Digital Health Annual Review 2025

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. Digital health businesses are now navigating a regulatory environment that is becoming more detailed and more demanding at the same time as innovation in AI-driven tools, remote care models and data-enabled products continues to accelerate. The result is greater scrutiny, tighter timelines and less tolerance for weak governance or unclear compliance frameworks.

In this edition of our Digital Health Annual Review, we bring together the most important legal and regulatory developments from the past year, with a focus on what they mean in practice for legal, compliance, regulatory and product teams working in the sector.

What we cover in this edition

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
The Commission’s proposals to reform the Medical Device and In Vitro Diagnostic Device regimes
Wider regulatory, enforcement and compliance trends affecting digital health products and services