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 objective of the Medical Informatics Initiative is to define a standardised framework for data access and usage across all of Germany. To this end, the data sharing working group is tasked with creating legally sound parameters for data access and usage. Moreover, the working group is developing standardised audit criteria as the basis for demonstrating effective data exchange at the end of the development and networking phase.

Activities

During the conceptual phase, the data sharing working group identified possible criteria for standardised access and usage on the basis of existing policies. These were then employed to develop key points that describe the main processes and structures. With regard to the development of audit criteria, a variety of options for verifying data exchange were discussed.

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. Martin Sedlmayr (Dresden University Hospital)
  • Prof. Ulrich Mansmann (Ludwig Maximilian University Munich (LMU)