Are mHealth apps safe? The intended purpose rule, its shortcomings and the regulatory options under the EU medical device framework

This chapter discusses the legality of operating commercially available applications or 'apps' for medical purposes. The chapter observes how the meticulous certification process established in the Medical Device Directive (MDD) is seldom applied to mHealth apps. This is the result of the application of the concept of "intended purpose.” This concept allows app developers to create apps that analogous to medical devices (i.e. having similar functions) but, because they have not been intended by their manufacturers to attain a medical purpose, they do not need to satisfy the stringent safety checks foreseen in the MDD. With the aid of concrete examples, the chapter highlights two gaps in the regulation of mHealth apps, concerning the reliability of the apps and the traceability of “bad apps”. In response to these concerns, the EU has taken a mixed approach-combining top down regulation with stakeholders’ participation and “self-assessment”. A comparison with the regulation of borderline apps in the United States allows the authors to make a recommendation for future research and policies concerning mHealth apps.

ISBN:978-3-319-60671-2

Publication year:2017

Keywords:mHealth, Medical Device, Borderline apps

Accessibility:Closed