TEHDAS2 has published ten guidelines and technical specifications to support the practical implementation of the European Health Data Space (EHDS) across Member States.
The documents address key aspects of the secondary use of health data, including fees and penalties, data access procedures, data protection, secure IT systems, citizens’ rights, and the responsibilities of health data access bodies and health data holders. Together, they provide practical guidance for organisations preparing for the implementation of the EHDS and its provisions on the reuse of health data.
The newly published documents are:
- D4.1 Guideline for health data access bodies on fees and penalties for non-compliance related to the EHDS regulation
- D5.2 Guideline for health data access bodies on minimum categories and limitations on the reuse of health data
- D6.1 Guideline for health data holders on making personal and non-personal electronic health data available for reuse
- D6.3 Guideline for health data access bodies on the procedures and formats for data access
- D6.4 Data Access Application Management System (DAAMS) – Technical specification for health data access bodies
- D7.2 Guideline for health data access bodies on data minimisation, pseudonymisation, anonymisation and synthetic data
- D7.3 Technical specification for health data access bodies on the implementation of the common IT infrastructure
- D7.4 Technical specification for health data access bodies on the implementation of secure processing environments
- D8.1 Guideline for health data access bodies on implementing opt-out from the secondary use of health data
- D8.2 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
The new and previously published TEHDAS2 guidelines can be explored on the results page of TEHDAS2 website.
Save the date: TEHDAS2 Final Conference
The TEHDAS2 Final Conference, “Shaping the EHDS together – from guidelines to implementation”, will take place on 16 November 2026 in Brussels. The event will bring together policymakers, experts and stakeholders from across Europe to reflect on the project’s results and discuss the next steps in the implementation of the EHDS.