Healthcare professionals trust CE marking as a guarantee of AI safety: 7.4 out of 10, compared with 3.1 for uncertified solutions

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Fenin has conducted the first survey on the real-world use of AI in Spanish hospitals, gathering responses from 216 professionals—including cardiologists, radiologists and healthcare executives—from the Spanish Society of Medical Radiology, the Spanish Society of Cardiology and the Spanish Society of Health Executives.

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Confidence in AI-enabled devices without CE marking falls to 3.1 out of 10, with consistent results across all medical specialties.

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A total of 93% of healthcare professionals report that they lack the necessary training to use and properly assess AI in clinical practice.

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Madrid, 25 May 2026. Spanish healthcare professionals and executives clearly trust artificial intelligence when it carries CE marking and are significantly less confident when it does not. This is the main conclusion of the survey entitled “The Use of AI in Healthcare”, conducted by the Spanish Federation of Healthcare Technology Companies, Fenin, in collaboration with the Spanish Society of Medical Radiology (SERAM), the Spanish Society of Cardiology (SEC) and the Spanish Society of Health Executives (SEDISA).

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The average confidence score for AI solutions certified with CE marking reaches 7.4 out of 10, with even higher scores among healthcare executives from SEDISA. By contrast, confidence in AI-enabled devices without CE marking falls to 3.1 out of 10. This level of support, in line with the current legal framework, highlights CE marking as a guarantee that AI algorithms are safe, high-quality and effective.

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“It is very important to see that the vast majority of healthcare professionals and executives understand the value of healthcare regulation. CE marking enables artificial intelligence solutions to be safely adopted within Spain’s National Health System. This study confirms that professionals feel confident when using algorithms that are certified and legally authorised for use. Nevertheless, Fenin will continue working in coordination with the health authorities to ensure that professionals verify that only algorithms compliant with the applicable regulations are used,” said Pablo Crespo, Secretary General of Fenin.

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Widespread personal use, but insufficient professional training

One of the report’s most striking findings is the gap between the personal use of AI and the lack of training for its professional application. A total of 71% of respondents report using artificial intelligence tools in their daily lives, with ChatGPT as the undisputed leader, followed by Gemini and Copilot, depending on the medical specialty. More than half of respondents, 56%, already use paid versions of these tools. However, 87% believe that they are not sufficiently trained to use these solutions responsibly and efficiently in clinical settings.

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Awareness of the Medical Device Regulation (MDR) as it applies to AI-based healthcare technology also remains limited, with only 38% of respondents stating that they understand its implications.

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“Training is essential for the deployment of AI in healthcare. We must work to accelerate the adoption of these new technologies, but we must do so while guaranteeing their responsible use and ensuring that professionals have the necessary skills. Training and regulation must progress at the same pace as innovation,” said Ignacio López, President of Fenin’s Digital Health Sector.

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In this context, Fenin is developing a free training course that will be accessible to all healthcare professionals and will provide the skills and knowledge required for the safe and effective use of these new technologies, which are expected to transform the healthcare delivery model. A specific guide for healthcare professionals is also being prepared.

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Only 22% know whether the AI used in their department is certified

As a result of the lack of training, despite the high level of confidence generated by CE marking, the survey reveals a significant gap between professionals’ recognition of its value and their awareness of whether the algorithms they use comply with the applicable regulations. Although 74% of professionals identify CE marking as a guarantee of safety, only 22% can confirm that the AI-enabled devices used in their departments actually hold this certification.

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Regarding the use of AI, diagnostic imaging is currently the area of medicine in which it is most widely used, with 40% of professionals reporting that they use it.

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Dr Carlos Escobar Cervantes, a member of the Spanish Society of Cardiology, said:

“Cardiology is one of the specialties in which artificial intelligence is already demonstrating a tangible clinical impact, particularly in risk stratification, diagnostic imaging and the optimisation of healthcare processes. However, for this transformation to be safe and sustainable, it is essential that the algorithms used comply with the current regulations and carry CE marking. The results of this survey clearly show that professionals trust AI when it is certified, while also highlighting the urgent need to strengthen training in this area. At the SEC, we consider it a priority for clinicians to have the robust skills required to assess, interpret and use these tools with scientific rigour and with the appropriate safeguards for patients.”

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Dr Ángel Morales Lezama, Clinical Head of the Radiology Department at Donostia University Hospital and a member of SERAM, stated:

“For AI to truly transform clinical practice in radiology, we need legal certainty through regulatory compliance, reliability based on comprehensive performance metrics, implementation that is fully integrated into radiologists’ workflows, clear data governance, explicitly assigned responsibilities and validation in local clinical settings. This will allow us to move from isolated pilot projects to routine and safe use. Only in this way will we gain the confidence of both radiologists and patients.”

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In this regard, José Soto Bonel, President of SEDISA, said:

“AI will not transform healthcare on its own. Healthcare will be transformed by the professionals and executives who are capable of governing AI with purpose, training, ethics, evidence and a patient-centred approach.”

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This morning, a think tank session was held as part of the “La tecnología que marca” (“Technology that Makes the Mark”) project. The event provided a forum for dialogue, bringing together participating experts to examine the main challenges and opportunities associated with the application of AI in healthcare.

Robotic surgery, a “well-established and expanding” innovation with varying levels of implementation across Spain’s National Health System

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At the 4th Technology, Health and Society Forum, organised by the Fenin Chair in Technology and Health—an initiative promoted by the Spanish Federation of Healthcare Technology Companies, Fenin, the Fenin Foundation and the Ortega-Marañón Foundation—hospital managers, Heads of Department and industry representatives discussed the presence of this technology within the healthcare system.

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Robotic surgery has become firmly established as a relevant technology whose implementation continues to grow, although access and use remain uneven. According to the experts, its impact largely depends on the clinical indication, the experience of the surgical team and the organisation of the care pathway. Structured training and accreditation are also essential to ensuring safety and generating value in robotic surgery.

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Robotic surgery has become established as a significant technological innovation within Spain’s National Health System (SNS), with increasing implementation in operating theatres and across multiple medical specialties due to the improved outcomes it can offer patients. Although it is now a well-established and expanding technology, variations in access and use remain, with implications for equity, quality and the efficiency of healthcare delivery.

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These were among the reflections shared by hospital managers, Heads of Department and representatives of the Healthcare Technology industry at the 4th Technology, Health and Society Forum. Entitled “The Present and Future of Robotic Surgery”, the event was held in Madrid and organised by the Fenin Chair in Technology and Health, promoted by the Spanish Federation of Healthcare Technology Companies, Fenin, the Fenin Foundation and the Ortega-Marañón Foundation.

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During the opening session, Professor Fernando Bandrés, President of the Fenin Foundation, stated:

“Robotic surgery is a technology with the potential to improve certain clinical and organisational outcomes, particularly in more complex settings. However, its value is neither uniform nor inherent to the technology itself; it depends on its integration into appropriate healthcare models. Through this forum, we aim to promote a present- and future-oriented approach to robotic surgery based on value, prioritising evaluation, organisation and the sustainability of healthcare organisations.”

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Lucía Sala, Director General of the Ortega-Marañón Foundation, said:

“The Fenin Chair in Technology and Health is an exceptional instrument for promoting innovation within Spain’s National Health System from the perspective of patients and healthcare professionals. Robotic surgery will improve the lives of many people and, for this reason, it deserves particular attention from knowledge and research institutions.”

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During the event, Miriam Toca, Coordinator of Fenin’s Robotics Group, presented the preliminary findings of a report promoted by the Fenin Chair. The report analyses the clinical impact, efficiency and value generated by robotic surgery for patients and Spain’s National Health System and will soon be made available to the entire healthcare ecosystem.

“The available evidence shows that, compared with open surgery, robotic surgery can reduce surgical trauma and blood loss, support faster patient recovery in certain procedures, and maintain or improve clinical outcomes in highly technically complex cases. Its impact depends largely on the clinical indication, the experience of the team using the technology and the organisation of the care pathway,” Miriam Toca explained, referring to the report’s preliminary conclusions.

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Regarding its implementation within the SNS, the introduction of robotic surgery entails significant organisational changes to healthcare models. These include establishing coordinated care structures, adapting operating theatre processes, developing new professional skills and systematically measuring outcomes.

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Value-based robotic surgery programmes

As part of the presentation, a panel discussion was held with the report’s authors: José M. Balibrea, Head of the General and Digestive Surgery Department at Germans Trias i Pujol University Hospital in Badalona; Nicolás Moreno, Head of the Thoracic Surgery Department at Ramón y Cajal University Hospital in Madrid; Víctor Díez Nicolás, Head of the Urology Department at Quirónsalud Madrid University Hospital; David Noriega, Head of the Traumatology and Orthopaedic Surgery Department at Valladolid University Clinical Hospital; and Berta Díaz-Feijoo, Head of the Gynaecology Department at Hospital Clínic Barcelona.

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The experts examined the organisational and healthcare implications of implementing robotic surgery programmes within their departments and discussed how to maximise the value generated by these programmes.

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Among other factors, the experts highlighted the need to develop official professional certification programmes and accreditation schemes for robotic surgery units, standardise procedures and promote training programmes involving not only technology providers but also hospitals, scientific societies, universities, public authorities and other relevant stakeholders.

What does the implementation of a robotic surgery programme mean for hospital management teams? What criteria should be considered, and what barriers arise when acquiring this equipment?

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These issues were discussed by Carlos Mingo, Managing Director of Ramón y Cajal University Hospital in Madrid, and José Antonio Arranz, Managing Director of Valladolid University Clinical Hospital. Both advocated for the adoption of value-based innovation and for integrating this innovation into well-established healthcare and organisational processes.

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The ultimate objective is to ensure that robotic surgery is used efficiently, safely and equitably.

Spain Can Make the Definitive Leap in Biomedical Research: From Scientific Powerhouse to Global Leader

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The 19th Conference of the Biomedical Research Technology Platforms brings together more than 200 representatives from public administrations, academia, patient organizations, and industry in Barcelona

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Experts highlight that Spain’s research ecosystem must continue advancing in collaboration, knowledge transfer, and business development to generate innovation that delivers impact for patients and drives national growth in an increasingly competitive international environment

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Barcelona, 28 May 2026 – More than 200 representatives from the pharmaceutical, biotechnology, medical technology and animal health industries, together with experts from the Spanish Agency of Medicines and Medical Devices (AEMPS), regional administrations, research institutes, patient organizations, start-ups, pharmaceutical companies and medical technology firms gathered today in Barcelona for the 19th Conference of the Biomedical Research Technology Platforms, a leading forum dedicated to fostering collaboration and advancing health research, development and innovation (R&D&I) in Spain.

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Organised by Farmaindustria, AseBio, Fenin, Veterindustria and Nanomed Spain, the conference highlighted the importance of strengthening public-private collaboration and moving towards more effective cooperation models between academia and industry. Spain has a unique opportunity to position itself as one of the world’s leading centres for healthcare innovation. While already recognised as a European leader in clinical research, consolidating its role as a global biomedical research hub will require scaling beyond traditional public-private partnership models and fostering deeper collaboration throughout the various stages of developing new medicines and therapies.

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Against a European backdrop shaped by initiatives such as the European Health Data Space (EHDS), the forthcoming European Biotech Act, and Spain’s National Deep Tech Strategy, participants agreed that the challenge extends beyond accelerating research. It also involves ensuring stable and effective collaboration capable of translating scientific knowledge into tangible solutions that improve people’s lives.

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During the opening session, Fina Lladós, President of Farmaindustria, stressed the need for a qualitative leap to transform scientific knowledge into business growth and globally competitive projects. She also drew attention to the current geopolitical landscape, describing it as “full of threats, risks and intense competition both within and beyond Europe.”

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“To address this situation, three essential elements are required,” she stated. “A strong commitment from public administrations to place R&D at the centre of strategic priorities; greater investment, particularly during the most complex stages of drug development; and a stable, predictable and agile regulatory environment that facilitates new projects and provides confidence to those willing to invest and grow in our country.”

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A similar message was conveyed by Cristina Nadal, President of AseBio:

“Spain has a world-class scientific and biomedical foundation, but we must also transform that excellence into greater industrial capacity, attract more investment, and ensure that innovation reaches patients and society. Biotechnology is strategic for strengthening competitiveness, technological sovereignty and security, while addressing major health and environmental challenges. At this decisive moment, initiatives such as the Biotech Act represent a unique opportunity to strengthen the innovation ecosystem, and Spain has the potential to establish itself as a key player in European biotechnology development.”

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Scaling Innovation

From the perspective of the medical technology sector, experts focused on key issues that will shape the future of healthcare systems, including the integration of industrial and scientific capabilities, the scalability of innovation, and the creation of environments that facilitate the adoption of disruptive solutions.

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Participants also emphasised the growing role of both Spain and Catalonia as biomedical and technological innovation hubs capable of connecting research, industry and healthcare delivery to enhance competitiveness and improve patient care.

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As Andreas Förster, Acting President of Fenin Catalunya, noted, the conference highlighted “the need to integrate scientific, technological and industrial capabilities to accelerate the arrival of innovative solutions for patients and healthcare professionals.”

“At Fenin, we believe that medical technology is a key driver in addressing the challenges of tomorrow, particularly in areas such as digitalisation, artificial intelligence, health data and advanced biomedical innovation. Dialogue forums such as this one are essential to consolidating Spain’s position as an international hub for health innovation,” he added.

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From the animal health perspective, Santiago de Andrés, President of the Vet+i Foundation, emphasised the strategic importance of animal health within the One Health approach.

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According to the World Organisation for Animal Health (WOAH), approximately 60% of human infectious diseases originate in animals, while nearly 75% of emerging diseases are zoonotic. In this context, innovation, digitalisation and strengthening Europe’s industrial strategic autonomy are essential to improving prevention, surveillance and preparedness for future health crises.

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In line with the objective of consolidating Spain as a leading biomedical innovation hub, Josep Samitier, Scientific Coordinator of Nanomed Spain, highlighted one of the sector’s major challenges: effectively translating scientific knowledge into real health impact.

“Within the framework of this conference, we organised a roundtable focused on how to accelerate this process by addressing the main challenges and opportunities throughout the entire value chain, from research to clinical application. The session brought together leading figures from academia, industry and the healthcare system to discuss how to strengthen public-private collaboration, improve innovation models and align scientific and industrial excellence, with the goal of transforming scientific advances into real-world solutions that benefit patients and enhance our country’s competitiveness.”

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Nearly Two Decades Strengthening the Innovation Ecosystem

The Annual Conference of the Biomedical Research Technology Platforms marks almost two decades as a collaborative space bringing together companies, research centres and public administrations, helping to strengthen Spain’s health innovation ecosystem.

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This year, organisers agreed that consolidating this ecosystem requires continued progress in collaboration, knowledge transfer and business development, with the ultimate goal of generating innovation that delivers meaningful impact on patient health while contributing to the country’s economic and social development.