eHealth Spare Parts as a Service: Modular eHealth Solutions and Medical Device Reform

Abstract

eHealth Platform as a Service (‘PaaS’) is an innovative way to build mHealth apps out of cloud-based generic components. Having examined the current and future regimes of safety and performance, this paper concludes that the ‘selling features’ of the PaaS (outsourced creation and maintenance of cloud-based parts for easy mHealth-building) undermine legal compliance, and the reform will not change this significantly. Although no safety and performance requirements apply yet to consumer eHealth, the medical apps are regulated. Their manufacturers must ensure the final apps are safe, while not being in control of the parts composing the apps. Generic components not meant for a specific medical device and their providers are not subject to safety and performance requirements. Market will likely push PaaS providers to offer mHealth manufacturers tools to ensure and control safety and performance when medical apps are concerned. I foresee no such incentives for consumer mHealth.

Keywords: eHealth; mHealth; EU medical device reform; cloud computing; modular eHealth; safety and performance of health apps