The Data Trustees.

With 10 years of experience, the Trusted Third Party of the University Medicine Greifswald supports medical research in Europe. Person-identifying data are sensitive information. Therefore, it’s extremely important to protect access to this data – this is especially true for research with patient data in studies and registries. The organisationally Independent Trusted Third Party develops and operates specialised software to protect this data and, thus, offers data protection compliant solutions for medical research: the rights and will of patients and study participants are protected by – among other things -electronic consent management and person-identifying data are protected by using pseudonyms. With its solutions, the Trusted Third Party of the University Medicine Greifswald is a partner in numerous Germany-wide and international projects, which are funded by the DFG, BMBF and EU as well as private sponsors. Examples are the German Centre for Cardiovascular Research (DZHK), the German National Cohort (GNC), the Baltic Fracture Competence Center (BFCC) and the MIRACUM Consortium of the Medical Informatics Initiative Germany. More than 25 employees from various disciplines form a young and committed team of computer scientists, Java and web specialists, medical data managers, lawyers, physicists and student assistants. As data trustees, we form the bridge between study participants, researchers and project partners and, thus, create trust, because: Trust makes medical research successful.

Core elements of clinical and epidemiological research projects are data protection procedures for the storage and use of personal data. Based on legal regulations, common procedures for implementation of data protection procedures have been established. The TMF e.V. proposed concrete models for distributing roles in data processing. Among others, the earliest possible separation of research data from person-identifying data (IDAT) of the persons is essential. For the administration of IDAT, the role of the data trustee is proposed, which operates both independently of a) the data-entering institution and b) respective research institutions. To implement data protection measures, the data trustee’s tasks include the following:

• Managing patient lists using technical procedures to fault-tolerantly identify persons, identify and merge duplicates as part of the record linkage process.
• Managing Informed Consent documents of patients and study participants electronically and conducting quality assurance procedures.
• Pseudonymisation/ Anonymisation of person-identifying data, e.g. to support pseudonmised storage of research data related to the person, or for data transfer to third parties for research purposes.
• Checks of person-identifying data against external data sources, e.g. registers of residents.

Based on that principle the Independent Trusted Third Party (TTP) of the University Medicine Greifswald was established as a core unit of the University Medicine Greifswald by the decision dated 22.04.2014 of the Board of Directors of the University Medicine Greifswald. With its establishment, the Trusted Third Party is guaranteed independence and autonomy from the University Medicine Greifswald. The data protection and IT security concept of the TTP received a positive vote in 2014 by the Data Protection Officer of Mecklenburg-Western Pomerania and was considered “examplary in many ways”. The concept of the TTP was successfully implemented and continuously adapted according to new regulations like the EU General Data Protection Regulation (EU GDPR). Please find a list with clients here.