Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic—An Experience Report of Corona Check and Corona Health

Marc Holfelder, Lena Mulansky, Winfried Schlee, Harald Baumeister, Johannes Schobel, Helmut Greger, Andreas Hoff and Rüdiger Pryss
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Marc Holfelder: LA2 GmbH, 91054 Erlangen, Germany
Lena Mulansky: Institute of Clinical Epidemiology and Biometry, University of Würzburg, 97070 Würzburg, Germany
Winfried Schlee: Clinic and Polyclinic for Psychiatry and Psychotherapy, University of Regensburg, 93053 Regensburg, Germany
Harald Baumeister: Department of Clinical Psychology and Psychotherapy, Ulm University, 89081 Ulm, Germany
Johannes Schobel: Institute DigiHealth, Neu-Ulm University of Applied Sciences, 89231 Ulm, Germany
Helmut Greger: Service Center Medical Informatics, Würzburg University Hospital, 97080 Würzburg, Germany
Andreas Hoff: LA2 GmbH, 91054 Erlangen, Germany
Rüdiger Pryss: Institute of Clinical Epidemiology and Biometry, University of Würzburg, 97070 Würzburg, Germany

J, 2021, vol. 4, issue 2, 1-17

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.

Keywords: mHealth; mobile application; MDR; medical device regulation; medical device software (search for similar items in EconPapers)
JEL-codes: I1 I10 I12 I13 I14 I18 I19 (search for similar items in EconPapers)
Date: 2021
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