• Stefaan Callens and Kim Cierkens.
• Brussels Bar, Health Law KULeuven.
• Stud Health Technol Inform. 2008 Jan 1; 141: 47-56.

AbstractCross-border activities in health care in the European single market are increasing. Many of these cross-border developments are related to e-Health. E-Health describes the application of information and communication technologies across the whole range of functions that affect the health care sector. E-health attracts a growing interest on the European level that highlights the sharp need of appropriate regulatory framework able to ensure its promotion in the European Union. Some Directives constitute a step in this direction. Both the Data Protection Directive, the E-Commerce Directive, the Medical Device Directive and the Directive on Distance Contracting are some of the most important European legal achievements related to e-Health. Although the directives are not adopted especially for e-health applications, they are indirectly very important for e-Health. Firstly, the Data Protection Directive applies to personal data which form part of a filing system and contains several important principles that have to be complied with by e-Health actors processing personal data concerning health. Secondly, the E-commerce Directive applies to services provided at a distance by electronic means. Many e-Health applications fall within this scope. Thirdly, the Medical Devices Directive is of importance for the e-Health sector, especially with regard to e.g. the medical software that is used in many e-health applications. Finally, the Directive on Distance Contracting applies to contracts for goods or services which make use of one or more means of distance communication; E-Health business may involve the conclusion of contracts. Despite these Directives more developments are needed at the European level in order to make sure that e-Health will play an even more important role in health care systems than is the case today. The new e-Health applications like electronic health records, e-health platforms, health grids and the further use of genetic data and tissue involve new legal challenges. Several member states are introducing electronic health records or e-Health platforms. The use of electronic health records that contain data of several health actors poses new risks with some legal consequences. Recently, grids are being used in some ambitious medical and healthcare applications. In order to be truly effective such grid applications must draw together huge amounts of data from disparately located computers - which implies data sharing across jurisdictions and the sharing of responsibilities by a range of different data controllers. E-Health will also enhance the further use of human tissue and genetic data. More and clear guidelines on the reimbursement criteria for telemedicine and on liability would also be very useful. Guidance at the European level can be given as to the criteria that (tele-) health sessions will have to comply with for reimbursement purposes, since it is still unclear when e-Health sessions will be reimbursed. It is clear that the existing European legal framework is not finished yet and that more specific European rules are needed.

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