Q&A: REGULATION AND REIMBURSEMENT OF DIGITAL THERAPEUTICS (DTX) / Denmark

To enable a consistent comparison of the legal frameworks surrounding digital therapeutics (DTx) across different jurisdictions, we have developed this Q&A template. It serves as the basis for a blog series on the BLE website that explores how various countries regulate, clas-sify, and reimburse digital health applications. By answering the following questions, you con-tribute to an international understanding of how DTx are integrated into national healthcare systems. We appreciate your time and expertise in supporting this cross-border digital health initiative.

A. Contributor Information

Name: Jan Bjerrum Bach, Attorney-at-Law

Law Firm / Organization: Jusmedico Law Firm Ltd. Advokatanpartsselskab

City / Country: Denmark

Email: jbb@jusmedico.com

B. Introduction – Status and Definition of DTx

1. Does your country have any uniform or established regulations for digital therapeutics (DTx) which provides for a legal definition of DTx? If not, are there any soft law instruments, guidance documents, or working definitions used by authorities or HTA bodies?

No, Denmark has no uniform or established regulations for digital therapeutics

(DTx) which provides for a legal definition of DTx. However, there are several soft law instruments and guidance documents, which authorities and Health Technology Assessment (HTA) bodies presumably are inspired by.

In the absence of legal definitions, our approach assumes that Digital Therapeutics (DTx) refers to evidence-based therapeutic interventions driven by high-quality software programs to prevent, manage, or treat a broad spectrum of physical, mental, and behavioral conditions. Such interventions are often used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. DTx products are typically delivered through smartphones, tablets, or computers and are designed to provide therapeutic benefits through mechanisms such as cognitive behavioral therapy, lifestyle modifications, medication adherence, and disease education.

In the European Union, Digital Therapeutics are subject to regulatory oversight to ensure their safety, efficacy, and quality. The primary regulatory framework governing DTx in the EU includes: i) Medical Device Regulation (MDR) 2017/745 (Software qualifying as medical devices – purpose driven – risk based classification), ii) In Vitro Diagnostic Regulation (IVDR) 2017/746 (in vitro diagnostic medical devices), iii) GDPR, General Data Protection Regulation (processing of personal health data), and iv) ePrivacy Directive (privacy in the electronic communications sector). None of these define "Digital Therapeutics", whereas they provide a framework that can encompass digital health products based on their functionality and the data they handle.

Apart from Denmark having implemented inter alia the above EU regulations and directives into Danish national legislation, the Danish Government has in March 2019 published a “National Strategy for Artificial Intelligence” defining AI as systems based on algorithms (mathematical formulae) that, by analyzing and identifying patterns in data, can identify the most appropriate solution in relation to, primarily, control, prediction and guidance. The technology can be designed to adapt its behaviour by observing how the environment is influenced by previous actions. Considering same, the Danish Medicines Agency has on 12 October 2020 issued guidance notes titled “New Tech – new technological possibilities and medical devices” providing DTx examples, offering support for manufacturers of medical technological devices and have emphasized its focus on patient information being handled correctly considering the roles of autonomous algorithms and the role of the DKMA being to ensure that the market for new health technologies is safe and secure. The latter objective is pursued by the DKMA to approve clinical investigations, monitoring the market, handling incidents with medical devices, inspecting companies and being active in international working parties on new technology.

C. Legal Classification of DTx in your Country

2. Under which legal framework do DTx fall in your country (e.g., medical devices, pharmaceuticals, others)?

The classification depends on what the therapy comprises, i.e. whether it involves a medicinal product, a device or a combination thereof. Digital therapy is, hence, not classified in its own right, but is merely a property of the underlying product.

3. What criteria determine whether a DTx is classified as a medical device or as a well-ness/lifestyle/other product?

The fact that a product may have a DTx property does not impact the normal classification of a product as a medicinal product, a device or a combination product. The classification is primarily determined by the product's primary characteristics, its mode of action and its intended use, rather than the inclusion of digital therapeutic features.

4. What are the regulatory requirements for market access (e.g., conformity assessment, CE marking, national registration)?

Products holding DTx properties are granted market access solely on basis of whether the underlying product meets the criteria for receiving a marketing authorization or CE marking. Whether or not there is a DTx property does not per se impact the regulatory assessment of the product, unless the DTx properties in their own right may influence the safety, efficacy and quality negatively. The inclusion of DTx properties does not inherently change the regulatory assessment process unless those properties themselves impact the safety, efficacy, or quality of the product.

5. Are there specific cybersecurity, interoperability, or data protection requirements that apply to DTx?

Although the fundamental regulatory pathways for market access do not differ between DTx and non-DTx products, the specific nature of DTx products often means that additional scrutiny may be applied to ensure compliance with cybersecurity, interoperability, and data protection requirements. Therefore, while the core legislation may be the same, the practical application and compliance measures might require more detailed attention for DTx products due to their digital and data-intensive nature. If, however, the marketeer complies with any other non-DTx product EU and national legislation, there are no further market access limitations on top relating to cybersecurity, interoperability, or data protection requirements.

6. Is there a specific regulatory pathway or fast-track available for digital health products or DTx (e.g., expedited review, sandbox programs)?

As per the “New Tech – new technological possibilities and medical devices” guidance notes mentioned under B.1 above, the DMA offers support for manufacturers of medical technological devices facilitating their way to the market.

7. How is the legal distinction between DTx and other digital health applications handled (if any) in your jurisdiction?

In the absence of a legal DTx definition and thereby a definition of “other digital health applications”, it is not possible for the regulator to make a distinction the two, merely to consider whether the DTx property influences the safety, efficacy and quality negatively as pe Topic 4 above.

D. Reimbursement According to your Jurisdiction

8. Is there a legal basis for the reimbursement of DTx in your healthcare system?

There is no specific reimbursement category or additional criteria solely based on a device having DTx properties. The reimbursement process focuses on the device's overall therapeutic value, safety, and cost-effectiveness, regardless of whether it includes digital therapeutic features or not. If, however, a device with DTx properties can demonstrate enhanced therapeutic outcomes or cost savings, this could positively influence its evaluation for reimbursement, although the DTx aspect itself does not automatically qualify or disqualify a device for reimbursement.

Devices with DTx properties must comply with the same general regulatory and reimbursement requirements as any other medical device, including by meeting safety and efficacy standards and demonstrating cost-effectiveness. Hence, DTx properties do not inherently change the reimbursement process, but they may contribute to the overall value proposition of a device. The key factor in the reimbursement decision remains the device's ability to meet the established criteria for safety, efficacy, and cost-effectiveness.

9. Under what conditions can DTx be eligible for reimbursement (e.g., prescription requirement, evidence of efficacy, medical benefit)?

DTx devices are eligible for reimbursement to the same extent as non-DTx devices, provided however that it may be easier to demonstrate that the expenses associated with a DTx device are proportional to its therapeutic effects than for non-DTx devices, as e.g. data reporting can be dealt with much more cost efficacious.

10. How is reimbursement of DTx practically carried out – through catalogs, individual

agreements, or direct claims to insurers?

Reimbursements in Denmark are primarily granted through centralized catalogs and lists, with some flexibility for individual agreements in special cases. The system is designed to ensure that reimbursed products are safe, effective, and provide good value for the healthcare system. Direct claims to insurers are not a typical part of this process, as the healthcare system is largely government-funded and managed. With respect to centralized procurement for hospitals and regional healthcare services, Amgros works in collaboration with the Danish Medicines Council and regional Drug and Therapeutics Committees (DTCs) to ensure that the products included in the system are cost-effective and beneficial for patient care. Procurement for primary care, including general practitioners and community pharmacies, is generally managed separately and may not fall under Amgros' direct responsibilities.

11. What role do health technology assessment (HTA) bodies or evidence evaluation procedures play in this process?

Health Technology Assessment (HTA) bodies and evidence evaluation procedures play a significant role in the reimbursement processes in Denmark. These assessments are crucial for determining whether a medical device or pharmaceutical should be reimbursed by the healthcare system. The stakeholders are i) the Danish Medicines Council (Recommendations on the use of medical devices and healthcare technologies / clinical and cost-effectiveness of the technologies), ii) Health Technology Council, Behandlingsrådet (Recommendations on use in hospitals / expense proportion to therapeutic effects), iii) Regional Drug and Therapeutics Committees, DTCs (5 Danish regions evaluate clinical evidence and cost-effectiveness from a local perspective), and iv) collaboration with procurement entities like Amgros to ensure cost-effectiveness for the healthcare system as a whole.

12. What limitations or uncertainties currently exist regarding the reimbursement of DTx in your country (e.g., missing lists, lack of contracts, definitional issues)?

In Denmark, the reimbursement DTx landscape faces several challenges and uncertainties, inter alia i) Insufficient Evidence: General concern about the lack of comprehensive evidence regarding the effectiveness, efficiency, and safety of DTx makes it difficult for the Council to confidently reimburse DTx products, as they require robust clinical evidence to justify the financial investment, ii) Regulatory and Definitional Issues: The regulatory framework for DTx is still evolving and there are uncertainties about how DTx should be defined and categorized within the existing healthcare system, which challenges the process of integrating DTx into standard care pathways and reimbursement models, iii) Market Access and Reimbursement Pathways: The pathways and criteria for DTx reimbursement are not as well-established as those for traditional pharmaceuticals, and iv) Health Technology Assessment (HTA): The HTA process in Denmark involves detailed health economic analyses, which include identifying and describing uncertainties in the health economic analysis. This process is essential for determining the reimbursement status but can be a barrier due to the nascent stage of DTx and the associated uncertainties. These limitations and uncertainties highlight the need for continued development and clarification of regulatory frameworks, increased generation of clinical evidence, and the establishment of clear pathways for reimbursement to fully integrate DTx into the Danish healthcare system.

13. Is temporary or conditional reimbursement (e.g., while real-world evidence is collected) possible in your jurisdiction?

Denmark has mechanisms in place for conditional reimbursement, which can include the provisional use of treatments while further evidence is gathered. This aligns with the broader trend in health technology assessment to incorporate real-world evidence and health economic evaluations into decision-making processes. Inter alia the HTA may allow conditional reimbursement pending further evidence generation, which authority also enables pilot programs for DTx although not explicitly mentioned.

E. Practical barriers

14. Have manufacturers of DTx in your country faced specific practical barriers (e.g., delays in evaluations, inconsistent insurer decisions, lack of digital infrastructure)?

Sources, such as EY, Ireland, "Navigating the digital wave: DTx regulations in Europe and beyond" and the QbD Group, "The DTx Landscape in Belgium, France, and their inspiration from the German Model" suggest that DTx manufacturers in Denmark face the following challenges: i) complex and lengthy evaluation processes, including the need for rigorous randomized controlled trials (RCTs) to prove the safety and efficacy of their products, ii) lack of clarity in the regulatory framework regarding evaluation criteria, timelines for assessment and reimbursement, and the specific economic evidence required, iii) the competitive environment in Denmark, with established local and international players, poses significant challenges for new DTx entrants, iv) Denmark is considered a lower maturity market for DTx compared to countries like Germany and France, indicating room for improvement in regulatory and market access landscapes.

We have not dealt with clients suffering in particular from these challenges.

F. Perspectives – Future Outlook

15. Are there any ongoing initiatives or legislative efforts in your country to further develop or reform the legal and reimbursement framework for DTx?

Denmark has pursued digital-ready legislation since 2018, mandating new laws undergo assessments for digital compatibility, overseen by a dedicated secretariat. Over 800 laws and 340 proposals have been screened, but pre-2018 legislation remains largely unreviewed, hampering digital innovation. Denmark sought support from the European Commission under the Technical Support Instrument (TSI) to develop a framework for revising older laws for digital readiness. The OECD, leveraging its regulatory expertise, is assisting with this initiative, aligning efforts with the EU’s goals for digital transformation, resilience, and innovation, as outlined in the “2030 Digital Compass” and Denmark’s Recovery and Resilience Plan.

16. Do these efforts include stakeholder consultations or pilot programs that manufacturers can engage with?

No, we do not see any specific mentioning of stakeholder consultations or pilot programs specifically for Digital Therapeutics (DTx) manufacturers in Denmark. However, the broader initiatives aimed at enhancing digital readiness and regulatory frameworks suggest that there could be opportunities for stakeholder engagement and pilot programs within these efforts: i) stakeholder workshops and training sessions have been conducted involving various stakeholders, including government agencies, industry representatives, and possibly manufacturers, to gather input and facilitate the digital transformation process, and ii) collaborative Efforts with HTA Organizations may provide avenues for manufacturers to engage in discussions and pilot programs aimed at integrating DTx into the healthcare system.

Copenhagen, 23 June 2025 / JBB