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Mobile Apps as Medical Devices

Author(s): Vincenzo Della Mea, Fabrizio Chiarizia, Omar Vuattolo

Background: In 2007, the European Parliament and Council amended the previous version of its directive on medical devices, allowing software to be by its own a medical device. Objectives: Aim of the present paper is to discuss the above mentioned issue when applied to mobile apps, and to tentatively apply medical devices classi cation rules to a sample of apps.

Methods: Medical devices can be assigned to four di erent classes (I, IIa, IIb, III) depending on their invasivity, clinical risk, duration of the contact with the body, and active or passive devices. Guidelines have been released regarding classi cation of software. We identi ed a sample of apps in Android Store (categories: Medical and Health&Fitness) suitable for such classi - cation, and attempted to apply the above mentioned rules.

Results: Among the 80 selected apps, 32 resulted not being classi able as medical devices (40%), 20 as class I (25%), 26 as class IIa (32.5%), and 2 as class IIb (2.5%). If we look at ratings and number of downloads as a measure of apps usefulness, it seems like class II apps are slightly more useful than class I apps.

Conclusions: It seems that a fair amount of present apps could be subject to medical device classi cation, and these of higher category (and thus higher risk) are those possibly more interesting for users. This pushes for some attention towards them, not necessarily in terms of ruling, but at least of clear identi cation of functions and limitations.


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