Digi-HTA, DHAF, and nHTA—apply more consistent and transparent criteria, while others continue to rely largely on general medical device legislation or payer-driven assessments. Our synthesis highlights a clear gradient of evidentiary requirements: Germany, France, and the UK demand robust clinical and economic data, whereas other settings primarily depend on descriptive or less standardized evidence. This variation directly affects reimbursement predictability, investor confidence, and the long-term sustainability of digital health systems. Moreover, current HTA approaches often fail to capture non-clinical dimensions of digital health technologies, including usability, interoperability, adaptability, and continuous learning capabilities.109–111 These methodological limitations are mainly noted in conceptual and methodological literature rather than empirical trials. In the present study, most countries—including Germany (DiGA39,40), France (ETAPES63,64), Belgium (mHealth 60 ), the UK (DTAC81,112), Spain (Digi-HT 47 ), South Korea (nHTA88), the USA (DHAF68,69), and Finland (Digi-HTA65,66)—have developed specific frameworks for evaluating digital health technologies. Many have integrated digital therapeutics (DTx) into existing legal classifications, such as medical devices or software incorporated into medical devices. However, in practice, countries differ considerably in regulatory maturity and reimbursement approaches. Some, such as Germany, have established specific frameworks to facilitate both access and funding for digital health technologies. The robustness of these frameworks varies, with Germany, France, and the UK maintaining stronger evidence requirements, while other countries rely on more descriptive evaluations. For instance, Germany's Digitale Anwendungen (DiGA) program, under the Digitale-Versorgung-Gesetz (DVG), provides a fast-track access route for DTx products that meet predefined criteria, granting public insurance coverage. This framework not only improves patient access but also enables the collection of clinical evidence during ongoing monitoring. The program is supported by regulatory documentation and peer-reviewed evaluations. Similarly, France's ETAPES program is being developed as a fast-track system to broaden access to DTx technologies, with reimbursement through public health insurance. This model accelerates market entry while ensuring safety and effectiveness, with evidence primarily drawn from policy documents and early implementation reports.
In the USA, reimbursement frameworks for DTx are highly heterogeneous. A substantial portion of costs is covered by private insurance, while government programs such as Medicaid (for low-income individuals) and the VA (Veterans Affairs) play important roles in covering certain DTx services. In some cases, patients also pay out-of-pocket. This multiplicity of funding sources creates challenges for ensuring equitable access and policy coherence, highlighting the critical importance of clear regulatory and reimbursement frameworks for the successful integration of DTx into health systems. Evidence from the USA remains predominantly descriptive and policy-based, with limited centralized HTA evaluation. Considerable heterogeneity exists across countries in the evaluation frameworks developed for digital health technologies.
This variation reflects factors unique to each context, including the existing technical infrastructure, level of innovation adoption, digital health literacy, allocated budgets, national health priorities, and the culture of the health system. Some countries, however, have established structured and relatively robust frameworks that can serve as models for others. Examples include Germany's DiGA, France's PECAN, Belgium's mHealth, the UK's ESF, and Finland and Spain's Digi-HTA. 56 Each framework has its own advantages and limitations but collectively provides templates for designing evaluation systems that can accommodate the complexity and rapid evolution of digital health technologies.
This diversity in approaches highlights the inherent complexity of evaluating rapidly evolving digital health technologies, which not only transform healthcare systems but also influence social structures and human behaviors. A study by Vis et al. 113 identified 23 different HTA frameworks for digital health technologies internationally. These frameworks typically assess technologies across multiple dimensions—technological, clinical, economic, legal, ethical, and organizational—using a wide variety of criteria. Some frameworks differentiate clearly between stages of technology development, while others apply a fixed set of criteria across all stages. 113 This methodological diversity presents both opportunities and challenges. On the one hand, it allows flexibility to accommodate the fast pace and variety of digital health innovations. On the other hand, it limits comparability between countries and complicates international coordination. In this context, Mezei et al. 114 have proposed strategic recommendations for countries like Hungary, emphasizing the development of tailored HTA frameworks that address clinical effectiveness, data security, cost-effectiveness, and stakeholder engagement, while promoting cross-border collaboration to reduce duplication and facilitate access to comparative evidence. These recommendations underscore that institutional design and evaluative capacity are as critical as technological readiness.
At the same time, centralized systems may face approval bottlenecks, whereas decentralized or lower-resource settings often lack structured reimbursement mechanisms altogether. This suggests that neither full centralization nor complete market decentralization offers a universal solution; rather, hybrid regulatory architectures combining centralized standards with adaptive implementation mechanisms may be more resilient.
In this context, international standards such as ISO 82304-2 offer opportunities for partial regulatory alignment and can help reduce duplication in evaluation efforts. Complementing formal HTA processes with structured real-world evidence collection and user-reported performance metrics can further balance the need for rapid innovation with safety and accountability. Across jurisdictions, successful frameworks share several core principles, including transparency, scientific validity, interoperability, and compliance with data protection regulations (e.g. GDPR/HIPAA). 108 Nonetheless, methodological fragmentation continues to limit cross-country comparability and coordinated scaling. The key challenge going forward is not full harmonization, but strategic alignment—establishing interoperable evaluation standards while maintaining flexibility to accommodate local contexts and evolving technologies.
Digital health reimbursement pricing mechanism
Pricing mechanisms reflect distinct policy priorities and institutional capacities. Value-based and negotiated pricing models (e.g. Germany, the UK, France, and Japan) are more closely aligned with the evolving and iterative nature of digital health technologies, whereas purely market-driven systems (e.g. the USA) may increase the risk of inequity and cost escalation. The pricing conclusions are primarily supported by policy analyses, payer reports, and a limited body of peer-reviewed economic studies.
Leading nations such as Germany, France, the UK, and Japan have achieved a relative balance between fostering innovation and ensuring affordability by implementing structured, evidence-based pricing frameworks. In contrast, the market-driven model in the US, while enabling rapid technological adoption, is associated with challenges including unequal access and potentially unsustainable expenditures. Countries such as Canada, Australia, and Singapore have adopted a more cautious and incremental approach to pricing and reimbursement, largely influenced by concerns regarding clinical effectiveness, budget impact, and long-term cost containment.
Key challenges include aligning prices with demonstrated clinical and societal value, ensuring transparency in negotiation processes, and adapting pricing structures to the rapid and continuous evolution of digital technologies.
Global experience suggests that evidence-based and value-driven pricing frameworks, particularly when supported by robust health data infrastructures, can play a pivotal role in facilitating broader and more sustainable adoption of digital health technologies. Studies indicate that traditional reimbursement systems, such as fee-for-service (FFS)—which remain dominant in many countries—are often poorly suited to the multidimensional and dynamic nature of digital health technologies. This underscores the need to develop innovative reimbursement approaches, including outcome-based payment models and value-based pricing mechanisms. 5
In this context, Raes et al. 36 compared telemedicine payment systems across 10 countries. Comparative evidence indicates that traditional FFS payment models are suboptimal for remote monitoring and continuous-care technologies, as they fail to capture longitudinal and outcome-oriented value. Hybrid and outcome-based models appear more compatible with the multidimensional value proposition of digital interventions, although large-scale implementation remains limited. Digital health technologies differ fundamentally from traditional health technologies such as pharmaceuticals and medical devices. According to Gomes et al., 115 these technologies evolve rapidly, require active user engagement, generate dynamic interactions with healthcare environments, exhibit distinct pricing structures, and produce broader non-clinical impacts, including reduced travel time, improved accessibility, and enhanced quality of life.
These characteristics pose challenges for traditional economic evaluation methods, such as cost–benefit analysis (CBA) and cost–effectiveness analysis (CEA), which were originally designed for non-digital health technologies. Conventional approaches may not fully capture the comprehensive value of digital health interventions, including non-clinical benefits, functional flexibility, scalability, and continuous technological evolution. Furthermore, Li et al. 12 emphasize that optimizing insurance payment structures for telehealth services is essential to enhance access, incentivize provider participation, and maintain quality standards. Strengthening service quality oversight and establishing clear performance and outcome metrics are critical to bridging the gap between telehealth and in-person care. Taken together, these findings underscore the need for methodological innovation in both economic evaluation and reimbursement design. Developing approaches that accurately assess the multidimensional value of digital health technologies is crucial to promoting equitable access—an issue of particular importance for low- and middle-income countries, where limited resources demand careful prioritization and sustainable pricing strategies.
Organizations involved in licensing, approval, and reimbursement of digital health
The diversity of organizational involvement across countries reflects varying levels of institutional maturity in digital health reimbursement systems. Key stakeholders include regulatory authorities (e.g. BfArM, HAS, FDA, Health Canada, TGA, PMDA/MHLW, and MFDS), health technology assessment (HTA) agencies (e.g. NICE, HAS, AOTMiT, ORCHA, HIRA, and NECA), and payers (e.g. statutory insurers, private insurance, Medicare, Medicaid, and National Health Insurance [NHI] schemes). Industry associations, such as the Digital Therapeutics Alliance, APACMed, and Digital Health Canada, further contribute through advocacy, standard-setting, and knowledge sharing.37,116 Countries with centralized and specialized institutions, such as Germany, France, and Japan, benefit from streamlined approval and reimbursement processes that foster innovation and facilitate patient access. In contrast, nations like Spain, Poland, and Finland lack dedicated digital health frameworks and rely on general public health institutions, which may limit coordination and scalability. The United States operates a hybrid public–private model led by CMS and private insurers, offering flexibility but introducing administrative complexity and variability in coverage decisions. Similarly, Canada's provincially fragmented system reduces national uniformity. Australia and Singapore combine stringent regulatory oversight (TGA/HSA) with targeted reimbursement schemes, such as MBS and CHAS, although coverage remains limited. China's NHSA and Japan's NHI integrate digital health into universal coverage, yet bureaucratic and procedural barriers persist. South Korea's emerging framework, led by MFDS and HIRA, shows institutional progress but still faces challenges in implementation and scaling. Overall, cross-country comparison highlights that clear institutional mandates, well-defined roles, and functional separation are critical enablers of efficient reimbursement systems. Countries with centralized and specialized bodies (e.g. BfArM, HAS, NICE, and PMDA) achieve more coherent coordination between regulation, HTA, and payment decisions. In contrast, fragmented organizational landscapes (e.g. Spain, Poland, and Finland) dilute accountability and slow system-level scaling, while hybrid systems (e.g. the USA and Australia) often trade coherence for flexibility. These findings suggest that organizational architecture—not regulatory stringency alone—is a decisive factor in shaping digital health reimbursement performance. This analysis is primarily based on official organizational documents and institutional gray literature.
Digital health technologies covered by insurance
The scope of insured digital health technologies varies considerably across the 15 countries included in this study. Coverage information was primarily obtained from official reimbursement lists, policy documents, and regulatory websites, with limited peer-reviewed validation. Telemedicine is the most widely reimbursed service, covered in all countries except South Korea, reflecting its established role in improving healthcare access.
Mobile applications are reimbursed mainly in Germany, Belgium, France, the UK, the Netherlands, the US, China, and Japan, particularly for chronic disease management and mental health, while coverage is limited in Spain, Finland, Poland, Canada, Australia, and Singapore. Wearable devices follow a similar pattern: they are reimbursed in Germany, Belgium, France, the UK, the Netherlands, the US, China, and Japan when used as part of treatment, but are rarely covered elsewhere. Digital therapeutics are expanding in the UK, the US, and Japan, and are gaining attention in Germany and France, yet remain largely uncovered in other countries.
Remote monitoring devices are reimbursed in France, the Netherlands, the US, China, Japan, and through specific programs in Canada, Australia, and Singapore, but are not publicly covered in Poland or South Korea. AI-based devices and online pharmacies are currently unique to China, reflecting the country's particular digital health priorities.
Countries with advanced, structured frameworks—such as Germany (DiGA), the UK (NHS), and Japan (NHI)—provide broader coverage, supporting both innovation and patient access. Belgium, France, and the Netherlands also offer extensive coverage, emphasizing clinical validation and integration into care pathways. In contrast, the US and China cover a wide range of technologies driven by market demand and population size, though reimbursement stability varies. Canada, Australia, and Singapore focus primarily on telemedicine to address access gaps, while cautiously expanding coverage to other digital health technologies.
Strengths and weaknesses
This scoping review followed established guidelines, including JBI and PRISMA-ScR, and systematically examined the available evidence. A key strength of the study lies in its comparative, multi-dimensional synthesis of digital health reimbursement systems across 15 countries, moving beyond descriptive, country-by-country summaries to identify patterns, typologies, and transferable policy lessons. The study also leveraged a wide range of sources, including scientific databases, government reports, policy documents, and health organization websites, while applying rigorous quality criteria such as the AACODS checklist. Another strength is the multilevel analysis of reimbursement dimensions, encompassing clinical, economic, and technical aspects, and highlighting coordination among key stakeholders, including ministries of health, insurers, and technology developers. This approach enhances the depth and practical relevance of the findings. Nonetheless, several limitations should be acknowledged. Evidence from low- and middle-income countries is sparse, and in some settings, the study relied heavily on grey literature, which may limit generalizability. Future research should expand comparative analyses to countries with similar income levels or regional blocs to strengthen contextual relevance and enhance the transferability of policy lessons.
Recommendation for policy makers in health system
Based on the findings of this study and the identified limitations, the following recommendations are proposed for policymakers and stakeholders in digital health. These recommendations are primarily informed by descriptive and policy-level evidence.
Establish a national classification system: Develop a clear definition and standardized classification framework for digital health technologies, capturing the diversity of interventions such as digital therapeutics, telemedicine, remote monitoring, and mobile health applications. Define a transparent evaluation and approval framework: Implement a structured, evidence-informed framework for assessing clinical effectiveness, safety, interoperability, and socio-economic value. This framework should guide approval, licensing, and reimbursement decisions. Design specific pricing mechanisms: Create clear and fair pricing models that consider clinical value, cost-effectiveness, and integration into care pathways. Pilot reimbursement programs, such as Germany's DiGA model, can help test feasibility and refine the approach. Clarify roles and responsibilities: Clearly define the duties of regulatory bodies, payers, and other stakeholders involved in approval, licensing, and reimbursement to ensure accountability and coordination. Prioritize technologies based on health needs: Focus on interventions that address high-burden diseases or critical public health priorities to maximize impact and ensure equitable access. Promote international collaboration: Build networks with countries facing similar challenges to share experiences, lessons learned, and best practices.
By implementing these recommendations, policymakers can establish a robust and adaptable framework for the approval, licensing, and reimbursement of digital health technologies. These steps offer an initial roadmap, which should be continuously refined through local studies, pilot programs, and ongoing monitoring of implementation outcomes.
Future research
While this scoping review provides a broad overview of digital health reimbursement across multiple countries, future research could focus on specific digital health interventions—such as digital therapeutics, remote monitoring, or mobile health applications—or on particular reimbursement mechanisms to generate more detailed insights. Narrowing the scope in future studies would enable deeper evaluation of causal relationships, effectiveness, and economic impact, complementing the broader mapping achieved here. Additionally, future research could explore regional or income-based comparisons, for instance by focusing on a specific continent, countries with similar health system maturity, or nations with comparable income levels. Such targeted analyses would provide context-specific evidence, helping policymakers and stakeholders understand how economic, regulatory, and infrastructural factors shape digital health reimbursement. By building on the findings of this review, these approaches can offer actionable insights for policy and practice while maintaining awareness of global trends.
Conclusion
Countries vary widely in how they regulate and reimburse digital health technologies, reflecting differences in healthcare structures, institutional maturity, and economic priorities. Some, like Germany, Belgium, and South Korea, have clear and structured reimbursement pathways, while others—including parts of Europe, the US, Canada, and Asia—operate with more fragmented systems. Although most classify health software as medical devices, specific approaches such as Germany's DiGA or Belgium's mHealth pyramid illustrate the diversity in classification practices and evaluation methods. Evaluation frameworks range from multi-level classification and traffic-light models to simple approve/reject systems, with varying evidentiary requirements from randomized trials to real-world evidence. This heterogeneity allows adaptation to local contexts but complicates harmonization and the creation of a unified digital health market, highlighting the need for alignment in evaluation criteria without compromising flexibility. Pricing and coverage mechanisms are similarly diverse. Some countries rely on negotiated pricing frameworks (e.g. Germany and France), others use national price lists (e.g. Japan and South Korea), and emerging markets face unique challenges (e.g. China and Singapore). Covered technologies range from telemedicine and mobile applications to advanced AI-based diagnostics, with priorities differing by nation. Regulatory authorities, ministries of health, and food and drug agencies play central roles, often collaborating with insurers and professional associations to ensure safe, effective, and equitable access. Developing a robust digital health reimbursement system requires a gradual, stepwise approach. Initial efforts should focus on low-risk pilot programs and primary classification systems based on safety and effectiveness. Later stages should incorporate global best practices, expand evaluation criteria to include cost-effectiveness, and establish independent assessment bodies with value-based reimbursement mechanisms for advanced technologies. Continuous monitoring and flexibility to respond to evolving innovations are essential. By integrating international experience with local needs, countries can build sustainable, equitable, and innovative reimbursement systems that foster adoption, efficiency, and patient access.
Supplemental Material
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Footnotes
Author contributions
Sohrab Almasi: writing–original draft, visualization, validation, methodology, investigation, formal analysis, and conceptualization. Reza Rabiei: writing–review and editing, writing–original draft, methodology, and conceptualization.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Data availability statement
All data generated or analyzed during this study are included in this published article. The data used to support the findings of this study are included within the supplementary information file(s).
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References
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