Digital therapeutics as a new weapon against diseases: focus on the current European legislation and possible therapeutic strategies.

Introduction: Digital therapeutics (DTx) are an emerging phenomenon within the scientific landscape which is attracting considerable international interest. This review aimed to provide an overview of the definition and classification of DTx, focusing on the contribution that DTx may provide in the treatment of a lot of diseases, compared with pharmacological treatments and highlighting it strengthens and weaknesses into the European regulatory landscape.

Areas Covered: They are software-generated therapeutic interventions directly to patients useful to prevent, manage or treat diseases. Digital therapeutics can come in many forms, including mobile apps, online programs, wearables, and virtual reality. The use of digital therapeutics has gained increasing attention in recent years as a potential alternative to traditional pharmacological treatments. According to the European legislation, DTx are not classified as medicinal products but as medical devices, and not always in a homogeneous way between different countries.

Expert Opinion: This regulatory lack could impact on the effectiveness of DTx in the European Union, which have the requirements to real impact on patients' health, like pharmacological treatments. It is therefore necessary to implement a stable regulatory system that can support conventional medicines prescriptions.