Understanding liability in eHealth: Towards greater clarity at European Union Level

Abstract

The European Commission has since 2004 declared its intention to drive greater legal certainty in the area of eHealth. Whilst some significant steps have been taken towards attaining this goal, the questions of liability for eHealth goods and services are still not fully addressed in EU level legislation. This chapter explores the extent to which current EU level legislation on consumer protection is applicable to eHealth and outlines where uncertainties still exist. It looks in particular at the applicability of eHealth product liability in the terms of Directive 2001/95 on General Product Safety and Directive 93/42 on Medical Devices and at liability for eHealth services within the scope of existing legislation on internal market services and the newer legislation on patients' rights in cross-border care.