How is Catalonia entering the European Health Data Space? Challenges, opportunities, and impact for the health innovation ecosystem

The European Health Data Space (EHDS) regulation, effective since March 2025, establishes a common framework for the use and exchange of electronic health data across the European Union. Its primary objective is twofold: on one hand, empowering individuals by enabling them to access, control, and share their electronic health data for better healthcare (primary use); on the other, enabling the secure and privacy-respecting reuse of this data for research, innovation, public policy, and regulatory activities (secondary use).

This regulation represents a profound change, requiring the adaptation of processes, systems, and data governance at a European scale. It aims to ensure that data such as medical records, test results, research data, and data from devices and apps can be safely shared and effectively utilized in a coordinated and interoperable way throughout Europe.

Over the past three years, Biocat has closely monitored the evolution of the proposed EHDS regulation, as well as Member States’ preparedness for its implementation. States currently find themselves at varying stages of readiness, with different levels of digital health infrastructure, significantly impacting the speed and effectiveness of EHDS implementation. Thus:

• The implementation of EHDS requirements will not occur simultaneously across Europe.
   
• Although EHDS applies to all EU countries, not all nations or regions are equally prepared. This disparity arises from differences in digital health system maturity, legal frameworks, infrastructure and data-sharing protocols, data protection laws, and varying political and regulatory contexts.
   
• It is essential to involve patients, data holders and users, access bodies, EHR system providers, innovators, industry, and public administration in designing these procedures.
   
• EHDS sustainability encompasses multiple dimensions—legal, governance, quality, and capacity—but one aspect repeatedly emphasized is trust. This trust, especially among patients, can only be assured if EHDS is built upon robust regulations ensuring cybersecurity and the privacy of services and processes.

In this context, it is beneficial to observe the countries and initiatives leading the EHDS implementation to identify successful models and effective strategies.

At the European level, the European Commission has already launched several instruments to foster harmonized implementation:

• Funding collaborative projects such as Xt-EHR, EHDS2, TEHDAS2, and QUANTUM, which are working on technical specifications, interconnection pilots, and quality criteria for health data usage.
   
• The MyHealth@EU infrastructure enabling cross-border exchange of services such as electronic prescriptions and patient summaries, already available in Catalonia through La Meva Salut.
   
• The HealthData@EU pilot, connecting access bodies and infrastructures to test the feasibility and impact of health data exploitation at the European scale.
   
• The HealthData@EU Central Platform, which compiles data from across Europe to facilitate secure, ethical, and harmonized access, expected to be fully operational by 2028.
   
• New requirements for Electronic Health Record (EHR) systems, ensuring interoperability and security across the entire European market.

This deployment is coordinated via a governance structure composed of a board of Member States, sectoral committees, and a stakeholder forum including patients, professionals, industry representatives, researchers, and academia.

Regarding successful examples, the Nordic countries, particularly Finland, stand out as prominent benchmarks. Finland was the first country to approve specific legislation for the secondary use of health data and has led European projects such as TEHDAS and TEHDAS2. Furthermore, the Findata Agency is pioneering the establishment of secure procedures for requesting and utilizing electronic health data in research and innovation.

According to Elina Drakvic, Senior Lead for International Programmes at Sitra, “It’s essential to involve the entire ecosystem from the outset: data holders, users, public authorities, and above all, end users, to ensure the system truly meets their needs and can be fully leveraged.”

EHDS Regulation establishes a phased implementation schedule with key milestones and specific obligations for stakeholders. The main stages and deadlines are detailed below:

• 2025: EHDS Regulation enters into force, marking the beginning of the transition period.
   
• 2027: Deadline for the European Commission to adopt key implementing acts, including technical specifications and detailed requirements for the regulation's practical implementation. Member States must designate one or more Health Data Access Bodies (HDABs).
   
• 2029: National access bodies must be connected to the HealthData@EU platform by 2029. Exchange of the first set of priority data categories will be mandatory across all Member States.
   
• 2031: Remaining priority categories must be incorporated. Data users (public research institutions and industry) will be able to request access permissions starting in 2029 or 2031, depending on the data category.
   
• 2034: Potential inclusion of third countries and international organizations as authorized participants in HealthData@EU for secondary data use.

This timeline reflects the project's complexity and ambition, with gradual implementation intended to ensure the technical, legal, and organizational maturity of all stakeholders involved.

Catalonia has established itself as a model in healthcare digitalization and interoperability, exemplified by projects such as EDAH, led by Biocat. This success is rooted in sustained investments in information technology and the creation of advanced clinical data ecosystems, positioning the region as a European benchmark for others looking to progress in implementing the EHDS.

In particular, the infrastructure managed by the Catalan Health Service encompasses data from eight million citizens. With more than two decades of continuous investment in IT, Catalonia’s healthcare system has built one of the continent’s most comprehensive clinical data ecosystems. Various healthcare organizations, some dating back to the 18th century, have quickly embraced digitalization, although the landscape remains fragmented.

To address this fragmentation, since the late 1990s, the Catalan Health Service has progressively integrated data and connected hundreds of health centers—including primary care, mental health and long-term care facilities, and hospital services—through a unified patient identification system. This effort has enabled clinical follow-up, optimized healthcare management, and facilitated research.

The jewel in the crown and a benchmark for many health systems is the Shared Clinical History of Catalonia (HC3). HC3 integrates information from 30 different systems, holding hundreds of millions of clinical documents, medical reports, diagnostic images, laboratory results, immunization records, and clinical parameters. These data are accessible to all authorized professionals within the public healthcare network.

Another notable example is the Electronic Prescription System, operational since 2006, processing over 130 million prescriptions annually through the region's 3,200 community pharmacies. This system not only facilitates patient access but also enables continuous, detailed monitoring of medication usage across the population.

Despite significant progress, there still coexist numerous clinical record systems developed by European providers as well as internally by healthcare organizations. To advance interoperability, CatSalut plans to deploy centralized solutions based on the OpenEHR standard. Recently, IBM Group was awarded a tender by CTTI (Catalan Government) and, together with other consortium partners, will provide a comprehensive and homogeneous clinical data platform across the entire region.

According to Jordi Piera, Director of Digital Health Strategy at CatSalut, “The deployment of a clinical data repository following the openEHR specification is the central technological component of Catalonia's digital health platform.”

Moreover, a critical factor for EHDS deployment in Catalonia is investment in research and development, with projects exploring generative artificial intelligence and predictive analytics to enhance diagnostics, optimize resources, and move towards more personalized healthcare. In this context, the leadership role of the BioRegion of Catalonia is highlighted through initiatives such as the AI Observatory, the Salut/IA program, and the AI Factory of the Barcelona Supercomputing Center (BSC).

Regarding specific data, the SIMDCAT platform stores approximately 120 million diagnostic imaging studies, including X-rays, ultrasounds, CT scans, and electrocardiograms, while the Catalan healthcare system has digitized over 37 million pathology examinations. Altogether, these datasets encompass several petabytes of medical data available—always under stringent privacy safeguards—for innovation and healthcare improvement projects.

Finally, the Catalan Health Surveillance System, operational since 1992, integrates and analyzes millions of hospitalization, emergency room, outpatient, and specialized service records. This system enables risk stratification, anticipates healthcare needs, and informs public health policy-making through data-driven tools like the Adjusted Morbidity Group (GMA).

Implementing the EHDS in Catalonia requires collaboration among multiple actors. In addition to Salut and CatSalut (with the future Data Office evolving from PADRIS*), the key entities expected to lead or facilitate the secondary use of data for research and innovation in Catalonia are:

• AQuAS: The PADRIS program, launched in 2017, was a pioneering initiative facilitating data reuse for evaluation, innovation, and research, though it currently lacks the scale and resources to fully meet EHDS requirements. AQuAS's 2027 plan includes a specific strategy for data governance and optimization for secondary use. It has already initiated tenders to establish a dedicated Data Access Office in response to the new European regulation governing secondary health data use across the EU.
   
• TIC Salut Social: Provides comprehensive support to the Health and Social Services Systems in Catalonia, promoting international standards such as HL7 FHIR, SNOMED CT, LOINC, IHE, DICOM, and OpenEHR. Additionally, it coordinates and implements actions for deploying the Salut/IA Program.
   
• Biocat: Acts as a strategic agent and catalyst for driving, transforming, and promoting the Catalan life sciences and healthcare innovation ecosystem. It serves as a vital link between ecosystem companies and the healthcare system, managing ongoing initiatives like the PASS program.

Catalonia can become a European benchmark by prioritizing leadership, governance, and collaboration. Success will depend on aligning with the EHDS framework, involving all relevant stakeholders, and ensuring trust, quality, and impact. The entire BioRegion ecosystem, as well as the general public, have active roles in this urgent and competitive race to establish an environment conducive to adopting best practices and realizing potential benefits—not only in healthcare but also in research and policy-making through the secondary use of data.