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The European healthcare system is undergoing a period of accelerated transformation. Demographic aging, rising chronic conditions and structural pressure on professionals and resources have made artificial intelligence an essential tool for ensuring the sustainability, equity and quality of healthcare. It has long been clear that the volume of data generated by healthcare systems—from medical imaging to omics, as well as clinical records and real world data—would eventually reach a scale requiring new analytical and integrative capabilities beyond human abilities.

This new phase cannot be explained solely by technological advances, the maturity of generative models, emergence of multimodality or increased computational power. Artificial intelligence is no longer a standalone tool; it has become a transversal infrastructure that can strengthen clinical decision-making, reorganize operational workflows, personalize treatments and accelerate industrial processes. In this context, the question is no longer whether AI will transform the European healthcare system, but how and where that transformation will come about and how to leverage it. Catalonia is emerging as one of Europe’s best positioned regions, thanks to the combination of scientific, clinical and business assets and pioneering governance of AI in health.
 

Europe charts the path: Artificial intelligence with guarantees

Europe is committed to a model that balances innovation and safety. The AI Act, the world’s first regulation on artificial intelligence, establishes a risk based system that classifies healthcare applications as high risk due to their direct impact on people’s lives and health. This framework requires functional transparency, data traceability, effective human oversight and continuous validation processes.

This environment does more than regulate AI; it makes it a strategic asset. As an EU regulation (not a directive), it establishes a uniform framework across all Member States, avoiding the need for each country to pass parallel legislation. Even so, there will be national supervisory authorities and notified bodies to assess AI system compliance.

At the same time, the European Health Data Space (EHDS) is an ambitious data infrastructure designed to share, harmonize and reuse high quality anonymized clinical data to drive research, develop AI and generate evidence under trustworthy conditions. The combination of the AI Act + EHDS will create a unique European ecosystem: regulated, secure and interoperable. 1

In addition to this regulatory drive, a new community of experts has been launched to guide and accelerate this transformation. The European Society for Artificial Intelligence in Health (ESAIH), based in Switzerland, brings together leaders from healthcare, academia and industry to strengthen collaboration, advance knowledge and ensure that AI reaches hospitals and clinical environments with guarantees.

Jorge Juan Fernández, director of Innovation at Hospital Clinic Barcelona and founding member of the Society highlights: “Artificial intelligence can transform health, but it will only do it well if we use it with judgment, evidence and values, maximizing opportunities and managing risks. ESAIH was created to put AI at the service of people, connect clinicians, industry, investors and regulators, and make this promise possible. We aim to fill a gap that is missing in Europe.” The Society has convened its first summit on February 12 in Cannes, as part of the 4th WAICF (World Artificial Intelligence Conference).

 

A sector ready to scale up impact 

The combination of operational transformation, modular innovation and investor interest is shaping a new phase in the evolution of healthcare systems. Reports from McKinsey 2and findings from the World Economic Forum3 indicate that AI in health will be one of the most dynamic sectors over the next five years. Annual global market growth is over twenty percent, and solutions adopting modular AI —meaning systems with interoperable modules for diagnostics, logistics, manufacturing or advanced therapies— are advancing faster and with lower integration costs. This modular architecture will allow Catalan hospitals to integrate, replace or expand solutions without resorting to long, costly implementation processes. For industry, especially the BioRegion’s4 digital health fabric , this opens the door to product models that are more scalable and exportable into Europe.

Source: 2024 BioRegion of Catalonia Report

In logistics and healthcare operations, predictive models help anticipate emergency room demand, optimize operating room use, reorganize beds and improve supply chain efficiency. This optimization not only cuts costs, it frees up clinical time and lowers operational stress. In biopharmaceutical manufacturing, especially for ATMPs, AI can be used to adjust biotechnological parameters, detect deviations in real time and ensure quality in GMP processes. This advance is critical for cell and gene therapies, which rely on extremely delicate processes that differ significantly from traditional industrial ones.

The World Economic Forum estimates that AI can substantially reduce diagnostic errors and improve early detection of serious diseases, with a direct impact on lives saved and costs avoided. This is one of the most promising dimensions of AI in health, and one of the reasons governments and international organizations consider it a priority.

However, McKinsey warns of a structural risk: without proper governance, AI could amplify errors and automate imprecisions. The ability of generative models to express incorrect information with apparent confidence is particularly concerning in clinical contexts. The promise of AI is huge, but so is its risk.

International perspective: USA and China accelerate the curve

The United States maintains a faster adoption pace, driven by large hospitals integrating multisector AI and highly active venture capital. The US regulatory flexibility allows new solutions to reach the market quickly, although with a higher risk of unequal access.5

China, in turn, has rolled out a hyperscalability policy combining mass telemedicine, smart biopharmaceutical manufacturing and low cost diagnostic tools6 . In China, AI in health is not merely a technological application; it is a core part of national strategy, integrating hospitals, data, digital health platforms and public policies to create a highly cohesive ecosystem. The model, based on vertical integration and volume of data, offers speed and efficiency, but relies on data governance practices Europe cannot reproduce. These dynamics highlight the need for Europe and Catalonia to advance decisively, upholding their principles but setting a competitive pace.

Catalonia accelerates AI in health adoption with pioneering interoperable model

On a national level, the AI Strategy for the National Health System (SNS) establishes a common framework linking all autonomous communities under a shared vision: to incorporate useful, reliable, humanized, universal AI. Its implementation is based on harmonized assessment processes, regulatory sandboxes to test solutions in controlled environments and a clear commitment to new hybrid profiles like clinicians with data skills. 

The funding agreement with the autonomous communities has allowed for initiatives like the interoperable medical imaging network, remote monitoring of chronic patients and advanced digitization of healthcare services. Catalonia is among the first communities to begin roll out7, demonstrating superior adoption capacity thanks to its prior experience in digital health projects and pioneering guidelines aligning regulation, ethics and clinical practice.

Catalonia has a set of assets that put it in a privileged position: an integrated, highly digitalized healthcare system; hospitals capable of generating high quality data and adopting technology; internationally renowned biomedical research centers; and a BioRegion with +150 companies already using AI as a core technology. In the words of Jordi Piera, Director of the Digital Health Strategy Office at the Catalan Health Service, “it is not just about adopting technology to innovate, but about ensuring that every AI solution provides real value to professionals and patients.” He adds, “the key factors are integration with existing workflows, data quality, professional training and, above all, that these solutions address real problems in everyday clinical practice.”

The Observatory of AI in Health has identified dozens of use cases currently being rolled out, ranging from imaging diagnostics to clinical risk prediction, managing waiting lists, monitoring patients, surgical planning and hospital logistics. The TIC Salut Social Foundation has produced pioneering guidelines on generative AI, reading the AI Act, qualification as a healthcare product and CE marking, facilitating adoption with guarantees. This group of assets creates the conditions for Catalonia to serve as a testbed and scale up territory in this new chapter of AI in health. Notably, the Estrategia IA Catalunya 2030 (Catalonia AI Strategy 2030) has recently been approved.

 

Conclusion: A call to action for the BioRegion 

One of Catalonia’s most distinctive assets is the AI Factory of the Barcelona Supercomputing Center – Centre Nacional de Supercomputació (BSC-CNS), conceived as a strategic facility to accelerate development and scalability of AI solutions with high value added. The AI Factory combines supercomputing, advanced data capabilities and an applied research environment, ensuring that AI does not remain at the experimental stage but advances toward robust, transferable products. Its capacity to generate, train and validate massive models makes the AI Factory a key platform for positioning Catalonia within Europe’s modular architecture, as well as a privileged meeting point to develop high impact solutions aligned with the AI Act and EHDS, while also serving as an accelerator to turn research into tangible economic and healthcare value. 

"Catalonia has a real window of opportunity to consolidate its place as a European hub for AI in health. It has a world class research ecosystem, an integrated and digitalized healthcare system, an innovative business base and pioneering governance. But Catalonia will only be able to lead if it succeeds in making the decisive leap from pilot innovation to systemic infrastructure", adds Montserrat Daban, Strategic Foresight and International Relations Director at Biocat and member of the Artificial Intelligence Commission of the Catalan Health Department.

This requires strengthening data infrastructures, developing hybrid talent, selecting high value use cases, actively connecting to EHDS and adopting modular AI architecture. Europe has set the rules; Spain has established a strategy; now Catalonia can demonstrate how to execute the transformation with ambition, rigor and impact.

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Laura Diéguez
Laura DiéguezHead of Media Relations and Content (+34) 606 81 63 80ldieguez@biocat.cat
silvia labe 2
Silvia LabéDirector of Marketing, Communications and Competitive Intelligence Departmentslabe@biocat.cat
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