The Data Protection and Medical Device Frameworks — Obstacles to the Deployment of mHealth across Europe?

Abstract

This article examines the receptivity of the current EU legal regime towards innovative mHealth technologies and their deployment on a pan-European basis. At present, a coherent legal strategy towards the development of mHealth technologies does not exist. The deployment of such technologies is influenced in an uncoordinated way by various disparate European legislative initiatives. This article focuses on problems that may be encountered by mHealth platforms through application of the Medical Device and Data Protection Frameworks. Theses frameworks are analysed in this article through the lens of a pan-European deployment of mHealth technologies. The aim throughout is to look for potential problems for the deployment of such technologies posed by these frameworks and, where possible, to suggest improvements.