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

J

卷:4

Winfried Schlee¹  Harald Baumeister²  Johannes Schobel³  Rüdiger Pryss⁴  Lena Mulansky⁴  Marc Holfelder⁵  Andreas Hoff⁵  Helmut Greger⁶ 

[1] Clinic and Polyclinic for Psychiatry and Psychotherapy, University of Regensburg, 93053 Regensburg, Germany;

[2] Department of Clinical Psychology and Psychotherapy, Ulm University, 89081 Ulm, Germany;

[3] Institute DigiHealth, Neu-Ulm University of Applied Sciences, 89231 Ulm, Germany;

[4] Institute of Clinical Epidemiology and Biometry, University of Würzburg, 97070 Würzburg, Germany;

[5] LA2 GmbH, 91054 Erlangen, Germany;

[6] Service Center Medical Informatics, Würzburg University Hospital, 97080 Würzburg, Germany;

关键词: mHealth;    mobile application;    MDR;    medical device regulation;    medical device software;   

DOI  :  10.3390/j4020017

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown