The European Health Data Space (EHDS) will promote the secure and trustworthy use of data, and is designed to benefit all EU citizens, including patients, healthcare professionals, researchers, policymakers and innovators. The EHDS Regulation entered into force on 26 March 2025 and will be implemented on a phased basis between 2027 and 2031. Under the Regulation, health data holders across Member States will have a number of obligations, including making certain categories of electronic health data available for secondary use, providing dataset descriptions and reporting on dataset quality.

In November 2025, HIQA hosted the first in a series of webinars, entitled, ‘Secondary use of data under the EHDS Regulation: what I need to know as a health data holder’. The webinar aimed to describe the key elements and timelines of the EHDS Regulation, to outline who is considered a health data holder and clarify their obligations under the EHDS Regulation and to support health data holders to understand the key elements of the National Health Dataset Catalogue (NHDsC) and the data quality and utility label.  

To support health data holders as they prepare for the implementation of the EHDS Regulation, a copy of the presentation slides from the webinar are available and a Frequently Asked Questions (FAQ) document which provides further details on key queries posed by attendees during a question and answers session at the end of the webinar. A leaflet outlining who is considered a health data holder under the EHDS Regulation and their key obligations is also available.