What is the Medical 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.
What is Broad Consent?
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.
How can I request data from MEDIC?
What documents do I need to include with my request for data?
Once the process has been approved, you can use the following documents to apply:
- To request data from the MeDIC, use the Request for Use form.
For external requests based on Broad Consent, please include the following documents with the usage request:
- Ethics vote of the study for which you are requesting data.
- Study protocol referenced in the ethics vote of the study for which you wish to request data.
Who decides whether I receive the requested data?
This is usually decided by the Heidelberg Use & Access Committee, which is currently being established.