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Medical device regulation efforts for mHealth apps during the COVID-19 pandemic — an experience report of Corona Check and Corona Health
Please always quote using this URN: urn:nbn:de:bvb:20-opus-285434
- 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 aWithin 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.…
Author: | Marc Holfelder, Lena Mulansky, Winfried Schlee, Harald Baumeister, Johannes Schobel, Helmut Greger, Andreas Hoff, Rüdiger Pryss |
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URN: | urn:nbn:de:bvb:20-opus-285434 |
Document Type: | Journal article |
Faculties: | Medizinische Fakultät / Institut für Klinische Epidemiologie und Biometrie |
Language: | English |
Parent Title (English): | J — Multidisciplinary Scientific Journal |
ISSN: | 2571-8800 |
Year of Completion: | 2021 |
Volume: | 4 |
Issue: | 2 |
First Page: | 206 |
Last Page: | 222 |
Source: | J — Multidisciplinary Scientific Journal (2021) 4:2, 206-222. https://doi.org/10.3390/j4020017 |
DOI: | https://doi.org/10.3390/j4020017 |
Sonstige beteiligte Institutionen: | Servicezentrum Medizin-Informatik (Universitätsklinikum) |
Dewey Decimal Classification: | 0 Informatik, Informationswissenschaft, allgemeine Werke / 00 Informatik, Wissen, Systeme / 004 Datenverarbeitung; Informatik |
6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit | |
Tag: | MDR; mHealth; medical device regulation; medical device software; mobile application |
Release Date: | 2023/06/07 |
Date of first Publication: | 2021/06/16 |
Licence (German): | CC BY: Creative-Commons-Lizenz: Namensnennung 4.0 International |