Patient care data are highly diverse. They originate from multiple source IT systems, and are sometimes structured, and sometimes unstructured. They differ in scope, defined format and content (medical significance, semantics). As a result, the proposed data integration centres face not just the challenge of consolidating data from multiple sources from a purely technical standpoint, but also of achieving a degree of standardisation that enables data analysis at acceptable effort and expense, and with transparent data quality – making them available for a variety of medical research purposes. This requires harmonisation across all sites and consortia to enable data to be effectively utilised in data integration centres throughout Germany. To date, there is no binding Germany-wide standardisation apart from codes for diagnoses and treatment procedures employed for health insurance invoicing and accounting – and it is unlikely to be implemented in the near future, despite corresponding proposals at Gematik (a multi-stakeholder association for the promotion of digitisation in German healthcare) in accordance with the German Electronic Healthcare Act.

Achievements to date:

All university hospitals have agreed on a shared core data set to be maintained as a minimum for all relevant patient data – irrespective of indication and of the research consortium’s defined use case. This entails not just defined requirements for the scope of data, but also with regard to standardisation of medical content in line with international standards. Defined requirements are pragmatic in nature, foresee a gradual increase in the core data set, and are intended to enable data usage at an early stage, for instance for healthcare research. The agreements already reached can be employed as a pilot for other standardisation efforts within electronic healthcare – above and beyond the medical informatics initiative. The core data set was defined with the help of recognised centres of expertise across Germany, in particular university departments of medical informatics, and national and international standardisation bodies.

>> Download (in German): Kerndatensatz der Medizininformatik-Initiative
      version 1.0 (March 10, 2017) [PDF | 579 kB]
>> Download (in English): MII Core Data Set
      version 1.0 (March 10, 2017) [PDF | 911 kB]