The challenge:

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It is a central goal of the Medical Informatics Initiative (MII) to create a harmonised framework and standardised rules throughout Germany for the exchange and use of patient data and biosamples for medical research purposes. To achieve this aim, it is necessary to ensure not only technological harmonisation, but also a standardised organisational and robust legal framework that enables the provision and use of patient data and biosamples and the use of analytical methods and routines.

Achievements to date:

The MII member university hospitals have agreed upon cross-institutional standardised use and access rules for the exchange of patient data, biosamples, and analysis methods and routines. The document describes and mandates the prerequisites for central access and the standardised conditions for the use of medical data for research. While placing emphasis on patient privacy, it has been possible to not only accommodate shared interests but also to reconcile the sometimes conflicting interests of attending physicians and medical researchers – resulting in a form of usage that is secure, ethical and features robust data protection. The document defines the corresponding standardised organisational structures, processes, and terms and conditions of use. In particular, it describes the following:

  • Use & access committees at all participating sites comprising corresponding experts and tasked with ruling on data use requests/applications,
  • A data transfer office at all participating sites that ensures the technical preconditions for secure data transfer,
  • An independent Central Application and Registration Office (ZARS) that centrally manages the application process for data and data use, and that ensures transparency regarding the purpose and achievements of data use vis á vis the general public and stakeholders,
  • a standardised, cross-site application process and
  • standardised, cross-site contract and rules for data access and use.

This establishes the prerequisites for a research infrastructure that enables Germany-wide collaboration and significantly easier data access for future research activities. The document’s development drew on the extensive expertise of leading research facilities, study centres, national research associations and cross-site research projects – in particular large-scale medical research cohorts and biobanks, but also on the knowledge of the legal departments and management boards of participating university hospitals.

Current document:

Download (in German): Standardised use and access rules

version 1.1 (08/12/2020) [PDF | 320 kb]

Predecessor document:

Download (in English): Data Sharing Working Group – Uniform Use and Access Policy Key Issues Paper
version 1.0 (23/03/2017) [PDF | 438 kB]

More information:

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