Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic—An Experience Report of Corona Check and Corona Health
Open Access
- 16 June 2021
- Vol. 4 (2), 206-222
- https://doi.org/10.3390/j4020017
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
Funding Information
- German Federal Ministry of Education and Research (01KX2021)
This publication has 20 references indexed in Scilit:
- Systematic evaluation of content and quality of English and German pain apps in European app storesInternet Interventions, 2021
- Mobile Apps for Older Adults: Systematic Search and Evaluation Within Online StoresJMIR Aging, 2021
- Stay Present with Your Phone: A Systematic Review and Standardized Rating of Mindfulness Apps in European App StoresInternational Journal of Behavioral Medicine, 2020
- Mobile Health App Database - A Repository for Quality Ratings of mHealth AppsPublished by Institute of Electrical and Electronics Engineers (IEEE) ,2020
- Medical Device Apps: An Introduction to Regulatory Affairs for DevelopersJMIR mHealth and uHealth, 2020
- ‘Help for trauma from the app stores?’ A systematic review and standardised rating of apps for Post-Traumatic Stress Disorder (PTSD)European Journal of Psychotraumatology, 2020
- «Hilfe aus dem App-Store?»: Eine systematische Übersichtsarbeit und Evaluation von Apps zur Anwendung bei DepressionenVerhaltenstherapie, 2018
- Heart Rate Monitoring Apps: Information for Engineers and Researchers About the New European Medical Devices Regulation 2017/745JMIR Biomedical Engineering, 2017
- Mobile medical app development with a focus on traceabilityJournal of Software: Evolution and Process, 2017
- Tailoring MDevSPICE® for mobile medical appsPublished by Association for Computing Machinery (ACM) ,2016