2021/04/28 by Marc Holfelder, Lena Mulansky, Holfelder, Marc +13
Engineering · Health Professions · Psychology · #Computers and Society (cs.CY) #Digital Mental Health Interventions #FOS: Computer and information sciences #Mobile Health and mHealth Applications #Software Engineering (cs.SE) #Wireless Body Area Networks
paper · pdf · doi:10.48550/arxiv.2104.13635
openalex publication_date 2021/04/28 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/28
Within the healthcare environment, mobile health (mHealth) applications\n(apps) are more and more important. The number of new mHealth apps has risen\nsteadily in the last years. Especially the Covid-19 pandemic has led to an\nenormous amount of app releases. Notably, in most countries, mHealth\napplications have to be already compliant with several regulatory aspects in\norder to be declared to be a 'medical app'. However, the latest applicable\nmedical device regulation (MDR) does not comment in more detail on the topic of\nthe requirements for mHealth applications. When developing a medical app, it is\nessential that all contributors in an interdisciplinary team - especially the\nsoftware engineers - are aware of the specific regulatory requirements\nbeforehand. The development process, however, should not be stalled too long\ndue to the integration of the MDR. Therefore, a developing framework, which\nincludes these aspects, is required, to enable a smooth development process.\nThe paper at hand introduces the creation of such a framework on the basis of\nthe Corona Health and Corona Check apps. The relevant regulatory guidelines are\nlisted and summarized to a guidance for medical app developments. In\nparticular, the important stages and faced challenges emerged during the entire\ndevelopment process are highlighted.\n