TEHDAS2 invites stakeholders to provide feedback on draft documents that will inform the implementation of the European Health Data Space (EHDS).
TEHDAS2 joint action has launched a 60-day public consultation on eleven draft guidelines and technical specifications designed to support the effective secondary use of health data across Europe as part of the European Health Data Space (EHDS).
This consultation aims to ensure that the final outputs broadly benefit stakeholders, including citizens, health professionals, authorities and regulators.
Eleven documents open for feedback
This second public consultation of the project focuses on fees, penalties, data access, data protection, secure IT systems and citizens’ rights, with the following documents now open for feedback.
1. Draft guideline for health data access bodies on fees related to the EHDS regulation
2. Draft guideline for health data access bodies on penalties for non-compliance related to the EHDS regulation
3. Draft guideline for health data access bodies on minimum categories and limitations on the reuse of health data
4. Draft guideline for data holders on making personal and non-personal electronic health data available for reuse
5. Draft guideline for health data access bodies on the procedures and formats for data access
6. Draft data access application management system (DAAMS) – Draft technical specification for health data access bodies
7. Draft guideline for health data access bodies on data minimization, pseudonymization, anonymization and synthetic data
8. Draft technical specification for health data access bodies on the implementation of the common IT infrastructure
9. Draft technical specification for health data access bodies on the implementation of secure processing environments
10. Draft guideline for health data access bodies on implementing opt-out from the secondary use of health data
11. Draft guideline for health data access bodies on implementing the obligation of notifying the natural person on a significant finding from the secondary use of health data
How to participate
The consultation closes on 30 November 2025. Stakeholders are encouraged to review the documents and provide their feedback through dedicated Webropol surveys available for each consultation.
View the documents and access the public consultation surveys.
Stakeholder feedback shapes the future of health data
Feedback from the consultation will guide the finalisation of these documents, ensuring they meet the needs of the public, data holders, users and regulators.
By providing guidelines and technical specifications, TEHDAS2 will support the harmonised implementation of the EHDS regulation, advancing the secondary use of health data in Europe to improve research, innovation and policymaking.
These efforts will facilitate smooth access to health data and strengthen European collaboration in using data efficiently, with some documents also contributing to the regulation’s implementing acts.