[Quality assurance versus regulation--the perspective of a lawyer].

In February 2003, the German Federal Ministry of Health presented a concept for establishing a German National Institute for Clinical Excellence. In sharp contrast to this concept, a closer look at other medical quality assurance activities in Germany shows that there is no area of responsibility in the German health care system where such an institution might prove useful. In Germany, the institutions of self-administration were the first to organise and promote medical quality assurance activities. The German Hospital Federation, the Association of Sickness Funds for salaried employees, the Association of Private Health Insurers, the professional organisations of German physicians and other organisations of self-administration entered into contracts pertaining to a medical quality partnership in order to create maximal benefit for all patients, i.e. to exactly address the patients' needs and treat their diseases with the best possible outcome. Such a framework of self-administration renders redundant the requirement for a German National Institute for Clinical Excellence.