Ethics of digital therapeutics (DTx)

P. Refolo, D. Sacchini, C. Raimondi, A.G. Spagnolo

Fondazione Policlinico Universitario “A. Gemelli” IRCCS, Rome (Italy); Department of Healthcare Surveillance and Bioethics, Università Cattolica del Sacro Cuore, Rome, Italy. dario.sacchini@unicatt.it

---

• Bioethics

Digital therapeutics (DTx) are a subset of digital health which are often coupled with artificial intelligence (A.I.) techniques and machine learning systems. DTx differ from common wellness apps or medication reminder tools in that they require “rigorous” clinical evidence. They are emerging as a new treatment option and are being applied in a variety of areas, including type II diabetes, hypertension, chronic respiratory problems, obesity, insomnia, Alzheimer’s disease, various types of dementia or addiction (smoking, alcohol, drugs), anxiety, depression, autism, learning disabilities, and attention deficits. Today, there are roughly 35 to 40 products on the market, 8 of which approved by regulatory agencies. The value of the global DTx market was estimated at USD 1.8 billion in 2018, and it is expected to reach USD 8.9 billion by 2027.

Implementing DTx across healthcare systems raises a number of ethical concerns. The present article aims to provide an overview of the main ethical issues pertaining the assessment, implementation, and use of this emerging technology. The final purpose is to support and facilitate an open and transparent deliberation with regard to DTx.

Free PDF Download