Medical devices for global health

AI and biomedical: UCBM brings Italy to the new WHO document redefining policies

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

by School Editorial

11 December 2025

4' min read

Translated by AI

Versione italiana

4' min read

Translated by AI

Versione italiana

The World Health Organisation (WHO) has published the second edition of the document 'Development of medical device policies' and the team from the Campus Bio-Medico University in Rome, led by Prof. Leandro Pecchia, pro-rector for research, coordinated the drafting. A strategic document that defines the overall lines for national and regional policies for medical devices, including AI for health. At a time when technological complexity and the rapid evolution of the market make it urgent to strengthen the governance of health technologies, Italy plays a leading role.

The drafting of the document

Leandro Pecchia, together with the team of the University Campus Bio-Medico of Rome, is in fact among the main experts who coordinated the drafting of the document, bringing excellent skills and the ability to integrate expertise and experience in the design, evaluation, regulation and management of medical devices, especially those highly dependent on AI. A decisive contribution to strengthen the technical, operational and strategic dimension of the document, and above all to maintain in it the centrality of the person, especially the most fragile ones living in resource-limited contexts.

What the new WHO report contains

● An operational guide addressed to governments and health authorities, with concrete recommendations to develop or update national medical device policies in the light of new disruptive innovations such as AI.

● Directions for building modern and robust regulatory frameworks capable of responding to technological innovations, new risks and increasing market complexity.

● An extension of analysis beyond traditional devices, with a focus on emerging technologies such as medical software, digital health and 'smart' systems.

● A new focus on sustainability, including environmental sustainability, of devices and health 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 clear position on the need to consider the entire lifecycle of medical devices in order to write policies and make assessments that are truly effective: this puts the figure of the clinical and biomedical engineer back at the centre, who are no longer seen as purely technical figures, but as profound connoisseurs of the sector and players to be increasingly involved in planning, and in political and strategic decisions, as has been the case in Italy for years.

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

Why it is important for Italy

The assignment given by the WHO to the Campus Bio-Medical University of Rome to coordinate the drafting of the WHO report is a prestigious recognition for Italian research, and for the great capacity for inclusion that it has shown for decades, for its scientific and human quality, and for its ability to include national and international expertise in the medical device sector. The team at the Campus Bio-Medico University in Rome, in collaboration with WHO, involved dozens of experts from six continents in the conception, drafting and revision of the document, bringing out voices of experts from low-income countries, who are not always able to be heard. To develop this document, between 2024 and 2025, the team did not only work remotely, but met several times in Rome, and organised workshops in Panama, Singapore, Shanghai, Nairobi, Taiwan, Cotonou, Adis 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 will be able to guide:

● future health technology regulation strategies;

● 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 the many experts coordinated by Prof. Pecchia, pro-rector for Research, and Dr. Marianna Zarro, a doctoral student at the University Campus Bio-Medico in Rome, is thus confirmed as an authoritative player in defining international policies and lines of development for the health technologies of the future. A model of 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 Campus Bio-Medico of Rome fielded an international and multidisciplinary team that also involved 2 researchers, Joseph Lovecchio (biomedical engineer, Italy) and Karina Ovejero Paredes (biotechnologist, Spain); 5 doctoral students supervised by Prof Pecchia, Nahimiya Hussein and Lemlem Degafu (clinical engineers, Ethiopia), Maria Elisabetta Pagnano and Martina Sassi (biomedical engineers, Italy), Marianna Zarro (physician, Italy); and a medical student, Nathan Samuel Ullman (USA), who has been attending the professor's lab for a few years.

"It's not just about technique"

'To be entrusted by the WHO with the task of coordinating the drafting of a strategic document such as this is for Italian research, not only for the Campus Bio-Medico University of Rome, a source of great pride,' says Prof. Leandro Pecchia. 'This document confirms that health policies for medical devices are no longer just a technical issue: they require vision, expertise and global collaboration to ensure technologies that really make a difference for patients. Above all, they require proactive listening skills: we need to listen to everyone's voices, but to do it well we need to put our ear to those voices, not just wait for them to come to us. Even if this means going around the world to meet experts and patients from all continents, as we have done over the past 10 months, to put even the most fragile people in a position to speak as equals, looking each other in the eye, and discovering that behind the titles and trappings, there are people of goodwill, who share hopes and dreams. Because on a personal level, to be called upon to coordinate the writing of a document that will guide the way in which the 193 member states of the United Nations will write sustainable and inclusive policies, then this work is a dream come true: the dream of someone who - born in a tiny village north of Naples and who grew up travelling the world, Africa in particular - wakes up, fifty years old, and finds himself living a dream. Let's hope we did a good job..."