German Medical Informatics InitiativeA National Approach to Integrating Health Data from Patient Care and Medical Research
18 May 2018
accepted: 18 May 2018
17 July 2018 (online)
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.
- 1 Federal Ministry of Education and Research [Bundesministerium für Bildung und Forschung, BMBF]. Medical Informatics Funding Scheme: Networking Data – improving health care. BMBF. Oct. 2015 [cited 2018 Jan 31]. Available from: https://www.bmbf.de/pub/Medical_Informatics_Funding_Scheme.pdf
- 2 Semler SC, Wissing F, Heyder R. Förderprogramm Medizininformatik: Quantensprung für Qualität und E-Health. In: Schug SH, Schmücker P, Semler SC, Seidel C. editors. E-Health-Rahmenbedingungen im europäischen Vergleich: Strategien, Gesetzgebung, Umsetzung. (Tagungsband zur TELEMED 2016 – 21. Nationalen Forum für Gesundheitstelematik und Telemedizin). AKA. 2016: 31-33 In German.:
- 3 Rules of Procedure for the National Steering Committee of the German Medical Informatics Initiative. [cited 2018 Apr 25]. Available from: http://www.medizininformatik-initiative.de/en/about-initiative/results
- 4 Roadmap for the Medical Informatics Initiative 2017–2025. [cited 2018 Apr 25]. Available from: http://www.medizininformatik-initiative.de/en/about-initiative/results
- 5 MII Roadmap for Strengthening Research, Teaching, and Continuing Education. [cited 2018 Apr 25]. Available from: http://www.medizininformatik-initiative.de/en/about-initiative/results
- 6 Data Sharing Working Group Audit Approach in Connection with the Medical Informatics Initiative. [cited 2018 Apr 25]. Available from: http://www.medizininformatik-initiative.de/en/about-initiative/results
- 7 MII Metadata on Data Availability, Analysis Opportunities, and Cooperation Options. [cited 2018 Apr 25]. Available from: http://www.medizininformatik-initiative.de/en/about-initiative/results
- 8 Fleurence RL, Curtis LH, Califf RM, Platt R, Selby JV, Brown JS. Launching PCORnet, a national patient-centered clinical research network. J Am Med Inform Assoc 2014; 21: 578-582.
- 9 Hripcsak G, Duke JD, Shah NH, Reich CG, Huser V, Schuemie MJ. et al. Observational Health Data Sciences and Informatics (OHDSI): Opportunities for Observational Researchers. Stud Health Technol Inform 2015; 216: 574-578.
- 10 Joint Interoperability Key Issues Paper. [cited 2018 Apr 25]. Available from: http://www.medizininformatik-initiative.de/en/about-initiative/results
- 11 MII Core Data Set. [cited 2018 Apr 25]. Available from: http://www.medizininformatik-initiative.de/en/about-initiative/results
- 12 Ganslandt T, Boeker M, Löbe M, Prasser F, Schepers J, Semler SC, Thun S, Sax U. Der Kerndatensatz der Medizininformatik-Initiative: Ein Schritt zur Sekundärnutzung von Versorgungsdaten auf nationaler Ebene. mdi 1/2018: 17-21 In German.
- 13 Schneider UK. Sekundärnutzung klinischer Daten – Rechtliche Rahmenbedingungen. TMF-Book Series. Vol.12. Berlin: MWV; 2015
- 14 Pommerening K, Drepper J, Helbing K, Ganslandt T. Guideline for Data Protection in Medical Research Projects – TMF’s generic solutions 2.0. TMF-Book Series. Vol.11. Berlin: MWV; 2014
- 15 Data Sharing Working Group – Uniform Use and Access Policy Key Issues Paper. [cited 2018 Apr 25]. Available from: http://www.medizininformatik-initiative.de/en/about-initiative/results