The use of telematics in medicine inaugurates a new era in the provision of healthcare services at a global level. The potential of improved quality of care, easy accessibility to innovative treatment and more efficient utilisation of resources are some of the challenges of health telematics applications. A sound legal basis is needed to boost the expansion of ICT systems in healthcare, which is also expected to enhance the confidence of patients and healthcare professionals in the use thereof. Because of the global nature of the Internet, the legal solutions that will be adopted cannot be fragmented on a per country basis. Solid legislation at the EU level that will frame the provision of Information Society services in general is now under construction. Some core EU directives have already been transposed into the national legal systems, while some others are under the way of implementation. It is highly likely that even after their implementation these acts will not secure an ideal harmonisation in the provision of services as far as healthcare is concerned. A flexible regulatory approach is therefore needed to complete the regulatory gaps that the everyday practice has been ascertaining. A remedy to this direction can be the preparation and adoption on an EU scale of self-regulatory instruments, insofar as they can be broadly recognised and enforced by the judge.