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  - 
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  -