This work is intended to provide an assessment of the E.U. Directive and how the legal obligations imposed on Member States will impact upon European health care activities within the European Union. The main features of the Directive are described and the author provides a summary of the main features of the Directive with recommendations as to the way ahead. Apart from the provisions found in the Directive, attention has been paid to the two Council of Europe Recommendations in the field, Recommendation R(81), Regulations for Automated Medical Data Banks, and Recommendation R(97)5, The Protection of Medical Data. Particular attention has been paid to this latter document, and references to the text of R(97)5 are made whenever R(97)5 provides valuable additional insights into key issues of definition, law or procedure.

The report is not jurisdiction specific - an assessment of various national laws has already taken place under the SEISMED project. Nor is it possible to provide a model statute, for the whole structure of the Directive affords Member States a degree of latitude in relation to modes of implementation. The primary recommendation made in this report is that Member States should be anxious to encourage sectoral initiatives and solutions, within a strong legal and administrative framework, so as to facilitate responsive and flexible methods of patient care and research, as well as achieving administrative efficiency. A balanced response to data privacy issues should be the goal of health professionals everywhere with the interests of the patient being the guiding principle.