At the beginning of April 2019, the Federal Cabinet has adopted the draft of a "Law on the Establishment of an Implant Registry in Germany and other amendments to the Fifth Book of the Social Code” (Implants Registry Establishment Law, Implantateregister-Errichtungsgesetz, EIRD).
The goal of the Registry is to improve the safety and quality of implantations for both privately and publicly health insured. By scientific assessment of the collected data, such as the lifetime of implants in the body, conclusions can be made, inter alias about the quality of the implants and the quality of the implanted devices.
Essential regulations of the EIRD include:
- The German Institute for Medical Documentation and Information (DIMDI) will take over the central data collection as registrar. The start-up financing will be provided by the federal government, ongoing operations will be financed by fees
- The Robert Koch Institute will establish an independent trust, which will pseudonymize all personal data
- The telematics infrastructure will be used for transmitting the data records
- In order to ensure the validity of the register, the registration will be obligatory for Health Care Institutions, statutory and private health insurances and all patients
- Manufacturers will be obliged to register their products in the register's product database. In case of implanting device reporting violation or the use of implants, which were not registered in the product database, the law will provide an exclusion of payment
- Comprehensive transparency requirements are included, such as annual reports from the Registry office and the Federal Institute for Drugs and Medical Devices (BfArM)
- The expense incurred by the health care institutions due to the obligatory registration will be reimbursed
- The framework conditions for the data transfer of existing registries are regulated
- The actual beginning of the reporting obligation for the individual types of implants depends on the existence of all technical prerequisites for the receipt of the registration and will be specified by corresponding ordinance
- It is expected that hip and knee endoprostheses and breast implants will be the first ones registered from mid-2021
The bill also contains provisions to speed up the procedure of the Federal Joint Committee (G-BA) for the evaluation of examination and treatment methods in contracted care. For this purpose, the previous timeframe for the G-BA will be shortened from three to two years.
The law does not require the approval of the Federal Council. The announcement is scheduled for the end of the current year. In addition to the law, a statutory ordinance will be worked out in order to regulate details of the Implant Registry operation.
The full details in German can be found here.
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