TEHDAS2 is developing guidelines and technical specifications to enable seamless use of health data across Europe under the upcoming European Health Data Space (EHDS). Join Understanding Patient Data to share your views, and ensure that the final outputs meet the needs of citizens, health professionals and regulators.
The European Health Data Space (EHDS)
The European Health Data Space (EHDS) Regulation – an EU regulation on the use and exchange of health data – entered into force earlier this year.
The Regulation as a whole covers individuals’ rights to their digital health data and how it can be shared for direct care, the arrangements for improved sharing of health data for secondary uses (such as research and innovation), and conformity assessment for electronic health record systems.
The EHDS sets out the framework and mechanisms for accessing and using health data from EU organisations for secondary purposes, such as policy development, research, and innovation. It will be highly relevant to anyone engaged in collaborative projects with EU-based colleagues or institutions, or who relies on EU health data to support their work.
The EHDS will require EU Member States to implement several policies and structures already in place in England, and colleagues across the channel may look to England for examples of best practice and to understand lessons from our experience as they develop guidelines and technical specifications.
Check out our report 'Sharing Health Data - Lessons for the UK from the European Health Data Space', detailing the attitudes of UK respondents from of a consultation of citizens in the UK, France and Belgium with regards to the future use of their data within the European Health Data Space. This piece of work was shaped ahead of TEHDAS2, when the UK was still formally part of the EU, and was therefore formally involved in TEHDAS1.
What is TEHDAS2?
TEHDAS2 (Towards the European Health Data Space) is a collaborative initiative involving 30 European countries. Its purpose is to develop the practical tools – such as guidelines and technical specifications – needed to implement Chapter IV of the EHDS Regulation.
Chapter IV introduces a new legal framework to enable the secure and lawful secondary use of health data across EU borders. This means using health data not just for individual care, but for broader purposes like scientific research, healthcare innovation, and evidence-based policymaking.
By harmonizing how health data is accessed and used across member states, TEHDAS2 aims to reduce fragmentation and support both national-level efforts and the European Commission’s legislative work. The result will be a more integrated and efficient health data ecosystem across Europe.
By enabling smooth, trustworthy access to health data, TEHDAS2 enhances public health and strengthens Europe’s competitiveness in health research.
International stakeholders are invited to contribute through public consultations, and the initiative builds on previous projects like TEHDAS and the HealthData@EU Pilot.
Find out more about TEHDAS2 here.
UK context and engagement
It is essential that the UK health research community understands the implications of the EHDS for their activities - particularly how to access EU health data, contribute perspectives, and potentially influence the EHDS as it evolves.
The Health Data Research Service will be the key UK infrastructure for enabling the use of patient data to supercharge research. To support more impactful and globally relevant research, we expect HDRS to welcome users internationally as well as across the UK; access for international users will always be in line with UK policy on international data sharing. We want to work alongside trusted international partners and the EHDS to develop common standards that ensure data protection and patient benefit remain the top priorities across all research.
Formal third-country participation in the EHDS will not be possible until 2035 at the earliest, and any decision on UK accession will rest with the UK government at that time. Nonetheless, given the emphasis on reciprocity and interoperability, we are closely monitoring the development of the EHDS and exploring opportunities for constructive engagement.
Who are Understanding Patient Data and what is their role?
Understanding Patient Data promotes transparency and trust in how health data is used beyond individual care. It explains the value and controversy of secondary data use, informs the public, and ensures patient perspectives shape policy and practice, supporting ethical, effective data use for research, planning, and innovation. Find out more about Understanding Patient Data here.
Understanding Patient Data will be acting as an independent convenor, facilitating engagement and bringing together experts from across the UK health data space to feed into TEHDAS 2 consultations over the coming months, funded by the Wellcome Trust.
If you are interested in taking part in engagement sessions, please register your interest here.
Live consultations
Current consultation documents focus on guidelines and technical specifications for health data access under the EHDS regulation. Topics include fees, penalties, data reuse limits, access procedures, data protection, IT infrastructure, secure environments, opt-out mechanisms, and obligations to notify individuals of significant findings from secondary health data use.
Each document is released for a public consultation to ensure that the final outputs meet the needs of citizens, health professionals and regulators.
The current consultation is live and closes on 30 November 2025.
Find out more about the current consultation here.
Priority questions to consider within the current consultation
High priority
Reuse limitations:
- Do TEHDAS’s proposed categories of “permitted purposes” reflect UK research and innovation uses?
- Any areas where UK access models (e.g. via TREs) could face barriers?
Making data available for reuse / reciprocity:
- Would UK data-holders be able to meet these expectations if reciprocity were required?
- What technical or governance challenges would that raise?
Medium priority
Procedures and formats for data access:
- How far do UK processes already align with the proposed EHDS templates?
- Any risks of duplication or conflict?
Pseudonymisation / synthetic data:
- Are TEHDAS definitions compatible with UK law and practice (ICO, DARS, TREs)?
- Could UK experience inform EU guidance here?
Secure Processing Environments:
- Does the UK TRE model meet or exceed the draft SPE specifications?
- Is there scope for mutual recognition or interoperability?
Upcoming consultations
The next consultation will be live in 2026, and we expect it to seek feedback on guidelines covering collaboration, international data sharing, dataset enrichment and linkage, citizen information, and responsible handling of health research outcomes.
Find out more about the upcoming consultation here.