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5. Change 5

Obligation to share data

From voluntary to mandatory sharing will be the biggest evolution the EHDS brings for data holders. Today, data holders in Europe are free to decide whether or not to share health data for secondary use. This leads to a fragmented landscape in which access to data often depends on individual choices, contracts, and national rules.

The European Health Data Space (EHDS) fundamentally changes this. The regulation introduces a binding obligation for health data holders to make electronic health data available for secondary use. Once the HDA receives a data request, it checks whether the request complies with the legally and ethically allowed processing purposes. After the request has been approved by the HDA, the data holder cannot refuse and must make the requested electronic health data available within strict deadlines. This obligation ensures a harmonized system that promotes transparency, reuse, research and innovation, public health, and policy-making, while ensuring privacy and security.