Zovi Andrea, Ferrara Francesco, Gelmi Martina, Messina Noemi, Pagani Alessandra Ana Maria, Patti Teresa, Zanetti Lorenzetti Elena, Torri Tiziana, Langella Roberto
School of Pharmacy, Università di Camerino, Camerino, Italy.
Pharmacy Department, Asl Napoli 3 Sud, Nola, Naples, Italy.
Expert Rev Med Devices. 2025 Jan-Feb;22(2):141-147. doi: 10.1080/17434440.2025.2457468. Epub 2025 Jan 25.
Digital therapeutics (DTx) are an emerging phenomenon within the scientific landscape which is attracting considerable international interest. This review aimed to provide an overview of the definition and classification of DTx, focusing on the contribution that DTx may provide in the treatment of a lot of diseases, compared with pharmacological treatments and highlighting it strengthens and weaknesses into the European regulatory landscape.
They are software-generated therapeutic interventions directly to patients useful to prevent, manage or treat diseases. Digital therapeutics can come in many forms, including mobile apps, online programs, wearables, and virtual reality. The use of digital therapeutics has gained increasing attention in recent years as a potential alternative to traditional pharmacological treatments. According to the European legislation, DTx are not classified as medicinal products but as medical devices, and not always in a homogeneous way between different countries.
This regulatory lack could impact on the effectiveness of DTx in the European Union, which have the requirements to real impact on patients' health, like pharmacological treatments. It is therefore necessary to implement a stable regulatory system that can support conventional medicines prescriptions.
数字疗法（DTx）是科学领域中一种新兴现象，正吸引着国际社会的广泛关注。本综述旨在概述数字疗法的定义和分类，重点关注数字疗法在多种疾病治疗中可能发挥的作用，与药物治疗进行比较，并突出其在欧洲监管环境中的优势和劣势。
数字疗法是直接针对患者的软件生成的治疗干预措施，有助于预防、管理或治疗疾病。数字疗法有多种形式，包括移动应用程序、在线程序、可穿戴设备和虚拟现实。近年来，作为传统药物治疗的潜在替代方案，数字疗法的使用越来越受到关注。根据欧洲法律，数字疗法不被归类为药品，而是医疗器械，并且不同国家之间的分类方式并不总是一致的。
这种监管缺失可能会影响数字疗法在欧盟的有效性，而数字疗法需要像药物治疗一样对患者健康产生实际影响。因此，有必要实施一个稳定的监管系统，以支持传统药物处方。
