TY  - JOUR
A1  - Holfelder, Marc
A1  - Mulansky, Lena
A1  - Schlee, Winfried
A1  - Baumeister, Harald
A1  - Schobel, Johannes
A1  - Greger, Helmut
A1  - Hoff, Andreas
A1  - Pryss, Rüdiger
T1  - Medical device regulation efforts for mHealth apps during the COVID-19 pandemic — an experience report of Corona Check and Corona Health
JF  - J — Multidisciplinary Scientific Journal
N2  - 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.
KW  - mHealth
KW  - mobile application
KW  - MDR
KW  - medical device regulation
KW  - medical device software
Y1  - 2021
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-285434
SN  - 2571-8800
VL  - 4
IS  - 2
SP  - 206
EP  - 222
ER  -