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.
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.
The consolidation process led to a paper summarising key points on standardised data usage policies. This document described the primary elements of the application procedure and data usage, and defines the key structures and processes. With regard to the development of audit criteria, the consortia have agreed that verification should take the form of an internal audit within each consortium. Each consortium will define a use case catalogue that presents the added value for research and healthcare. Moreover, a system audit will verify structures, processes and results. It was also agreed that an audit will be carried out across all consortia to ensure the quality of the core data set.
Working group chairpersons:
Prof. Markus Löffler (Leipzig University)
Prof. Ulrich Mansmann (Ludwig Maximilian University Munich (LMU))