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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 10 CELEX: 32025R0327 Right of natural persons to opt out in primary use
1. Member States’ laws may provide that natural persons have the right to opt out from the access to their personal electronic health data registered in an EHR system through the electronic health data access services referred to in Articles 4 and 12. In such cases, Member States shall ensure that the exercise of that right is reversible. 2. If a Member State provides for a right referred to in paragraph 1 of this Article, it shall establish the rules and specific safeguards regarding the opt-out mechanism. In particular, Member States may provide for a healthcare provider or health professional to be able to get access to the personal electronic health data in cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person as referred to in Article 9(2), point (c), of Regulation (EU) 2016/679, even if the patient has exercised the right to opt out in primary use. |