VIG Trusted Third Party for Implant Register and Health Data

Establishment and operation of an independent trust center for the pseudonymization of personal data

Date:  26/01/2022

Leader: 
Rüdiger Dölle
Deputy: 
Anna Lübbe
Bernhard Otto
Robert Koch Institute
Nordufer 20
D-13353  Berlin
Germany

The Trusted Third Party for Implant Register and Health Data (VIG) at the Robert Koch Institute was established as a trust center[1] based on the task assigned to it in the Implant Register Act (IRegG, entered into force on 01.01.2020). Additionally, the VIG department has also taken on the role of trust center in other medical data networks on the basis of legal legitimation. The legal mandate includes the establishment and operation of high-quality and secure infrastructure for the pseudonymization of medical data. Pseudonymization, i.e. the processing of identifiable information in a way that it can no longer be attributed to a data subject without the use of additional, not publicly known information, is carried out for the purpose of excluding or significantly complicating the identification of a specific person[2].

Further tasks of the VIG unit are

  1. the development and application of technical procedures for the pseudonymization of person-identifying data
  2. the creation and management of project-related pseudonyms for a comprehensive authorized linkage of health data (record linkage[3], as defined by the respective legal legitimation)

[1] The term is used in the Guidelines 01/2025 on Pseudonymisation (version for public consultation) published by the European Data Protection Board as well as the patient information of the Implant Register Germany. A synonym and often used term is ‘Trusted Third Party’.
[2] A legal definition of pseudonymisation can be found in the Guidelines 01/2025 on Pseudonymisation (version for public consultation) published by the European Data Protection Board.
[3] Record linkage refers to a process by which data records from different sources can be linked, e.g. to a uniform identifier.

ProjectLegal basis (available in German only)
Data Transparency (DaTraV) 

§ 303 ff SGB V

Verordnung zur näheren Regelung von Verfahren nach dem Gesetz zur verbesserten Nutzung von Gesundheitsdaten vom 29.01.2025

Electronic Patient Record (ePA) data extraction for research purposes

§ 363 SGB V

Verordnung zur näheren Regelung von Verfahren nach dem Gesetz zur verbesserten Nutzung von Gesundheitsdaten vom 29.01.2025

Health Data Use Act (GDNG)

Gesundheitsdatennutzungsgesetz (GDNG) vom 26.03.2024, in particular §4

Verordnung zur näheren Regelung von Verfahren nach dem Gesetz zur verbesserten Nutzung von Gesundheitsdaten vom 29.01.2025
Implant Register Germany (IRD)

Implantateregistergesetz (IRegG)

Implantateregister-Betriebsverordnung (IRegBV)

Model Project for the comprehensive diagnosis and therapy identification by means of genome sequencing in cases of rare and oncological diseases (MVH Genom)

§ 64 e SGB V

Verordnung zum Modellvorhaben zur umfassenden Diagnostik und Therapiefindung mittels Genomsequenzierung bei seltenen und bei onkologischen Erkrankungen (Genomdatenverordnung - GenDV) vom 08.07.2024, in particular §7