Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic—An Experience Report of Corona Check and Corona Health
| Autor: | Johannes Schobel, Helmut Greger, Andreas Hoff, Lena Mulansky, Rüdiger Pryss, Marc Holfelder, Harald Baumeister, Winfried Schlee |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Medical device
020205 medical informatics Coronavirus disease 2019 (COVID-19) Computer science Process (engineering) medical device regulation Science Internet privacy 02 engineering and technology computer.software_genre App 03 medical and health sciences Mobile applications 0302 clinical medicine Medical software Pandemic Health care mental disorders MDR 0202 electrical engineering electronic engineering information engineering Experience report 030212 general & internal medicine ddc:610 mHealth business.industry mobile application Telemedizin Telemedicine medical device software E-Health ddc:004 App business DDC 610 / Medicine & health computer |
| Zdroj: | J, Vol 4, Iss 17, Pp 206-222 (2021) Volume 4 Issue 2 Pages 17-222 |
| ISSN: | 2571-8800 |
| Popis: | Within the healthcare environment, mobile health (mHealth) applications (apps) are becoming 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. In most countries, mHealth applications have to be compliant with several regulatory aspects to be declared a “medical app”. However, the latest applicable medical device regulation (MDR) does not provide more details on the requirements for mHealth applications. When developing a medical app, it is essential that all contributors in an interdisciplinary team—especially software engineers—are aware of the specific regulatory requirements beforehand. The development process, however, should not be stalled due to integration of the MDR. Therefore, a developing framework that includes these aspects is required to facilitate a reliable and quick 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 as a guidance for medical app developments during the pandemic and beyond. In particular, the important stages and challenges faced that emerged during the entire development process are highlighted. publishedVersion |
| Databáze: | OpenAIRE |
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