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Public consultations

TEHDAS2 is developing guidelines and technical specifications to enable seamless use of health data across Europe under the upcoming European Health Data Space (EHDS). Each product is released for a 30-day public consultation to ensure that the final outputs meet the needs of citizens, health professionals and regulators.

First public consultation

20 JAN 2025 – 28 FEB 2025
TOPIC: Data discovery and dataset description

Thank you to everyone who participated in the first public consultation. We will carefully review all feedback received. The final versions of the documents will be published in fall 2025. You can view the draft documents that were consulted on below.

Read more about the outcomes of the public consultation and what’s next.

1. DRAFT GUIDELINE FOR DATA HOLDERS ON DATA DESCRIPTION (Click to view more details)

TEHDAS2 sought feedback on its draft guideline for HealthDCAT-AP, a metadata standard supporting the EHDS. This guideline aims to help health data holders comply with EHDS metadata description requirements, enhancing the discoverability, sharing and accessibility of health data across the EU.

The document outlines modifications to the baseline DCAT-AP specification to address the specific needs of health data and provides practical examples to guide metadata records creation.

Stakeholders, including health data holders and users, were invited to share their views on the usability of this standard for describing datasets within the EHDS framework.

Read the full report
Access high-resolution versions of Figure 1 and Figure 2 here below:
Figure 1
Figure 2

High-quality metadata powers FAIR principles, making health data discoverable, accessible, interoperable and reusable for responsible sharing as well as research, innovation and policymaking.

Nienke Schutte, PhD, Sciensano
2. DRAFT TECHNICAL SPECIFICATION ON THE NATIONAL METADATA CATALOGUE (Click to view more details)

TEHDAS2 sought feedback on its draft technical specification for a national health dataset catalogue that supports the EHDS. The specification defines a minimum set of capabilities member states need to adopt to achieve interoperability across national dataset catalogues.

The specification focuses on metadata input, management, export and access, ensuring a user-friendly system while meeting EU-level requirements and allowing national adaptability.

Stakeholders, including health data holders, health data users and health data access bodies, were invited to share their views on this specification to ensure it addresses key challenges in achieving interoperability and a unified EHDS.

Read the full the report

This technical specification outlines the key features of a minimum viable product (MVP) for a national metadata catalogue within national health data access bodies, in accordance with the EHDS regulation. This task is essential for ensuring interoperability between national and European health data catalogues.

Ann Gustaffson, Swedish eHealth Agency
3. DRAFT GUIDELINE FOR DATA USERS ON GOOD APPLICATION PRACTICE FOR DATA ACCESS AND REQUESTS (Click to view more details)

TEHDAS2 sought input on its draft guideline for data users navigating the application process for accessing or requesting health data under the EHDS regulation. This guideline offers step-by-step instructions for identifying datasets, meeting regulatory requirements and adhering to access and usage conditions.

Designed for a wide range of users, including researchers, public authorities and private entities, the guideline aims to provide complementary document to the data application form, enabling clear understanding of what is needed to fill in the application and why. Data applicants will be able to work with the application form easily when reading the guidelines before stepping into the form itself. This will streamline the cross-border secondary use of health data, enhancing compliance and efficiency.

Stakeholders, including health data users, were invited to share their views on the content of this guideline to ensure it meets their needs.

Read the full report

The guideline helps the data applicant to become a data user and serves as an overarching introduction to the EHDS regulation from their perspective.The complexity of the data access application appears lower with the guideline document.

Zdenka Dudová, PhD, Masaryk University Brno
4. DRAFT GUIDELINE FOR DATA USERS ON HOW TO USE DATA IN A SECURE PROCESSING ENVIRONMENT (Click to view more details)

TEHDAS2 sought feedback on its draft guideline for data users working with health data in a Secure Processing Environment (SPE) under the EHDS. The guideline aims at providing practical steps for choosing an SPE, accessing datasets in an SPE, conducting analyses and exporting results from the SPE, while safeguarding privacy and complying with EHDS standards. It also highlights best practices for secure and lawful secondary data use.

Stakeholders, including data users, were invited to share their views on the guideline to ensure it supports their needs.

Read the full report

The aim of this guideline is to provide support for data users before requesting access to health data in an SPE and/or after receiving an approved permit. Therefore, feedback regarding user-friendliness and the level of support from this guideline for the user is very valuable input.

Pia Brinkmann, The German Federal Institute for Drugs and Medical Devices

Upcoming public consultations 

SEP-OCT 2025
TOPIC: Processes to manage permits or data pseudonymisation 

Documents scheduled for public consultation (Click to view)

1. Draft guideline for Health Data Access Bodies on fees and penalties for non-compliance regulated 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. Draft technical specification for Health Data Access Bodies on data minimisation and de-identification  

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

MAY-JUN 2026
TOPIC: Collaboration with third countries, data enrichment and informing citizens 

Documents scheduled for public consultation (Click to view)

1. Draft guideline for Health Data Access Bodies on collaboration with other parties 

2. Draft guideline for Health Data Access Bodies on international and third country access and transfer of electronic health data

3. Draft guideline for Health Data Access Bodies on enrichment of health datasets 

4. Draft guideline for Health Data Access Bodies on linkage of health datasets

5. Draft guideline for Health Data Access Bodies on informing natural persons about the use of health data – “Citizen Information Point” 

6. Draft guideline for data users on handling research outcomes

FAQs

Q1: Why are the documents open for public consultation? 

A1: Our aim is to ensure that the documents meet the needs of all stakeholders (e.g. citizens, health professionals, authorities and regulators). You can have your say by sharing your feedback, views and experiences related to the document topics. Your feedback is very valuable and will be carefully reviewed and considered by the document authors as they refine the documents.

Q2: Can I submit feedback on more than one document? 

A2: Yes, you are welcome to fill in all four public consultation surveys.

Q3: If I cannot answer every question in the survey, is it possible to skip some questions?

A3: A3: Questions marked with an asterisk (*) are mandatory and cannot be skipped entirely. However, they include a “Not applicable” option, which you can select if the question does not apply to you.

Q4: I represent more than one stakeholder (e.g. a health data user and a health data holder). In the survey I can only choose one of these options. How should I proceed? 

A4: Please choose one of the stakeholders you are representing and fill in the survey from that perspective. You are warmly welcome to fill in the survey more than once, if you wish to provide feedback from different stakeholders’ perspectives. We appreciate your contribution.

Q5: Can I submit feedback in Word or PDF format? 

A5: No, unfortunately it is not possible. We only accept feedback through the survey. It is not possible to add attachments to the survey form. However, in the open text fields, you can include links to external documents/articles/statements e.g. on your organisation’s website, if you have any.  

For questions, please contact tehdascoordination@sitra.fi.