Mason Hayes & Curran charts progression of EU rules in Digital Health Review
The regulation of digital healthcare continues to develop under new and revised EU rules. Mason Hayes & Curran’s Digital Health Mid-Year Review 2025 outlines these changes and explains the regulatory trends currently shaping the delivery of digital health products and services across Europe.
Michaela Herron, head of life sciences at Mason Hayes & Curran, said: “Standalone software, including AI systems and medical device apps are now treated like any other physical product under EU product liability law. That is a major shift and expands liability to more actors in the healthcare ecosystem. Our Mid-Year Review outlines the implications for digital health companies and analyses other key regulatory changes across the sector.”
The Review includes a detailed analysis of the revised EU Product Liability Directive, which now expands the definition of a ‘product’ to include software. Developers of apps and digital platforms intended for use in a healthcare setting may now be liable for harm caused by defects in their products. This includes issues linked to software updates, self-learning capabilities or cybersecurity vulnerabilities.
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