Abstract
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.
Highlights
Introduction iationsRegardless of pandemic mobile apps, regulatory requirements in the area of medical mobile apps have been neglected for a very long time
As currently less works exist about how mobile health (mHealth) apps have to be developed in this context, the experiences of LA2 were transferred for the approach used in Corona Check and Corona Health
Based on years of experience in the field of app development as well as regulatory software development in general, especially those that were responsible for the Corona
Summary
Introduction iationsRegardless of pandemic mobile apps, regulatory requirements in the area of medical mobile apps have been neglected for a very long time. Since neither the Medical Devices Act nor the Medical Device Regulation provide more detail on the requirements for a medical app, first, common standards and regulations were identified [4,5]. They had to be analyzed and compared with regards to relevant topics. As currently less works exist about how mHealth apps have to be developed in this context, the experiences of LA2 were transferred for the approach used in Corona Check and Corona Health. The final list used to accomplish the self-validation covers the following regulations and standards: IEC 62304—Medical Devices Software—Software Life Cycle Processes
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