PanDa@IDS

 

Pandemic-related data donation based on data sovereignty principles within IDS

 

Care and research in relation to pandemics requires the availability of medical care data in retrospective, acute and prospective terms. A longitudinal view of disease progression requires a) complex legal constructs (ethics, purpose), but in particular the consent of patients, and b) access points to data-gathering endpoints in care and research.

The data sovereignty of citizens in the context of data donation is currently not ensured. The use of data cannot be controlled by the individual. This is also fatal from the point of view of research - e.g. with regard to the subsequent use of the data.

 



 

The challenge

The EU Commission calls for "Data for the Common Good" in order to be able to react better in pandemic situations in the future. Ohmann et al. (Ohmann et al. 2017) show that sharing clinical data is essential for forward-looking research, but it is precisely the legal consents that pose major challenges to research. Currently, data use in research requires individual consent from subjects. The National Steering Group (NSG) has developed initial approaches to broad consent for the medical informatics initiative, but these counteract the traceability of data use.
The demonstrator for data donation is intended to enable the intervention of citizens in the transfer of medical data for research projects. Breaking down data silos seems possible, provided that the data integration centers (DIZ) have appropriate gateway tools (e.g. IDS connectors). The demonstrator-like testing of a data donation in the PanDa project shows that a cross-sector data network is possible. A wide-ranging data network can contribute to improved data availability and thus contribute to addressing the coronavirus crisis.

Our contribution

The objective of the PanDa@IDS project is to build up the overall concept for trustworthy, self-determined and traceable data use on the basis of existing solution modules. The existing approaches are:

  • Digital Life Journey: the DLJ is a framework that describes sovereignty of citizens on a technical as well as organizational level (e.g. governance) and is extended by the use case of data donation. (Fraunhofer ISST)
  • Trusted Connector: Connector with the currently highest security level, which ensures trustworthy and tamper-proof handling of data. This will be extended for the project and transferred to a higher TRL. (Fraunhofer AISEC)
  • Trusted Connector: Connector with the currently highest security level, which ensures trustworthy and tamper-proof handling of data. This will be extended for the project and transferred to a higher TRL. (Fraunhofer AISEC)

In the PanDa@IDS project, a demonstrator was developed to support data donation by integrating citizens into the data usage process. Until now, citizens and patients have not been able to access their own medical data, which could be used for research purposes in a medical context. The demonstrator developed from PanDa@IDs shows how, using IDS technology, data usage conditions can be managed by citizens and also technically and contractually complied with. This particularly increases transparency for citizens and patients with regard to their personal data in the healthcare system. Furthermore, the tested scenario leads to a participation of the individual in the further processing of medical data by research.

Results

A demonstrator for an informationally self-determined data donation was achieved as part of the procedure for evaluating data use requests of the MII, which also maps the legal framework (broad consent, use request and use contract). A prototype was shown of how data use requests from external researchers can be managed and responded to by citizens*. In case of consent by the citizen, the data transfer is enabled via the secure and sovereign channel of the IDS connectors. The implementation of the IDS connectors ensures technical and contractual enforcement of data use conditions from a data sovereign perspective. In addition, the donation of data leads to the creation of transparency about the data available to individuals. The demonstrator illustrates an integration of citizens* into IDS technology, which led to an extension of the Trusted Connector. Thus, the project was successfully completed.

 

Partners

  • Fraunhofer ISST
  • Fraunhofer AISEC
  • Fraunhofer IESE
     

Funding

  • Fraunhofer-Gesellschaft within the framework of the Anti-Corona Program



Video: donate patient data for medical research in a self-determined and transparent way

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