Pseudonymization services in a translational research DB. Theoretical and practical application with regard to the i2b2 software project

      Аннотация: The secondary use of quality assured study-data originating from clinical trials is an important step for research networks to generate new hypotheses and conduct feasibility studies. The i2b2 software project, which is based on an open source software license, provides graphical query and analysis tools for medical data records. These tools are based on a relational database whose underlying scheme is optimized to handle large amounts of data. Using pseudonymization within the i2b2 framework acting as a research database is an important goal to satisfy privacy protection rules and to enable additional features, for example the ability to inform patients about new medical findings if they are generated during the secondary use of study-data. Pseudonymization and de-pseudonymization of patient records can be performed using the software product Pseudonymization-Service provided by the TMF e.V.. Results show that it is generally possible to integrate pseudony­mization into the i2b2 Hive. For exporting pseudonyms, additional database interactions are required.

Ключевые слова: privacy protection, clinical research, pseudonymization, i2b2, translational research database, TMV e.V., practical application