Public consultation opens on guidelines for harmonising health data use in Europe
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 30-day public consultation on four 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.
Four documents open for feedback
This first public consultation of the project focuses on data discovery and dataset description, with the following documents now open for feedback.
- Draft guideline for data holders on data description
This document introduces HealthDCAT-AP, a metadata standard for describing datasets under the EHDS, to improve the discoverability, accessibility and sharing of datasets across EU member states. Practical examples are included to assist health data holders in creating metadata records that meet the EHDS requirements.
- Draft technical specification for a national metadata catalogue
This specification outlines the key features of a minimum viable product (MVP) that ensures interoperability between national and European health data catalogues. It covers the topics of how dataset descriptions are submitted, managed, shared and accessed, ensuring compliance with EU standards while allowing flexibility for national needs.
- Draft guideline for data users on good application practice for data access and data requests
This guideline offers a detailed overview of the steps for applying to access health data under the EHDS Regulation, helping data users understand the application process, regulatory requirements and conditions for data use.
- Draft guideline for data users on how to use data in a secure processing environment
This document outlines steps for securely accessing and using health data in a secure processing environment (SPE). It includes best practices for protecting privacy and ensuring compliance with EHDS standards.
“These four draft guidelines and technical specifications are a first step towards creating a consistent and efficient framework for using health data across Europe,” said Markus Kalliola, Programme Director at Sitra and TEHDAS2 Coordinator. “We look forward to engaging with stakeholders to refine these documents and address their needs effectively.”
How to participate
The consultation is open until 28 February 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.
From input to impact
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.
Upcoming consultations
Future consultations will cover additional topics, including data pseudonymisation, permit management and collaboration with third countries. For more details, visit the Public consultations page on tehdas.eu.
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