AI AND BIOMEDICAL: UCBM BRING ITALY INTO THE NEW WHO DOCUMENT THAT REDEFINES POLICIES FOR MEDICAL DEVICES FOR GLOBAL HEALTH

In the second edition of the WHO strategic report, the contribution of Italian experts, coordinated by Prof. Leandro Pecchia and by the students of the Campus Bio-Medico University of Rome  

Rome, 11 December 2025 – THEWorld Health Organization (WHO) The second edition of the document "Development of Medical Device Policies" has been published. The drafting team at Campus Bio-Medico University of Rome, led by Professor Leandro Pecchia, Vice Rector for Research, coordinated the drafting process. This strategic document defines the global guidelines for national and regional policies for medical devices, including AI for health. At a time when technological complexity and rapidly evolving markets make it urgent to strengthen the governance of health technologies, Italy plays a leading role.  

Prof. 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 for governments and health authorities, with concrete recommendations for developing or updating national medical device policies in light of new disruptive innovations like AI.  
• Guidelines for building modern and robust 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 “smart” systems.  
• A new focus on the 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  
• One 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 managing devices.  

Why it is important for Italy The task given by WHO to theCampus Bio-Medico University of Rome The WHO's role in coordinating the drafting of the report represents a prestigious recognition for Italian research, for the great capacity for inclusion it has demonstrated for decades, for its scientific and human quality, and for its ability to incorporate national and international expertise in the medical devices sector. The teamCampus Bio-Medico University of Rome, 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 of theCampus Bio-Medico University of Rome, thus confirms itself as an authoritative player in defining international policies and development guidelines for future healthcare technologies. A 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 Campus Bio-Medico University of Rome has put in place an international and multidisciplinary team which also involved 2 researchers, Joseph Lovecchio (biomedical engineer, Italy) and Karina Ovejero Paredes (biotechnologist, Spain); 5 PhD students supervised by Prof Pecchia, Nahimiya Hussein and Lemlem Degafu (clinical engineers, Ethiopians), Maria Elisabetta Pagnano and 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 just for the Campus Bio-Medico University of Rome,” says 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