Liability and responsibility for clinical software in the Federal Republic of Germany

Western Europe is faced with the same technological developments in the field of medical computer systems as the U.S.A. Differences in the medical and legal systems can provide opportunities for analysis of different approaches to the same problems. This paper traces the development of medical computer systems and the corresponding developments of legal requirements for such systems. Proposals are made for a novel regulatory approach to realize the advantages of this technology without unnecessary risks.