The European Health Data Space (EHDS) is an initiative which aims to unlock the potential of the safe and secure exchange, use, and re-use of health data in the EU. This treasure trove of health data could help to dramatically accelerate research and innovation, advance the development of new treatments, and improve healthcare.
However, many data holders such as hospitals, research centres and industry are concerned that by sharing data, they may lose control over sensitive data, intellectual property (IP), and trade secrets. The challenge for the EHDS is to strike the right balance between facilitating data sharing while protecting innovators.
The aim of the FORTIFY project is to deliver a framework comprising legal, governance and technical solutions that will allow health data to be reused safely, fairly and efficiently without undermining the IP framework that underpins Europe’s capacity for innovation.
FORTIFY to turn trust into practical tools
“Europe’s health data has enormous potential to drive medical breakthroughs, but that potential will only be realised if health data holders trust the system,” said the project’s scientific coordinator, Pedro Ramos of Karolinska Institutet. “FORTIFY is about turning trust into practical tools—so data can flow without compromising innovation.”
The project will prepare clear legal guidance, model contractual clauses, and practical governance tools designed to clarify how IP, trade secrets and regulatory data can be protected throughout the EHDS data sharing process.
On the technical front, FORTIFY will create and test traceability and watermarking tools that will allow data owners to track how their data is used and protect it – even after it has been shared. The project will also issue guidance on when synthetic, anonymised or transformed data can be used to reduce risks while still giving robust results.
Fostering a culture of trust and collaboration
All project outputs will be co-designed in collaboration with a wide range of stakeholders including health data holders, health data access bodies, health data users, patients, industry, and policymakers. This will ensure that the outputs meet stakeholder needs and more broadly, will foster a culture of trust and collaboration among all EHDS actors.
The project’s tools and resources will be tested and validated in 10 real-world use cases covering diverse health data environments, including clinical trials, medical imaging, real world evidence, and more.
“This is not a theoretical exercise,” said project lead Simon Bates of Johnson & Johnson. “We are working with real data holders, real researchers, and real access bodies to show what works in practice.”
A framework for a successful EHDS
The resulting FORTIFY framework should be ready for adoption by health data access bodies and data holders throughout Europe. Meanwhile, training material and policy recommendations will help EU and national authorities to ensure the EHDS meets its goals.
Inge Franki of Belgium’s Health Data Agency said: “By combining law, technology, and governance, FORTIFY will provide future health data access bodies with practical tools supporting their tasks as independent bodies responsible for fair, consistent and efficient evaluation of data access procedures.”
In the long term, by facilitating access to high value health data, the FORTIFY framework will boost health research, accelerate the development of new treatments, and advance the competitiveness of Europe’s life science sector. For their part, patients will gain reassurance that their health data is being reused responsibly, securely, and in the public interest.