Digital Health in Europe: eHealth, AI, and the Health Data Space

The EU AI Act classifies most health AI applications as high-risk, establishing compliance obligations that will apply from 2027 for AI medical devices. An analysis of where clinical AI deployment is most advanced, the bias and explainability challenges, and how the EU's regulatory philosophy compares with the US approach.

Clinical evidence supports CBT-based mental health applications for mild-to-moderate symptoms, but the European market contains thousands of apps with limited or no clinical evaluation. Regulatory classification under EU MDR and data privacy protections add further complexity to a landscape users and clinicians struggle to navigate.

The European Health Data Space regulation entered into force in March 2025, establishing a framework for cross-border health data exchange and research access across 27 member states. The implementation timeline runs to 2029 and beyond — and the gaps in national infrastructure and governance capacity are already visible.

Digital Health Despite significant investment in digital health infrastructure, a gap between technology and the skills to use it persists across the EU. By Elena...