All your patient data are collected, i.e. any personal information obtained during examinations and treatment, e.g. the data contained in medical reports, your medical history or medical findings, or data gathered in medical examinations, such as blood pressure measurements or X-rays; laboratory test results are also collected, including examinations of your genetic material (e.g. with regard to congenital genetic diseases or acquired genetic disorders, including tumours).

Some participating clinics may also collect biospecimens (tissue samples and/or body fluids) taken for diagnostic or therapeutic purposes. Furthermore, these clinics may give you the opportunity to donate additional samples for medical research purposes during a routine blood test or a puncture that is planned anyway.

Q&A regarding biospecimens will be available soon.

This is not possible yet.  

However it is planned that - subject to your prior consent - any of your patient data collected by resident physicians may also be used for research within the framework of the MII in the future. To this effect, so-called "Digital Hubs: Advances in Research and Health Care” will first test how various regional partners, such as general practitioners, hospitals, nursing homes and rehabilitation facilities, can collaborate on digital care approaches just like the clinics participating in MII.

Any data that can lead to the direct identification of an individual – name, date of birth, address – are replaced (encoded) by a combination of characters. This means that your data can no longer be directly attributed to you. Personal data are never passed on to researchers, other third parties or insurance companies or employers – unless the person in question has specifically given his or her consent or in cases governed by law.

Your data will be stored by the clinic that treated you. After careful examination, they will be exclusively handed over in encoded form for specific research projects to be carried out. Moreover, the researchers are contractually obligated to maintain data privacy and to erase all data by the time a research project has been completed at the latest.

In certain cases, your data may not need to be passed on for research projects but can be evaluated at the clinic according to the instructions given by researchers. In such instances, the completely anonymised evaluation results will be passed on to the researchers.

With your consent, your patient data will be collected for medical research purposes during the following five years. After this period, you will be asked to renew your consent. Your patient data may be stored and used for research purposes for up to 30 years, unless you withdraw your consent.

Consent is given on a voluntary basis and does not affect your treatment. 

The process of obtaining consent can vary between different clinics and institutions. While the consent can be obtained during the admission process, it is possible to seek consent at a different time as well. The timing and manner of obtaining consent can be adapted to suit the specific practices and policies of each clinic.

The Use & Access Committee (UAC) is an interdisciplinary committee at a clinic equipped with a Data Integration Centre (DIC). The UAC decides whether and to what extent the DIC will provide data collected by the clinic for a specifically proposed research project. 

Each clinic is free to decide on the individual members of its UAC. It is in principle possible and desirable for patient representatives to be UAC members. 

A medical research project may generally only be carried out if an independent ethics committee has first evaluated the project. Before researchers may use the patient data for medical research, they must request the clinics involved for their permission to use the data. The UAC at each clinic will review the request to use the data and will also consider the vote of the independent ethics committee. Each UAC is free to decide whether the data collected by the clinic may be used for such a research project.

Further information is available in the MII’s Terms of Use.  

The encoded patient data will be exclusively used for research purposes by research institutions, universities or companies conducting medical research. The research project in question will first be reviewed by an independent ethics committee and the UAC of the participating clinics before the encoded data may be used for any such research project. Due to this procedure the unethical use of the data concerned is ruled out and high-quality scientific data analyses are ensured. Once a research proposal has been approved, the researchers are granted access to the data. The respective universities, research institutes and companies conducting medical research may then use the patient data – but solely for the proposed medical research purpose.

Just like other institutions, health insurance companies may apply for the use of data for strictly medical research purposes. If the research project in question is approved by an ethics committee and the UAC of the participating clinics, the health insurance company will receive the requested data in an encoded format, which in turn means that the health insurer cannot identify the individual concerned. 

Just like other institutions, companies conducting medical research may apply for the use of data for strictly medical research purposes. If the respective research project is approved by an ethics committee and the UAC of the participating clinics, the requested data will be transmitted to the company conducting medical research in an encoded format, so that the company cannot identify the individual in question. 

Patients and citizens may refer to the German Portal for Medical Research Data (FDPG) to find out which research projects are conducted within the framework of the MII. However, the project for which one’s personal encoded patient data are used is not indicated.

It would not only be very elaborate to trace the use of one's personal data in research projects, but could also pose additional risk of re-identifiability of one’s personal data.

Moreover, knowing that one's personal data are used in a specific research project might lead to uncertainties and misunderstandings. For example, if a particular medical condition is examined in a research project, patients with this condition can be included in the intervention group of the study, while people without this condition can be included in the control group. The mere fact that one's personal patient data are used in research projects does therefore not allow for clear conclusions and might easily lead to misunderstandings.   

You may withdraw your consent informally at any time and without giving any reasons. All you have to do is contact the clinic that you gave your consent to. The person to contact is named in your consent documents. You may withdraw your consent in whole or in part, e.g., your consent to the use of biospecimens or health insurance data for research purposes. Once you have withdrawn your consent, your patient data stored for new research projects will be erased respectively your biospecimens will be destroyed.

Regretfully, this is not possible. If you withdraw your consent, your patient data will be erased or anonymised, and may generally no longer be used in new research projects.

Should a specific research result have such an enormous impact on your health and require urgent attention, the doctors or researchers will get in touch with your attending physician.

Furthermore, there may be further analysis results that could be relevant to your health or indicate the need for treatment, so-called additional findings. Knowing about such additional findings may either have positive effects or negative effects on you. It may lead to uncertainty or unnecessary examinations and follow-up treatments. Moreover, disclosing information on additional findings may be necessary in other contexts, e.g., when applying for a health or life insurance. Thus, in the consent form you may decide whether you would like to be informed of additional findings.

Patient information and the broad consent form are available here. 

An overview of the research projects that were proposed and carried out within the framework of the MII can be viewed here.

Refer to www.medizininformatik-initiative.de for detailed information on the MII and the latest MII research results.