TEHDAS2 invites stakeholders to provide feedback on draft documents that will inform the implementation of the European Health Data Space (EHDS).
The TEHDAS2 joint action has launched a 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 EHDS.
The four guidelines which are now open to comments are key building blocks which will serve as reference for the implementing acts of EHDS for secondary use. Their wide implementation will drastically improve access to quality data for researchers, health authorities and industry. It will thus also contribute to more informed strategies and policies, which will benefit European healthcare professionals and citizens.
Four documents open for feedback
This first TEHDAS2 public consultation focuses on dataset descriptions and data access. Four draft documents are now open for stakeholder feedback.
- Draft guideline for data holders on data description: Modifications to the baseline DCAT-AP specification designed to address the specific needs of health data and provide practical examples to guide metadata records creation. (DCAT-AP relates to catalogues containing datasets and data services' descriptions in Europe.)
- Draft technical specification for a national metadata catalogue: A specification that defines a minimum set of capabilities that Member States need to adopt to achieve interoperability across national dataset catalogues.
- Draft guideline for data users on good application practice for data access and data requests: The guideline provides complementary documentation to the data application form, enabling a clear understanding of what is needed to fill in an application and why.
- 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.
How to participate
The consultation closes on 28 February 2025. Stakeholders are encouraged to review the documents and provide their feedback through dedicated Webropol surveys available for each consultation.
Respondents can choose to offer their opinions on any of the four drafts of guidelines and draft specifications. They can read the questionnaire formats in Word (if they wish) before answering the surveys more formally.
Two main types of respondents are especially encouraged to respond to the consultation: data holders and health data users.
➡️ View the documents and access the public consultation surveys.
What's in it for you
“These four draft guidelines and technical specifications are a first step towards creating a consistent and efficient framework for using health data across Europe”, says Markus Kalliola, Programme Director at Finland's Sitra and TEHDAS2 Coordinator. “We look forward to engaging with stakeholders to refine these documents and address their needs effectively.”
Your feedback will guide the finalisation of the four documents, ensuring that they meet the needs of the public, data holders, users, and regulators.
These efforts will facilitate smooth access to health data and strengthen European collaboration in the efficient use of data. Some documents will contribute to the content of the EHDS’s proposed implementing acts.
By providing such carefully revised guidelines and technical specifications, TEHDAS2 will support the harmonised implementation of the EHDS Regulation. This initiative will advance the secondary use of health data in Europe to improve research, innovation, and policymaking.
TEHDAS2 is a strategic project carried out by 29 European countries which started in 2024 and will end in December 2026. Project partners include main partners nominated by national governments and other public organisations such as hospitals, research centres and universities. TEHDAS2 project advances the cross-border secondary use of health data in Europe to improve research, innovation and policymaking. The project also builds on the work of previous TEHDAS and other European projects. The results of the project will guide health data authorities, data holders as well as data users in fulfilling their future responsibilities under the regulation.
For more information on TEHDAS2, see this article.
