TEHDAS2 releases a guideline to help researchers apply for health data under EHDS
TEHDAS2 has published a practical new guideline to support data users preparing to access electronic health data for secondary use in the European Health Data Space (EHDS).
The document provides clear, step-by-step instructions on how to submit high-quality applications through the HealthData@EU infrastructure.
The guideline targets applicants such as researchers, public health authorities, healthcare innovators and other professionals aiming to use health data for research, innovation, policy or education. It explains how to choose between the two available access paths (data access application vs. data request), how to complete the application form and what to expect in terms of timelines, fees and responsibilities.
“We wanted to empower applicants to navigate the EHDS process with confidence. A well-understood application path leads to a well-prepared application, which speeds up processing and strengthens trust of applicants in the Health Data Access Bodies and the whole HealthData@EU infrastructure,” said Zdenka Dudová of Masaryk University, Czech Republic, the lead of the authors’ working group for the guideline.
The document also clarifies which data can be accessed, how to justify the use of pseudonymised data and how to request access to datasets across multiple countries. Common mistakes are addressed and illustrative examples are provided throughout.
“This guideline reflects the real-world challenges that applicants face and offers concrete help, not just theory,” added Pinar Alper of the Luxembourg National Data Service, co-author of the deliverable.
This publication forms part of TEHDAS2’s broader efforts to ensure a smooth and harmonised implementation of the EHDS regulation. It complements technical specifications, guidance on secure data environments and user obligations during data use.
Download document: Guideline for data users on good application and access practice
A summary of the comments received during the public consultation and how they were addressed is available in the annex.
View published TEHDAS2 results
Key recommendations stemming from the work
For health data applicants
- Ask for the least sensitive data that can answer your question.
- Be precise, as vague requests may be delayed or refused.
- Clearly link your project to an EHDS-permitted purpose and explain the expected public, scientific or health system benefit.
- Plan for secure processing environment constraints, costs and timelines early.
- Cooperate with HDABs if clarification is needed, respect permit conditions, publish results within the required timelines, and request amendments before changing the scope, data or methods.
- Acknowledge EHDS data sources, document your work and be prepared for scrutiny, as transparency helps maintain future access for everyone.
Share away!