ABSTRACT

This chapter focuses on digital therapeutics (DTx)—software-based treatment modalities that deliver therapeutic interventions directly to patients. It defines digital therapeutics and describes foundational principles that any DTx product should satisfy. The chapter describes digital therapeutics within a broader class of digital health products. It presents some important considerations on the use of digital health technologies in general and digital therapeutics in particular. The chapter outlines existing best practices on the standards of evidence for digital therapeutics. It describes the potential merits of digital therapeutics, and presents some considerations on how DTx products can be used in practice. The chapter also describes existing gaps in clinical care that may be filled by digital therapeutics, and corroborates these ideas in the COVID-19 pandemic crisis. It is not only important to match the product's intended use and environment of care to the end user's clinical need but also the product's functionality during the various phases of clinical care.