The European Health Data Space (EHDS), with its final text published in the Official Journal of the EU on March 5th, is a landmark initiative by the European Union aimed at transforming healthcare through the secure and efficient use of health data. The EHDS regulation seeks to establish a unified framework for health data exchange across the EU, thereby enhancing both healthcare delivery (primary use) and research/policy-making (secondary use).

The secondary use of health data regulated by the EHDS can revolutionize cancer screening by enabling researchers and policymakers to analyze anonymized datasets across populations, improving early detection through risk stratification (e.g., identifying high-risk groups via genetic or lifestyle factors), enhancing screening accuracy via AI trained on diverse data, reducing disparities by addressing gaps in access or outcomes, and accelerating innovation by testing new methods or biomarkers. By pooling EU-wide data, it strengthens evidence-based guidelines, monitors program effectiveness, and supports cross-border collaboration for rare cancers, all while adhering to strict privacy safeguards and ethical governance to ensure equitable, efficient, and personalized public health strategies.

In the context of the EUCanScreen project, the Aragon Health Sciences Institute (IACS), a public institution dedicated to generating knowledge in health sciences in the Aragón region (Spain), is collaborating with the Cancer Society of Finland (CSF) to lead a pilot program. This program is designed to test how the EHDS will facilitate the monitoring of cancer screening programs across Europe. Through a rigorous process of aligning methodologies and software tools, an EHDS-compliant solution to compute the European Cancer Information System (ECIS) indicators—which were established in the CanScreen-ECIS project— will be developed and tested across a number of joint action partners.

IACS has been instrumental in the development of the EHDS since its inception. The expertise of the IACS team in developing BIGAN, the Aragón region health data lake, has provided the

opportunity to participate in a range of EHDS construction-related projects, including the TEHDAS Joint Action, the HealthData@EU pilot, QUANTUM project —as coordinators— and SHAIPED, which began this month.

In this conjunction between the EHDS and its application to fight cancer, IACS will also participate in a new series of projects with this goal, specifically CANDLE and EU-CIP—both part of the Cancer Mission of the Horizon Europe Programme—, and the eCAN Plus and Personalised Cancer Medicine Joint Actions—part of the European Beating Cancer Plan of the EU4Health programme—. All these projects will focus on how the data available in the health systems can be accessed, shared, and utilized through the EHDS, with all necessary security and privacy measures, to improve the prevention, early detection, treatment, and follow-up for cancer patients. This includes informing their families and providing the most up-to-date evidence to healthcare professionals.

Juan González-García, Head of Health Data Strategy and Head of the Biocomputing Unit at IACS, said: ‘The EHDS is a breakthrough in the fight against cancer.’ He added: ‘Member States must prepare to maximise the potential of the EHDS and provide researchers, clinicians and policy makers with the data and tools they need to save the lives of cancer patients.’

https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202500327

https://ecis.jrc.ec.europa.eu

https://www.iacs.es 

https://www.cancersociety.fi

https://bigan.iacs.es/en/home

Spain has been selected as the Screening Campaign Country of the month for March 2025.

The Catalan Institute of Oncology (ICO) was assigned as the Competent Authority representing Spain. There are five Spanish Affiliated Entities participating in EUCanScreen:

• – Instituto Aragonés de Ciencias de la Salud (IACS) IACS | IACS
• – Instituto de Investigación Sanitaria de Valdecilla (IDIVAL) Inicio – IDIVAL
• – Instituto de Investigaciónj en Sistemas de Salud (Biosistemak) Instituto de Investigación en Sistemas de Salud Biosistemak
• – Fundación per al Foment de la Investigació Sanitaria i Biomedica de la Comunitat Valenciana (Fisabio) FISABIO | Fisabio
• – Institut de Investigació Hospital del Mar (IMIM) Hospital del Mar Research Institute

Between the Competent Authority and its Affiliated Entities, Spain has a significant contribution in all Work Packages of EUCanScreen.

ICO Leads Work Package 7 – Implementation Research to improve the existing cancer screening programmes and Co-Leads T7.1 Implementing Quality assurance (QA) scheme alongside UCY, Cyprus. ICO also Leads on T7.5 Implementing informed decision-making in population-based cancer screening programmes.

IACS Co-leads T5.5 Piloting developed standardised data model for Euorpean Health Data Space (EHDS) alongside CSF, Finland.

Within the following weeks, each Spanish institution participating in EUCanScreen will post an update on their specific involvement and contributions to the project.

Spain has a decentralised cancer screening structure. The Ministry of Health is responsible for national planning and regulation, while regional health authorities manage operational aspects. Therefore, during March, Spanish institutions will share news relating to their regional screening programmes, updates and advancements.

Stay tuned this March for more information on Spain’s contributions to making cancer screening more accessible and effective across Europe.

IACS | IACS

Inicio – IDIVAL

Instituto de Investigación en Sistemas de Salud Biosistemak

FISABIO | Fisabio

Hospital del Mar Research Institute