European Health Dataspace Regulation - Paving the European Health Union: Xt-EHR for Primary use of Health Data

Lecturer: Christos Schizas

The Extended Electronic Health Record (Xt-EHR) Joint Action supports the Commission’s policy priority for “A Europe fit for the digital age” by implementing the EU4Health Programme’s general objective of “strengthening health systems”. This project enhances the cooperation among Member States (MS) regarding the content and functionality of EHR, the interoperability and the exchange of healthcare data, contribute to the preparation of the foundations for the improved primary use of electronic health data, the most recently voted new regulation for the European Health Data Space (EHDS), and empower individuals to control their health data.

More specifically, the Xt-EHR activities since November of 2023 are effectively performing common actions across MS as above-mentioned for:

• The adoption of the EEHRxF common requirements and specifications on interoperability and health information.
• Evaluate telemedicine, mobile health, and other health software in the context of the EEHRxF and the EHDS Regulation proposal.
• Evaluate common EHR requirements for electronic identification for health professionals and patients, and the necessary metadata layer needed.
• Evaluate the sustainability of cross-border telemedicine services, including telemonitoring.
• Prepare a guideline and interoperability requirements for mobile wellness applications and provide a respective conformity assessment and or labelling scheme.
• Provide a conformity assessment scheme for the certification of EHRs under the EHDS regulation.

The Xt-EHR Joint Action is preparing implementation guides, technical specifications, and a conformity assessment framework for the adoption of the European Electronic Health Record Exchange Format (EEHRxF), at a European Level. Through Xt-EHR, the content and functionality, the interoperability and cross-border exchange of different types of health data are promoted by proposing the necessary implementation guidelines for the implementation of new services that will complement the MyHealth@EU initiative.

Learning from the Past, Building the Future

Lecturer: Markus Kalliola

The European Health Data Space aims to transform the use of health data across the EU, enabling better research, innovation, and policy-making. This session will examine the evolution of EHDS from its initial ideation to current implementation efforts, highlighting key initiatives like TEHDAS2 and the Nordic VALO project. It will address challenges in interoperability, governance, and regulatory alignment while showcasing successful strategies for collaboration among member states. The discussion will provide insights into the future direction of EHDS and how it can unlock new opportunities for healthcare and digital transformation in Europe.

Critical role of Ukraine’s Electronic Health System as a foundation for healthcare resilience during wartime

Lecturer: Inna Onyshchenko

Even under the most extreme conditions — including full-scale invasion, mass displacement of civilians, and systematic attacks on healthcare infrastructure — Ukraine has managed to maintain the functioning of its health system by relying on a robust digital backbone: the national Electronic Health System. With over 35 million patient records and more than 400,000 connected healthcare professionals, the system ensures secure medical data exchange, supports continuity of healthcare services, and enables real-time coordination across all regions of the country.

What began as part of a healthcare reform agenda before the pandemic has evolved into a nationwide system ensuring interoperability and efficiency under extreme conditions. Ukraine’s experience demonstrates how public digital infrastructure — when built with flexibility, national stewardship, and long-term vision — can sustain essential services even in crisis.

This presentation offers a powerful case study on how public sector digital transformation, driven by urgency, innovation, and determination, can operate under fire—and inspire international partnerships for the future of health data exchange in Europe.

PANEL: European Health Data Space in 10 years - Look into the Future

Moderator: Dmitry Etin
Panelists: Christos Schizas, Inna Onyshchenko, Louisa Stuwe, Markus Kalliola

Following their individual presentations, Prof. Cristos Schizas (Xt-EHR), Markus Kalliola (TEHDAS2), and Inna Onyshchenko (Ukrainian Ministry of Health) are joined by Louisa Stüwe (French Ministry of Health) in a forward-looking dialogue moderated by Dmitry Etin to imagine the 10 years long road ahead. The discussion will challenge participants to move beyond current implementation plans toward articulating concrete milestones for a system that delivers seamless cross-border care, trustworthy data exchange, and inclusive participation for both established and candidate Member States. Bringing together perspectives from foundational Joint Actions, France's advanced digital health program (previously involved in developing the EHDS at the Health Data Hub), and a candidate country navigating digital health transformation under extraordinary circumstances, the panel will identify critical junction points, policy decisions, governance structures required in the coming decade. Attendees will gain insights into both the aspirational vision and practical realities of building a truly European Health Data Space that serves all citizens, researchers, and healthcare systems across an expanding Union.

The road towards an ecosystem of healthdata for primary and secondary needs

Lecturers: Mattias Fredricson, Mona Heurgren

• The national Board of Health and Welfare
• The historical legacy of Swedish health data
• The world of digital health data is changing
•  Moving forward

European Health Data Space: The European Electronic Health Records Exchange Format Lesson from the XpanDH Project and Key Recommendations Moving Forward

Lecturer: Henrique Martins

The European Health Data Space (EHDS) represents a transformative step toward harmonising health data exchange across Europe, with the European Electronic Health Record Exchange Format (EEHRxF) at its core. This session delves into the lessons learned from the XpanDH project, which played a pivotal role in addressing the practical challenges of EEHRxF adoption.

Attendees will gain insights into how the XpanDH project engaged stakeholders, facilitated experimentation environments, and identified key enablers for interoperability. The session will outline actionable recommendations for accelerating EHDS implementation, including robust quality assurance frameworks, scalable processes, and leveraging emerging technologies like artificial intelligence to future-proofing the EEHRxF. Education on advanced digital health interoperability will be mentioned as a key enabler for the implementation of the EHDS using the XiA project.

With a focus on fostering trust in data quality, promoting collaboration through communities of practice, and embedding the EEHRxF into national strategies, this session provides a roadmap for stakeholders to unlock the full potential of the EHDS. Attendees will leave with practical strategies to enhance healthcare delivery, support research, and drive innovation across Europe.

The XpanDH project was funded by the European Commission (Grant agreement ID: 101095594). DOI: 10.3030/101095594. The XiA project is co-funded by the European Commission (ID: 101187650), like the i2X project (ID: 101195323). This work was supported by Mr. Simon Lewerenz, Dr. Anderson Carmo and Mr Syed Abrar Ahmed.

Dataspace4Health: A Practical Path to EHDS Implementation from Luxembourg

Lecturer: Dmitry Etin

Dataspace4Health (DS4H) in Luxembourg provides a compelling example of how countries can prepare for large-scale implementation of the European Health Data Space. Focused on real-world use cases in diabetes and cancer, the initiative illustrates how secure, GDPR-compliant data-sharing ecosystems can enhance patient care and support innovative research. With contributions from partners such as NTT DATA, Hôpitaux Robert Schuman, the University of Luxembourg, and the Luxembourg Institute of Health, DS4H addresses critical challenges in interoperability, governance, and trust while leveraging federated infrastructure principles. This lecture will highlight Luxembourg's current progress in piloting primary and secondary data use, aiming to simplify data journeys and thus accelerate research for complex clinical cases. Attendees will learn practical strategies for building connected health data ecosystems and gain valuable insights for stakeholders navigating similar readiness efforts.

Real world data use in precision cancer medicine: EHDS implications in separating primary and secondary use of data

Lecturer: Åslaug Helland

In precision cancer medicine, some subgroups of patients are very small. International collaboration is a necessity to treat patients across borders and to  gain the insights required for improving treatment. For efficient secondary use, data capture and structuring are essential, while federated analyses is one way of securing the person-level data security.

Data Initiatives for Digital Health & Care Innovation

Lecturer: Kyriacos Hatzaras

Policy Update

CNECT.H3 eHealth, Well-Being & Ageing

PANEL: How to make Data work for Health and Care

Moderator: Henrique Martins
Panelists: Dmitry Etin, Kyriacos Hatzaras, Mona Heurgren, Åslaug Helland

Following their presentations on building health data ecosystems (Mattias Fredricson and Mona Heurgren), XpanDH Project lessons (Henrique Martins), Luxembourg's EHDS implementation approach (Dmitry Etin), and cancer research data initiatives (Åslaug Helland), the panelists will explore how these diverse yet complementary approaches can overcome the challenges of data fragmentation, quality issues, and inconsistent implementation. The discussion, moderated by Henrique Martins, will examine practical strategies to ensure EHDS delivers tangible benefits rather than becoming "just another law we criticize"—focusing on interoperability solutions, governance models that bridge primary and secondary use cases, and quality frameworks that enhance data utility. Representing perspectives from national implementation, research applications, EU project experience, and Commission oversight, the panel will identify critical success factors for ensuring health data works effectively across boundaries, sectors, and use cases. Attendees will gain insights into actionable approaches that can accelerate the EHDS journey toward a purpose-driven implementation that truly serves patients, researchers, and healthcare systems across Europe. 

Ensuring Ethical and Trustworthy Secondary Use of Health Data: Insights from the Dorieh Platform

Lecturer: Michael Bouzinier

The Dorieh Data Platform, developed in collaboration with Harvard, utilizes comprehensive data management tools, including domain-specific languages, to enhance data provenance and regulatory compliance in health research. By enabling detailed lineage tracking and error logging, Dorieh ensures trustworthy and reproducible use of health data. Its application to Medicare data demonstrates its effectiveness, with potential scalability to frameworks like the European Health Data Space, reinforcing modern data governance strategies.

EHDS from a Swedish regional perspective

Lecturer: Rikard Lövström

EHDS will facilitate the use of health data in a European perspective. EU citizens will have their electronic health record data availible for primary use and research and medtech will have increased possibilities to work with the health data for secondary use. The EHDS regulation has been decided and we are now entering the implementation of the new regulation. This presentation will walk you through experiences, questions and important topics from a healthcare provider perspective.

We have some singular AI initiatives at Karolinska already, but personally I am focused on how to strategize to prepare and manage data to make it available for efficient development of AI as an integrated way of analyzing our clinical data and make use of it. 

Some important things in this work are:

1. working close to the healthcare professionals to achieve single documentation (once-only principle),

2. using of information standards like openEHR, SNOMED CT, FHIR etc,

3. working “information centric” with one "original" information that is continuously updated instead of locking the data in the applications,

4. organizing the data legally into platform compartments with defined regulations in each compartment, and

5. letting the data holder own the data as long as possible and build analytical tools for federative analysis locally, and not share results in the form of personal data, but instead more like statistics which will not be personal data. 

PANEL: Balancing Innovation and Regulation: Building Trusted Research Infrastructures

Moderator: Maria Hassel
Panelists: Michael Bouzinier, Päivi Östling, Rikard Lövström

Michael Bouzinier (Harvard Research Center), Rikard Lövström (Karolinska Hospital), and Päivi Östling (SciLifeLab) will share insights from their work developing secure data platforms, trusted research infrastructures that enable health data collection and availability while maintaining essential safeguards. The discussion, moderated by Maria Hassel, will address the perceived trade-off between regulation and innovation, examining whether these goals are inherently contradictory or potentially complementary when approached strategically. Drawing from their experiences with ethical secondary use frameworks, data strategy for innovation, and research infrastructure development, panelists will offer concrete examples of successful models that have maintained innovation velocity despite regulatory constraints. Attendees will gain practical insights into building future-proof research data ecosystems that remain compliant and innovative even as regulatory frameworks continue to evolve worldwide.

AIDAVA: AI based DAta curation and publishing Virtual Assistant

Lecturer: Wenjie Liang

This presentation with introduce the Horizon Europe project, AIDAVA.  The project that started in September 2022  and aims to provide patients (or their delegate) with an AI-based virtual assistant that maximises automation in the integration and transformation of their health data into an interoperable, longitudinal health record. This personal record can then be used for multiple purposes: to generate patient related information such as in International Patient Summary in FHIR format or a specific risk score for the patients, or to derive population datasets for research and policymaking such as a clinical registries. The proposed solution will enable a much-needed paradigm shift in health data management, implementing a ‘curate once at patient level, use many times’ approach, primarily for the benefit of patients and their care providers, but also for more efficient generation of high-quality secondary datasets. 
The first generation of the prototype was evaluated with patients in 3 sites. While this first prototype is - as expected, suboptimal but well accepted by the patients  - it demonstrates that there is true potential for automation in data curation of health data into an harmonised semantic standard, under the form of a Personal Health Knowledge Graph. The second generation of the prototype to be developed in the next 24 months will focus on on the  improvements in the curation tools and overall performance in data curation. 

The call with focus on the following aspects

• high level project objectives and architecture with different technology components
• results of the evaluation of the first generation of the prototype and plans for the second generation
• how AIDAVA could enable interoperability of healthcare authorities and healthcare organisations as part of implementation of the EHDS

EUCAIM - the European infrastructure for AI development in cancer imaging

Lecturer: Katrine Riklund

The advances in medical AI are fast but the translation to clinical usage is still challenging and need to be faster. The adoption of AI is limited in clinical practice and guidance is needed. There is a need of legal and ethical guidance, large numbers of high quality structured data, improved possibilities for data sharing. EUCAIM is dealing with all these issues.

The infrastructure, called Cancer Image Europe, is designed to preserve the data sovereignty of providers, and provide a platform, including an Atlas of Cancer Images, for the development and benchmarking of AI tools towards Precision Medicine.

EUCAIM and the Cancer Image Europe platform targets clinicians, researchers, and innovators, providing the means to finally build up validated clinical decision-making systems supporting diagnosis, treatment, and predictive medicine to benefit citizens.

By EUCANIMAGE we will:

Improve detection and diagnosis

Capitalize on the recent advances and successes of Artificial Intelligence systems in helping medical professionals to detect and diagnose cancers

Accelerate AI development

Support the piloting and development of innovative computer-aided solutions to achieve greater accuracy and reliability in cancer imaging and personalised care, in line with the objectives of the Europe’s Beating Cancer Plan

Showcase trustworthiness

Showcase how medical images can be accessed, used and/or pooled while ensuring a high level of ethics, trust, security and personal data protection in full compliance with EU values and rules

During the work we found a need of guidelines for trustworthy and deployable AI in healthcare and the dynamic framework created in the FUTURE-AI consortium will also be presented. 

PANEL: AI in Healthcare. Bridging Ethical Gaps and Practical Implementation

Moderator: Michel Silvestri
Panelists: Katrine Riklund, Sebastian Slej, Wenjie Liang

Following their presentations on AI-based data curation (Wenjie Liang, AIDAVA) and the European infrastructure for AI in cancer imaging (Katrine Riklund, EUCAIM), the panelists joined by Sebastian Slej (Corti.ai) will explore how these emerging technologies can be responsibly deployed to address critical patient care gaps while navigating evolving regulatory frameworks. Moderated by Michel Silvestri, the discussion will examine realistic expectations for AI implementation across pan-European healthcare systems, considering how improved understanding of the AI Act, MDR, and EHDS requirements might simultaneously enhance quality while potentially slowing development. The panel will critically assess current ethical tools and approaches, questioning whether they adequately address patient experience concerns and what practical steps can accelerate responsible implementation. Attendees will gain insights into the tension between ambitious AI promises and implementation realities, with concrete examples of how organizations are successfully navigating technical, ethical, and regulatory challenges to deliver real-world AI solutions in healthcare.

OMOP as a standard for analytics and generating real world evidence 

Lecturer: Eric Fey

The Future of Clinical Modeling and Interoperability: A Fireside Chat

The Future of Clinical Modeling and Interoperability: A Fireside Chat Passed

Wednesday May 21, 2025 15:45 - 16:05 Vitalis Plaza

Join Rachel Dunscombe, CEO of openEHR International, and Grahame Grieve, Product Director of HL7 FHIR, in a dynamic fireside chat exploring the evolving collaboration between openEHR and FHIR. As Europe advances toward the implementation of the European Health Data Space and aligns with broader global interoperability efforts, this discussion will provide key insights into how these two standards complement each other in addressing clinical data modeling, exchange, and long-term persistence. This session will examine the practical implications of integrating openEHR’s structured data models with FHIR’s agile exchange frameworks, highlighting their roles in EU regulatory initiatives and digital health infrastructure modernization. Rachel and Grahame will share their perspectives on the progress made so far, the challenges of aligning different approaches, and the opportunities for further standardization. Whether you are a policymaker, health IT leader, or innovator, this fireside chat will offer valuable insights into the future of healthcare interoperability and its impact on European and global health systems.

Good standardisation practices: profiling and testing at a global scale

Lecturer: Alexander Berler

IHE (Integrating the Healthcare Enterprise) is an international initiative that develops standards-based interoperability frameworks to improve the way healthcare systems share and exchange information. Key Aspects of IHE methodology:

• Focus on Interoperability – Ensures that healthcare IT systems (e.g., EHRs, EMRs, PACS, medical devices, etc) can communicate seamlessly in real life project implementations.
• Use of Existing Standards – Builds upon standards like HL7, DICOM, HL7 FHIR, W3C, ETSI, SNOMED CT and others, to define how systems should implement them in real-world use cases.
• IHE Profiles – Defines specific workflows and interoperability specifications for different healthcare scenarios, based on defining specific sequence diagrams, definitions of actors and transactions

IHE enhances the quality of interoperability specifications by providing support for the testing continumm where

• IHE organises "Connectathons®", where vendors test their software for compliance with IHE profiles
• IHE organizes Projectathons where IHE profiles and other specifications are orchestrated and tested before implementation
• IHE maintains via IHE Catalyst the IHE Gazelle testing platform used in all testing events with more than 30 running installations around the globe.

IHE Profiles play a major role in implementing the European Health Data Space (EHDS) by ensuring standardized EHR interoperability across EU member states. IHE Gazelle is used across the Globe in various National, cross border and regional implementation projects.

IHE Gazelle is an open-source testing suite of connected testing tools designed to:

• Validate healthcare IT systems for compliance with IHE profiles and FHIR implementation guides.
•  Ensure interoperability across hospitals, national health systems, and EU-wide platforms like MyHealth@EU.
•  Facilitate pre-production and real-world testing through automated and manual test scenarios.

IHE methodologies are supporting the implementation and operation of cross border, national and regional interoperability framework in practices enabling governance of interoperability and ecosystem building that create stable and testable interoperability specifications that can be implemented in practice.

During the presentation examples of use of IHE profiles and IHE test tools will be provided to better understand how all those processes work as one.

PANEL: Standardize or Not to Standardize - Fit-for-Purpose Approaches to Interoperability

Moderator: Alexander Berler
Panelists: Licínio Kustra Mano, Oskar Thunman, Sara Meunier, Serkawt Khola

In the race to operationalize the European Health Data Space (EHDS), one of the most debated challenges is not whether to standardize, but how to standardize smartly. This panel brings together key organizations deeply involved in shaping health data infrastructures across Europe: Inera, which leads national digital health services for Sweden; SNOMED International, the steward of the globally adopted clinical terminology SNOMED CT; Cambio, a leading implementer of openEHR-based platforms; and CEN/TC 251, the European committee responsible for health informatics standardization.

Moderated by Alexander Berler (IHE), the session will explore how different standards—including FHIR, openEHR, SNOMED CT, and OMOP—can be aligned or profiled to support EHDS use cases such as cross-border care, secondary data use, and real-time clinical decision-making. How can regions build on existing infrastructure, as Sweden aims to do, while ensuring future compatibility with pan-European requirements? What governance and conformance mechanisms are needed to make these standards workable in practice, not just on paper?

This panel offers a grounded conversation on what “fit-for-purpose standardization” really means in the context of EHDS. Attendees will hear diverse views on coexistence vs. convergence, the role of open platforms, and how to navigate Europe's fragmented—but rapidly maturing—interoperability landscape. The session is designed to move beyond abstract principles and offer practical takeaways for policymakers, implementers, and vendors alike.