The Development of Digital Therapies as a New Therapeutic Option to Treat Diseases: Focus on the International Regulatory Framework

Introduction The development of digital therapies (DTx) has attracted considerable attention in the scientific community worldwide. DTx are software-based therapeutic interventions specifically designed to prevent, manage, or treat various diseases directly in patients. Method Given the limited available sources on this topic in the current international scientific literature, the purpose of this review is to provide an overview of the definition and history leading up to the marketing of DTx, as well as to categorize the major DTx currently on the market on the basis of indications and mechanisms of action, with a focus on the regulatory processes that have enabled their use in clinical practice. Discussion It is well-known that currently regulatory frameworks on DTx are not globally harmonized. The American legislation, for instance, has more uniformly addressed DTx than other legislation such as Europe; in fact, the first globally approved DTX have been authorized in the USA. This lack which currently characterizes regulatory frameworks worldwide may lead to the risk of misclassifying genuine therapies that have undergone multiple clinical trials, each with a distinct impact on patient health. Conclusion To obtain full advantage of the enormous potential of DTx, an appropriate regulatory framework needs to be established by the governments of the main countries where DTx are placed on the market, able to complement traditional medicine prescriptions.

Automated summary

Digital therapies (DTx) are software-based therapeutic interventions designed to prevent, manage, or treat diseases. This review provides an overview of the definition and history of DTx, categorizes the major DTx currently on the market based on indications and mechanisms of action, and discusses the regulatory processes enabling their use in clinical practice.