Globally, the term Digital Therapeutics first appeared in 2015, with the first FDA approval in 2017 [5], paving the way for a new generation of “digital prescriptions.” Countries such as Germany, with the DiGA Fast Track reimbursement program launched in 2020, have established public reimbursement systems for these therapies [6], followed by similar initiatives in France, the UK, Belgium, Spain, Japan, and South Korea.
In Italy, the topic began to take shape in 2019 with the “Digital Therapeutics, an Opportunity for Italy” project, promoted by Fondazione Smith Kline (FSK), which led to the publication of the first official document on the subject [7]. Interest in DTx has since grown across the scientific community, institutions, and industry. In 2023, a more structured phase began with the updated initiative Digital Therapeutics, a Necessity for Italy, the result of collaboration between FSK and FADOI, aiming to respond to the sector’s evolution more systematically [8]. That same year, the first of three draft laws (DDL no. 1208, XVII Legislature) was submitted to the Italian Parliament, containing specific provisions on digital therapeutics, including those for rehabilitation [9].

Further confirmation of this growing interest came in 2025 from the Life Science Innovation Observatory of the Politecnico di Milano, which provided a detailed picture of both the Italian and international landscape. The data showed that 65% of patients are willing to use a DTx, especially if recommended by their physician, and more than half of healthcare professionals, including general practitioners and specialists, would be in favor of prescribing one, provided patients have the necessary digital skills [10].

Despite this rising interest, significant barriers remain to the widespread adoption of DTx in Italy. Chief among them: the absence of a national reimbursement system under the Italian National Health Service (SSN) and the challenges for companies to demonstrate clinical and economic benefits in a structured way. Many companies are nevertheless investing in this direction: one in three has plans to develop or commercialize DTx solutions, though fewer have begun clinical trials, and many are constrained by development costs and the lack of reimbursement mechanisms.

In this context, the idea is gaining traction that, for DTx to become truly sustainable in Italy, a B2G model similar to that of traditional drugs must be adopted, where access is granted via medical prescription and public or insurance reimbursement. This approach would ensure equity of access, incentivize rigorous clinical validation, and allow integration of DTx into care pathways. At the same time, hybrid models are also being tested, such as reimbursement conditional on clinical outcomes, licenses purchased by local health authorities or hospitals, and pay-per-performance formulas [11].

For DTx to become an integral part of the healthcare system, however, several fundamental steps are needed: establishing an updated regulatory framework, allocating public funds to research and scientific validation, launching training and awareness programs for physicians and patients, and seriously addressing ethical issues related to sensitive data use and AI.

In the rehabilitation sector, digital therapeutics designed to support personalized, continuous, home-based pathways are of particular interest. In Italy, also thanks to investments from the National Recovery and Resilience Plan (PNRR), a favorable regulatory context for telerehabilitation has been created. Since 2022, several ministerial decrees and guidelines have detailed the requirements for teleconsultation, telemonitoring, and remote rehabilitation treatments, including organizational, legal, and safety aspects [12]. A key milestone was the 2025 launch of the National Telemedicine Platform, expected to reach up to 800,000 patients by 2026, ensuring interoperability with the new Electronic Health Record (FSE 2.0) and compliance with European security standards.

The Italian context is now mature, at least from a regulatory and infrastructural standpoint, to welcome DTx as an integral part of the healthcare system. Operational challenges remain: fostering digital culture, training healthcare professionals, supporting research, and structuring evaluation and reimbursement pathways. But the foundations are in place, and the future of rehabilitation, more personalized, accessible, and digital, has already begun.