- About the transplant registerThere is currently no central authority in Germany that collects data on organ donation, transplants, donors and recipients. With the amendment of the Transplantation Act, which came into force on November 1st 2016, the Federal Government wants to ensure greater patient safety, transparency and quality in transplantation medicine. By combining donor and transplant patient data in one register, a reliable basis is created for further improving transplantation medicine and increasing patient safety in Germany. For example, the registry can provide well-founded information on which donor organ would be best suited for which organ recipient. The medically relevant information is only entered into the transplant register with the consent of both the donor and the recipient. In addition, they are stored in such a way that they do not allow any direct references to the persons. Information on the organ donor card is not recorded. The transplant register consists of an autonomous transplant register office and an independent trust. An agency will be set up to operate the transplant registry. Being the central authority it collects, stores, checks, creates and makes available the transmitted medical transplantation data. In the trust centre, personal data is pseudonymised before it is transmitted to the transplant registry. The transplant register is under the supervision of the Federal Commissioner for Data Protection and Freedom of Information.
- Advisory BoardThe advisory board supports the work of the agency and the independent trust. As an external expert it advises on medical and scientific questions. It proposes the nationwide uniform data set, participates in its further development and is involved in the determination of the procedural rules for data transfers. The members of the advisory belong to:
- AgencyThe transplant register consists of an autonomous transplant register office and an independent trust. An agency will be set up to operate the transplant registry. The agency is in charge of the organisational and administrative groundwork for the transplant registry to fulfil its legal tasks. The main tasks of the agency are:
- Establishment and operation of the transplantation register with recording, integration and plausibility check of data from different data sources into one register data base
- If necessary, requesting corrections or additions to the transmitted data via the trust centre
- Preparation, recording and moderation of advisory board meetings
- Reporting to TPG-sponsors
- Data transmission to the parties involved (e. g. coordination centre, German Medical Association, Joint Federal Committee, transplant centres)
- Answering inquiries from affected persons and research institutions
- Conducting correspondence
- Public Relations
- Data and PrivacyThe following institutions are obliged to transmit medical transplantation data to the transplant registry:
- coordinating body
- transplantation centres
- Joint Federal Committee
- Aftercare facilities and doctors in outpatient care
- Independent TrustThe transplant register consists of an autonomous transplant registry office and an independent trust. When data is transferred between the suppliers and the registry, the independent trust centre is placed in such a way that it serves as a pseudonymisation centre. This means that the transferred personal organ donor and organ recipient data are anonymised (from January 1st 2006 to December 31th 2016 inclusive - old data) or pseudonymised (data from January 1st 2017 with the consent - new data) by the suppliers and transferred to the transplant registry. Also de-pseudonymization, for example in the case of inquiries from affected persons, is carried out via the independent trust. Feedback from the transplantation registry to the data suppliers also goes through the independent trust. In addition, the independent trust is responsible for merging and anonymising the old data. The trust office is also helped by the advisory board. Here you get to the independent trust:
- Persons concernedAs a living donor or organ recipient, you have the possibility to obtain information regarding the processing of your personal data by the transplantation registry at any time. For your request for information, please contact the independent trust. Only they can establish a link between your personal data and the pseudonym stored in the transplantation register. This procedure serves to protect your data. The independent trust requests your pseudonymised information stored in the transplant register and responds to your inquiry. Here you get to the trust office: www.tx-vst.de
- PressIf you would like further informationen of the transplant register or if you have questions or suggestions, please contact us. Our contact person will answer your inquiries as soon as possible. Contact person and coordinator for press inquiries: Marieluise Panzer T +49 341 98988-350 F +49 341 98988-9301 M email@example.com
Data Validation Report
Transplantationsmedizinische Daten der Jahre 2006 - 2016 V1.4 | 23.07.2021
In accordance with § 15b Section 4 Number 3 Transplantationsgesetz (TPG), the data transmitted to the transplantation registry for the years 2006 - 2016 (Altdaten) were validated regarding the criteria plausibility, completeness and comprehensiveness. The results of the data validation are summarized in the data validation report. The report provides interested parties and data recipients with an overview of the scope and structure of the data stored in the transplant registry (Altdaten).
- ResearchThe legislator explicitly wants to promote research in the field of transplantation medicine. Therefore, according to § 15g Transplantation Act (TPG), it is possible to request or apply for data from the Transplantation Registry for scientific research purposes in the field of transplantation medicine. In order to gain initial knowledge as quickly as possible, for example, for the further development of waiting list admission rules, for the further development of organ and donor characterization or for the improvement of quality in transplantation medical care and follow-up, anonymized data that were collected decentrally at various institutions up to ten years before the law came into force are included in the Transplantation Registry (§ 15e para. 8 TPG). The transplant medical data according to § 15e para. 8 TPG (so-called legacy data) can be requested for research purposes and will be transmitted electronically by the Transplantation Registry after conclusion of a user agreement. For this purpose, the Transplantation Registry provides an online portal (https://export.transplantations-register.de). For the transmission of anonymized transplantation medical data, the research center fills out the online form and selects the data required for the research project according to the data set description of the nationally standardized data set. In addition, it must be indicated whether service provider- and payer-identifying data are requested anonymized or pseudonymized. The Transplantation Registry verifies the request for completeness and plausibility. In the case of requested pseudonymized service provider- and payer-identifying data, the TPG contracting authorities decide in agreement with the PKV association, depending on the stated research purpose, whether the request is granted. The Transplantation Registry Office informs the requestor of the decision. The Transplantation Registry Office publishes an annual report on the submitted data.
- Service Documents
Nationwide Standardised Dataset
The Nationwide Standardised Dataset (BED) was developed for the central aggregation and storage of data in the transplant registry. The version published in the Bundesanzeiger comprises the data to be supplied to the transplant registry. (German)
BED 2020 (2017 – 2020) V2020.1 | 19.07.2021
BED Altdaten (2006 – 2016) V1.2.3 | 31.05.2019
Altdaten V1.4 | 17.07.2021
This specification serves to describe the Altdaten module of the transplant registry. The document covers: Overall process, delivery files, data set, Altdaten module. (German)
Neudatenübermittlung V1.10 | 19.10.2021
This specification serves to describe the transmission of Neudaten to the transplant registry. The document covers: Overall process data delivery, data update, data deletion, data set, delivery files, public key infrastructure, transplant registry interface description, transplant registry trust authority interface description, transplant registry trust authority REST client. (German)
Datenübermittlung durch das Register V1.7 | 08.09.2021
This specification serves to describe the data transmission by the transplant registry. The document covers: Data transmission from the Tx registry to data recipients, data transmission by the transplant registry, data extraction and preparation, anonymization and pseudonymization of export files. (German)
Registerdatenbank V1.5 | 15.07.2021
This specification serves to describe the registry database of the transplant registry. The document covers: Architecture of the registry database, technical data model, data set. (German)
Rules of Procedure
Verfahrensordnung V2.0 | 01.06.2021
The Rules of Procedure define the procedures for data transmission to the transplant registry and by the transplant registry as required by the Transplantationsregistergesetz (TPG). The Rules of Procedure are issued by the TPG-Auftraggeber (GKV-Spitzenverband, Bundesärztekammer and Deutsche Krankenhausgesellschaft) in agreement with the Verband der Privaten Krankenversicher. (German)
Manual Export Portal
Handbuch zum Tx-Exportportal V2.1 | 15.07.2021
The Tx-Exportportal is used to request or apply for and retrieve transplant medical data from the transplant registry. This user manual serves as a guide for independent use of the portal. (German)
Shortnames in the BED-DB
Shortnames V1.0 | 13.08.2021
The length of column names is limited in the SQL database on which the BED-DB is based for technical reasons. The BED element names are therefore replaced by so-called short names in the BED-DB. These short names also remain the names of the columns in the exported tables when the data is exported. The table provides an overview of the BED element names and the associated short names.
- Site NoticeThis website is operated by Gesundheitsforen Leipzig GmbH on behalf of TPG clients (German Medical Association, GKV Central Association, German Hospital Federation e. V. ). Contact: Transplant register office Gesundheitsforen Leipzig GmbH Hainstraße 16 04109 Leipzig T +49 341 98988-350 F +49 341 98988-9301 E firstname.lastname@example.org I www.transplantations-register.de Authorized managing director: Dipl.-Inform. (FH) Roland Nagel, Executive MBA (HSG) Dipl.-Winf. Axel Schmidt Court of Registration: Amtsgericht Leipzig HRB 25802 USt.-IdNr.: DE268809429 Responsible for content according to § 7 TMG: Dipl.-Inform. (FH) Roland Nagel, Executive MBA (HSG) Responsible for the journalistic-editorial part according to § 55 Abs. 2 RStV (Rundfunkstaatsvertrag): Martin Grohmann Gesundheitsforen Leipzig GmbH Hainstraße 16 04109 Leipzig T +49 341 98988-350 F +49 341 98988-9301 E email@example.com Disclaimer: The World Wide Web is a constantly changing medium. It is therefore impossible to collect all relevant information and make it available to our partners. We therefore make no claim to completeness, although we strive to be comprehensive. On our pages we make information available to you with the help of external links. We assume no liability for the content and accuracy of the information on these external sites. As a rule, we comment on the information of an external page. We make no claim to completeness of our short comments or our own research results.
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- The national transplant register[su_row][su_column size="2/3" center="yes" class=""] Unlike other countries such as the USA, there is currently no central authority in Germany that collects data on organ donation, transplants, donors and recipients. For the first time the transplantation register collects and links together medically relevant data from deceased organ donors. Thus far this data has been collected in different places and not combined. With the amendment of the Transplantation Act, which came into force on November 1st 2016, the Federal Government wants to ensure greater patient safety, transparency and quality in transplantation medicine. The aim of the transplant register is to improve the achieved results. In order to gain initial information as quickly as possible, old data will also be included in the register retrospectively up to January 1st 2006 during the start-up phase. The Central Federal Association of Health Insurance Funds, the German Medical Association and the German Hospital Federation (so called TPG-sponsors) jointly monitor the implementation of the requirements of the Transplantation Act.
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