Following the approval on February 10th by the Council of Ministers of the Royal Decree regulating the procedure for the selective funding of medical devices within the pharmaceutical benefits for non-hospitalized patients—pending its upcoming publication in the Official State Gazette (BOE)—the Federación Española de Empresas de Tecnología Sanitaria (Fenin) wishes to state the following:

• We welcome the Ministry of Health’s commitment to adopting regulatory changes that allow for the incorporation of technological innovation into pharmaceutical benefits. This ensures that patients have access to better treatments for their conditions, a situation that has been pending since 2006.

• We trust in the Ministry’s agility regarding the swift resolution of applications for the inclusion of new products, as well as the updating of conditions to guarantee the supply of essential products.

• It is essential to include new categories and product groups within the National Health System’s pharmaceutical benefits. This will allow users—many of whom are chronic patients, dependents, or elderly—to access new clinical solutions and medical devices aimed at disease prevention or managing their consequences. This brings significant cost savings for the health administration and improves patients’ quality of life. Given this sector’s innovative capacity, a streamlined mechanism should be established to incorporate new categories or product groups into public funding.

• However, it must be noted that the current regulation of pharmaceutical benefits is designed for the pharmaceutical sector, not for the Healthcare Technology sector. Therefore, we expect the new Law on Medicines and Medical Devices to provide our sector with a distinct regulatory framework that recognizes the unique characteristics and specificities of these products, as the Ministry of Health has informed us.

• The Federación Española de Empresas de Tecnología Sanitaria, Fenin, has held the conference ‘AI in Healthcare: CE marking as a guarantee for the patient’, in which administrations, regulatory agencies, managers, clinicians, and industry reflected on the challenges and opportunities of this disruptive technology for the healthcare system.

• Pilar Navarro, Director of Innovation at Fenin: “AI must be incorporated through rigor, ethics, and compliance with healthcare regulations. Our sector already has a significant track record of innovative solutions incorporating AI that have undergone certification processes that guarantee their quality and safety.”

• Advancing in AI “literacy,” the training of all involved actors, proper data management, the development of codes and guidelines for best practices, and the acceleration of evaluation timelines were other challenges identified by the experts.

Artificial Intelligence has enormous potential to transform Healthcare, advance personalized medicine, increase productivity and health outcomes, contribute to the sustainability of the system, and resolve current challenges of the NHS such as the shortage of professionals. But its implementation also raises challenges to be considered: What regulatory framework should be developed to address the connotations of its use in Healthcare? How can it be applied ethically and safely in the diagnosis and treatment of diseases? What responsibilities derive from improper use? Representatives from the entire healthcare ecosystem (administrations, regulatory agencies, managers, researchers, clinicians, and industry) reflected on this at the conference “AI in Healthcare: CE marking as a guarantee for the patient” organized by the Spanish Federation of Healthcare Technology Companies, Fenin.

Pilar Navarro, Director of Innovation at Fenin, highlights that “AI must necessarily be incorporated into the healthcare system, but through good governance, rigor, ethics, safety, and compliance with healthcare regulations.” The Director of Innovation at Fenin pointed out the importance that all software, algorithms, or medical devices incorporating AI used in the prevention, diagnosis, and treatment of diseases, or that assist professionals in clinical decision-making, hold the medical device CE marking. A premise in which the Healthcare Technology sector is at the forefront: “our companies already have a significant track record of innovative solutions incorporating AI that have undergone regulatory and certification processes that guarantee their quality and safety,” she recalled.

The analysis of the regulatory framework surrounding the implementation of AI in Healthcare was carried out at this conference by Margarita Martín López, Head of the Market Control Area for Medical Devices and IVD at the Spanish Agency for Medicines and Health Products (Aemps), regarding how its correct application is supervised by this regulatory agency. The Aemps representative pointed out the importance for developers of digital solutions incorporating AI “to be clear on when it is considered a medical device, its classification, and thus comply with all health guarantees.” The Aemps representative noted some of the new features introduced by AI regulations, such as the figure of the “deployment lead” for the solution within the healthcare center. Likewise, regarding the possible “in-house” manufacturing of AI solutions by hospitals and healthcare centers when no commercial alternatives exist, Margarita Martín López recalled that, in any case, they must follow the same procedures and certifications required for commercial solutions.

Regarding the application of AI in Medicine, Josep Munuera, Head of Diagnostic Imaging at Hospital Sant Pau in Barcelona and an expert in digital technologies applied to health, valued the importance of AI as a support for clinical decisions and the discovery of incidental findings, among other advantages. “The most mature AI models are those that have worked on signals: radiology, cardiology, ophthalmology…” he exemplified. In the specific case of Hospital Sant Pau in Barcelona, an AI program is already being applied with two main branches: operational AI and clinical AI.

Success cases in the development of digital health

Various “success cases” in the development of digital health and Artificial Intelligence in Healthcare by administrations and industry were presented during this conference.

Joaquín Velilla, Director of Digital Health and Infrastructure for the Regional Ministry of Health of Aragon, detailed the 2025-2029 Strategic Digital Health Plan promoted by the regional Government, which includes various projects related to the implementation of AI. “With this strategy, we want to move toward an innovative, sustainable healthcare system that leverages disruptive technologies and digitalization to offer integrated, proactive, and top-quality care to the patients of Aragon,” he stated in his presentation.

As examples developed by the industry, GE HealthCare and Tucuvi presented their AI-based projects and solutions already applied in healthcare for diagnosis and monitoring, respectively (in the case of the former, in a joint project with the Regional Ministry of Health of the Valencian Community).

Likewise, reflections were made on the challenges linked to the certification process, and specifically, the suitability of accelerating timelines and committing to certainty throughout the entire evaluation process cycle.   Furthermore, a panel discussion was held where, from a multidisciplinary perspective, researchers, clinicians, managers, and industry representatives analyzed the present and future challenges and opportunities of AI in Healthcare. Participants pointed out the importance of advancing in AI “literacy,” the training of all involved actors, the development of codes and guidelines for best practices, and the medical device CE marking as the “axis” of quality and safety in its use.