The European Health Data Space (EHDS) is the first common data space to emerge from the European data strategy. The EHDS Regulation entered into force in March 2025, with full implementation required between 2029 and 2031. The regulation aims to support the use of data for healthcare delivery (known as primary use of data) and to facilitate other uses of data, such as for research and policy-making (known as secondary use of data). 

Under the regulation, data holders across Member States will be required to make certain categories of data available for secondary use, including electronic health record data such as medical history, diagnoses and treatments; administrative data such as hospital discharge records and research data such as clinical trials.

HIQA has developed a guidance document which outlines key aspects of the secondary use of health data under the regulation, and the implications for data holders in Ireland. It aims to support data holders to better understand their obligations, and to assist in the identification of organisational changes required to achieve compliance with the regulation. The guidance describes the process of applying for and accessing datasets through a Health Data Access Body (HDAB) service, and sets out a number of specific obligations for data holders. It also aims to support data holders to review their data quality practices and the interoperability of their datasets to identify improvements and enhancements that are necessary in advance of the full implementation of the EHDS Regulation.  

Further information and technical details will be provided by way of EU Implementing Acts and national-level policy which will be developed over the coming years. The guidance document will be reviewed at key intervals during the implementation phase and may be revised where appropriate.