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.
Over the next three years (36 months), FORTIFY will bring together 33 public and private partners from academia, industry, healthcare, policy and patient organisations to develop, test and validate legal, governance and technical solutions that support safe, fair and efficient data reuse—without undermining Europe’s capacity for health innovation.
The European Health Data Space is intended to accelerate research and better health outcomes by enabling cross-border data access. Yet many data holders—including hospitals, research infrastructures and companies—remain concerned about losing control over sensitive data once it is shared. FORTIFY aims to show that broader data sharing and innovation protection do not have to be a trade-off.
FORTIFY brings together 33 public and private partners from academia, industry, healthcare, policy and patient organisations to develop, test and validate legal, governance and technical solutions to support EHDS data sharing.
The project will produce practical tools such as legal guidance and model contracts, alongside governance approaches to clarify how intellectual property, trade secrets and regulatory data can be protected across the EHDS data-sharing process. On the technical side, it will test traceability and watermarking solutions to help data owners track use after sharing, and provide guidance on when synthetic, anonymised or transformed data may reduce risk while preserving scientific value. These solutions will be validated in real health data environments—including clinical trials, medical imaging, biobanks, federated studies, genomics, real-world evidence, AI models and device-generated data.
“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 Pedro Ramos (Karolinska Institutet), scientific coordinator of FORTIFY.
By reducing uncertainty and administrative delays while strengthening safeguards for innovators, the consortium expects FORTIFY to support faster research, better treatments and stronger European competitiveness in health and life sciences—while increasing confidence that health data is reused responsibly, securely and in the public interest.
Read the full announcement here.
