Digital Therapeutics: Scientific, Technological, and Regulatory Challenges

Abstract

Digital Health Technologies have the potential to improve human health and well-being, optimize the quality and safety of care, increase access to treatment, making health services more efficient and reducing overall health care costs. Within the framework of Digital Health and Medicine, Digital Therapeutics are an emerging class of therapeutics that offer interventions driven by high-quality software programs, based on scientific evidence obtained through methodologically rigorous confirmatory clinical investigation, to prevent, manage, and treat a broad spectrum of physical, mental, and behavioural conditions. Similar to drugs, Digital Therapeutics consist of active ingredients and excipients. While the “digital active ingredient” is primarily responsible for the clinical outcome, “digital excipients” (virtual assistant, reminders, reward systems, etc.) are necessary to ensure the best user experience to the patient and to allow the prolonged use of the therapy. The research and development process of Digital Therapeutics may be divided into different phases, like research, discovery, pilot, and full clinical development. The confirmatory randomized controlled clinical trials are critical to generate evidence of benefit for regulatory approval, reimbursement, and prescription. Digital Therapeutics have the potential to transform the management of chronic diseases and to represent the first therapeutic option offered by doctors to their patients with chronic disease and dependence. In order to fulfil this transformative potential of Digital Therapeutics, it is necessary to address several barriers that prevent their uptake in medical practice, such as clinical evidence, reimbursement, data safety and privacy issues, information and education of patients and healthcare professionals.