Public consultations
The 20 guidelines and technical specifications developed in TEHDAS2 will be presented in three separate 30-day public consultation waves, each featuring different documents. The feedback, gathered through surveys, will be analysed to finalise the documents.
Public consultation schedule
Wave 1: Jan – Feb 2025 (dates to be announced)
Topic: Data discovery and dataset description
Documents scheduled for public consultation:
1. Guideline for data holders on data description
This guideline outlines a set of requirements for data description to assist data holders in fulfilling their obligations under the European Health Data Space (EHDS).
2. Technical specification for Health Data Access Bodies (HDABs) on the national metadata catalogue
This technical specification contains guidelines for HDABs concerning the national metadata catalogue, including its maintenance and technical coordination.
3. Guideline for data users on good application and access practice
This guideline guides data users regarding the requirements and obligations during the application process for data access.
4. Guideline for data users on how to use data in a secure processing environment
This guideline outlines for data users on how to fulfil duties regarding processing of electronic health data in a secure processing environment (SPE).
Wave 2: Sep – Oct 2025 (dates to be announced)
Topic: Processes to manage permits or data pseudonymisation
Documents scheduled for public consultation:
1. Guideline for Health Data Access Bodies on fees and penalties for non-compliance regulated to the EHDS regulation
2. Guideline for Health Data Access Bodies on minimum categories and limitations on the reuse of health data
3. Guideline for data holders on making personal and non-personal electronic health data available for reuse
4. Guideline for Health Data Access Bodies on the procedures and formats for data access
5. Technical specification for Health Data Access Bodies on data minimisation and de-identification
6. Technical specification for Health Data Access Bodies on the implementation of the common IT infrastructure
7. Guideline for Health Data Access Bodies on linkage of health datasets
8. Guideline for Health Data Access Bodies on obligations towards natural persons
9. Guideline for Health Data Access Bodies on data altruism in health
Wave 3: May – Jun 2026 (dates to be announced)
Topic: Collaboration with third countries, data enrichment and informing citizens
DOCUMENTS scheduled FOR PUBLIC CONSULTATION:
1. Guideline for Health Data Access Bodies on collaboration with other parties
2. Guideline for Health Data Access Bodies on international and third country access and transfer of electronic health data
3. Guideline for Health Data Access Bodies on enrichment of health datasets
4. Data Access Application Management System (DAAMS) – Technical specification for health data access bodies
5. Technical specification for Health Data Access Bodies on the implementation of secure processing environments
6. Guideline for Health Data Access Bodies on informing natural persons about the use of health data – “Citizen Information Point”
7. Guideline for data users on handling research outcomes
