Current reimbursement landscape for health apps in Europe
In Europe, reimbursement for health apps varies by country, with most countries still developing reimbursement frameworks. Several European countries (Belgium, France, and Germany) have established reimbursement models for health apps, but the processes and conditions can differ significantly from one country to another. In England, Netherlands, Italy, Spain, and Scandinavian countries, there is clearly no defined reimbursement framework for health apps.
In Belgium, the development of a reimbursement framework for health apps was initiated in 2016. The reimbursement framework for software applications is managed by the National Institute for Health and Disability Insurance (INAMI/RIZIV). The first agreement (Convention) allowing reimbursement for software applications for remote monitoring of patients with chronic heart failure came into force on January 1, 2025. However, as of January 2025, eligible health apps are not specified.
In Germany, the Digital Health Law (DVG), which entered into force in 2019, allowed for reimbursement of various digital health care, including health apps. It also defined the pathway for the statutory introduction of health apps and the process for manufacturers to apply for reimbursement. The regulation uses the German term Digitale Gesundheitsanwendung (DiGA) to define health apps. In the current version of the EBM catalog (Einheitlicher Bewertungsmaßstab, the first quarter of 2025), which regulates the reimbursement of services in the public outpatient sector in Germany, there are specific service codes for patient follow-up and evaluation using eight health apps (for orthopedic and urology indications, obesity, and mental health).
Policy considerations
In general, health apps are not eligible for national coverage decisions; it is unlikely to be a subject for approval at the national level by payers or national decision-makers. However, health apps might be funded by local payor decisions or decisions of individual health insurance companies.
For example, in England, it is up to local commissioners (historically Clinical Commissioning Groups, CCGs, from July 2022 – Integrated Care Boards, ICBs) and NHS Trusts to negotiate reimbursement with the app developers. NHS England provides a certain number of apps to their insured population free of charge.
Administrative framework for the use of health apps
Though there are no national policies for health apps, in those countries where the reimbursement for health apps is established, an administrative framework for the use of health apps is in place.
In England, the Digital Technology Assessment Criteria for Health and Social Care (DTAC) was implemented in 2021. It specifies the requirements that must be evidenced before digital health technologies, including health apps, can be used directly by patients or procured by commissioners and the wider health and care system in five key areas: clinical safety, data protection, technical assurance, interoperability, and usability and accessibility.
The Evidence Standards Framework (ESF) for digital health technologies by the National Institute for Health and Care Excellence (NICE) has been designed to complement the existing regulatory and technical standards that apply to digital health technologies, including health apps. The ESF focuses on evaluating digital health technologies to ensure they are likely to perform as expected and represent good value for money to the health and care system. ESF is used by commissioners and evaluators in the health and care system to make more informed and consistent decisions when evaluating, commissioning, or purchasing digital health technologies. Companies (developers and distributors of digital health technologies) use ESF to understand how to demonstrate the effectiveness and value of their products and facilitate adoption in the national health system.
In Belgium, the administrative framework for the use of software applications with the involvement of patients (including health apps) is called the “validation pyramid” and is managed by the INAMI/RIZIV. It consists of three levels: level 1 – the software application is a CE-certified medical device; level 2 – additional ICT criteria fulfilled, and reimbursement application is submitted to the software application is safely connected with the basic services of the eHealth platform; level 3 – reimbursement is granted within the context of a specific care process (this level is subdivided into two sub-levels for temporary and regular reimbursement). As of January 2025, 26 software applications are present on the mHealth Belgium validation pyramid: 20 are on level 1, six are on level 2, and none achieved level 3. The first apps are expected to reach level 3 in winter 2025 within the care pathway for "Remote monitoring and therapeutic guidance in chronic heart failure".
In the Netherlands, the Digizo.nu Platform was introduced by the Ministry of Health, Welfare, and Sport in 2023 in collaboration with health insurers, clinical societies, and healthcare providers. The platform's objective is to assess new innovative medical care using health apps and/or digital technologies. The platform is further developing the Digital Care Knowledge Center of the umbrella organization of Dutch health insurers (Zorgverzekeraars Nederland, ZN) alone. As of January 2025, there is an ongoing assessment of fourteen digital health projects.
Role of HTA
Health Technology Assessment is an important factor influencing the adoption of health apps, apart from reimbursement and acceptance by payers / national decision-makers. HTAs can be incorporated into reimbursement decision-making (Belgium, France, Germany, and the Netherlands). However, in some countries, there are stand-alone HTA organizations whose recommendations can support the adoption of the new health apps by healthcare providers (England).
In England, NICE typically evaluates digital technologies, including health apps, within the Medical Technologies Evaluation Program and Early Value Assessment (EVA). As of January 2025, three Medical Technologies Evaluations have been published for health apps: myCOPD, KardiaMobile, and Sleepio.
NICE implemented a new program for the evaluation of digital technologies using the Early Value Assessment approach in 2022. 16 EVAs were published for digital technologies, of which 11 are related to health apps. For example, in December 2024, NICE released an early value assessment of digital technologies to support self-management of chronic obstructive pulmonary disease (COPD). Seven digital technologies to support self-management of COPD in adults can be used in the NHS during the evidence-generation period: Active+me REMOTE; Clinitouch; COPDhub; COPDPredict; Lenus COPD Support Service; Luscii; myCOPD.
Role of Innovation Funding
Various innovative funding mechanisms at the European Union (EU) and national levels support the development, adoption, and scaling of digital health technologies, including health apps.
Innovative payment schemes play an important role in market access for digital technologies in Europe: around 52% of the innovative payment schemes can cover digital technologies, including health apps (Medtech Funding Mandate in England; Government-co-sponsored studies according to the §137e of the German Social Code Book V in Germany; small-scale experiments for introduction of innovations in the Netherlands). Some of the innovative schemes allow for direct application by the industry (Artificial Intelligence in Health & Care Award and Innovative Devices Access Pathway (IDAP) in England, Early Support for Digital Technologies (PECAN) in France, Provisional Listing of Digital Health Applications (DiGA) in Germany).
In Germany, the Provisional Listing in the Digital Health Applications (DiGA) Directory was introduced to simplify the implementation of innovative apps into standard healthcare. It offers the possibility of being included in the Directory for a one-year trial phase, with reimbursement available at a price set by the manufacturer. Once the digital health app is listed in the Directory, it can be prescribed by physicians and psychotherapists and will be reimbursed by sickness funds. In 2024, eight health apps were considered in the Provisional Listing, including “glucura Diabetestherapie” for treating type 2 diabetes mellitus with a tariff of €499.80 or “Uroletics” app for patients with prostate cancer who suffer from urinary incontinence and/or erectile dysfunction because of radical prostatectomy with a tariff of €895.
Future challenges
Digital health care is gaining traction in Europe, but challenges related to reimbursement and funding may hinder its widespread adoption and long-term sustainability. In many European countries, there is no established reimbursement for health apps, and many European healthcare systems lack clear methodologies to evaluate the value of digital technologies compared to traditional interventions.
Future challenges mostly include establishing a reimbursement framework for digital care using health apps and expanding existing reimbursement frameworks to novel digital technologies or different indications for its application. HTAs and innovation funding schemes will play an important role in the future adoption of digital health care.
How can MTRC help?
Development of reimbursement analysis (procedure coding, payment mechanism, reimbursement tariffs, and policy considerations)
Development of reimbursement strategy
Development of the value dossier
Performing evidence gap analysis for novel technologies
Development of reimbursement and HTA submission dossiers
Adaptation of the global health economic model to EU settings
MTRC has experience with nine projects related to health apps in Europe
Get in touch
Contact us to discuss your needs and learn about our services