The legislator wants to promote research in the field of transplantation medicine. According to § 15g TPG (German transplant law), it is possible to request or apply for data from the Transplant Registry for scientific research purposes in the field of transplantation medicine.
In order quickly develop updated waiting list admission rules and improve the quality of transplantation medical care and follow-up procedures, anonymised data was collected at various institutions (e.g. ET, DSO). Data included in the Transplant Registry was stored decentrally up to ten years before the law came into force (§ 15e para. 8 TPG).
According to § 15e para. 8 TPG the transplant medical data (so-called legacy data from 2006 – 2016) can be requested for research purposes and will be transmitted electronically by the Transplant Registry after a user agreement has been concluded. For this purpose, the Transplant Registry provides an online portal (https://export.transplantations-register.de).
For the transmission of anonymised transplantation medical data, the research center has to fill out an online form and select the data required for the research project according to the data set description of the nationally standardised data set. In addition, it must be specified whether anonymised or pseudonymised data is being requested.
The Transplant Registry verifies the request for completeness and plausibility. In the case of a request for pseudonymised data, the TPG contracting authorities have to decide on whether or not the request will be granted. This happens in agreement with the PKV (association of private health insurance), depending on the research purpose. The Transplant Registry Office will inform the applicant about the decision.
The Transplant Registry Office publishes an annual report on the submitted data.