©MilouSK / shutterstock.com

The challenge:

It is a central goal of the Medical Informatics Initiative (MII) to create a harmonised framework and standardised rules throughout Germany for the exchange and use of patient data and biosamples for medical research purposes. To guarantee secure and ethical data usage and robust data protection for medical research, it is necessary to establish the corresponding technical and organisational means, in particular the appropriate legislative basis.

Achievements to date:

To this end, the MII member university hospitals have developed and agreed a contract that governs the terms and conditions of cross-site use of patient data and biosamples in individual cases within the scope of the MII.

The contract was agreed with all legal departments of the funded university hospital sites and was approved by the MII’s National Steering Committee (NSG) on 6 October 2020. The MII has therefore taken an important step towards achieving consensus on the legal framework for cross-site data use for medical research. The contract comprises a (main) contractual document and an appendix of general terms and conditions (Version 1.3). It is currently being trialled under real-world conditions. Notes on the contract, providing an overview of the structure and goals of the MII, and the key basis of, background to, and origins of the contract’s development, can be found in the corresponding hand-out.

The contract drew on the extensive expertise of the legal departments of participating university hospital sites, and of leading research facilities, study centres, national research associations and cross-site research projects.

In addition, the NSG has approved an MII-agreed hard-copy form, developed for capturing the content required for the standardised data use application (Version 1.0). This will serve as the basis for the technical implementation and further development of the content of the digital application template for the MII.

Current documents:

Download (in German): Contract governing the use of patient data, biosamples, analysis methods and routines within the scope of the Medical Informatics Initiative (MII ) (version 1.3, 06/10/2020)

Download (in German): Appendix of general terms and conditions (version 1.3, 06/10/2020)

Download (in German): Hand-out (version 1.2, 06/10/2020)

Download (in German): Hard-copy form for the standardised data use application (version 1.0, 06/10/2020)

More information:

Standardised use and access rules