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FORTIFY - FRAMEWORK FOR OPTIMIZED REGULATION, TRADE SECRETS, AND INTELLECTUAL PROPERTY IN A FEDERATED EUROPEAN HEALTH DATA SPACE

Objective

The European Health Data Space (EHDS) promises to unlock unprecedented opportunities for data-driven healthcare innovation by enabling the secure reuse of health data across Europe. However, realizing this vision requires robust safeguards to build trust among all stakeholders, protect privacy, and preserve the rights of data holders. FORTIFY directly addresses this challenge by delivering a comprehensive FORTIFY Framework that seamlessly integrates legal, technical, and governance measures to safeguard innovation while promoting data access. Key components of the FORTIFY Framework include clear legal, technical and governance guidelines to protect intellectual property rights, standardized template contracts for transparent and consistent data access agreements, digital data processing technologies for robust IP protection and traceability, and quantitative utility benchmarks for managing IP utility. The project actively engages a broad range of stakeholders—including health data holders, health data access bodies, health data users, patients, industry, and policymakers—in co-designing these solutions through an established Multistakeholder Forum, ensuring diverse needs are met and fostering a culture of trust, collaboration, and continuous feedback. Validation of the FORTIFY Framework will be carried out through ten real-world use cases, simulating the EHDS user journey, workflows, and ensuring practical applicability and effectiveness across diverse data sharing settings.

Fields of science (EuroSciVoc)

Keywords

Programme(s)

Topic(s)

Funding Scheme

HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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Call for proposal

(opens in new window) HORIZON-JU-IHI-2025-10-two-stage

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Coordinator

KAROLINSKA INSTITUTET
Net EU contribution
€ 1 396 312,50
Address
NOBELS VAG 5
171 77 STOCKHOLM
Sweden
Region
Östra Sverige Stockholm Stockholms län
Activity type
Higher or Secondary Education Establishments
Links
Total cost
€ 1 396 312,50

Participants (32)

Partners (31)