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Designing and piloting a generic research architecture and workflows to unlock German primary care data for secondary use

Authors: Bahls, Thomas; Pung, Johannes; Heinemann, Stephanie; Hauswaldt, Johannes; Demmer, Iris; Blumentritt, Arne; Rau, Henriette; +17 Authors
APC: 2,310.72 EUR

Designing and piloting a generic research architecture and workflows to unlock German primary care data for secondary use

Abstract

Abstract Background Medical data from family doctors are of great importance to health care researchers but seem to be locked in German practices and, thus, are underused in research. The RADAR project (Routine Anonymized Data for Advanced Health Services Research) aims at designing, implementing and piloting a generic research architecture, technical software solutions as well as procedures and workflows to unlock data from family doctor’s practices. A long-term medical data repository for research taking legal requirements into account is established. Thereby, RADAR helps closing the gap between the European countries and to contribute data from primary care in Germany. Methods The RADAR project comprises three phases: (1) analysis phase, (2) design phase, and (3) pilot. First, interdisciplinary workshops were held to list prerequisites and requirements. Second, an architecture diagram with building blocks and functions, and an ordered list of process steps (workflow) for data capture and storage were designed. Third, technical components and workflows were piloted. The pilot was extended by a data integration workflow using patient-reported outcomes (paper-based questionnaires). Results The analysis phase resulted in listing 17 essential prerequisites and guiding requirements for data management compliant with the General Data Protection Regulation (GDPR). Based on this list existing approaches to fulfil the RADAR tasks were evaluated—for example, re-using BDT interface for data exchange and Trusted Third Party-approach for consent management and record linkage. Consented data sets of 100 patients were successfully exported, separated into person-identifying and medical data, pseudonymised and saved. Record linkage and data integration workflows for patient-reported outcomes in the RADAR research database were successfully piloted for 63 responders. Conclusion The RADAR project successfully developed a generic architecture together with a technical framework of tools, interfaces, and workflows for a complete infrastructure for practicable and secure processing of patient data from family doctors. All technical components and workflows can be reused for further research projects. Additionally, a Trusted Third Party-approach can be used as core element to implement data privacy protection in such heterogeneous family doctor’s settings. Optimisations identified comprise a fully-electronic consent recording using tablet computers, which is part of the project’s extension phase.

Country
Germany
Keywords

Europe [MeSH] ; Workflow [MeSH] ; Humans [MeSH] ; Software [MeSH] ; Medical record linkage ; Informed consent ; Trusted third party ; Secondary use ; Electronic health records ; Research ; Germany [MeSH] ; GDPR ; Computational Modelling and Epidemiology ; Health information exchange ; Primary health care ; Data management architecture ; Primary Health Care [MeSH], Health information exchange, Primary Health Care, Research, R, Data management architecture, Workflow, Europe, Germany, Electronic health records, Medicine, Humans, Informed consent, GDPR, Software, Primary health care

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    popularity
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    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Top 10%
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Top 10%
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
17
Top 10%
Top 10%
Top 10%
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gold