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Agreement on nationwide patient consent

Medical Informatics Initiative sets milestone in research

Press Release from Medical Informatics Initiative TMF e. V. | 27.04.2020

Data Protection Conference of the Federal Government and the States agrees to uniform model text for consent to research with pseudonymized patient data – milestone for Germany as a research location.

The Conference of Independent Data Protection Commissioners of the Federal Government and the States gave their agreement on April 15 to a nationwide standardized model text for patient consent. All university hospital sites participating in the Medical Informatics Initiative (MII) of the Federal Ministry of Education and Research had previously agreed on this. The acceptance of the consent documents now enables medical research to obtain broad consent for the use of pseudonymized clinical data nationwide on the basis of the EU General Data Protection Regulation. This is an important prerequisite for a wide range of research projects aimed at optimizing patient care and personalized medicine through to the development of AI-based decision support tools.

The MII is currently creating the conditions to make routine clinical care data available for medical research throughout Germany. In order for a patient’s own health data to be used, for example, to develop new therapies, the patient must explicitly consent to the use of the data.

The concrete application of the sample text in the university hospitals will now be coordinated in the short term in each case locally with the ethics committees of the sites and the sample text will be used practically in a timely manner. 

image source: © Medizininformatik-Initiative TMF e. V.

More information:
Patienteninformation und Einwilligungserklärung [PDF] (German)
Handreichung [PDF] (German)
Pressemitteilung Datenschutzkonferenz (German)

To the press release from Medical Informatics Initiative TMF e.V. | 27.04.2020