Regulations and Reimbursement of Digital Therapeutics: A Review of Current Global Practices and Future Prospects

Applied drug research, clinical trials and regulatory affairs Pub Date : 2021-10-18 DOI:10.2174/2667337108666211018101106

A. Dang, Dimple Dang, P. Rane

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Abstract

The ever-increasing use of digital technologies is rapidly changing the face of modern healthcare delivery. Healthcare systems are embracing digital health solutions to improve patient outcomes, enhance healthcare delivery, and reduce costs. Digital therapeutics (DTx) are now a popular category of digital health solutions aimed at preventing, managing, or treating medical disorders. These evidence-based technologies/products either complement a conventional therapy or are prescribed as stand-alone treatments for a range of conditions, including chronic diseases and mental health disorders. Many pharmaceutical companies and healthcare start-ups are developing DTx products for different health conditions. Despite similarities between DTx and conventional medicines, DTx products are not covered under reimbursement at present in many countries. There are no uniform regulations for DTx prescription and reimbursement. This review aims to analyse the current DTx scenario, particularly highlighting the regulatory aspect and reimbursement of DTx products globally.

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数字治疗的法规和报销:当前全球实践和未来展望的回顾

数字技术的日益普及正在迅速改变现代医疗保健服务的面貌。医疗保健系统正在采用数字医疗解决方案来改善患者的治疗效果、加强医疗保健服务并降低成本。数字疗法(DTx)现在是一种流行的数字健康解决方案，旨在预防、管理或治疗医疗疾病。这些以证据为基础的技术/产品或作为常规疗法的补充，或作为一系列病症(包括慢性病和精神健康障碍)的独立治疗处方。许多制药公司和医疗保健初创企业正在开发针对不同健康状况的DTx产品。尽管DTx与传统药物有相似之处，但目前在许多国家，DTx产品不在报销范围内。DTx的处方和报销没有统一的规定。本综述旨在分析当前DTx方案，特别强调全球DTx产品的监管方面和报销。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Applied drug research, clinical trials and regulatory affairs

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