New legal update warns digital health firms of rising regulatory risk

Mason Hayes & Curran has released its Digital Health Mid-Year Review 2025, flagging major regulatory shifts that redefine how software and AI tools in healthcare are treated under EU law. The headline change: standalone software—including AI-driven apps—now falls under the EU’s revised product liability regime, placing greater legal exposure on developers and digital health providers.

The review also unpacks fresh international guidance on AI medical devices, new frameworks for telemedicine regulation, and the wide-reaching impact of the European Health Data Space Regulation, adopted earlier this year.

As the legal landscape tightens around software updates, cybersecurity, and AI learning systems, the message to digital health companies is clear—regulatory clarity is no longer optional, it’s operational.

Download the full update to see what’s changing and what it means for your organisation.