Within the healthcare environment, mobile health (mHealth) applications (apps) are more and more important. The number of new mHealth apps has risen steadily in the last years. Especially the Covid-19 pandemic has led to an enormous amount of app releases. Notably, in most countries, mHealth applications have to be already compliant with several regulatory aspects in order to be declared to be a 'medical app'. However, the latest applicable medical device regulation (MDR) does not comment in more detail on the topic of the requirements for mHealth applications. When developing a medical app, it is essential that all contributors in an interdisciplinary team - especially the software engineers - are aware of the specific regulatory requirements beforehand. The development process, however, should not be stalled too long due to the integration of the MDR. Therefore, a developing framework, which includes these aspects, is required, to enable a smooth development process. The paper at hand introduces the creation of such a framework on the basis of the Corona Health and Corona Check apps. The relevant regulatory guidelines are listed and summarized to a guidance for medical app developments. In particular, the important stages and faced challenges emerged during the entire development process are highlighted.
翻译:在医疗保健环境内,移动保健(保健)应用(应用)越来越重要。在过去几年里,新的保健应用(应用)数量稳步增加。特别是Covid-19大流行导致大量软件释放。值得注意的是,在大多数国家,保健应用必须已经符合若干监管方面,才能被宣布为“医疗应用 ” 。然而,最新适用的医疗设备管理条例(MDR)没有更详细地评论健康应用要求的主题。在开发医疗应用时,所有跨学科团队的参与者,特别是软件工程师,都必须事先了解具体的监管要求。然而,由于MDR的整合,开发过程不应停顿太久。因此,需要有一个包括这些方面的发展框架,以便能够顺利地发展。手头的文件介绍了在Corona健康应用和Corona Check Apps的基础上建立这样一个框架。相关的管理准则被列出并概括为医疗应用发展指南。特别是整个开发过程中的重要阶段和面临的挑战都得到了强调。