Legal issues in medical informatics: a bird's eye view.

The present paper is the result of a study investigating the legal issues, problems and obstacles which have arisen as a result of the R&D projects financed by the AIM Program 1991-94. Two parallel lines of investigation were adopted in this study. First of all, a questionnaire was sent to all project partners listed in the AIM 93 Report, with the objective of collecting information on the legal questions with which the individual projects were confronted in the course of their R&D work. This allowed for an initial mapping out of the legal aspects relevant in the field of medical informatics. Secondly, the actual projects were studied as to their legal content and in particular those which included a legal workpackage. This allowed for an assessment of further legal questions, some of which had as yet perhaps not been perceived as such. The present paper deals with five key aspects, describing the nature of the issues and the relevant law and case law or legal vacuum as it may be. It must be emphasised that, as pointed out in the title, this study offers an overview of the legal issues debate in medical informatics and is somewhat exploratory in nature. It is not intended to offer a critical analysis of existing picces of legislation or case law. This would call for more fundamental legal research. Instead the study restricts itself to a general description of existing legal principles and their relevance in the health care sector. As the reader will gather from this paper, legally speaking information technology is still a relatively new entity in the health care sector, which means that legal research and any resulting recommendations may have a real impact on the future course of the law in this field.