title: [Benefit assessment of medical services in German health service - legal framework, historical and international perspective].
abstract: The term benefit describes the (positive) causal, patient-relevant consequences of medical interventions, whether diagnostic or therapeutic. Benefit assessments form the basis of rational decision-making within a health care system. They are based on clinical trials that are able to provide valid answers to the question regarding the relevant benefit or harm that can be caused by an intervention. In Germany, evidence-based benefit assessments are fixed by law, i.e., the Social Code Book V. The application and the practical impact of these assessments could be improved.
authors.affiliation: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), Im Mediapark 8, 50670, Köln, Deutschland, juergen.windeler@iqwig.de.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Windeler
authors.forename: Stefan
authors.initials: S
authors.lastname: Lange
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003362:Cost-Benefit Analysis / Q000331:legislation & jurisprudence*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D019317:Evidence-Based Medicine / Q000331:legislation & jurisprudence; D005858:Germany; D017063:Outcome Assessment, Health Care / Q000331:legislation & jurisprudence*; D018570:Risk Assessment / Q000331:legislation & jurisprudence*; D016896:Treatment Outcome