Italy: A Life Sciences Overview

Life Sciences in Italy: Between Challenges and Opportunities

The Life Sciences sector, both in Italy and globally, has been undergoing a significant transformation in recent years, driven by the adoption of artificial intelligence (AI) and digital therapies.

Incorporating digital technologies

Digital technologies are profoundly reshaping the entire healthcare system - with largely positive effects - from pharmaceutical research, which is becoming increasingly rapid and efficient, to healthcare organisational models, to the personalised management of patients' needs and the promotion of longevity and wellbeing in the population. Tools such as Artificial Intelligence, Digital Therapies and easier, safer access to health data open new opportunities to develop preventive, personalised and precision-based forms of medicine.

In this context of accelerated innovation, the National Health Service is called upon to address significant challenges, including population ageing, the sustainability of the healthcare system and the need for equitable and timely access to care.

To ensure that these innovations truly generate widespread benefits, it is essential to adopt a strategic and coordinated vision, capable of organically involving all system stakeholders - institutions, healthcare professionals, businesses, citizens and the scientific community. This implies the definition of a genuine national digital health plan, supported by adequate resources, clear objectives and indicators to measure its impact.

The digital revolution is unfolding within a complex geopolitical landscape: rising US tariffs and aggressive industrial policies by certain global powers are pushing many major companies to concentrate their investments in the United States, diverting attention and resources away from Europe. This shift risks slowing the continent’s technological development and widening the competitive gap - including in the field of digital health.

In this context, it becomes essential to “act as a system” so that the digital transformation of healthcare generates lasting value, improves the quality of care, strengthens professional skills and supports business innovation.

New digital technologies - from certified software-based clinical interventions to artificial intelligence - will play a crucial role in research and development, accelerating drug discovery and supporting clinical trials, while also optimising the supply chain and post-marketing safety monitoring through real-world data analysis.

Artificial intelligence is becoming an increasingly important ally in community-based medicine, in direct contact with citizens: from predictive analysis of clinical data to support the diagnostic process, from personalised treatments to remote monitoring of health parameters.

Moreover, the development of digital therapies and health apps also continues to grow, gaining ground among patients and healthcare professionals. Personalised care pathways enabled by advanced technologies are thus emerging as key factors for improving development processes and offering innovative therapeutic solutions.

To embrace this innovation, the regulatory framework governing the Life Sciences sector must also evolve, and regulatory changes are indeed a daily occurrence. The growing technological and legal complexity, for example, is reshaping the concept of product liability, both in the production of “intelligent” medical devices and in their use by healthcare professionals and facilities, so understanding and adapting to this change will be essential to ensure patient safety and minimise legal risks.

Regulatory framework alignment with the adoption of new technologies

Within this regulatory framework, Law No 132 of 2025 (in force since 10 October 2025) transposes the European AI ACT principles (EU Regulation 2024/1689). Article 7 specifically governs the use of AI in healthcare, affirming the fundamental principles on the subject, including the fact that AI systems constitute “a support in the processes of prevention, diagnosis, treatment and therapeutic choice, without prejudice to the decision, which is always referred to the medical profession” and that they, together with the data used, “must be reliable, periodically verified and updated in order to minimise the risk of errors and improve patient safety”.

Additionally, last July, the Social Affairs Commission of the Chamber of Deputies presented a consolidated draft bill establishing a national committee within the Ministry of Health to guide the inclusion of Digital Therapeutics (DTx) within the Essential Levels of Care (LEA).

Moreover, on 8 October 2025, the Senate approved the Simplification Bill, which introduces important innovations in telemedicine, in particular by extending existing penalties for false certifications to digital certifications. An agreement to be approved within the State–Regions Conference, upon proposal of the Ministry of Health, will define the cases and procedures for tele-certification.

Finally, on 14 October 2025, the National Agency for Regional Health Services (Agenas) published on its official website the “Analytical Document on the Guiding Model for the Provision of Telemonitoring and Telecontrol” and the “Analytical Document on the Guiding Model for the Provision of Televisits”. These are guidelines outlining the reference models for the provision of Telemonitoring, Telecontrol and Televisits, with the aim of supporting the development and use of the National Telemedicine Platform and the Regional Telemedicine Infrastructures, and ultimately promoting a more integrated, accessible and sustainable healthcare system.

The confirmation that telemedicine is one of the most strategic instruments for modernising the Italian healthcare system is reflected in the 2026 Budget Law, currently under approval, which allocates new and significant funding to Agenas to:

• coordinate and monitor telemedicine services;
• define new operational standards; and
• distribute technological devices to professionals for teleconsultation activities.

New European guidelines for health apps also come into play, introducing common criteria for certification and interoperability standards, promoting transparency and compliance with the GDPR.

Conclusion

In conclusion, the Italian Life Sciences sector shows a growing maturity in its approach to digital innovation, with targeted investments and increasingly structured governance.

However, the success of the transformation - within a sector that is highly regulated, socially impactful, and inherently complex - will also depend largely on the ability to coordinate the various applicable disciplines and to fill the gaps that still remain in a regulatory framework that struggles to align with the pace of technological innovation, as well as to promote and support the necessary literacy of healthcare professionals and citizens towards new technologies.

Healthcare professionals, in particular, need specific skills to:

• assess the reliability of technologies;
• correctly interpret data generated by digital tools;
• integrate predictive algorithms into clinical processes; and
• communicate transparently with patients about the benefits, limitations and responsibilities of use.

In parallel, digital therapies require people to understand not only how they work, but also the rights, limits and responsibilities associated with their use. Without adequate digital education, there is a risk that such tools remain underused or are perceived with suspicion, despite their ability to support the management of chronic diseases, psychological disorders or rehabilitation pathways in a continuous and personalised manner.

A proper digital literacy programme in healthcare can bridge the gap between technological innovation and the ability of those involved to use it in an informed and responsible manner. This means providing tools to:

• assess platform reliability;
• understand data flows;
• actively participate in digital care pathways; and
• engage with healthcare professionals using a common language.

This will require pragmatically addressing new issues as they arise on the basis of general principles of law, and filling regulatory gaps through analogical interpretation of existing rules. All this without forgetting that, in the Life Sciences sector, an important role is also played by the rules of ethics, which are periodically updated to reflect ongoing developments and, although not binding for non-member companies, serve as best practice for cases not expressly regulated by law.