As the European Health Data Space (EHDS) moves towards implementation, one of the most complex challenges will be balancing greater access to health data for research and innovation with appropriate protection for intellectual property (IP), trade secrets and commercially sensitive information.
To help inform this debate, UPD supported three UK experts to contribute to a TEHDAS2 workshop exploring the legal, technical and practical implications of these issues. Their discussions highlighted several considerations that are likely to shape implementation of the EHDS and wider international approaches to health data governance.
Key considerations
Balancing openness with commercial protection: The EHDS aims to make health data more accessible for research, innovation and public benefit. At the same time, organisations need confidence that sharing data will not inadvertently expose commercially valuable information, undermine patent protection or weaken incentives to invest in new medicines, technologies and AI. Achieving this balance will require clear guidance on how IP rights, database rights and trade secrets apply in practice.
Protecting sensitive information throughout the data lifecycle: Commercially sensitive information may extend beyond the data itself. Metadata, dataset descriptions and the outputs of research can all reveal information that has commercial value or supports future innovation. This raises practical questions about how data should be described, accessed and published while minimising the risk of unintended disclosure.
Building infrastructure and governance that enables participation: Effective participation in cross-border data sharing depends on more than legislation. Trusted research environments, consistent metadata standards, skilled data stewardship and clear governance processes will all be essential. Without sufficient capability and investment, organisations may struggle to participate confidently or realise the benefits of international collaboration.
Providing clarity on value and commercial use: Questions remain about how curated datasets should be valued, what constitutes commercial use, how licensing should operate and whether public organisations should share in the value created through downstream innovation. Transparent and proportionate commercial frameworks will be important to support collaboration while ensuring that public benefit remains central.
Maintaining trust through transparency and proportionate safeguards: Implementation will also require careful management of competing priorities. Greater transparency supports accountability and public confidence, but publication requirements must also take account of legitimate commercial confidentiality and patent timelines. Clear governance, consistent decision-making and proportionate safeguards will be needed to navigate these trade-offs.
Why this matters for the UK
Although the UK is not part of the EHDS, many of the challenges it seeks to address are shared internationally. The framework is likely to influence expectations around health data access, governance and research collaboration across Europe and beyond.
Continued engagement with these discussions provides an opportunity for the UK to contribute expertise, strengthen cross-border research partnerships and help shape approaches that enable innovation while protecting commercial interests and maintaining public trust.
With thanks to the following UK experts:
- Charlie Morgan, Senior Intellectual Property and Commercial Partnerships Manager, The Royal Marsden NHS Foundation Trust;
- Jon Round, Associate Director, Osborne Clarke;
- And Shaun Rowark, Associate Director – Healthcare Data Analytics, NICE.