Driving AI Health Innovation through the European Health Data Space: Opportunities and Challenges for Non-EU Country Participation

In March 2025, the European Union (EU) launched the European Health Data Space (EHDS) to streamline access to and sharing and reuse of health data across all 27 Member States. The EHDS aims to give patients greater control over electronic health records and permits secondary use of data for research, policy, and innovation under strong safeguards. Pooling diverse clinical, genomic, and wearable-device data across borders could create one of the world’s most comprehensive health data ecosystems, providing an unprecedented resource for advancing data-driven innovation, including artificial intelligence in health care. For non-EU researchers and companies, including those in the United States, this development presents both opportunities and challenges. Strict reciprocity requirements and divergent legal frameworks may limit direct U.S. participation in the near term, but partnerships with EU institutions or EU-based subsidiaries could provide entry points. Beyond the EU, the EHDS is poised to set global benchmarks for responsible secondary use of health data. This article explores its potential and the implications for third-country participation (i.e., participation by countries that are not part of the EU) and global health data governance. (Funded by Novo Nordisk Foundation, grant no. NNF23SA0087056.)