Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic—An Experience Report of Corona Check and Corona Health
Open accessAbstract
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.
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Special issue on digital health interventions in chronic medical conditions: Editorial
Baumeister, H., Ebert, D. D., & Snoek, F. (2022) · Internet Interventions · doi:10.1016/j.invent.2021.100457 · Cited by 13 · see citing works
“…gathered in the past two decades of digital intervention development, that have led to intervention development guidelines and recommendations from both a clinical and a technological perspective (Edwards-Stewart et al., 2019; Holfelder et al., 2021; Karekla et al., 2019; Michie et al., 2017).”
BackgroundSelf-citation
- Authors
- Holfelder, M., Mulansky, L., Schlee, W., Baumeister, H., Schobel, J., Greger, H., Hoff, A., & Pryss, R.
- Affiliations
- LA2 GmbH, 91054 Erlangen, Germany
- University of Würzburg (DE)
- University of Regensburg (DE)
- Universität Ulm (DE)
- Neu-Ulm University of Applied Sciences (DE)
- Universitätsklinikum Würzburg (DE)
- Corresponding author
- Mulansky, Lena
- Venue
- J
- Publisher
- MDPI AG
- Published
- 2021-06-16
- Volume
- 4
- Issue
- 2
- Pages
- 206-222
- ISSN
- 2571-8800 (ISSN-L)
- OpenAlex
- W3168581581
- Cited by
- 31
- References
- 4
- Citations by year
- 2026: 6 · 2025: 3 · 2024: 8 · 2023: 3 · 2022: 7 · 2021: 4
- FWCI
- 6.18
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- J — Multidisciplinary Scientific Journal (publishedVersion, cc-by)
- OPen Access Repositorium der Universität Ulm (OPARU) (Ulm University) (submittedVersion, other-oa)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Online Publication Service of Würzburg University (Würzburg University) (submittedVersion, cc-by)
- Universität Ulm, Kommunikations- und Informationszentrum (kiz) (cc-by)
- Funders
- German Federal Ministry of Education and Research (01KX2021)
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Physical Sciences › Computer Science › Information Systems › COVID-19 Digital Contact Tracing
- Keywords
- mobile health apps, medical device regulation, COVID-19 pandemic, regulatory compliance, development framework, interdisciplinary teams
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