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探索数字疗法:现代医疗保健行业的下一个范式。

Exploring digital therapeutics: The next paradigm of modern health-care industry.

作者信息

Khirasaria Raj, Singh Vikramjit, Batta Angelika

机构信息

Saket District Center, New Delhi, India.

Department of Pharmacology, Maulana Azad Medical College, New Delhi, India.

出版信息

Perspect Clin Res. 2020 Apr-Jun;11(2):54-58. doi: 10.4103/picr.PICR_89_19. Epub 2020 May 6.

Abstract

In this era of 21 century, the most valuable resource is data. Digital technology can generate terabytes of data which has a tremendous potential in the modern-day world. Pharmaceuticals play an essential role in improving and maintaining the health of patients. However, their cost in health-care budget is a major issue. Due to high prevalence and unfavorable consequences, managing chronic and lifestyle disorders has now become areas of major clinical concern globally. Harnessing this digital technology in our overburdened health-care industry can improve the treatment outcome and even replace the existing treatment. Health authorities such as U.S. Food and Drug Administration (USFDA) are also acknowledging their potential. FDA's Center for Devices and Radiological Health has established the "Digital Health Program" which seeks to promote public health and provide continued regulatory clarity by enhancing outreach to digital health customers and developing and implementing regulatory strategies and policies for digital health technologies. The main focus of this article is to give an overview of digital therapeutics (DT), its clinical applications, role of regulators, and challenges ahead along with potential areas for developers and to present an update on major developments and initiatives taken in this field. The most important advantages of DT are that it has direct access to patients, decreases cost of treatment, encourages healthy lifestyle modifications, and can substitute or complement conventional treatments. Many of these models are still in infancy stage, and further research and development is needed to demonstrate their enormous potential in near future. If used judiciously, they can modernize our health-care industry.

摘要

在21世纪这个时代,最宝贵的资源是数据。数字技术能够生成数万亿字节的数据,这些数据在当今世界具有巨大潜力。制药行业在改善和维持患者健康方面发挥着至关重要的作用。然而,其在医疗保健预算中的成本却是一个主要问题。由于慢性病和生活方式紊乱的高患病率及不良后果,对其进行管理现已成为全球主要的临床关注领域。在负担过重的医疗保健行业中利用这种数字技术可以改善治疗效果,甚至取代现有的治疗方法。美国食品药品监督管理局(USFDA)等卫生当局也认可其潜力。FDA的设备与放射健康中心已设立了“数字健康计划”,该计划旨在通过加强与数字健康客户的沟通,并为数字健康技术制定和实施监管战略及政策,来促进公众健康并持续提供明确的监管规定。本文的主要重点是概述数字疗法(DT)、其临床应用、监管机构的作用、未来面临的挑战以及开发者的潜在领域,并介绍该领域的主要发展和举措的最新情况。数字疗法最重要的优势在于它可以直接接触患者、降低治疗成本、鼓励改变健康的生活方式,并且能够替代或补充传统治疗方法。许多此类模式仍处于起步阶段,需要进一步的研究和开发来证明它们在不久的将来的巨大潜力。如果明智地使用,它们可以使我们的医疗保健行业实现现代化。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c145/7342342/74cc3f844096/PCR-11-54-g001.jpg

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