European Digital Health Industry Urges Unified Standards
Brussels, Monday, 1 September 2025.
A coalition of 33 European digital health organizations recommends EU-wide rules for digital therapeutics to maintain competitiveness, emphasizing collaboration for successful healthcare system integration.
Fragmented Regulations Threaten EU’s Leadership
Today, a coalition comprising 33 digital health organizations, including industry associations and startups from France, Germany, and other EU member states, issued a stark warning to European policymakers. They emphasized that Europe’s position as a global leader in digital health is at risk due to the fragmented regulatory landscape across the continent. The coalition calls for the establishment of a convergent and pragmatic evaluation framework for digital medical devices (DMDs) to be implemented starting in 2026 [1].
The Call for Unified Standards
Without a unified approach, the European digital single market remains a theoretical construct. Each nation’s unique regulatory frameworks lead to duplication of efforts, hindering companies from scaling across borders and delaying patient access to proven technologies. The coalition argues that a unified EU evaluation framework is needed to ensure consistent clinical and technical criteria, allowing for the emergence of strong European players capable of competing globally. This move is essential to safeguard Europe’s technological sovereignty and support the integration of digital health solutions into the upcoming European Health Data Space (EHDS) [1].
Implications for Digital Health Integration
The coalition has made it clear that starting in 2026, particularly in France and Germany, there is a need for alignment on evaluation frameworks for digital health solutions. This includes setting technical requirements for DMDs certification, clinical evaluation criteria for Digital Therapeutics (DTx), and operational procedures for reimbursement pathways. The future European evaluation framework should be pragmatic, ensuring that healthcare innovations can access the EU-wide market within a reasonable timeframe of 2 to 3 years after their launch in their home country. Beyond this timeframe, such technologies risk becoming obsolete [1].
Digital Therapeutics and Remote Patient Monitoring
As remote patient monitoring and digital therapeutics gain traction, hundreds of thousands of patients in France have already benefited. However, without widespread adoption across the EU, the EHDS risks remaining a theoretical construct with limited operational impact. The coalition stresses that collaboration among stakeholders is essential to ensure the successful integration of innovative digital health solutions into healthcare systems across Europe [1][2].