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James Hazel and Mahsa Shabani from Law for Health and Life together with Patricia Cervera de la Cruz, LLM and I. Glenn Cohen have published a new article in NEJM AI on the launch of the European Health Data Space (EHDS).

The EHDS is a framework designed to facilitate access to, sharing, and reuse of health data across all member states of the European Union (EU). The main goal of the EHDS is to enhance patients’ control over electronic health records. In addition, the EHDS enables the secondary use of health data for research, policy, and innovation, while safeguarding data security and privacy. This secondary use could support AI-driven innovations in healthcare.  

The article describes that, by enabling cross-border access to health data through the EHDS, researchers can train AI algorithms on a larger and more heterogeneous dataset. It also notes the possible future implementation of the EHDS in non-EU member states such as the United States of America. 

While implementation within the EU already presents challenges, the authors are optimistic about the EHDS’s potential beyond EU borders. For now, non-EU countries still face significant legal and procedural challenges to short-term participation. These challenges are due to strict reciprocity requirements and divergent legal frameworks between the EU and non-EU countries.