The European digital health ecosystem is at a decisive moment. As digital medical devices (DMDs) multiply, driven by innovative start-ups and adopted by thousands of patients and healthcare professionals, their evaluation remains fragmented across the European Union. This heterogeneity threatens not only the future of European companies, but also the ability of digital medical devices to address major public health challenges in the EU—such as population ageing, the rise of chronic diseases, and the growing shortage of healthcare professionals.
It is in this context that a coalition of associations and companies, including France Biotech, SVDGV (its German counterpart), France Digitale, as well as leading players like Doctolib, HelloBetter, and Implicity, issued a collective declaration. Their objective: to obtain by 2026 a harmonized European evaluation framework for digital medical devices, based on common clinical and technical criteria.
Digital medical devices on the rise
Digital medical devices encompass a wide variety of solutions: chronic disease management apps, telemonitoring platforms, digital therapeutics prescribed by physicians, and artificial intelligence tools supporting diagnosis.
In Germany, digital therapeutics already benefit from a dedicated framework: DiGA (Digitale Gesundheitsanwendungen). Introduced in 2019, this system allows certain validated digital health applications to be prescribed by a physician and reimbursed by health insurance. To be listed in the official registry managed by the BfArM (Federal Institute for Drugs and Medical Devices), a solution must demonstrate technical safety and clinical or organizational value for patients.
Thanks to DiGA, several German start-ups have been able to deploy their solutions rapidly, ensuring equitable patient access and official recognition of their medical value.
HelloBetter: a case emblematic of fragmentation
Among these start-ups, HelloBetter has become a striking example of the European divide. Specializing in digital mental health, it offers online therapeutic programs designed by clinical psychologists. These programs address depression, anxiety, chronic stress, and insomnia through interactive modules, scientifically validated exercises, and professional follow-up.
In Germany, HelloBetter was included in the DiGA registry on the basis of robust clinical data:
- Several randomized controlled trials demonstrated significant reductions in depressive and anxiety symptoms compared to a control group.
- Positive and lasting effects after 6 and 12 months of follow-up.
- High patient adherence to digital protocols.
Yet in France, despite this solid evidence, the Haute Autorité de Santé (HAS) issued a negative opinion regarding reimbursement. This refusal perfectly illustrates the limits of the current situation: a solution may be prescribed and reimbursed in Germany but rejected in France, creating unequal access to innovation.
Fragmentation slowing down innovation
The HelloBetter case is far from unique. Many developers of digital medical devices face regulatory and economic barriers depending on the country.
This fragmentation leads to several consequences:
- Inequalities in access to digital health tools for European patients.
- Additional costs for companies forced to adapt dossiers to each national system.
- Loss of competitiveness compared to the United States or Asia, where markets are more unified and responsive.
A strategic issue for Europe’s digital sovereignty
Beyond public health, the issue is also one of European technological sovereignty. If Europe fails to harmonize its rules, its start-ups risk being sidelined in favor of foreign giants.
A common framework would:
- Foster the emergence of European champions in digital health.
- Strengthen investor confidence.
- Enable the effective integration of these solutions into the European Health Data Space (EHDS), a key pillar of the EU’s future health data strategy.
Political advances but a tight timeline
Several recent initiatives point towards convergence:
- A European evaluation matrix for digital medical devices published in 2025.
- A Franco-German agreement aimed at aligning evaluation methodologies.
- The EU’s Start-up & Scale-up Strategy supporting innovative companies.
However, divergences persist in practice. The signatories of the collective declaration therefore demand an operational harmonized framework by 2026, with a maximum delay of two to three years between national validation and EU-wide market access.
France at the center of the debate
France, very active in clinical research and e-health, has a crucial role to play. To remain a European leader, it must strengthen the clarity and transparency of its procedures. Alignment with Germany, Europe’s largest healthcare market, will be decisive in giving digital medical devices a real opportunity to scale up.
Towards a European framework in 2026
The digital health revolution will only fully benefit patients if Europe manages to overcome its internal regulatory borders. Establishing a pragmatic European framework for the evaluation of digital medical devices is now an urgent necessity.
Without it, innovations risk remaining confined to their national markets, with unequal access for patients and a weakened European industry. With it, by contrast, Europe could establish itself as a global leader in digital health.
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