Safeguarding innovation in secondary use of health data in the European Health Data Space (EHDS)

Program Code: HORIZON-JU-IHI-2025-10-02-two-stage

Program Type: Research and Innovation Action

The European Health Data Space (EHDS) is a key initiative under the European Strategy for Data and the European Health Union that enables the secondary use of health data for various purposes, including research and innovation. The outcomes of this topic will lead to the identification of pathways for enabling innovation through the EHDS while safeguarding intellectual property, Regulatory Data Protection (RDP)1, and trade secrets in health data.

Within a collaborative public-private partnership consortium reflecting the cross-sectoral nature of the Innovative Health Initiative, proposals will achieve all of the following impacts:

• fostering data-driven research and innovation advancing healthcare in the EU
• world-leading approach to IP protection of data
• balance between data utilization and access control rights
• best practices for data sharing, data security and prevention of unauthorized disclosure
• recommendations for legal and ethical standards
• increased industry confidence in the EHDS

Research activities in the proposal will include:

• research into data strategy, management and governance
• comparative reviews of existing data exchanges and the need for transparency, interoperability and standardization of data
• conduct comparative reviews with work developed in the context of national data spaces
• through elaborate use cases, explore the procedural and operational aspects of the EHDS from various perspectives
• identify best practices, guidelines, standards, and tools for intellectual property, trade secret, and opt-in/out management that can be used and advanced within the EHDS frameworks
• develop proposals for comprehensive frameworks, processes, policies and guidelines balancing the needs of HDHs to safeguard the IP system and minimize the administrative burden while facilitating data sharing and collaboration
• develop mechanisms for IPR-aware data manipulation, including reviewing best practices in anonymization techniques and synthetic data generation, to facilitate reuse of electronic health data that is subject to IP protection
• prepare recommendations for technical standards for access controls, data minimization, secure data storage, anonymization techniques, handling of evolving data sets, etc., which might benefit innovation related to trade secrets and IP protected data covered by the EHDS.

The successful consortium from stage 1 will merge with the pre-identified industry consortium; then they will submit a full stage 2 application together. 

Total Funding Available: $7.8M CAD for 1 grant.