EU Health Data Space Regulation (EHDS) - Overview on Multi-country data access applications

A researcher is looking for data on the effectiveness of the flu vaccine and wants to conduct an EU-wide analysis. When an applicant requests access to electronic health data only from a single member state, this is called a Data Access Application. When data sets from several data holders across member states are requested, this is called a Multi-Country Data Access Application.

The researcher searches for suitable data sets in the EU dataset catalog, which includes descriptions of data sets from many EU countries. If there are doubts about the contents of a dataset, the data user can seek support from health data access bodies or data holders.

Once the required data sets are identified, the researcher submits a common data access application form. A single application can be submitted through the health data access body of the main establishment of the applicant. The form must include the selected data sets and all required fields.

The application is distributed to relevant health data access bodies. These bodies may contact data users for additional information or clarifications. They can exchange opinions or share information about a permit application.

After assessment, the health data access body notifies the data user of the outcome—positive, negative, or positive with conditions—and provides fee details. They also inform other concerned health data access bodies and participants. Ideally, application status is communicated through automated notifications within three months.

In a multi-country data access application, multiple decision-makers assess access under their jurisdiction. Countries may issue different assessment conclusions. Upon positive decisions, permits are issued, data is gathered, and access is provided in a secure processing environment.