Digital therapies, Italy needs to get out of limbo

The evolution of digital therapies (Dtx) represents one of the most ambitious challenges for modern healthcare, moving on a delicate ridge between technological innovation and clinical rigour. As the global market accelerates, with forecasts approaching USD 67 billion by 2034, the Italia context finds itself managing a complex transition to prevent these tools from remaining confined in regulatory limbo. The distinction between a simple wellness application and a true digital therapy lies in the software's ability to produce a demonstrable clinical effect through scientific evidence and proof comparable to that of medicines.

These issues were at the heart of the debate during the second meeting dedicated to Institutional and Regulatory Affairs, an event promoted and organised by AFI in Rome on 24 and 25 March 2026. During the two-day event, the need to overcome the stalemate that requires a regulatory act that clearly separates the criteria for conformity marking from those necessary for reimbursability by the healthcare system emerged.

In the European context, there are already mature integration models, such as the German one, which has made it possible to channel significant investments and generate hundreds of thousands of therapeutic activations. On the contrary, the Italia system, while showing signs of growth in investments planned for the next three years and an increasing number of certified devices (26 at the end of last year), still suffers from the absence of a clear prescriptive and reimbursement pathway.

This uncertainty hampers the full adoption of solutions that have already proven effective in the treatment of widespread chronic diseases, such as hypertension and obesity, where digital intervention can radically improve patient adherence to treatment and the effectiveness of treatments. The national legislative process of a dedicated law has been significantly accelerated after the vote in the Social Affairs Committee of the Chamber of Deputies last February, and it is hoped that it will quickly reach approval.

Only through a clear legislative framework will it be possible to integrate new technologies into ordinary care pathways, while guaranteeing data security and the clinical quality of the services provided to citizens.