Digital Health Technology
2025 was another demanding year for companies operating in the digital health sector. Regulators across the EU continued to expand and refine the rules governing software, data, connected devices and online healthcare services, while enforcement activity became more targeted, technical and coordinated across borders.
As we move into 2026, those pressures are not easing. The result is greater scrutiny, tighter timelines and less tolerance for weak governance or unclear compliance frameworks.
This year’s Review includes analysis and guidance on:
- The future obligations that the European Health Data Space Regulation will impose on digital health businesses, and how to prepare
- The European Commission’s guidelines on what constitutes an AI system under the AI Act
- The impact of a recent Court of Justice of the EU decision on telemedicine
- The implications of the NIS2 Directive for life sciences and digital health providers, particularly around cyber security governance
