The roll-out of the European Health Data Space marks a new chapter in innovation, research and evidence-based practice

redaccionmedica.com

The search for scientific evidence and the exploitation of health data have never been so deeply embedded in the functioning of a shared space such as the European one. Now, the roll-out of the European Health Data Space (EHDS) marks a new chapter for the pharmaceutical industry and European healthcare systems, with direct implications for research, innovation and data usage.

This is the view of Amelia Martín Uranga, Director of Clinical and Translational Research at Farmaindustria, who emphasises in an interview with Redacción Médica that “Spain is in a comparatively favourable position due to the high level of digitalisation of its healthcare system, its experience and leadership in clinical trials, and robust regulations for the protection of personal data”.

However, the implementation of the EHDS goes far beyond technology. According to Martín Uranga, “the challenge is not only technical, but also relates to governance, organisation, and technical and semantic interoperability”, to which are added challenges such as building trust, training professionals and citizens, and issues relating to data ownership.

The European regulation, which came into force in March 2025, sets out a phased implementation timetable that will extend into the next decade. “Its implementation will be gradual and structured,” he notes, pointing out that “the rules on the secondary use of most data will begin to apply in 2029, whilst others, such as genomic data, will not do so until 2031”.

From clinical trials to data leadership

The sector’s employers’ association explains that one of the main objectives is to develop the current research model. “The EHDS and the National Health Data Space represent a major opportunity to take the next step: moving from being a highly attractive country for traditional clinical trials to becoming a global leader in data-driven research throughout the entire lifecycle of a medicine.”

This paradigm shift is underpinned by the development of the National Health Data Space (ENDS), launched in 2026, which aims to establish a federated, secure and ethical model for managing health information. According to Martín Uranga, this system will enable ‘the preservation of data sovereignty and confidentiality whilst facilitating its use for research, innovation and public policy’.

The key, she insists, will lie in combining high-quality data with efficient governance. ‘If we manage to integrate high-quality data with clear governance, we will offer research sponsors something unique: clinical trials, registries and follow-up within a single ecosystem,’ says the Director of Research.

A strategic opportunity for Europe

Beyond the national context, the EHDS is intended as a tool to strengthen Europe’s position on the global stage. ‘It is a key element in enabling Europe to regain its leadership against competitors such as the United States or China,’ notes Martín Uranga, whilst considering that, in the case of Spain, the potential is particularly significant, as ‘it represents an opportunity to move from being a leader in clinical trials to becoming a global hub for innovation in data and artificial intelligence’.

In line with this, the sector is already driving forward specific initiatives. Farmaindustria has set up a strategic committee focused on health data and artificial intelligence, with projects aimed at the secondary use of data and the development of technology-based clinical trials. The aim, according to the industry body, is ‘to promote more accessible, efficient and inclusive models, enabling greater participation by centres and patients’.

Another cornerstone of the EHDS is the secondary use of health data, particularly for generating real-world evidence (RWE). Expectations within the industry are high. “The secondary use of data is key to generating real-world evidence, which has evolved from a promise into a critical asset for regulatory decision-making,” notes Martín Uranga.

This approach will complement information from traditional clinical trials and reduce uncertainty in the evaluation of new treatments. Furthermore, its impact extends across the entire lifecycle of the medicine, from initial research through to pharmacovigilance.

‘It will enable us to transform the way we assess the efficacy and value of treatments across diverse populations and in real-world settings,’ he explains. In this regard, initiatives such as Darwin EU will facilitate the use of high-quality data for evaluation and safety.

Towards a new model of collaboration

In the medium to long term, the EHDS also promises to redefine collaboration between industry, healthcare systems and research centres. ‘It will enable more iterative, interconnected and agile translational research,’ says Martín Uranga.

Structured, cross-border access to data will encourage the creation of public-private consortia, data-driven hospital networks and European real-world evidence projects. All of this with the aim of moving towards more personalised, predictive and sustainable medicine.

Spain, Pharma concludes, has already demonstrated its capacity for leadership when there is collaboration between stakeholders. “The challenge now is to replicate that success in the field of health data and technology,” it notes. And it adds: “We have come a long way and can learn from our experience in clinical trials to consolidate this new phase.”