OBJECTIVES: Technological innovation, in its broadest meaning, is one of the elements characterizing the governance and the transformation of health systems. The analysis aims to analyze the impact of Digital Medicines on the current clinical pathway of patients with chronic diseases in Italy.

METHODS: The analysis of the impact of Digital Medicines in the Italian national healthcare context started from a previous review aimed at understanding the readiness of the different regions regarding the implementation of digital therapies within healthcare processes. The ultimate goal was the creation of a "new pathway" for the management of patients suffering by chronic diseases (i.e. type 2 diabetes) integrated by Digital Health technologies.

RESULTS: Starting from the current managerial model used for patients with diabetes, the analysis of the literature and the available scientific evidence we developed a new model composed by four pillars: organizational and managerial assets, skills, software enabling the use of new health technologies and the regulatory framework. Each pillar contains the bricks characterizing the ideal therapeutic pathway. In particular, some of these elements represent the evolution of already available feature adopted by the Italian Regions. The innovative bricks flank the previous ones and define the new model for the diabetic disease management within the Italian NHS.

CONCLUSIONS: The development of a new framework integrated with the new tools of Digital Medicine must consider two major ecosystems: one concerning the management of health records generated by the digital therapies and another one related to the policy framework in which those technologies should be embedded.