The professional and scientific basis for the German mammography screening programme, in accordance with the decision taken by the German parliament in June 2002, are the European Guidelines on the Early Detection of Breast Cancer (EU Guidelines), at that time existing in their third edition, which were transferred to the healthcare structures in Germany. With a resolution adopted on 15.12.2003 by the Federal Committee of Physicians and Health Insurers, the Early Detection of Breast Cancer through Mammography Screening Guideline (KFE-RL) was introduced as a supplement to the Early Cancer Detection Directive. On the basis of § 92 and § 25 of Volume Five of the Social Insurance Code, this guideline defines not only the medical and organisational implementation of the programme but also contains stipulations on ensuring and promoting the quality of structures, processes and results.
A detailed elaboration of the programme between the Association of Statutory Health Insurance Physicians and the National Association of Statutory Health Insurance Funds was laid down in Annex 9.2 of the Federal Framework Agreement for Physicians (BMV-Ä). Section B No. III of KFE-RL and Annex 9.2 of BMV-Ä are legally binding, as non-legislative standards, for all persons and institutes involved in the mammography screening programme – persons covered by statutory health insurance, physicians and non-medical staff, associations of health fund physicians
Besides radiation protection and social legislation, the mammography screening programme is embedded in other sets of regulations. The data protection basis for data flows is regulated by, among others, the General Data Protection Regulation (applicable since 25.08.2018), the Federal Data Protection Act, and legislation valid in individual federal states. The following diagram provides an overview of the legal bases of the mammography screening programme.
Protocols on electronic documentation in mammography screening
Protocols on evaluations of mammography screening. Provisions for supplying statistical details as part of the evaluation and quality assurance processes in the screening units.
Protocols on evaluations of central offices
Protocols on comparisons between cancer registries
Protocol on the technical and organisational requirements for holding multidisciplinary case discussions in the form of online videoconferences in accordance with Attachment 13 of Annex 9.2 of the Federal Framework Agreement for Physicians.
Re-certifications of the screening units by the Cooperative Association of the German Mammography Screening Programme in accordance with Section B III § 22 of the Early Detection of Breast Cancer Guideline (KFE-RL)