27/04/2020. On April 15, 2020, the Conference of Independent German Federal and State Data Protection Supervisory Authorities (DSK) approved a nationwide standardised template document for patient consent. The wording had been previously harmonised and agreed by all university hospitals in the German Federal Ministry of Education and Research’s (BMBF) Medical Informatics Initiative (MII). The approval of these consent documents enables medical researchers across Germany to obtain broad consent to the use of pseudonymised health data in accordance with the EU General Data Protection Regulation. This is an important prerequisite for many research projects seeking to improve patient care, achieve more personalised medicine, develop AI-based decision-making aids, and more.
The Medical Informatics Initiative is laying the groundwork for the provision of routine clinical data for medical research activities throughout Germany. In order to leverage healthcare data, for example for the development of new treatments, patients must first give their express consent.
Legal certainty enables rapid data analysis for COVID-19 research
The MII’s coordination office in Berlin – jointly managed by TMF (Technology, Methods and Infrastructure for Networked Medical Research), MFT (German Association of Medical Faculties), and VUD (German Association of Academic Medical Centers) – organises cross-project collaboration across Germany. As Sebastian C. Semler, Executive Director of TMF, explained: “Medical Informatics Initiative members have decided in favour of active, informed consent of patients as the lawful basis for Germany-wide research involving routine healthcare data. I am pleased that close and constructive coordination between all sites and the data protection authorities has led to a standardised nationwide, good and practical outcome. This comes just in time to support urgently needed research on COVID-19. Moreover, the approval of a standardised patient consent document highlights and strengthens the innovativeness and competitiveness of Germany’s university hospitals, and of Germany itself as a centre of research and science.”
Milestone for Germany’s entire medical research landscape
Dr Sven Zenker (University Hospital Bonn), chair of MII’s consent working group, continued: “We are very pleased with the approval of a standard patient consent template text for use across multiple sites – this is a major milestone in terms of the achievements of the Medical Informatics Initiative and of the entire medical research landscape in Germany. Coordinating our efforts with the data protection authorities was a meticulous process, with work on details continuing until very recently to ensure agreement among all stakeholders. I think it is especially important that, with these documents, there is now a thoroughly vetted standard solution that can be communicated and analysed nationwide – providing patients with a trustworthy and transparent basis for informed decision-making.”
Greater transparency and autonomy for patients
“Another important achievement has been harmonised informative resources that go hand-in-hand with the use of the template text. This includes, in particular, a central, online source of information for the public on all concrete medical research projects being conducted with patient data. People can therefore experience ‘live’ how a learning healthcare system works,” underlined the working group’s co-chair Professor Daniel Strech (BIH/Charité Berlin). “Without broad consent, this would not be possible – because future medical questions to be addressed with the data are unknown when the patient gives their consent.”
The expertise of multiple stakeholders across Germany, including the biobanks working group of the Association of Medical Ethics-Committees in Germany (AK EK), informed the development and harmonisation of the template. Furthermore, preliminary versions were submitted to all AK EK ethics committees, who made valuable suggestions and greatly improved the documents. Established processes for information exchange between relevant working groups and TMF were used to bring together scientific experts, and to coordinate activities with German state-level data protection authorities.
The concrete implementation of the template text in university hospitals will now follow in the near future. Its introduction will be coordinated with local ethics committees, enabling the consent form to be promptly put into practice.
Statements from the MII consortia:
Professor Roland Eils (BIH/Charité Berlin, Heidelberg University Hospital), coordinator of the HiGHmed consortium: “The ability to now use clinical data on a broad scale for medical research is nothing less than a minor revolution. It is a key milestone on the road to establishing ‘Digital Health Made in Germany’ as an internationally visible brand.”
Professor Markus Löffler (Leipzig University), head of the SMITH consortium: “The approved patient consent procedure represents a milestone in German medical research. We can now use patient healthcare data from university hospitals for clinical research – on the basis of nationally standardised provisions with defined preconditions. This provides us with significant momentum for improving patient care.”
Professor Hans-Ulrich Prokosch (Friedrich Alexander University Erlangen-Nuremberg), head of the MIRACUM consortium: “It is very positive that we now have a nationwide standardised template for patient consent. We can now ask patients themselves, as informed citizens, whether they are willing to allow data collected on them to be used for research purposes. All previous relevant surveys have indicated great willingness on the part of Germans to support scientific research. This template is a big step forward for the Medical Informatics Initiative, and for medical research as a whole.
Professor Georg Schmidt (Technical University of Munich (TUM)/ University Hospital rechts der Isar (MRI)), representative of the DIFUTURE consortium and deputy chair of Association of Medical Ethics-Committees in Germany: “I am pleased that the Medical Informatics Initiative’s consortia have worked with representatives from the Association of Medical Ethics-Committees and with data protection authorities to harmonise the informed-consent documents now available. In my opinion, patients will now be adequately informed of the ramifications of broad consent, with privacy protections for participants, making long-term digital research projects possible.”
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The aim of the Medical Informatics Initiative (MII) is to enhance research and patient care through innovative IT solutions. These will enable the sharing and use of data from healthcare and from clinical and biomedical research across multiple entities and sites. The German Federal Ministry of Education and Research (BMBF) is investing a total of 160 million euros in the initiative through 2021. Within the scope of four consortia – DIFUTURE, HiGHmed, MIRACUM and SMITH – all German university hospitals and medical centres at over 30 locations are cooperating with research institutions, businesses, health insurers and patient representatives. Their mission is to enable the use of research findings to the direct benefit of patients. At the same time, priority is given to robust data protection and security.
The Berlin-based coordination office, operated by TMF (Technology, Methods and Infrastructure for Networked Medical Research) with MFT (German Association of Medical Faculties) and VUD (German Association of Academic Medical Centers), is responsible for managing cooperation within MII at national level.