New guideline to help health data holders describe datasets for reuse in the European Health Data Space

Since the European Health Data Space (EHDS) Regulation entered into force in March, attention has turned to how it will be put into practice. The Regulation specifies that certain health data must be made available not only for healthcare, but also for reuse for other purposes such as scientific research, innovation, public health and policy-making. This is known as secondary use of health data. In this context, one of the new obligations is that health data holders must describe the datasets they hold. These descriptions, also known as metadata, or “information about data”, are essential to make health data easier to find, combine and reuse across Europe.

The new guideline helps health data holders with two key questions: which data must be described for secondary use under the EHDS, and how should this be done. It explains the legal requirements, gives practical examples of the 17 categories of electronic health data covered by the Regulation for secondary use, and provides step-by-step instructions for creating accurate and interoperable descriptions.

A central part of the guideline is HealthDCAT-AP, the common European model for describing health datasets. Developed under Sciensano’s lead in the European HealthData@EU pilot, HealthDCAT-AP builds on the European Union (EU) metadata model DCAT-AP (Data Catalog Vocabulary – Application Profile) and adds elements specific to health, such as the type of health data, the population it refers to, or the medical standards used. Its aim is to make health datasets more visible, comparable and reusable across Europe.

To support implementation, Sciensano is also developing practical tools such as a HealthDCAT-AP metadata editor, which helps create standardised descriptions, and a literacy platform, which explains how to work with the model. More information and resources are available through the European Health Information Portal.