European Union: European Health Data Space Regulation (2025/327) including provisions on expanded data categories and EHR system requirements enters into force
Description
European Health Data Space Regulation (2025/327) including provisions on expanded data categories and EHR system requirements enters into force
On 26 March 2031, specific provisions of the European Health Data Space (EHDS) Regulation (2025/327) become applicable. In particular, the priority categories of personal electronic health data referred to in Article 14(1)(d), (e) and (f) will be subject to the Regulation. EHR systems that process these expanded data categories must comply with interoperability and security requirements. Furthermore, EHR systems placed into service within the Union, as referenced in Article 26(2) of the EHDS Regulation, are obligated to adhere to the requirements stipulated in Chapter III. Furthermore, Articles 51(1)(b), (f), (g), (m), and (p) will be implemented, setting out requirements for data security, governance, compliance monitoring, and processing of electronic health data. These provisions will apply to the secondary use, sharing, and management of health-related data within the European Health Data Space.
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