@article{HolfelderMulanskySchleeetal.2021,
  author    = {Holfelder, Marc and Mulansky, Lena and Schlee, Winfried and Baumeister, Harald and Schobel, Johannes and Greger, Helmut and Hoff, Andreas and Pryss, R{\"u}diger},
  title     = {Medical device regulation efforts for mHealth apps during the COVID-19 pandemic — an experience report of Corona Check and Corona Health},
  series = {J — Multidisciplinary Scientific Journal},
  volume    = {4},
  journal   = {J — Multidisciplinary Scientific Journal},
  number    = {2},
  issn      = {2571-8800},
  doi       = {10.3390/j4020017},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-285434},
  pages     = {206 -- 222},
  year      = {2021},
  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.},
  language  = {en}
}
@article{BeierleSchobelVogeletal.2021,
  author    = {Beierle, Felix and Schobel, Johannes and Vogel, Carsten and Allgaier, Johannes and Mulansky, Lena and Haug, Fabian and Haug, Julian and Schlee, Winfried and Holfelder, Marc and Stach, Michael and Schickler, Marc and Baumeister, Harald and Cohrdes, Caroline and Deckert, J{\"u}rgen and Deserno, Lorenz and Edler, Johanna-Sophie and Eichner, Felizitas A. and Greger, Helmut and Hein, Grit and Heuschmann, Peter and John, Dennis and Kestler, Hans A. and Krefting, Dagmar and Langguth, Berthold and Meybohm, Patrick and Probst, Thomas and Reichert, Manfred and Romanos, Marcel and St{\"o}rk, Stefan and Terhorst, Yannik and Weiß, Martin and Pryss, R{\"u}diger},
  title     = {Corona Health — A Study- and Sensor-Based Mobile App Platform Exploring Aspects of the COVID-19 Pandemic},
  series = {International Journal of Environmental Research and Public Health},
  volume    = {18},
  journal   = {International Journal of Environmental Research and Public Health},
  number    = {14},
  issn      = {1660-4601},
  doi       = {10.3390/ijerph18147395},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-242658},
  year      = {2021},
  abstract  = {Physical and mental well-being during the COVID-19 pandemic is typically assessed via surveys, which might make it difficult to conduct longitudinal studies and might lead to data suffering from recall bias. Ecological momentary assessment (EMA) driven smartphone apps can help alleviate such issues, allowing for in situ recordings. Implementing such an app is not trivial, necessitates strict regulatory and legal requirements, and requires short development cycles to appropriately react to abrupt changes in the pandemic. Based on an existing app framework, we developed Corona Health, an app that serves as a platform for deploying questionnaire-based studies in combination with recordings of mobile sensors. In this paper, we present the technical details of Corona Health and provide first insights into the collected data. Through collaborative efforts from experts from public health, medicine, psychology, and computer science, we released Corona Health publicly on Google Play and the Apple App Store (in July 2020) in eight languages and attracted 7290 installations so far. Currently, five studies related to physical and mental well-being are deployed and 17,241 questionnaires have been filled out. Corona Health proves to be a viable tool for conducting research related to the COVID-19 pandemic and can serve as a blueprint for future EMA-based studies. The data we collected will substantially improve our knowledge on mental and physical health states, traits and trajectories as well as its risk and protective factors over the course of the COVID-19 pandemic and its diverse prevention measures.},
  language  = {en}
}