Minister for Health welcomes the publication of the European Health Data Space Regulation
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From: Department of Health
- Published on: 5 March 2025
- Last updated on: 10 March 2025
The Minister for Health Jennifer Carroll MacNeill has today welcomed the publication of the EU Regulation on the European Health Data Space (EHDS) in the Official Journal of the European Union.
The EHDS Regulation is set to revolutionise healthcare by:
- empowering individuals with better access to their personal electronic health data
- enabling health professionals to access relevant health data for seamless healthcare delivery across the EU (primary use of data)
- facilitating access to health data for research, innovation, policy-making, and regulatory activities (secondary use of data)
This will be achieved by:
- providing a common governance framework and harmonised infrastructure for the safe and secure exchange of electronic health data across the EU
- facilitating the use of EU standardised and interoperable electronic health records (EHRs) and harmonisation of EHR systems
- establishing key fundamental patient rights surrounding personal electronic health information
Minister for Health Jennifer Carroll MacNeill welcomed the publication saying:
"Publication of the EHDS Regulation is another important milestone in creating a fit for purpose national health information system that enhances patient care and treatment as well as supporting better planning and delivery of health services into the future. In preparation for the EHDS Regulation, Ireland has been proactively working with our European counterparts to provide the foundations for this Regulation.
"Implementation of the EHDS Regulation will place obligations on Member States beginning in 2027 and continuing through to 2031. While giving full effect to the EHDS Regulation will take a number of years and follow a phased implementation timeline, the first steps have already been taken through initiatives such as the recently launched HSE Health App and the procurement of a Shared Care Record."
Notes
The EHDS Regulation will enter into force on the 26 March 2025 and will take direct effect in all EU Member States.
Further information on the EHDS Regulation is available and the full text of the Regulation is available.
The EHDS Regulation will follow a phased implementation timeline. By Q1 2027, Member States will be required to appoint the three supervisory authorities (Digital Health Authority, Health Data Access Body, Market Surveillance Authority). By Q1 2029, Member States will be required to make priority category data in EHRs available for patient and healthcare provider access, and for cross-border exchange. Member States will also be required to establish initial secondary data access services through the Health Data Access Body. Full compliance with the Regulation will be required by Q1 2031.
Implementation of the EHDS Regulation in Ireland is underway through initiatives under the Digital for Care: A Digital Health Framework for Ireland 2024-2030. In addition, the Health Information Bill, which is a strategic enabler of Digital for Care, is part of a suite of planned legislative measures to give full effect to the EHDS Regulation. The Health Information Bill will provide the legal basis for the establishment of electronic health records while also facilitating appropriate sharing of patient information across healthcare settings.