The European Health Data Space (EHDS) regulation was accepted on 11 February 2025, the full applicability will be achieved from 26 March 2031. The Regulation has double aims, firstly to improve the patients’ access to and control over their personal electronic health data in the context of healthcare and secondly to better achieve other purposes that would benefit society, such as to support research, patient safety, personalised medicine, health threats (including pandemics), innovation, policymaking, official statistics or regulatory activities. The EHDS is the first EU common dataspace with many promises, expectations and challenges.

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