@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{KraftBirkReichertetal.2020, author = {Kraft, Robin and Birk, Ferdinand and Reichert, Manfred and Deshpande, Aniruddha and Schlee, Winfried and Langguth, Berthold and Baumeister, Harald and Probst, Thomas and Spiliopoulou, Myra and Pryss, R{\"u}diger}, title = {Efficient processing of geospatial mHealth data using a scalable crowdsensing platform}, series = {Sensors}, volume = {20}, journal = {Sensors}, number = {12}, issn = {1424-8220}, doi = {10.3390/s20123456}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-207826}, year = {2020}, abstract = {Smart sensors and smartphones are becoming increasingly prevalent. Both can be used to gather environmental data (e.g., noise). Importantly, these devices can be connected to each other as well as to the Internet to collect large amounts of sensor data, which leads to many new opportunities. In particular, mobile crowdsensing techniques can be used to capture phenomena of common interest. Especially valuable insights can be gained if the collected data are additionally related to the time and place of the measurements. However, many technical solutions still use monolithic backends that are not capable of processing crowdsensing data in a flexible, efficient, and scalable manner. In this work, an architectural design was conceived with the goal to manage geospatial data in challenging crowdsensing healthcare scenarios. It will be shown how the proposed approach can be used to provide users with an interactive map of environmental noise, allowing tinnitus patients and other health-conscious people to avoid locations with harmful sound levels. Technically, the shown approach combines cloud-native applications with Big Data and stream processing concepts. In general, the presented architectural design shall serve as a foundation to implement practical and scalable crowdsensing platforms for various healthcare scenarios beyond the addressed use case.}, language = {en} } @article{PryssSchleeHoppenstedtetal.2020, author = {Pryss, R{\"u}diger and Schlee, Winfried and Hoppenstedt, Burkhard and Reichert, Manfred and Spiliopoulou, Myra and Langguth, Berthold and Breitmayer, Marius and Probst, Thomas}, title = {Applying Machine Learning to Daily-Life Data From the TrackYourTinnitus Mobile Health Crowdsensing Platform to Predict the Mobile Operating System Used With High Accuracy: Longitudinal Observational Study}, series = {Journal of Medical Internet Research}, volume = {22}, journal = {Journal of Medical Internet Research}, number = {6}, doi = {10.2196/15547}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-229517}, year = {2020}, abstract = {Background: Tinnitus is often described as the phantom perception of a sound and is experienced by 5.1\% to 42.7\% of the population worldwide, at least once during their lifetime. The symptoms often reduce the patient's quality of life. The TrackYourTinnitus (TYT) mobile health (mHealth) crowdsensing platform was developed for two operating systems (OS)-Android and iOS-to help patients demystify the daily moment-to-moment variations of their tinnitus symptoms. In all platforms developed for more than one OS, it is important to investigate whether the crowdsensed data predicts the OS that was used in order to understand the degree to which the OS is a confounder that is necessary to consider.}, language = {en} } @article{UnnikrishnanSchleicherShahetal.2020, author = {Unnikrishnan, Vishnu and Schleicher, Miro and Shah, Yash and Jamaludeen, Noor and Pryss, Ruediger and Schobel, Johannes and Kraft, Robin and Schlee, Winfried and Spiliopoulou, Myra}, title = {The effect of non-personalised tips on the continued use of self-monitoring mHealth applications}, series = {Brain Sciences}, volume = {10}, journal = {Brain Sciences}, number = {12}, issn = {2076-3425}, doi = {10.3390/brainsci10120924}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-219435}, year = {2020}, abstract = {Chronic tinnitus, the perception of a phantom sound in the absence of corresponding stimulus, is a condition known to affect patients' quality of life. Recent advances in mHealth have enabled patients to maintain a 'disease journal' of ecologically-valid momentary assessments, improving patients' own awareness of their disease while also providing clinicians valuable data for research. In this study, we investigate the effect of non-personalised tips on patients' perception of tinnitus, and on their continued use of the application. The data collected from the study involved three groups of patients that used the app for 16 weeks. Groups A \& Y were exposed to feedback from the start of the study, while group B only received tips for the second half of the study. Groups A and Y were run by different supervisors and also differed in the number of hospital visits during the study. Users of Group A and B underwent assessment at baseline, mid-study, post-study and follow-up, while users of group Y were only assessed at baseline and post-study. It is seen that the users in group B use the app for longer, and also more often during the day. The answers of the users to the Ecological Momentary Assessments are seen to form clusters where the degree to which the tinnitus distress depends on tinnitus loudness varies. Additionally, cluster-level models were able to predict new unseen data with better accuracy than a single global model. This strengthens the argument that the discovered clusters really do reflect underlying patterns in disease expression.}, language = {en} }