The second public consultation is now open for the first set of guidelines towards the harmonization of secondary use of health data in the European Union: Your opinion matters!  

In the continuation of the Joint Action TEHDAS –Second Joint Action Towards the European Health Data Space, the second wave of guidelines and technical specifications aimed at guiding the future implementing acts of the European Health Data Space (EHDS) is now available for public consultation.

This consultation will be live for 2 months, to ensure that the guidelines and specifications meet the needs of citizens, healthcare professionals, researchers and policymakers.

The first version of 10 guidelines is now publicly available for comments: 

1. Draft guideline for Health Data Access Bodies on fees and penalties for non-compliance related to the EHDS regulation 
2. Draft guideline for Health Data Access Bodies on minimum categories and limitations on the reuse of health data 
3. Draft guideline for data holders on making personal and non-personal electronic health data available for reuse 
4. Draft guideline for Health Data Access Bodies on the procedures and formats for data access  
5. Data Access Application Management System (DAAMS) – Draft technical specification for health data access bodies
6. Guideline for Health Data Access Bodies on data minimisation, pseudonymisation, anonymisation and synthetic data  
7. Draft technical specification for Health Data Access Bodies on the implementation of the common IT infrastructure
8. Draft technical specification for Health Data Access Bodies on the implementation of secure processing environments 
9. Draft guideline for Health Data Access Bodies on implementing opt-out from the secondary use of health data
10. 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

Both these guidelines and the survey for submitting feedback are available  https://tehdas.eu/public-consultations/.

Feedback is critical for the implementation of an EHDS that satisfies the needs of the different stakeholders. Contributions will be collected until November 30th.

Your opinion is key to creating an EHDS for all!

Disclaimer: The TEHDAS2 joint action is co-funded by the European Union, EU4Health Program 2021-2027 (Grant Agreement nº 101176773). The views and opinions expressed are those of the author(s) and do not necessarily reflect the position of the European Union or HaDEA. Neither the European Union nor the grant-awarding authority can be held responsible for these opinions.