Therapeutic innovation and digital therapies in the world: Comparison between the American and European regulatory framework, with focus on Italy

Digital therapies (DTx) are software-generated therapeutic interventions directly to patients developed to prevent, manage or treat a disease. They figure as an emerging phenomenon within the scientific landscape which is attracting considerable international interest. In the absence of any in-depth study in the current international scientific literature, this review aimed to provide an overview of the definition and classification of DTx and the main issues relating to clinical studies, ethical implications and gray areas in the international regulatory processes, eventually providing an in-depth look focused on the American and European regulatory landscape. It emerged that DTx are not contemplated in a homogeneous way by the European legislation currently in force. This lack would risk incorrectly classifying real therapies, subjected to clinical trials, often very different from each other and with a real impact on patients’ health, causing several critical issues both of safety and guarantee of access to treatment. Since the great potential of DTx will be only exploited when there is an appropriate regulatory framework which frame and define the field, the implementation of a stable regulatory system complementing conventional drug prescriptions is needed as soon as possible. Besides, TDx-specific research ethics, patient-centered care, as well as training and education of health professionals need strengthened and consolidated interprofessional cooperation in order to address the new skills, competences and challenges posed by DTx-related practices.