This white paper provides an in-depth overview of the European Health Data Space initiative and its implications for secondary health data use. It explains the EHDS regulatory framework, governance structures, and data access bodies designed to enable cross-border research, policy-making, and innovation. The paper highlights opportunities for real-world evidence generation, clinical research acceleration, and AI development, while also addressing challenges related to privacy, interoperability, and compliance. It emphasizes the need for early stakeholder engagement, operational readiness, and robust data governance to successfully leverage EHDS for healthcare and life sciences advancement.

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