Discussions pointed to three early pressure points for EHDS implementation: legal uncertainty over protected data, the need for robust traceability and access safeguards, and the challenge of creating tools that work across real-world use cases from clinical trials to genomics.
The FORTIFY consortium met in Stockholm on 6-7 May for an hybrid kick-off meeting, bringing together representatives from 33 partners from academia, industry, healthcare, policy and patient organisations. Funded by the Innovative Health Initiative Joint Undertaking, the 36-month project will develop practical legal, governance and technical tools to support the secondary use of health data under the EHDS while safeguarding intellectual property, trade secrets, commercially confidential information and regulatory data protection.
Setting the scene: what FORTIFY will deliver—and why it matters for EHDS
The opening session framed FORTIFY as a practical response to one of the EHDS’s central challenges: how to expand access to health data for innovation without weakening the protections that support research and investment.
FORTIFY industry lead, Simon Bates (J&J) said the project would combine legal, technical and validation work with continuous feedback loops to ensure solutions are tested and refined in real-world settings. “Our vision is that the EHDS will become a critical enabler of health innovation in Europe,” he said, stressing that FORTIFY’s role is to make sure “the IP aspects underpinning innovation are reinforcing rather than blocking the way the EHDS operates.”
“Our vision is that the EHDS will become a critical enabler of health innovation in Europe”, Simon Bates (J&J)
Project scientific coordinator, Pedro Ramos (KI) underlined the urgency of turning that ambition into practical results which are expected to have direct practical relevance for EHDS implementation by 2029. “Over the next three years, we will bring together everyone involved in the EHDS ecosystem—from health data holders and access bodies to data users—to understand their needs and turn them into practical solutions that help the EHDS work effectively in day-to-day practice, with full respect for intellectual property and the interests of all stakeholders,” explained Ramos.
Framing the challenge
A dedicated session with Guillaume Byk (DG Santé) examined how intellectual property interacts with EHDS implementation, drawing on experience and outputs from earlier initiatives. Byk pointed to the key role of health data access bodies in assessing risks, applying safeguards and deciding, case by case, when access can go ahead. The talk also highlighted the complexity of turning the regulation into day-to-day practice, from identifying protected elements in datasets to developing workable legal, organisational and technical solutions. “The EHDS does not alter existing intellectual property, trade secret or regulatory data protections; it builds on them to make lawful access to health data possible under appropriate safeguards”, he said.
“The EHDS does not alter existing intellectual property, trade secret or regulatory data protections; it builds on them to make lawful access to health data possible under appropriate safeguards”, Guillaume Byk (DG Santé)
Multiple perspectives on EHDS implementation
Stakeholder discussions brought together the perspectives of health data access bodies, data holders and data users. Participants pointed to progress in data-sharing infrastructure and governance, but said implementation will require secure processing environments, workable access models, clearer legal frameworks and more harmonised tools to assess IP and trade-secret risks. Speakers also stressed the need to avoid slow case-by-case decisions, develop tailored approaches for data types such as medical imaging, and give innovators confidence that using or sharing data through the EHDS will not jeopardise future research, patents or market uptake.
The solution: legal tools, technical safeguards and real-world validation
The second half of the meeting focused on FORTIFY’s solutions. Partners outlined plans to develop legal guidance on how EHDS rules interact with EU IP frameworks, model clauses to support data-sharing agreements, and technical tools to strengthen traceability and reduce leakage risk. These outputs will be tested through real-world use cases spanning areas such as clinical trials, imaging, biobanks, genomics and real-world evidence, while a multi-stakeholder forum and outreach activities will help validate results and support uptake.
Over the coming months, FORTIFY will begin turning the kick-off discussions into concrete outputs aimed at supporting more consistent processes for health data access bodies and greater legal certainty for data holders and users under the EHDS.
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