  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.

Software Engineering;Computers and Society