DATA PROTECTION
EU Regulation establishing the European Health Data Space (EHDS Regulation) definitively approved.
In its last legislative session, the European Parliament gave final approval - 445 votes to 142 - to the EU Regulation establishing the European Health Data Space (EHDS), implementing the agreement reached with the EU Council.
The European Health Data Space will be a key pillar of the European Health Union and is the first common EU data space in a specific area to emerge from the European Data Strategy. In essence, it is the first lex specialis with respect to the Data Governance Act (Regulation 2022/868 - DGA) which, as a lex generalis, sets the rules on the cross-sectoral circulation of data in European Data Spaces.
The EHDS will enable citizen-patients to take full control of their health data, facilitating their exchange for the provision of healthcare across the EU (so-called primary use of data circulating through a dedicated European electronic platform). A true single market for electronic health record systems is also promoted. Furthermore, a coherent, reliable and efficient system for the re-use of health data for research, innovation, development of personalised medicine and apps, training of AI algorithms, policy-making and regulatory activities is implemented: the so-called secondary use of data, for which a second and dedicated electronic platform will be activated.
At this point, it can be said that thisEU Legislature that is coming to an end has been among the most relevant in terms of the full implementation of the EU regulatory framework implementing the Data Strategy: after the GDPR, the DGA, the Data Act and the EDHS, together with the cybersecurity framework (NIS 2, DORA, Critical Systems Resilience Directive, GPSR, CRA, TERREG).
The European Health Data Space will be a key pillar of the European Health Union and is the first common EU data space in a specific area to emerge from the European Data Strategy. In essence, it is the first lex specialis with respect to the Data Governance Act (Regulation 2022/868 - DGA) which, as a lex generalis, sets the rules on the cross-sectoral circulation of data in European Data Spaces.
The EHDS will enable citizen-patients to take full control of their health data, facilitating their exchange for the provision of healthcare across the EU (so-called primary use of data circulating through a dedicated European electronic platform). A true single market for electronic health record systems is also promoted. Furthermore, a coherent, reliable and efficient system for the re-use of health data for research, innovation, development of personalised medicine and apps, training of AI algorithms, policy-making and regulatory activities is implemented: the so-called secondary use of data, for which a second and dedicated electronic platform will be activated.
At this point, it can be said that thisEU Legislature that is coming to an end has been among the most relevant in terms of the full implementation of the EU regulatory framework implementing the Data Strategy: after the GDPR, the DGA, the Data Act and the EDHS, together with the cybersecurity framework (NIS 2, DORA, Critical Systems Resilience Directive, GPSR, CRA, TERREG).
