Institute for Medical… Research Medical Data… For patients

What is the Medical Data Integration Center?

Logo Data Integration Center

The Medical Data Integration Center at Heidelberg University Hospital is currently being established as part of the Medical Informatics Initiative (MII). The consortia of the Medical Informatics Initiative (MII) have established so-called Data Integration Centers (DIZ). In the DIZs, the technical and organizational prerequisites for cross-site data use processes between patient care and medical research are being created. The aim of the Medical Data Integration Centers (MeDICs) at Heidelberg University Hospital is to make data from medical care available to practitioners and researchers so that it can be used for improved integrated patient care or for greatly expanded interdisciplinary research opportunities. To this end, the hospital's currently fragmented data pools will be merged into a central MeDIC platform. The consolidation will be done using international, open standards such as HL7v2, HL7 FHIR, DICOM, W3 and OpenEHR. IHE profiles are used as far as possible.

Heidelberg University Hospital is one of the founding partners of the HiGHmed consortium. HiGHmed focuses on the three use cases cardiology, oncology and infection control. However, the data can also be used for use cases of the MII as well as other projects.

The collection and storage of data will comply with data protection regulations in accordance with the German Data Protection Regulation (DSGVO). Data are only made available to researchers if the patient has consented to the use of his or her data for research purposes. For more detailed information on the provision and use of data, see the Processes section.

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The Broad Consent of the MII provides that the patient can agree to various modules of the Broad Consent. This includes consent to the use of pseudonymized patient data for research. The prerequisite for this is that the research project is conducted in countries that have a similar EU data protection level as the EU.

In addition, the patient can consent to being contacted by the university hospital about additional findings.

In addition, the patient can agree to be contacted for additional information.

In Heidelberg, it is not yet possible to obtain broad consent for biomaterials and health insurance data. Both are being sought.

Detailed information can be found in the following video.

Processes

The introduction of Broad Consent is currently being piloted in Radiation Oncology. In addition, you can provide consent forms for the use of your data in MeDIC in the HiGHmed Use Case Cardiology.

In the future, this will also be made possible for other patients.

The revocation is made via the e-mail address treuhand@med.uni-heidelberg.de.

How do I get more answers to my questions?

In the Medical Informatics Initiative (MII), a nationwide funded project, scientists from medicine, informatics and other disciplines at German university hospitals are working together. Their goal is to digitally network patient data generated during a hospital stay throughout Germany. In this way, research can be conducted using this data to cure diseases faster and better in the future. The German Federal Ministry of Education and Research (BMBF) is funding the medical informatics initiative initially until 2021 with around 160 million euros.

The aim of the medical informatics initiative is to make patient data from routine care usable for medical research. The research results thus obtained should help to better detect, treat and prevent diseases as effectively as possible. The medical informatics initiative is also intended to help patients benefit more quickly from validated research findings.

The data will be used to gain new insights into the development of diseases, including the interaction of genetic predispositions, lifestyle and environmental influences. However, the scientists also expect to gain insights, for example, into risk and protective factors in diseases and into individual factors that influence the effectiveness of drugs and therapies. With the totality of the findings, the care of patients is to be further improved.

Many different players from medical research and healthcare are involved in the medical informatics initiative. The German Federal Ministry of Education and Research (BMBF) is funding four associations of university hospitals and other partners, known as 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)

In the four consortia, almost all of Germany's university hospitals are working together with research institutions and companies at more than 30 locations. In dialog with other stakeholders such as health insurance companies, patient representatives and physicians' associations, they jointly develop the framework conditions for ensuring that findings from research can reach patients directly. A coordination office organizes and supports the overarching and nationwide collaboration of all players. It is run by the Technology and Methods Platform for Networked Medical Research e.V. (TMF). The Medical Faculty Association (MFT) and the Association of University Hospitals in Germany (VUD) are also involved in the management.

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 broad benefits for the general public. The goal is to feed medical research results back into care. This can optimize 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. In addition, patients can be characterized more individually. This will increasingly make it possible to determine the best treatment approach before therapy begins. These tailored therapies can lead to greater treatment success or reduce side effects.

As Heidelberg University Hospital, our trained staff will inform you on site about the possibility of participating in the medical informatics initiative. During the discussions, you will learn how to consent to the use of their data and how to revoke their consent at any time. Of course, they will also have the opportunity to ask questions. Consent to data use for research as part of the Medical Informatics Initiative is currently not possible without treatment at a participating university hospital. Regardless of participation in the initiative, future improvements in care through medical informatics will, of course, benefit all patients.

 

After the educational interview, you will be asked to consent to the use of your data for medical research purposes. This consent is voluntary and can be revoked at any time without giving reasons. Since it is not yet possible to say for which medical issues health data may be relevant in the future, consent to the use of data within medical research and care is formulated in general terms. This ensures that medical research in Germany can also solve future tasks and new challenges more quickly with the help of data analyses.

Detailed information on the declaration of consent can be found in the patient information leaflet.

Your patient data is collected. This is all information about you that is used on the occasion of your examination and treatment, e.g.: Data from doctor's letters, your medical history or findings and data from medical examinations such as blood pressure measurements or X-rays; this also includes the results of laboratory tests, including any tests carried out on your genetic material (e.g. for congenital genetic diseases or acquired genetic changes, including tumors).

All data that directly identifies a person - name, date of birth, address - is encrypted (pseudonymized) before being passed on to other researchers. This means that the data can no longer be directly assigned to your person. Only if you explicitly request it, selected data can be traced back to you, e.g. so that your attending physician can inform you about additional medical findings discovered through data analyses. Personally identifying data will never be disclosed to researchers or other third parties, in particular insurance companies or employers, except in cases permitted by the individual or regulated by law.

Your consent is voluntary and will not affect your treatment.

In order to be allowed to use data for a research project, researchers must first submit an application. This application is reviewed by an independent ethics committee and our Use & Access Committee at Heidelberg University Hospital. The Use&Access Committee approves or rejects the application. This procedure excludes any unethical use of the data and ensures a high scientific quality of the data analyses. If a research application is evaluated positively, the researchers are given access to the data. In this way, universities, research institutes and research-based companies can use the patient data - but only for the requested medical research purpose.

With your consent, your patient data for the next five years will be used for medical research. After that, you will be asked for your consent again. Your patient data can be stored and used for research purposes for up to 30 years if you do not revoke.

You can revoke or change your consent at any time without giving reasons.

For more in-depth information on the medical informatics initiative and current work results, please visit the initiative's homepage: www.medizininformatik-initiative.de.

Cooperating projects

Contact

E-mail: medic(at)med.uni-heidelberg.de

Telephone: 06221 - 56 6256

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