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Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance)

article  3

CELEX:  32025R0327

Right of natural persons to access their personal electronic health data
1. Natural persons shall have the right to access at least personal electronic health data relating to them that belong to the priority categories referred to in Article 14 and are processed for the provision of healthcare through the electronic health data access services referred to in Article 4. Access shall be provided immediately after the personal electronic health data have been registered in an EHR system, while respecting the need for technological practicability, and shall be provided free of charge and in an easily readable, consolidated and accessible format.
2. Natural persons, or their representatives referred to in Article 4(2), shall have the right to download free of charge an electronic copy of at least the personal electronic health data in the priority categories referred to in Article 14 related to those natural persons, through the electronic health data access services referred to in Article 4, in the European electronic health record exchange format referred to in Article 15.
Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance)

article  3

CELEX:  32025R0327

3. In accordance with Article 23 of Regulation (EU) 2016/679, Member States may restrict the scope of rights provided for in paragraphs 1 and 2 of this Article, in particular whenever those restrictions are necessary to protect natural persons, on the basis of patient safety and ethical considerations by delaying access to their personal electronic health data for a limited period of time until a health professional is able to properly communicate and explain to the natural persons concerned information that can have a significant impact on their health.