FORTIFY launches to strengthen innovation protection in the European Health Data Space

The FORTIFY project has officially launched with the ambition of strengthening innovation protection within the European Health Data Space (EHDS), helping to ensure that health data can be used to advance research and innovation while safeguarding intellectual property, trade secrets and commercially confidential information.

As the EHDS creates new opportunities for the secondary use of health data across Europe, many health data holders, including hospitals, research infrastructures and industry actors, continue to express concerns about maintaining control over sensitive datasets once they are shared. FORTIFY addresses these challenges by developing and validating practical solutions that demonstrate that data sharing and innovation protection do not have to be competing objectives.

The project brings together legal, governance and technical expertise to design a comprehensive framework for secure and trusted health data sharing. Its work will be tested through a series of real-world use cases covering areas such as clinical trials, medical imaging, biobanks, federated studies, genomics, real-world evidence, artificial intelligence and device-generated data.

FORTIFY is supported by a multidisciplinary consortium of 33 organisations representing academia, industry, healthcare providers, policymakers and patient organisations. The project is jointly led by Karolinska Institute and Johnson & Johnson, reflecting the importance of collaboration across sectors to address the complex challenges associated with health data access and reuse.

Over the course of the project, partners will develop and validate the FORTIFY Framework, which will include model contractual provisions, operational guidelines and a suite of technical tools designed to enhance trust and transparency. These solutions will include mechanisms such as traceability features, watermarking technologies and recommendations on the use of synthetic and transformed data.

By addressing concerns related to innovation protection while supporting responsible data access, FORTIFY aims to contribute to the successful implementation of the EHDS and help unlock the full potential of health data for research, innovation and better health outcomes across Europe.

More information about the project and its upcoming activities will be shared in the coming months.