AI and biomedical: UCBM brings Italy into the new WHO document for global health  

THEWorld Health Organization (WHO) published the second edition of the document "Development of medical device policies" and the editorial team was coordinated by the Campus Bio-Medico University of Rome, led by Prof. Leandro Pecchia, Vice-Rector for Research UCBMA strategic document that defines the global guidelines for national and regional policies for medical devices, including theAI for healthAt a time when technological complexity and rapidly evolving markets make it urgent to strengthen the governance of health technologies, Italy plays a leading role.  

The professor. Leandro Pecchia, together with the team of theUniversità Campus Bio-Medico di Roma, is among the key experts who coordinated the drafting of the document, contributing outstanding expertise and the ability to integrate skills and experience in the design, evaluation, regulatory, and management of medical devices, especially those heavily dependent on AI. This is a crucial contribution to strengthening the technical, operational, and strategic dimensions of the document, and above all, to maintaining the centrality of the person, especially the most vulnerable living in contexts with limited resources.  

What does the new WHO report contain?:

● An operational guide aimed at governments and health authorities, with concrete recommendations for developing or updating national policies on medical devices, in light of new disruptive innovations such as AI.  

● Guidelines for building modern and solid regulatory frameworks, capable of responding to technological innovations, new risks and growing market complexity.  

● An extension of analytics beyond traditional devices, with a focus on emerging technologies such as medical software, digital health and “intelligent” systems.  

● A new focus on sustainability, including environmental sustainability, of devices and healthcare technologies in general.  

● A strong call for Health Technology Assessment (HTA) as an essential tool for evidence-based decisions, if well integrated with regulatory and medical device management  

● A position chiara The need to consider the entire life cycle of medical devices to formulate policies and conduct truly effective assessments: this puts the role of clinical and biomedical engineers back at the center, no longer seen as purely technical figures, but as experts in the sector and stakeholders who should be increasingly involved in planning, political, and strategic decisions, as has been the case in Italy for years.  

● Emphasis on capacity building: training of experts, but also of healthcare workers and patients themselves, and the creation of adequate infrastructure for planning, monitoring and management of devices.  

The assignment given by WHO to the Campus Bio-Medico University of Rome to coordinate the drafting of the WHO report represents a prestigious recognition for Italian research, and for the great capacity for inclusion that it has shown for decades, for the scientific and human quality, For the ability to include national and international skills in the medical devices sectorThe team UCBM, in collaboration with the WHO, involved dozens of experts from six continents from the conception, drafting, and revision of the document, bringing out the voices of experts from low-income countries, who are not always heard. To develop this document, between 2024 and 2025, the team did not work exclusively remotely, but met several times in Rome and organized in-depth meetings in Panama. Singapore, Shanghai, Nairobi, Taiwan, Cotonou, Addis Ababa, and Kigali, moving tirelessly for 10 months to ensure that the voices of experts from all continents could be heard, understood, and well represented.  

WHO recommendations may guide:  

● future strategies for regulating health technologies;  

● innovation choices in the MedTech industry;  

● safety, quality and sustainability policies in public health services and public-private health systems.  

Italy, thanks to the work of many experts coordinated by Prof. Pecchia, Vice-Rector for Research, and by Dr. Marianna Zarro, PhD student UCBM, thus confirms itself as an authoritative actor in defining international policies and development lines for future health technologiesA model for dialogue between institutions, experts, patients, and companies in the sector, to be exported as the country's cultural heritage. To coordinate this project, the University has deployed an international, multidisciplinary team that also includes two researchers, Joseph Lovecchio (biomedical engineer, Italy) and Karina Ovejero Paredes (biotechnologist, Spain); 5 PhD students supervised by Prof. Pecchia, Nahimiya Hussein e Lemlem Degafu (clinical engineers, Ethiopians), Maria Elisabetta Pagnano e Martina Sassi (biomedical engineers, Italy), Marianna Zarro (doctor, Italy); and a medical student, Nathan Samuel Ullman (USA), who has been attending the professor's lab for a few years. 

"Being entrusted by the WHO to coordinate the drafting of a strategic document like this is a source of great pride for Italian research, not only for the Campus Bio-Medico University of Rome – says the prof. Leandro Pecchia This document confirms that healthcare policies for medical devices are no longer just a technical matter: they require vision, expertise, and global collaboration to ensure technologies that truly make a difference for patients. Above all, they require a great capacity for proactive listening: we urgently need to listen to everyone's voices, but to do so well, we need to listen to those voices, not just wait for them to reach us. Even if this means traveling the world to meet experts and patients from every continent, as we have done over the past 10 months, to empower even the most vulnerable to speak on equal terms, looking each other in the eye, and discovering that behind the titles and the bells and whistles, there are people of good will, sharing hopes and dreams. Because on a personal level, being asked to coordinate the drafting of a document that will guide the way the 193 member states of the United Nations develop sustainable and inclusive policies, then this job is a dream come true: the dream of someone who—born in a tiny village north of Naples and raised traveling the world, Africa in particular—wakes up, in his fifties, and finds himself living a dream. We hope we've done a good job..."  

>> The second edition of the report Development of medical device policies It is available on the WHO website: https://www.who.int/publications/i/item/978924011440