Mobile health applications – so-called mHealth applications – are becoming increasingly important in the healthcare sector. The COVID 19 pandemic, in particular, has recently strengthened this overall trend. In most countries, mHealth applications have to fulfil a number of regulatory aspects in order to be approved and released as a medical application. In Europe, this is mainly regulated by the current amended Medical Device Regulation (MDR) of the European Union, which, however, lays out the requirements for mHealth applications rather imprecisely. Nevertheless, it is in the interest of developers and users that the production of new mHealth applications is not delayed or even brought to a complete halt by the hurdles of regulatory standards. When developing such an application, developers in particular should, therefore, be aware of the regulatory requirements in order to successfully implement and integrate them early on during production.
A new paper, in which Prof. Dr. Johannes Schobel from HNU's DigiHealth Institute participated alongside first author Marc Holfelder from the company LA2 GmbH in Erlangen and researchers at the universities of Regensburg, Ulm and Würzburg, now closes this gap. Based on the self-developed mHealth applications "Corona Health" and "Corona Check", the authors present an optimised development concept that directly integrates international guidelines as well as conceptual and ethical aspects into the development process in cooperation with health authorities. This way, the development of the application could be achieved fast, safe, and cost-efficient. The paper, published in the MDPI journal "J", summarises all relevant regulations in a guideline for the development of mHealth applications, highlights particular challenges and lessons learned during the development process and, thus, provides valuable support for future medical digitisation projects during and after the current pandemic. The project, moreover, strengthens HNU’s research focus "Digitisation of Healthcare".
Holfelder, M., Mulansky, L., Schlee, W., Baumeister, H., Schobel, J., Greger, H., Hoff, A. and Pryss, R., 2021. Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic - An Experience Report of Corona Check and Corona Health. J, 4(2), pp. 206- 222. DOI: 10.3390/j4020017.