Exploring the ethical issues of digital therapeutics (DTx)

Digital therapeutics (DTx) are innovative evidence-based medical interventions, driven by high-quality software programs to prevent, manage, or treat diseases of patients. DTx are also defined as “drugs” where algorithms are the active ingredient instead of a chemical or biological substance. DTX can be used alone or in combination with other devices or medications. DTxs are finding application in a variety of areas, including chronic diseases (type II diabetes, hypertension, obesity, insomnia, Alzheimer’s), and above all addictions (alcohol, smoking, and drugs). To date there are roughly 35 to 40 products on the market, 8 of which approved by regulatory agencies. The value of the global DTx market has been estimated at USD 1.8 billion in 2018, and it is expected to reach USD 8.9 billion by 2027. DTx differ from common wellness apps or medication reminder tools in that they require “rigorous” clinical evidence. However, their use raises a number of ethical concerns. Aim of the present work is to provide an overview of the main ethical issues pertaining the assessment of this emerging technology. The final purpose is to support and facilitate an open and transparent ethical debate with regard to DTx.