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Drugs and medical devices: a study centre on artificial intelligence in Pavia

It will promote highly specialised research and studies on the ethics and regulation of innovative technologies applied to healthcare

by Claudio Testuzza

27 April 2026

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4' min read

Translated by AI

Versione italiana

Key points

Importance of EFS on medical devices
The Role of the Ministry of Health and the Regions
The right behind the regularisation of AI in healthcare
Positive WHO report on IA work in Europe

4' min read

Translated by AI

Versione italiana

Inaugurated in Pavia is the Study and Research Centre on "Ethics and Regulation of Technological Innovation and Drugs", set up at the Law Department of the University of Pavia, directed by Prof. Michele Madonna, in the presence of esteemed representatives of the health and legal world. It is directed by Prof. Stefano Colloca (Professor of Philosophy of Law and Rector of the Giasone del Maino University College) with the aim of promoting highly specialised research and studies on the ethics and regulation of new technologies, drugs and medical devices characterised by a high level of technological innovation, such as those based on AI.

The study conference 'The Regulation of Medicines and Medical Devices in the Digital Age and the New Frontiers of Research', held in the University's Aula Foscolo, was dedicated to the birth of the Centre, in order to investigate, with an authentically interdisciplinary perspective, the 'intersections' between law, ethics, economics and health, which are fully in keeping with the tradition of the University of Pavia. A university that, in the past and in recent times, has always been characterised by great attention to studies and research in the legal, philosophical-legal, economic-legal and medical fields.

Importance of EFS on medical devices

In presenting the first areas of investigation that the Centre's members are working on, Colloca spoke about the ethics of technological innovation and AI, recalling the risk, from an ethical point of view, of blocking or under-utilising technological innovation. He emphasised, therefore, the role of early feasibility studies (EFS) on medical devices in speeding up access to innovation in an appropriate and safe manner, since such early feasibility investigations make it possible to modify the product before the completion of its design, according to the paradigm of the self-correcting nature of science, responding better and faster to health care needs that have not yet been met.

The topic that the Centre is investigating, in close collaboration with the Interdepartmental Research Centre 'Innovation and Health' of the University of Roma Tre, directed by Guerino Fares, is precisely the role of early feasibility studies (EFS) to whose development, activated according to safety and efficacy criteria, the Italian Ministry of Health is giving great impetus.

EFS are a type of clinical trial conducted in the early stages of the production of an innovative medical device, before its final design is finalised.

The role of the Ministry of Health and the Regions

Francesco Saverio Mennini, Head of the Ministry of Health's Department for Planning, who spoke at the opening on behalf of the ministry, stated, as a preliminary remark, that since diseases have an economic and social weight, healthcare spending should be considered not as a cost, but as an investment. Consequently, the ministry is constantly working to increase prevention, early diagnosis, early patient care, and faster access to quality care based on advanced technologies.

Mennini also spoke about the implementation of a new National Health Plan based on the definition of health objectives and illustrated the aspects of technological innovation in healthcare that the Ministry of Health is promoting. He then illustrated the ministry's commitment to training medical and health personnel.

Guido Carpani, Professor of Health Law at the LUISS Guido Carli University in Rome and former head of the Cabinet of the Ministries of Health, Environment and Civil Service, explained how, over time, the Regions' responsibility for the management of their health services has been entrusted to new instruments to control minute and more punctual management, with the introduction of ceilings on the Regions' expenditure for the purchase of drugs and medical devices, for the acquisition of services from accredited private parties, and for health service personnel.

The right behind the regularisation of AI in healthcare

For her part Cristina Campiglio, Deputy Vice-Chancellor for Legal Affairs at the University of Pavia and Professor of International Law, outlined the latest regulatory developments in the field of medical devices.

It has been emphasised that innovation in health matters obviously also concerns medical devices and, specifically, the development of increasingly 'intelligent' medical devices. With the caveat that, precisely because they are based on artificial intelligence, these are high-risk devices, which therefore require particularly strict controls.

In the US, the FDA has already authorised over a thousand artificial intelligence (AI)/machine learning (ML)-based medical devices. China has also been moving in the same direction for some time now.

Hence, for the European Union, the need to simplify the procedures for marketing these devices without, of course, sacrificing, on the one hand, their security and, on the other, the protection of personal data.

This simplification would facilitate the launch of early feasibility studies, which the Ministry of Health is promoting, allowing clinical trials of medical devices based on artificial intelligence to be included.

Positive WHO report on IA work in Europe

Artificial intelligence, fortunately, is no longer just a distant promise even for European healthcare. It has already entered hospitals, diagnostic pathways, patient services and governance choices.

The new WHO/Europe report, presented these days, the first comprehensive study on the preparedness level of the 27 EU Member States, recounts a rapid and widespread transformation, driven above all by a goal shared by all countries: to improve patient care.

For Italia, the picture is that of a country in the leading group on several fronts: strategy in development, ethical lines, data hubs, funding and breadth of applications. Called upon now to make a qualitative leap, that is, to move from activism to system maturity, because artificial intelligence, as the report suggests, will not be judged by its technical sophistication, but by its concrete ability to improve care, access, security and trust.