Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome (Italy); Department of Healthcare Surveillance and Bioethics, Università Cattolica del Sacro Cuore, Rome, Italy.
Eur Rev Med Pharmacol Sci. 2022 Sep;26(18):6418-6423. doi: 10.26355/eurrev_202209_29741.
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.
数字疗法（DTx）是数字健康的一个分支，通常与人工智能（AI）技术和机器学习系统结合使用。DTx 与常见的健康应用程序或药物提醒工具不同，它们需要“严格”的临床证据。它们作为一种新的治疗选择正在出现，并在包括 II 型糖尿病、高血压、慢性呼吸问题、肥胖、失眠、阿尔茨海默病、各种类型的痴呆或成瘾（吸烟、酒精、药物）、焦虑、抑郁、自闭症、学习障碍和注意力缺陷在内的各种领域得到应用。如今，市场上大约有 35 到 40 种产品，其中 8 种获得了监管机构的批准。2018 年全球 DTx 市场价值估计为 18 亿美元，预计到 2027 年将达到 89 亿美元。在医疗保健系统中实施 DTx 引发了许多伦理问题。本文旨在概述与评估、实施和使用这项新兴技术相关的主要伦理问题。最终目的是支持和促进对 DTx 的公开透明讨论。
