[Legal aspects of quality assurance in medicine according to SGB V]

The German social security legislation has recognized only recently the concern of quality assessment in the field of social and medical services. The legal frame for quality assessment in the field of medical treatment was enacted in the sickness insurance provision (Social Code-Book V) only in 1989. Quality assessment is considered to be a part of the production of medical services and, therefore, is regulated in the context of providing medical services. The legal provisions do not establish standards for quality and quality assessment. Due to the variety of medical services, quality assessment is not regulated in an exhaustive or systematic manner. According to the law, providers of medical services (doctors, hospitals) are bound to participate in quality assessment. As internal quality assessment prevails in the definition of the various measures of quality assessment and the control of quality in all fields of medical treatment, external quality assessment is also prescribed for hospitals. Because the establishment of quality assessment is considered to be a part of the service production organization, consumers (patients) or their representatives are not involved in the definition, establishment, and control of quality assessment. The participation of patients should be provided by law.