The data sharing working group is developing a legally robust framework for data access and usage within the scope of the Medical Informatics Initiative.

Goals and tasks

A central goal of the previous development and networking phase of the Medical Informatics Initiative was to define a standardised framework for data access and usage across all of Germany. In order to implement this goal, the Data Sharing Working Group (WG) developed legally secured framework conditions and corresponding contracts for data access and data usage. In addition, the prerequisites for cross-site queries were developed and created, and the specification of cross-consortium use cases was defined. In addition, audit criteria were developed to serve as evidence of functioning data exchange. In the Use & Access Task Force, the tasks and processes of data use were defined in a uniform and binding manner in the MII's use regulations.

In the current consolidation and extension phase, a central task of the Data Sharing WG is to further develop the governance of data use within the MII. Consideration must be given to expansion to new, additional institutions and support for new scenarios and data types. The coordination office is responsible for coordinating the content of the work together with the representatives of the consortia. Individual tasks are taken over by task forces, which also require central coordination. Certain tasks, in particular the examination of legal issues in the further development of contractual bases, will also be taken over by the coordination office.

Activities

The Data Sharing Working Group coordinates its activities in meetings and web conferences. Within the Data Sharing WG, the following task forces have been established:

  • Audit Preparation Task Force
  • Data Protection Task Force
  • Use & Access Task Force
  • Distributed Analyses Task Force

Results

Contract governing the use of patient data, biosamples, analysis methods and routines within the scope of the Medical Informatics Initiative (MII)

Standardised use and access rules

The German Portal for Medical Research Data (formerly Central Application and Registration Office - ZARS)

Working group chairpersons:

  • Prof. Dr. Oliver Kohlbacher (Eberhard Karls Universität Tübingen)
  • Prof. Dr. Toralf Kirsten (Universitätsmedizin Leipzig)