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Are mHealth Apps Safe? The Intended Purpose Rule, Its Shortcomings and the Regulatory Options Under the EU Medical Device Framework

  • Eugenio Mantovani
  • Pedro Cristobal Bocos
Chapter
Part of the Human–Computer Interaction Series book series (HCIS)

Abstract

This chapter discusses the legality of operating commercially available applications or ‘apps’ for medical purposes in Europe. The meticulous certification process established in the Medical Device Directive (MDD) is seldom applied to mHealth apps. This is due to the application of the concept of “intended purpose”, which allows app developers to create apps that are 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. The chapter highlights two vulnerabilities of this regulatory framework, 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 in Europe.

Keywords

EU medical device law Intended purpose mHealth apps safety US medical device law 

Notes

Acknowledgements

The authors acknowledge the support of the IRIS project – Interoperable platform for Remote monitoring and Integrated e-Solutions (Grant agreement Nr. BRGEOZ234), funded by INNOVIRIS, the Brussels Institute for Research & Innovation.

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Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  1. 1.LSTS – VUBBrusselsBelgium

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