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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  66

CELEX:  32025R0327

Data minimisation and purpose limitation
1. Where health data access bodies receive a health data access application, they shall ensure that access is only provided to electronic health data that are adequate, relevant and limited to what is necessary in relation to the purpose of processing indicated in the health data access application by the health data user and in line with the data permit issued pursuant to Article 68.
2. Health data access bodies shall provide electronic health data in an anonymised format, where the purpose of processing by the health data user can be achieved with such data, taking into account the information provided by the health data user.
3. Where the health data user has sufficiently demonstrated that the purpose of processing cannot be achieved with anonymised data in accordance with Article 68(1), point (c), health data access bodies shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the health data access body or an entity that acts as a trusted third party in accordance with national law.