Do Mobile Medical Apps Need to Follow European and US Regulations or Not: Decisions Exemplified by Diabetes Management App

Anna Holubová
Faculty of Biomedical Engineering, Czech Technical University in Prague, Kladno, Czech Republic / Department of Computer Science, University of Tromsø - The Arctic University of Norway, Tromsø, Norway

Meghan Bradway
Norwegian Centre for Integrated Care and Telemedicine (NST), University Hospital of North Norway, Tromsø, Norway

Eirik Årsand
Norwegian Centre for Integrated Care and Telemedicine (NST), University Hospital of North Norway, Tromsø, Norway

Daniel Hallgren
Norwegian Centre for Integrated Care and Telemedicine (NST), University Hospital of North Norway, Tromsø, Norway

Gunnar Hartvigsen
Department of Computer Science, University of Tromsø - The Arctic University of Norway, Tromsø, Norway / Norwegian Centre for Integrated Care and Telemedicine (NST), University Hospital of North Norway, Tromsø, Norway

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Ingår i: SHI 2015, Proceedings from The 13th Scandinavien Conference on Health Informatics, June 15-17, 2015, Tromsø, Norway

Linköping Electronic Conference Proceedings 115:9, s. 55-62

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Publicerad: 2015-06-26

ISBN: 978-91-7685-985-8

ISSN: 1650-3686 (tryckt), 1650-3740 (online)


Rapid development of medical and health-related mobile applications (apps) has caught the attention of the regulatory institutions. Despite the fact that we have valid sources of information regarding related legislative issues, it is not easy for developers to interpret specific laws, directives and definitions. To clarify this situation, we summarize the main points of EU and US medical device directives and regulations for developers of mobile medical-oriented applications. To help developers decide whether their app should be considered under these regulations or not, we describe the process of evaluating the mobile phone app called Diabetes Diary (Diabetesdagboka) for classification as a medical device. In addition, we also highlight some serious issues the developers and regulatory bodies should keep in mind when inventing or encountering a new product.


Mobile Medical Application; mHealth regulations; classification of stand-alone software; diabetes.


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