TEHDAS2 launches final consultation round on EHDS secondary use guidance

TEHDAS2 has launched the final consultation phase on seven draft guidance documents designed to support implementation of the European Health Data Space for secondary use of health data across research, policymaking, and innovation.

The Baseline

• TEHDAS2 has launched the third and final public consultation round on seven draft EHDS guidance documents focused on secondary use of health data.
• The guidance addresses operational areas including collaboration frameworks, international data access, data linkage, data enrichment, citizen transparency obligations, and research outcome handling.
• The consultation reflects the move from EHDS policy development toward practical implementation, with growing attention on governance consistency, interoperability, and public trust across Member States.

Stakeholders across Europe are being invited to provide feedback on seven draft guidance documents intended to support implementation of the European Health Data Space (EHDS) framework for the secondary use of health data. The consultation, launched under TEHDAS2 (the second Joint Action Towards the European Health Data Space), will remain open until June 28, 2026. The initiative seeks input from public authorities, health data access bodies (HDABs), researchers, data users, data holders, industry stakeholders, and members of the public before the guidance documents are finalized.

Formally adopted under Regulation (EU) 2025/327 in January 2025, the EHDS represents one of the EU’s most significant digital health initiatives to date. The regulation aims to establish a harmonized framework for the use and exchange of electronic health data across Member States, supporting both primary and secondary uses of health data. More broadly, the EHDS reflects an attempt to reshape how healthcare evidence is generated, accessed, and applied across Europe, spanning regulatory decision-making, health technology assessment (HTA), public health, and reimbursement.

TEHDAS2 supports this implementation process by helping Member States prepare governance structures, operational processes, and technical infrastructure, while also developing guidance and technical specifications for HDABs, data holders, and data users. The current consultation focuses specifically on secondary use of health data, including research, innovation, policymaking, regulatory activities, and public health analysis. It represents the third and final phase of public engagement following earlier consultation rounds in 2025.

Partial application of the EHDS is expected from March 2029, with full application beginning in March 2031. Following implementation, the regulation could help move Europe from a fragmented landscape of national health data systems toward a more connected evidence infrastructure capable of supporting large-scale real-world research, innovation, and cross-border analysis. The initiative also reflects wider European ambitions around data-driven healthcare and aligns with the European Medicines Agency’s “Clinical Evidence 2030” vision.

Guidelines overview

The seven draft guidelines address practical and organizational questions that are expected to emerge during EHDS implementation. Although non-binding, the documents are intended to support a more consistent interpretation of responsibilities and operational practices across Member States. These include:

Draft guideline on a framework for collaboration

Focused on governance and coordination across the EHDS ecosystem, this two-part guideline examines ethical oversight, intellectual property protections, and collaboration models involving research infrastructures and networks. Drawing on stakeholder engagement, it aims to support sustainable approaches to cooperation and operational implementation across Member States.

“…the two parts aim to provide a grounded and actionable basis for the development of collaboration approaches. They reflect the operational realities of EHDS implementation and the diversity of actors whose engagement will be essential to the framework's long-term success.”

Draft guideline for health data access bodies on international and third country access and transfer of electronic health data

Addressing international access to electronic health data, this document clarifies how EHDS provisions interact with GDPR and the Data Governance Act. It examines reciprocity arrangements, third-country participation in HealthData@EU, and safeguards such as secure processing environments (SPEs) intended to protect sensitive health data during international access and transfer activities.

“…the document formulates practical recommendations for Health Data Access Bodies (HDABs) aimed at ensuring a consistent, secure, and transparent approach to international data access, while facilitating responsible global research collaboration and maintaining a high level of protection for EU citizens’ health data within the EHDS framework.”

Draft guideline for data enrichment

Focused on increasing the analytical value of datasets, the data enrichment guideline describes how authorized users within SPEs may add new detail, context, or interpretive value to health data during secondary use. The document distinguishes between internal and external enrichment approaches and explains how enrichment may improve dataset completeness, accuracy, and clarity. It also emphasizes that enrichment remains an optional, user-driven activity under the EHDS, leaving flexibility for national implementation approaches.

“This guideline therefore does not seek to impose obligations, but to illustrate possible approaches and promote a shared understanding across the EHDS ecosystem. Data enrichment is an optional, user-driven activity. Any practices described in this guide are non-binding and subject to national implementation choices.”

Draft guideline for data users navigating the catalogue

Designed to support cross-border dataset discovery, this guideline explains how users can navigate the HealthData@EU EU Dataset Catalogue using search functions, metadata standards, and interoperability information. It also introduces “basket” functionality to help users compare and shortlist datasets before initiating formal data access applications.

“The document focuses specifically on the pre-authentication workflow, delineating a systematic user journey for identifying and evaluating datasets prior to formal login. Central to this infrastructure is the use of standardized metadata compliant with the HealthDCAT-AP model, which ensures interoperability and comparability across the federated network of national catalogues.”

Draft guideline on the linkage of health datasets

Providing operational and legal support for dataset linkage activities, this guideline outlines linkage methods, governance responsibilities, validation procedures, and quality assessment processes. It also includes practical annexes covering AI development scenarios, trusted third parties, and technical examples intended to support implementation across different linkage environments.

“This guideline aims at providing practical and legal support for Health Data Access Bodies (HDABs) on linkage of health datasets. It helps answering several questions of data linkage in the EHDS: Why, when and by whom can data be linked within the EHDS? What data are being linked? How is data linked? How is quality and accuracy of linked datasets ensured?”

Draft guideline for health data access bodies on informing natural persons about the use of health data – “Citizen Information Point”

Focused on transparency obligations under the EHDS, this guideline introduces the concept of a “Citizen Information Point” for informing individuals about secondary use of health data. It covers opt-out rights, publication of access decisions, communication requirements, and accessibility considerations intended to strengthen public awareness and trust.

“This guideline serves as operational guidance for HDABs describing all information obligations of HDABs towards natural persons regarding secondary use of electronic health data. In doing so, it ensures alignment with the EHDS regulation.”

Draft guideline for data users on handling research outcomes

Examining responsibilities associated with research outcomes, this guidance addresses reporting, dissemination, reuse, anonymization, and accountability requirements linked to secondary use of electronic health data. It also distinguishes between use of EHDS-accessed data and the subsequent use of knowledge generated from those data under the EHDS framework.

“By using this guidance, secondary data users will be better equipped to comply with their legal obligations under the EHDS when generating, disseminating, reporting, and reusing outcomes. The guidance contributes to legal certainty, consistent interpretation of outcome-related duties, and responsible innovation within the EHDS.”