TY - JOUR A1 - Holfelder, Marc A1 - Mulansky, Lena A1 - Schlee, Winfried A1 - Baumeister, Harald A1 - Schobel, Johannes A1 - Greger, Helmut A1 - Hoff, Andreas A1 - Pryss, Rüdiger T1 - Medical device regulation efforts for mHealth apps during the COVID-19 pandemic — an experience report of Corona Check and Corona Health JF - J — Multidisciplinary Scientific Journal N2 - 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. KW - mHealth KW - mobile application KW - MDR KW - medical device regulation KW - medical device software Y1 - 2021 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-285434 SN - 2571-8800 VL - 4 IS - 2 SP - 206 EP - 222 ER - TY - JOUR A1 - Kraft, Robin A1 - Birk, Ferdinand A1 - Reichert, Manfred A1 - Deshpande, Aniruddha A1 - Schlee, Winfried A1 - Langguth, Berthold A1 - Baumeister, Harald A1 - Probst, Thomas A1 - Spiliopoulou, Myra A1 - Pryss, Rüdiger T1 - Efficient processing of geospatial mHealth data using a scalable crowdsensing platform JF - Sensors N2 - 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. KW - mHealth KW - crowdsensing KW - tinnitus KW - geospatial data KW - cloud-native KW - stream processing KW - scalability KW - architectural design Y1 - 2020 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-207826 SN - 1424-8220 VL - 20 IS - 12 ER - TY - JOUR A1 - Prakash, Subash A1 - Unnikrishnan, Vishnu A1 - Pryss, Rüdiger A1 - Kraft, Robin A1 - Schobel, Johannes A1 - Hannemann, Ronny A1 - Langguth, Berthold A1 - Schlee, Winfried A1 - Spiliopoulou, Myra T1 - Interactive system for similarity-based inspection and assessment of the well-being of mHealth users JF - Entropy N2 - Recent digitization technologies empower mHealth users to conveniently record their Ecological Momentary Assessments (EMA) through web applications, smartphones, and wearable devices. These recordings can help clinicians understand how the users' condition changes, but appropriate learning and visualization mechanisms are required for this purpose. We propose a web-based visual analytics tool, which processes clinical data as well as EMAs that were recorded through a mHealth application. The goals we pursue are (1) to predict the condition of the user in the near and the far future, while also identifying the clinical data that mostly contribute to EMA predictions, (2) to identify users with outlier EMA, and (3) to show to what extent the EMAs of a user are in line with or diverge from those users similar to him/her. We report our findings based on a pilot study on patient empowerment, involving tinnitus patients who recorded EMAs with the mHealth app TinnitusTips. To validate our method, we also derived synthetic data from the same pilot study. Based on this setting, results for different use cases are reported. KW - medical analytics KW - condition prediction KW - ecological momentary assessment KW - visual analytics KW - time series Y1 - 2021 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-252333 SN - 1099-4300 VL - 23 IS - 12 ER -