Digital health faces new EU rules on liability and data control

Medical apps and AI-based healthcare tools are now legally classified as “products” under EU law, according to a review by Mason Hayes & Curran. This means developers could be held liable for defects, cybersecurity weaknesses, and problematic updates—radically shifting compliance expectations in the digital health sector.

The updated EU Product Liability Directive, along with new guidance from global regulators and the rollout of the European Health Data Space Regulation, brings tighter oversight and greater patient control over data sharing. With overlapping rules on safety, AI, privacy and telemedicine, regulatory complexity is rising fast.

Navigating these changes is no longer optional—it’s core to digital health strategy.

Explore the legal implications in full here.