MedTech Europe responded to the final Towards the European Health Data Space 2 (TEHDAS2) consultation
Posted on 02.07.2026
The final public consultation under the Joint Action “Towards the European Health Data Space 2” (TEHDAS2) closed on 28 June 2026. This marks an important milestone in shaping how the European Health Data Space (EHDS) will be implemented in practice, including how companies access, use, link, and share health data across Europe.
The EHDS is expected to open new possibilities for the use of health data for research, innovation, evidence generation, and regulatory purposes. At the same time, it will introduce new responsibilities for health data users and holders. The TEHDAS2 Joint Action aims to support a practical and workable implementation of the EHDS by developing non‑legally binding guidelines that lay the groundwork for a harmonised approach across Member States by the end of 2026.
The third round of public consultations focused on seven draft guidelines covering key operational aspects of the EHDS:
- Framework for collaboration
- International and third‑country access and transfer of electronic health data
- Data enrichment
- Data users navigating the catalogue
- Linkage of health datasets
- Informing natural persons about the use of health data (“Citizen Information Point”)
- Data users’ handling of research outcomes
In its response, MedTech Europe reaffirmed its strong support for the EHDS objective of enabling better use of health data in Europe. At the same time, it stressed that successful implementation will depend on whether the framework works for industry in practice. This includes clear and proportionate procedures, realistic timelines, effective protection of intellectual property and trade secrets, and consistent interpretation and application across Member States.
MedTech Europe has supported the TEHDAS2 Joint Action throughout its duration, contributing to earlier public consultations (results here), participating as a member of the TEHDAS2 Advisory Board, and engaging in the April 2026 stakeholder forum, which focused on the interaction between the EHDS and the AI Act.
What comes next
The 21 guidelines and technical specifications developed under TEHDAS2 will serve as an important reference for the implementation of the EHDS. They are expected to guide Health Data Access Bodies, health data holders, and data users in fulfilling their future responsibilities under the EHDS Regulation. For companies, this guidance will influence governance, data access strategies, compliance processes, and interactions with national authorities, making harmonised implementation critical to the success of the EHDS.
The TEHDAS2 Joint Action will conclude with its final conference on 16 November 2026, held in Brussels and online, bringing together policymakers, experts, and key stakeholders to reflect on the project’s achievements and discuss next steps for EHDS implementation.
For more information, please contact Verena Thaler, Senior Expert Digital Health.