Strengthening innovation protection in the European Health Data Space
The European Health Data Space (EHDS) is meant to accelerate research and innovation through secondary use of health data. Yet many health data holders —hospitals, research infrastructures and industry— remain concerned about loss of control once sensitive datasets are shared. FORTIFY tackles this gap by developing and validating practical solutions to show that data sharing and innovation protection do not have to be a trade-off.
At a glance
Aim
Pioneer legal, governance and technical solutions that enable health data to drive ground-breaking research while protecting intellectual property, trade secrets and commercially confidential information.
APPROACH
Combine law + governance + technology, and test solutions in real-world practical scenarios such as clinical trials, medical imaging, biobanks, federated studies, genomics, real-world evidence, artificial intelligence, and device-generated data.
MUTI-STAKEHOLDER COLLABORATION
Our Consortium spans 33 organisations from academia, industry, healthcare, policy, and patient advocacy, under the leadership of Karolinska Institutet and Johnson & Johnson.
RESULTS
A validated FORTIFY Framework encompassing model contracts, operational guidelines and a suite of technical tools, including traceability features, watermarking, and recommendations for synthetic and transformed data.
Latest news
FORTIFY kick-off meeting maps out priorities for practical EHDS implementation with IP safeguards
The project will develop legal guidance, technical safeguards and validation pathways to help health data access bodies, data holders and users apply the EHDS in practice.
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.
FORTIFY launches to protect innovation while enabling health data reuse in Europe
The project will develop and test practical safeguards—contracts, governance models and traceability—to support trusted EHDS data sharing
The IHI-funded FORTIFY project has officially launched to address a core challenge for the European Health Data Space (EHDS): how to enable the secondary use of health data for research while safeguarding intellectual property, trade secrets and commercially sensitive information.
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