This TEHDAS2 expert guideline supports the implementation of the European Health Data Space (EHDS).The European Health Data Space (EHDS) Regulation aims to harmonise and facilitate the cross-border secondary use of electronic health data. A key component is the common data access and request form, ensuring a common application procedure. Guidelines are developed to inform decision-making and aligned practices across member states, ensuring consistent, secure handling of electronic health data in compliance with EU regulations. This guideline, based on the EHDS2 pilot project and its preliminary implementation in Release 3 of the EU central platform, provides practical, step-by-step instructions for applicants on the data access step of the user journey. It covers: selecting the appropriate application pathway (data access vs. data request); check list for preparing necessary documents and information; introduction to the application process and the application form; meeting obligations under the EHDS regulation; understanding timelines, expectations and the role of HDABs during the application process. By following this guideline, applicants will: increase their chances of successful application by providing thorough, accurate information; facilitate faster and more efficient reviews by HDABs, reducing the time to obtain the data permit; ensure compliance with applicable regulations, including the EHDS regulation and the General Data Protection Regulation (GDPR).
Dudová et al. (Tue,) studied this question.