The challenge:

Diverse rules and policies governing which researchers are to be provided with medical data and for what research purposes (use and access rules) are in place for a large number of research data sources (assuming patient consent has been given). However, there are no equivalent rules in Germany that would allow broad access to and use of primary data from patient care. A set of standardised rules is required to enable data use and analysis throughout Germany across all sites and consortia. Otherwise, there is a risk of a request for data being denied due to the diversity of preconditions.

Achievements to date:

All university hospitals have agreed a paper describing standardised key preconditions for data access and use of medical data. The paper succeeds in balancing the rights and interests of data providers and users, between the research interests of the institution generating the data and those of the institution requesting the data. The paper also sets out the future bodies and process required to ensure standardised access and use that is secure, ethical and compliant with data protection requirements. This includes the following:

  • Use and access committees at all data integration centres tasked with ruling on data use requests,
  • A data transfer office at each data integration centre that guarantees secure data transfer from a technical perspective,
  • A central, independent coordination and registration office that receives and manages central data requests, and that ensures transparency regarding the purpose and achievements of data use vis á vis the general public and stakeholders.
  • These steps will help establish a Germany-wide collaborative infrastructure that will greatly facilitate data use and access for future research. The paper drew upon the expertise of recognised organisations throughout Germany – in particular large research cohorts and biobanks, but also advice from legal experts and executive boards of directors at university hospitals.

Download (in German): Eckpunktepapier einer einheitlichen Nutzungsordnung der Medizininformatik-Initiative
      version 1.0 (March 23, 2017) [PDF | 271 kB]

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