FAQ - Frequently Asked Questions

Scientists in the fields of medicine, information technology and other disciplines at German university clinics collaborate on the Medical Informatics Initiative (MII), a project funded throughout Germany. Its objective is to digitally connect patient data generated during hospital treatment nationwide. Research can thus be conducted on such data in order to better and faster treat diseases in the future. 

The Federal Ministry of Education and Research (BMBF) is funding the consortia, data integration centres and the cross-consortia use cases in the development and networking phase (2018 to 2022) and the current consolidation and extension phase (2023 to 2026) with a total of over 400 million euros.

The pioneering work carried out by the university hospitals is to be incorporated into all areas of the healthcare system as far as possible: from outpatient care in GP practices and inpatient stays in local hospitals to care in nursing and rehabilitation facilities. Developing and optimising model solutions for this transfer is the task of the six BMBF-funded Digital Hubs. The BMBF provides further 50 million euros for this flagship initiative of its digital strategy (2021-2025).

Well-trained specialists are a key success factor for the initiative. For this reason, the BMBF is also funding 21 junior research groups at the interface of computer science and medicine with around 30 million euros (2020-2026). This makes the pioneering field of research in Germany attractive for scientists and motivates universities to establish new chairs in medical informatics.

What are the goals of the Medical Informatics Initiative?

It is the aim of the Medical Informatics Initiative (MII) to make the patient data from routine care generated during hospital treatment available for medical research. The respective research results should help ensure to better detect, treat and prevent diseases as effectively as possible in the future. The MII is also meant to ensure that patients can benefit faster from validated research findings. Too much time often passes before new findings improve everyday medical care. The reason for this is that the latest knowledge is not immediately available to doctors everywhere when making treatment decisions. The networking of care and research data across institutions and locations should change this in the future. The data collected will contribute to gain new insights into the development of diseases, such as the interaction of genetic predispositions, lifestyle and environmental influences. Furthermore, the scientists expect to uncover information about risks and protective factors in diseases and the individual factors that influence the effectiveness of medication and therapies.  By combining all these findings, the overall goal is to enhance the healthcare provided to patients.

Who is involved in the Medical Informatics Initiative?

Many different stakeholders in the fields of medical research and healthcare are involved in the Medical Informatics Initiative (MII). In four consortia, all German university hospitals collaborate with research institutions and companies at more than 30 locations. In consultation with other stakeholders, such as health insurance companies, patient representatives and medical associations, they jointly develop the framework for research findings to directly benefit patients. Patient participation by consenting to the use of their data is crucial to the success of the initiative. A coordination centre organises and facilitates the interdisciplinary and nationwide collaboration of all parties concerned. It is managed by the TMF – Technology, Methods and Infrastructure for Networked Medical Research. The German Association of Medical Faculties (MFT) and the German Association of Academic Medical Centers (VUD) are also involved in the management of the coordination centre. 

How does the Medical Informatics Initiative work?

The medical informatics initiative comprises three phases from 2016 to 2026:

• Firstly, the stakeholders resolved issues critical to success in a nine-month concept phase (2016-2017). For example, they developed concepts for exchanging and sharing data. They also selected suitable use cases to demonstrate the possibilities of modern digital services and infrastructures in the healthcare sector. Patient representatives and data protection organisations were involved in the initiative at an early stage.
• Four selected consortia (DIFUTURE, HiGHmed, MIRACUM and SMITH) were funded in a development and networking phase (2018-2022). During this time, the consortia have set up so-called data integration centres (DIC), which are responsible for data exchange, developing IT solutions and demonstrating the benefits for patients in specific use cases.
• Successful solutions are to be rolled out in the consolidation and extension phase (2023-2026) and transferred to other locations.

Digital Hubs: Advances in Research and Health Care (2021-2025): The hubs incorporate data from regional care into medical informatics structures and solutions initially in pilot projects. They demonstrate the benefits of this networking for regional patient care in specific use cases.

Junior research groups (2020-2026): Well-trained specialists are a key success factor for the initiative. The BMBF is therefore promoting young scientists at the interface of informatics and medicine and is specifically supporting newly established medical informatics professorships with the new junior research groups.

Why are there several consortia?

In the concept phase (2016-2017), seven consortia applied to participate in the Medical Informatics Initiative. An international jury evaluated the applications and recommended four consortia for funding. The selection decision of the international experts in the competition for good ideas and the effective use of research funds strengthens the efficiency and competitiveness of Germany as a centre of science in the long term.

What consortia are currently being funded?

The German Federal Ministry of Education and Research is funding the following four associations of clinics and other partners, the so-called consortia:

DIFUTURE (Data Integration for Future Medicine)

HiGHmed

MIRACUM (Medical Informatics in Research and Care in University Medicine)

SMITH (Smart Medical Information Technology for Healthcare)

What are the tasks of the consortia?

In the consortia of the Medical Informatics Initiative, university hospitals have joined forces with other partners, e.g. research institutes, universities, companies and non-university hospitals. Together, the consortia create the conditions for research and patient care to be able to exchange data with each other across locations. Their task is to set up so-called data integration centres (DIC) at the university hospitals and partner institutions. In these centres, the technical and organisational prerequisites for cross-site data exchange between patient care and medical research are created.

In addition, the consortia are developing IT solutions for the first applications of medical informatics, the so-called use cases. These specific use cases are intended to demonstrate the medical added value of data exchange and IT solutions for patients.

These include, among others:

• Clinical studies
• Asthma and chronic obstructive pulmonary disease (COPD)
• Oncology: precision medicine for tumour patients
• Cardiology
• Infection medicine and hospital hygiene
• Intensive care medicine
• Neurology: multiple sclerosis and Parkinson's disease
• Rare diseases
• Drug interactions
• Utilisation of biosample data
• Improvement of care processes
• Improvement of care processes

The consortia also promote medical informatics in Germany by increasing the training of scientists in data sciences. To this end, new professorships in the field of medical informatics and new degree programmes in medical data science are being established at universities, for example.

What are the Data Integration Centres (DIC)?

The consortia of the Medical Informatics Initiative (MII) have established Data Integration Centres (DIC) at their university medical sites. In these new facilities, data from healthcare and research of a university hospital are collected, whereby data quality and data protection are essential. The DIC is usually an institution within the hospital and is generally closely linked to the clinical IT units, thus ensuring a close connection to the systems of patient care. The tasks of the DIC include the transfer of data from a wide range of data-providing systems, the integration and processing of this data, and ensuring data quality and data protection. The processed data is then made available for use in medical research and research results are fed back into the health care system via the DIC.

The DIC thus create the technical and organisational prerequisites for data use processes between patient care and medical research across multiple sites. The DIC thus enable medical data to be recorded, integrated and exchanged in such a way that they can be used effectively in health care and research - even repeatedly. Standardisation, reusability and interoperability of data are key factors here. In the future, researchers should be able to use harmonised data from all German university hospitals with a single query within a uniform legal framework. The DIC will be maintained as a permanent, sustainable infrastructure, thus improving digital, targeted health care and preparing the federal research system for the future.

Why is it so important to link data from patient care and medical research?

A great deal of information on the patient's state of health is collected in everyday clinical practice. This includes information on the patient's illness, treatments already carried out, laboratory values and the success of prescribed therapies. Health research in Germany has so far only been able to utilise all of this valuable information to a very limited extent. The Medical Informatics Initiative wants to change this: it will make the information from the clinic usable for research and link it with research data and biobank data. With the help of this information, which has so far been isolated from each other in the clinical and research data worlds, researchers will be able to gain new insights and doctors will be able to treat their patients better and more individually in the future.

How will doctors benefit from the Medical Informatics Initiative in the future?

The electronic consolidation of all available and relevant data should provide doctors with a better picture of the situation of each individual patient and enable them to better predict the course of the disease. The nationwide comparison of health data, therapy decisions and treatment results is intended to support more accurate diagnosis and treatment decisions in the future.

How do patients benefit from the Medical Informatics Initiative?

The Medical Informatics Initiative aims to network patient data for many different medical research purposes and make it available to medical research in order to achieve a broad benefit for the general public. The aim is to channel the results of medical research back into healthcare. This can optimise treatment and increase patient safety, for example because diagnoses can be made more quickly and accurately, duplicate examinations can be avoided or adverse drug reactions can be prevented. Moreover, new technologies progressively enable personalised medicine. As a result, it will be increasingly possible to determine the best treatment approach before the therapy is due to start. Such personalised therapies may result in more successful treatments or fewer side effects.

How is patient data protected?

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 the data can no longer be directly attributed to a person. 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.

Patient data will be stored by the clinic that treated the patient. 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, the 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.

Information on the handling of genetic data as part of the Medical Informatics Initiative can be found here.

What is a Use and Access Committee (UAC)?

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. 

Can patient representatives participate in the Use and Access Committee (UAC)?

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

Who decides whether a research project may be carried out with the patient data collected as part of the Medical Informatics Initiative?

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.  

Who is authorised to conduct research with my patient data?

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.

How can I participate as a scientist?

Researching physicians who would like to participate in a specific use case or initiate a research project with the data from the data integration centres (DIC), for example, can contact the consortia and their DIC directly.

Healthcare stakeholders who would like to adopt the IT solutions of a consortium in the consolidation and extension phase from 2023 can join the initiative as a networking partner or roll-out partner. Additional partners are included in the data exchange as early as the development and networking phase (2018-2022), e.g. from outpatient care or private clinics. The aim is for researchers, doctors and patients to benefit from the advances made by the medical informatics initiative as comprehensively as possible. Interested healthcare stakeholders can contact the respective consortium or the coordination office directly.

How can I participate as a patient or citizen?

Trained employees of the participating university hospitals inform patients on site about the possibility of participating in the Medical Informatics Initiative (MII). During the informative discussions, patients will learn how they can consent to the use of their data and revoke their consent at any time. Of course, they also have the opportunity to ask questions. Consent to the use of data for research as part of the MII is currently only possible in the context of treatment at a participating hospital. Irrespective of participation in the initiative, future improvements in care through medical informatics will of course benefit all patients.

How can patients consent to the use of their data?

Patients are asked to consent to the use of their data for medical research purposes by signing a patient consent form. Consent is voluntary and can be withdrawn at any time without giving reasons.

As it is not possible yet to determine the specific medical issues which the use of health data may help resolve in the future, the informed consent to the use of health data for medical research and healthcare purposes is phrased in general terms (broad consent). It is thereby ensured that the medical research conducted in Germany will also tackle future tasks and new challenges in a much faster manner thanks to data analyses.

Detailed information on the broad consent is provided in the patient information leaflet.

Where can I find further information?

More detailed information on the Medical Informatics Initiative and current work results can be found on this homepage.

More information on the consortia and the coordination office can be found here:
DIFUTURE
HiGHmed
MIRACUM
SMITH
Coordination Office

You can find more information on the Digital Hubs at gesundheitsforschung-bmbf.de:
Digitale FortschrittsHubs Gesundheit
CAEHR
DECIDE
DISTANCE
LeMeDaRT
MIDIA-Hub
MiHUBx

The coordination office also answers press enquiries (presse@medizininformatik-initiative.de) and requests for accompanying research (info@medizininformatik-initiative.de).