@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{KraftReichertPryss2021,
  author    = {Kraft, Robin and Reichert, Manfred and Pryss, R{\"u}diger},
  title     = {Towards the interpretation of sound measurements from smartphones collected with mobile crowdsensing in the healthcare domain: an experiment with Android devices},
  series = {Sensors},
  volume    = {22},
  journal   = {Sensors},
  number    = {1},
  issn      = {1424-8220},
  doi       = {10.3390/s22010170},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-252246},
  year      = {2021},
  abstract  = {The ubiquity of mobile devices fosters the combined use of ecological momentary assessments (EMA) and mobile crowdsensing (MCS) in the field of healthcare. This combination not only allows researchers to collect ecologically valid data, but also to use smartphone sensors to capture the context in which these data are collected. The TrackYourTinnitus (TYT) platform uses EMA to track users' individual subjective tinnitus perception and MCS to capture an objective environmental sound level while the EMA questionnaire is filled in. However, the sound level data cannot be used directly among the different smartphones used by TYT users, since uncalibrated raw values are stored. This work describes an approach towards making these values comparable. In the described setting, the evaluation of sensor measurements from different smartphone users becomes increasingly prevalent. Therefore, the shown approach can be also considered as a more general solution as it not only shows how it helped to interpret TYT sound level data, but may also stimulate other researchers, especially those who need to interpret sensor data in a similar setting. Altogether, the approach will show that measuring sound levels with mobile devices is possible in healthcare scenarios, but there are many challenges to ensuring that the measured values are interpretable.},
  language  = {en}
}