Jansen Marilou, Meijer Henriëtte A W, Barsom Esther Z, van Raamsdonk Annette J, Schijven Marlies P
Amsterdam UMC, locatie AMC, afd. Chirurgie, Amsterdam.
Contact: Marilou Jansen (
Ned Tijdschr Geneeskd. 2020 Nov 5;164:D4956.
During the current coronacrisis, there is an increasing call for the use of corona-apps. Meanwhile, discussions are increasing about the safety and privacy of our patients, and whether these can be guaranteed when using e-health apps. Though this topic has been relevant for a while, the global corona discussion gives it the attention it should always receive. Healthcare professionals are often unaware of specific rules and regulations regarding the development and use of e-health applications. When does a mobile app qualify as a medical device? What requirements need to be fulfilled before an app can safely be used in patient care? This article provides an overview of important steps in the development of e-health apps. The article describes where to start and which rules and regulations to follow. The provided descriptions are not only important in the development and implementation of corona-apps, but in the use of all e-health apps.
在当前的新冠疫情危机期间，对使用新冠应用程序的呼声越来越高。与此同时，关于我们患者的安全和隐私以及在使用电子健康应用程序时这些能否得到保障的讨论也日益增多。尽管这个话题已经存在了一段时间，但全球范围内的新冠疫情讨论使其得到了应有的关注。医疗保健专业人员通常不了解有关电子健康应用程序开发和使用的具体规则和规定。移动应用程序何时可被认定为医疗设备？在应用程序能够安全地用于患者护理之前需要满足哪些要求？本文概述了电子健康应用程序开发中的重要步骤。文章描述了从何处着手以及应遵循哪些规则和规定。所提供的描述不仅在新冠应用程序的开发和实施中很重要，在所有电子健康应用程序的使用中也很重要。
