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The Federal Joint Committee has a major role to play in quality assurance. The Committee includes representatives of the national associations of joint self-government, that is to say of the National Association of Statutory Health Insurance Funds, of the German Hospital Federation, of the National Association of Statutory Health Insurance Dentists, and of the National Association of Statutory Health Insurance Physicians. The Federal Joint Committee determines what adequate, expedient, economical healthcare must look like. These stipulations are binding on healthcare providers (doctors, dentists and hospitals), as well as on statutory health insurance.
Amongst other things, the Federal Joint Committee sets out directives on quality assurance in all areas of healthcare. These directives for instance determine which medical treatment methods, such as operations, may be carried out at the expense of the statutory health insurance funds.
If you undergo medical treatment in Germany within the framework of the European Patient Mobility Directive, be it on an out-patient or in-patient basis, the directives in the field of quality assurance that were issued by the Federal Joint Committee also apply to you with regard to treatment in a hospital .
The Agency for Quality in Medicine (ÄZQ) was established by the German Medical Associationand the National Association of Statutory Health Insurance Physicians in order to support them in carrying out their own tasks in quality assurance in the exercise of the medical profession.
The Agency hands down healthcare guidelines for the healthcare providers. The latter are to assist in their decision-making and orientation in finding the correct diagnosis and treatment decision of diseases. As a rule, the healthcare guidelines provide information on the medical standard of a treatment, and are therefore binding on the respective healthcare providers. They are developed jointly by the German Medical Association, the National Association of Statutory Health Insurance Physicians and the Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften). As a rule, a corresponding patients’ guide is drawn up for a healthcare guideline in language which is accessible to the patients concerned and their relatives. Amongst other things, it provides practical information on coping with the disease on an everyday basis.
The Institute for Quality and Efficiency in Health Care (IQWiG) is an independent specialist scientific institution which is commissioned by the Federal Joint Committee or the Federal Ministry of Health to draw up evidence-based reports on benefits provided by statutory health insurance. The IQWiG does not carry out any studies on patients, but evaluates existing international studies according to standard methods. The IQWiG can make recommendations to the Federal Joint Committee in its reports regarding the benefits and costs of medical services and medicinal products. The Federal Joint Committee can decide on this basis whether the costs of a service are to be refunded by the health insurance funds. The IQWiG can however also draw up working papers at its own initiative on topics which are of fundamental significance.
The IQWiG also has a statutory mandate to publish generally-accessible information on diseases, as well as on testing and treatment methods for patients on its own website.
The IQWiG is funded through the contributions of individuals in Germany who are covered by statutory health insurance.
The Federal Institute for Drugs and Medical Devices (BfArM) operates within the portfolio of the Federal Ministry of Health, and is responsible for the safety of medicinal products in Germany. The Institute licences, registers and monitors medicinal products. Together with the Drug Commission of the German Medical Association, it runs the Medical Committee for Drug Safety.
On the basis of reports from manufacturers and healthcare providers regarding undesirable events related to medical devices, the Institute makes a record of the risks and evaluates them. It also uses test persons to carry out clinical trials on medical devices. Furthermore, it licences and monitors the legal traffic in narcotic drugs and precursors.