Legally eHealth – Study on Legal and Regulatory Aspects of eHealth

The study on legal and regulatory aspects of eHealth had the central objective of contributing to the Actions of the eHealth Communication and Action Plan that address the need to establish greater legal certainty in Europe with respect to the practice of eHealth service delivery and the use of eHealth tools within the context of the existing legal framework of relevant EU level legislation.

Objectives of the study

eHealth is premised on a fundamentally new patient experience that is unconstrained by familiar points of entry to healthcare or traditional channels for delivering information or care. eHealth allows services to be delivered at a distance, outside standard healthcare settings and with a preservation of anonymity or pseudonymity if the patient so wishes. Not surprisingly, therefore, the eHealth revolution has as many serious implications for healthcare regulators and lawyers as well as for medical professionals.

Although policy makers have noted at both European and national level that a lack of legal certainty about the use of eHealth tools and services exists, little has been done to study the issue in detail, to the point that legal barriers are perceived as an obstacle to the deployment of eHealth. Accordingly the Action Plan proposes that by 2009 the European Commission shall “provide a framework for greater legal certainty of eHealth products and services liability within the context of existing product liability legislation.”

In this context, the Commission called for the present study in order to establish a baseline report on existing EU level legislation, its impact on the delivery of eHealth and an analysis of the legal lacunae that may exist.

Download key project documents here:

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