The European Joint Action TEHDAS2 has prepared the first draft guidelines for working with health data for public consultation

The European project TEHDAS2 has launched a public consultation on the first four draft guidelines and technical specifications, focusing on harmonizing and processing health data for secondary used processing health data for so-called secondary use. These documents will facilitate the implementation of the Regulation on the European Healthimplementation DS) in terms of using health data for further purposes such as diagnostics and patient treatment, for example, in scientific research, educational, and training activities.

20 Feb 2025 Lucie Skřičková

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EHDS is a major initiative of the European Union aimed at sharing electronic health data for healthcare service provision and making health data available for various other purposes, such as scientific research, including innovation development, education, and health policy - making. EHDS will provide the scientific community with secure and reliable access to electronic health data, respecting data protection (GDPR), intellectual property rights, and trade secrets. This is crucial for gaining the trust of individuals and other stakeholders in a new system that facilitates research, supports innovation, and contributes to improving healthcare quality.

The ongoing first round of public consultations on documents developed within the TEHDAS2 project— which involves 29 European countries— focuses on the description of datasets, interoperability of catalogs, and secure access to data.

Among these documents is also the Draft Guideline for Data Users on Good Application Practice for Data Access and Requests, which was prepared under the leadership of Zdenka Dudová from Masaryk University, head of the Sensitive Data working group of EOSC CZ, in collaboration with an international team. This document describes the process of requesting access to health data and the regulatory requirements that applicants must meet.

These draft documents were presented at the European Health Data & Innovation Summit in January 2025 in Warsaw, where Zdenka Dudová was also actively involved. Information regarding the public consultation on these drafts is available on the TEHDAS2 project website.

The public can submit feedback and suggestions for modifications until February 28, 2025. The final outputs will then be further processed by the European Commission and gradually put into practice. The TEHDAS2 outputs will thus help define the future framework for the use of health data in Europe.

Mgr. Zdenka Dudová, Ph.D.


works at the Institute of Computer Science at Masaryk University (MUNI). She leads a team responsible for IT and data infrastructure of the national BBMRI.cz node and contributes to developing an international platform for federated sample and associated data search within BBMRI-ERIC. She applies her expertise in sensitive data management in consortium projects focused on the secondary use of patient data (EDIReX, EHDS2 Pilot, TEHDAS2). She also significantly contributes to developing this field within EOSC CZ, where she leads the Sensitive Data working group.


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