Robert Troy (Longford-Westmeath, Fianna Fail)
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1954.To ask the Minister for Health the plans he is putting in place to get Ireland ready for the EU Health Data Space Regulation; and if he is confident Ireland can move its health records online in time.[35960/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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The European Health Data Space (EHDS) Regulation will provide a common governance framework and harmonised infrastructure for the use and reuse of electronic health information in and between EU Member States for primary purposes (patient care and treatment) and secondary purposes (research and innovation, policy making, education and training). It will achieve this by:

• building a common governance framework and harmonised infrastructure for the use of electronic health data for primary and secondary purposes
• facilitating the use of EU standardised and interoperable Electronic Health Records (EHRs)
• providing for EU cross-border exchange of health data:
  • for primary use through MyHealth@EU
  • for secondary purposes through HealthData@EU
• establishing key fundamental patient rights surrounding personal electronic health information

I welcome the forthcoming Regulation as a powerful driver of health services improvement and a key for unlocking for the tremendous potential of health data to improve the lives of patients and the professionals who care for them.

My department has significantly increased our activity in recent years to support readying our legislative and policy landscape for the implementation of the EHDS. To achieve this, I have published the Health Information Bill 2024, which will provide a legal basis for the establishment of Digital Health Records in Ireland and have published the Digital for Care: A Digital Health Framework for Ireland 2024 – 2030 to guide strategic development and investment in digital transformation. The HSE has also published their accompanying Digital Health Strategic Implementation Roadmap 2024-2030. With the publication of the Digital for Care Framework and Roadmap, we now have the vision, guiding principles, roadmap, appetite, and a growing momentum to deliver on our ambition to digitally transform health services in Ireland and into the next decade.

The Health Information Bill 2024 is the first in a series of legislative measures that will facilitate our national EHDS implementation. It will be followed by the transposition of the EHDS into national law in 2025 and an expansion of our national health information legislation in 2026 to provide comprehensively for secondary use including research and innovation.

By 2026, Member States will be required to appoint three supervisory authorities to coordinate and provide oversight to national implementation. These bodies are:

• a Digital Health Authority to support the governance of health data for primary use and oversight of the MyHealth@EU platform
• a Market Surveillance Authority to serve as the supervisory body for Electronic Health Record systems
• a Health Data Access Body to support the governance of health data for secondary use and oversight of the HealthData@EU platform

By 2028, Member States will be required to have initial categories of data in EHRs available for patients and healthcare practitioners to access and edit. Initial categories of data will include:

• Patient summaries
• Electronic prescriptions
• Electronic dispensations

Member States will also be required establish health data access services for secondary use and make initial categories of health data available for access upon data permit request. To date, Ireland has received €3.6 million in EU funding to develop our secondary health data infrastructure. This funding will support the establishment our national Health Data Access Body and its required services such as a national metadata catalogue.

Full compliance with the Regulation will be required by 2030. This will include making expanded categories of data available in the patient EHR as follows:

• medical images
• medical tests and laboratory reports
• discharge reports

The work to ensure Ireland meets these expanded categories is currently underway and will continue over the coming years, being driven by the supervisory authorities.