Insights Life Sciences
Digital Health Annual Review 2024
Jan 17, 2025

The EU digital health landscape continued to evolve throughout 2024 as stakeholders sought to implement sophisticated regulations aimed at protecting consumers, while safeguarding innovation and growth in the region. This has proven demanding for businesses trying to navigate everchanging market conditions while also staying abreast of their regulatory obligations.
In this edition of our annual Digital Health Review, we highlight some of the key developments in 2024 and offer a look ahead to some developments to come in 2025:
- The General Product Safety Regulation came into effect in December, with an expanded scope extending beyond physical products to now capture software, mobile apps and AI systems. We address these changes and the challenges faced by consumers and digital health businesses alike in this new legislative era
- The EU Batteries Regulation came into operation earlier in 2024 placing more stringent obligations on producers in terms of sustainability, performance, and safety. We provide a detailed overview of the challenges faced by medical device and consumer wearable stakeholders seeking to comply with these new requirements
- The EU Digital Governance Act aims to increase and ease the sharing of data for the benefit of businesses and citizens. We provide insight into the re-use of data, the role of data intermediaries and the subject of data altruism as well as the role of European Data Innovation Board (EDIB) in this area
- The Court of Justice of the European Union considered the interplay of prescription medications and the GDPR in October. In particular, the CJEU offered determinations in relation to what constitutes ‘health data’ under the GDPR and the question of whether commercial competitors are permitted to bring legal proceedings for GDPR infringements
We hope you enjoy this latest edition of our Annual Digital Health Review.
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