German Medical Informatics Initiative

Abstract

This article is part of the Focus Theme of Methods of Information in Medicine on the German Medical Informatics Initiative. The Medical Informatics Initiative (MII) was launched within the scope of the German Federal Ministry of Education and Research's (BMBF) Medical Informatics Funding Scheme, with the goal of developing infrastructure for the integration of clinical data from patient care and medical research in Germany. Its work is to be performed over the course of a decade (2016-2025) across three funding phases, with the first two concentrating on university hospitals. During the conceptual phase (now concluded), a central supporting project ensured coordination - and laid the ground for standardised solutions for all the initiative's sites and scientific consortia that will enable effective data use and exchange, both for health care as well as research. The conceptual phase focused on the following: a) interoperability, through the consistent use of international standards (from an early stage, i.e. primary IT systems in patient care); b) standardised templates for patient consent and harmonised data protection; and c) standard rules for data use and access (monitoring and safeguarding access to data). On this basis, the initiative aims in the long term to improve medical research (particularly health care research, using data from treatments), to accelerate the transfer of knowledge from research to patient care - and to provide important impetus for the digitalization of medicine in Germany.

Figure 1

The phases of the Medical Informatics Initiative: funding is provided to the scientific consortia over three successive phases (the nine-month conceptual phase, four-year development and networking phase, and four-year consolidation and further development phase). There are also concurrent activities (support activities, supplementary funding modules). (Modified from [ 1 ]).

Figure 2

The governance structure of the German Medical Informatics Initiative: the National Steering Committee (NSC) and its working groups (and task forces – selected examples are shown here), the central coordination office, the annual general meeting, and the dialogue forum for engagement with stakeholders. The German Federal Ministry of Education and Research (BMBF) provides funding, plus support in the shape of its project management agencies, for the NSC and the coordination office.

Figure 3

The seven consortia and their participating sites during the conceptual phase 2016 –17 are shown on the map (only the consortia’s university sites – not including non-university and industry partners).

Figure 4

This diagram outlines the modules of the MII core data set. These will be made available in stages as data from research and health care are integrated. The basic modules include administrative (orange) and medical (green) data elements that can be made available in harmonised form relatively quickly. More complex data elements, which require more extensive preparation and harmonisation, are shown in the advanced modules (blue). In addition to data on specific patient cases, it is also possible to aggregate structural data of a general nature (e.g. on the institution providing treatment) (structural data, grey).

Figure 5

This illustrates the various legislative environments in each of Germany’s 16 states and at federal level – with regard to whether and to what extent research can use treatment data, and whether informed patient consent is required. The traffic lights indicate each state’s legal situation: a) permissible with no restrictions (green) with consent; consent limited to an individual case or specific research project is not required; b) permissible with restrictions (yellow), where consent must be limited to an individual case or specific research project. (Similar differences between the German states have also been observed for other relevant parameters) (see [ 13 ]).

Figure 6

The sites of the four consortia chosen for funding during the development and networking phase 2018–2021 are shown on the map (including additional university, non-university and industry partners). Universities from discontinued consortia that were active during the conceptual phase can join these four consortia by 2019 (see ► Figure 3 ; not depicted here).