Introduction

The development of digital therapies (DTx) has attracted considerable attention in the scientific community worldwide. DTx are software-based therapeutic interventions specifically designed to prevent, manage, or treat various diseases directly in patients.

Method

Given the limited available sources on this topic in the current international scientific literature, the purpose of this review is to provide an overview of the definition and history leading up to the marketing of DTx, as well as to categorize the major DTx currently on the market on the basis of indications and mechanisms of action, with a focus on the regulatory processes that have enabled their use in clinical practice.

Discussion

It is well-known that currently regulatory frameworks on DTx are not globally harmonized. The American legislation, for instance, has more uniformly addressed DTx than other legislation such as Europe; in fact, the first globally approved DTX have been authorized in the USA. This lack which currently characterizes regulatory frameworks worldwide may lead to the risk of misclassifying genuine therapies that have undergone multiple clinical trials, each with a distinct impact on patient health.

Conclusion

To obtain full advantage of the enormous potential of DTx, an appropriate regulatory framework needs to be established by the governments of the main countries where DTx are placed on the market, able to complement traditional medicine prescriptions.

中文翻译：

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数字疗法作为治疗疾病的新治疗选择的发展：关注国际监管框架

介绍

数字疗法（DTx）的发展引起了全球科学界的广泛关注。DTx 是基于软件的治疗干预措施，专门用于直接预防、管理或治疗患者的各种疾病。

方法

鉴于当前国际科学文献中关于该主题的可用资源有限，本次综述的目的是概述 DTx 的定义和营销历史，并对目前市场上的主要 DTx 进行分类以适应症和作用机制为基础，重点关注使其能够在临床实践中使用的监管流程。

讨论

众所周知，目前 DTx 的监管框架尚未在全球范围内统一。例如，美国立法比欧洲等其他立法更统一地解决了 DTx 问题；事实上，第一个全球批准的 DTX 已在美国获得授权。目前全球监管框架的这种缺乏可能会导致对经过多次临床试验的真正疗法进行错误分类的风险，而每一次临床试验都会对患者的健康产生不同的影响。

结论

为了充分利用 DTx 的巨大潜力，DTx 投放市场的主要国家政府需要建立适当的监管框架，以补充传统药物处方。