Pandemic-related data donation based on data sovereignty principles of the Medical Data Space
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 EU Commission is calling for "Data for the Common Good" in order to be able to react better in future in pandemic situations. Ohmann et al. (Ohmann et al. 2017) show that sharing clinical data is indispensable for future-oriented research, although it is precisely the legal consents that present research with great challenges.
The use of data in research currently requires the individual consent of the test persons. The National Steering Committee (NSG) has developed initial approaches to broad consent for the medical informatics initiative, but these counteract the traceability of data use. Ploug et al (Ploug and Holm 2016, 2017) therefore pursue a more fine-grained approach with the "Meta-Consent", including the data donors. The "MyData approach" (Hakkila et al. 2016; Poikola et al. 2015), which originates from Finland, describes a personal data storage that can be personalised.
The objective of the PanDa@IDS project is to build up the overall concept for a trustworthy, self-determined and traceable use of data on the basis of existing solution modules. The existing approaches are:
- Digital Life Journey (Technology Readiness Level (TRL) 4): The DLJ is a framework that describes sovereignty of citizens on a technical and organisational level (e.g. governance) and is extended to include the use case of data donation. (Fraunhofer ISST)
- Trusted Connector (TRL 7). Connector with the currently highest security level, which ensures a trustworthy and manipulation-protected handling of data. This will be extended for the project and transferred to a higher TRL. (Fraunhofer AISEC)
- MYDATA Control Technologies (TRL 8): Leading framework for Data Usage Control, which implements the concepts of International Data Spaces (IDS) technically. The policies for data use are extended by the specific requirements for handling health data. (Fraunhofer IESE)
PanDa@IDS aims to support data donation while ensuring informal self-determination and transparency for data suppliers. This means determining the type and scope of data use before the data is released and being able to trace the use of the data afterwards. To this end, the Fraunhofer Institutes AISEC, IESE and ISST, as participants of the International Data Spaces, rely on the concept of data sovereignty in order to
- to guarantee use in compliance with the legal framework,
- improve data availability, and
- to guarantee transparency and traceability for data donors.
The project refers to the political demands within the framework of the Digital Supply Act (DVG) and the Patient Data Protection Act (PDSG) for the implementation of the electronic patient file and the safeguarding of the legally intended data donation for citizens.
- Fraunhofer AISEC
- Fraunhofer IESE
- International Data Spaces Association (IDSA)
- Fraunhofer-Gesellschaft within the framework of the Anti-Corona Program