Written answer
Patient Files
Ireland’s HealthData@IE project is improving EHDS secondary-use readiness, while the Health Information Policy Unit will designate Ireland’s health data access body by March 2027.
3923. Deputy Pádraig O'Sullivan asked the Minister for Health her response to the findings of the Health Information and Quality Authority's readiness assessment for data holders, published in March 2026, on Ireland's preparedness for the secondary use of health data under the European Health Data Space Regulation; the body that will be designated as Ireland's health data access body for secondary use; and the timeline for putting the necessary arrangements in place; and if she will make a statement on the matter. [58159/26]
Comment on this
The EU Regulation on the European Health Data Space (EHDS) provides for a framework for the use and reuse of health data within and across Member States. The Regulation follows a phased implementation timeline with obligations on Member States falling due between 2027 to 2031. With regard to secondary use of data, Health Data Access Bodies (HDAB) must be operational by March 2029 and data access services are to be expanded by March 2031 to include additional categories of data.
Ireland is a recipient of EU funding under the EU4Health programme to support the establishment of a national Health Data Access Body. The HealthData@IE project (2023-2027) advances development of infrastructures needed for data access, including a national metadata catalogue, a data access application management system and a secure processing environment. The project is also delivering workstreams on stakeholder engagement and data quality enhancement.
The “Report on the findings of a readiness assessment of data holders in Ireland in relation to health data access body services” was delivered as part of the data quality enhancement workstream of the HealthData@IE project. The readiness assessment is a welcome step in our preparations for EHDS implementation and informs other initiatives in data quality enhancement to be delivered at later phases of the HealthData@IE project.
Under the EHDS Regulation, Member States are required to designate one or more HDABs by March 2027. The Health Information Policy Unit within my Department is engaged in work supporting the decision to determine the national HDAB within this timeframe.