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. 2022 Dec 19;22(1):335.
doi: 10.1186/s12911-022-02081-4.

A FHIR has been lit on gICS: facilitating the standardised exchange of informed consent in a large network of university medicine

Martin Bialke #  1 , Lars Geidel #  2 , Christopher Hampf  2 , Arne Blumentritt  2 , Peter Penndorf  2 , Ronny Schuldt  2 , Frank-Michael Moser  2 , Stefan Lang  3 , Patrick Werner  4 , Sebastian Stäubert  5   6 , Hauke Hund  7 , Fady Albashiti  8 , Jürgen Gührer  9 , Hans-Ulrich Prokosch  10 , Thomas Bahls  2 , Wolfgang Hoffmann  2
Affiliations

A FHIR has been lit on gICS: facilitating the standardised exchange of informed consent in a large network of university medicine

Martin Bialke et al. BMC Med Inform Decis Mak. .

Abstract

Background: The Federal Ministry of Education and Research of Germany (BMBF) funds a network of university medicines (NUM) to support COVID-19 and pandemic research at national level. The "COVID-19 Data Exchange Platform" (CODEX) as part of NUM establishes a harmonised infrastructure that supports research use of COVID-19 datasets. The broad consent (BC) of the Medical Informatics Initiative (MII) is agreed by all German federal states and forms the legal base for data processing. All 34 participating university hospitals (NUM sites) work upon a harmonised infrastructural as well as legal basis for their data protection-compliant collection and transfer of their research dataset to the central CODEX platform. Each NUM site ensures that the exchanged consent information conforms to the already-balloted HL7 FHIR consent profiles and the interoperability concept of the MII Task Force "Consent Implementation" (TFCI). The Independent Trusted Third-Party (TTP) of the University Medicine Greifswald supports data protection-compliant data processing and provides the consent management solutions gICS.

Methods: Based on a stakeholder dialogue a required set of FHIR-functionalities was identified and technically specified supported by official FHIR experts. Next, a "TTP-FHIR Gateway" for the HL7 FHIR-compliant exchange of consent information using gICS was implemented. A last step included external integration tests and the development of a pre-configured consent template for the BC for the NUM sites.

Results: A FHIR-compliant gICS-release and a corresponding consent template for the BC were provided to all NUM sites in June 2021. All FHIR functionalities comply with the already-balloted FHIR consent profiles of the HL7 Working Group Consent Management. The consent template simplifies the technical BC rollout and the corresponding implementation of the TFCI interoperability concept at the NUM sites.

Conclusions: This article shows that a HL7 FHIR-compliant and interoperable nationwide exchange of consent information could be built using of the consent management software gICS and the provided TTP-FHIR Gateway. The initial functional scope of the solution covers the requirements identified in the NUM-CODEX setting. The semantic correctness of these functionalities was validated by project-partners from the Ludwig-Maximilian University in Munich. The production rollout of the solution package to all NUM sites has started successfully.

Keywords: Consent management; FHIR; Informed Consent; Medical data management; Patient rights.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The modular architecture of the TTP-FHIR Gateway supports simplified provision of consent-related content from the consent management gICS as FHIR resources (The authors have the necessary rights to use the registered image trademarks of E-PIX, gPAS and gICS)
Fig. 2
Fig. 2
Structural representation of the provided consent template (detailed view) with TFCI-specific external properties. These are evaluated by the TTP-FHIR Gateway and considered when generating FHIR resources (The authors have the necessary rights to use the registered image trademarks of E-PIX, gPAS and gICS)
See this image and copyright information in PMC

References

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    1. Netzwerk-universitaetsmedizin.de. NUM Project CODEX. https://www.netzwerk-universitaetsmedizin.de/projekte/codex (2021). Accessed 03 Aug 2021.
    1. Netzwerk-universitaetsmedizin.de. GECCO-Dataset. https://www.netzwerk-universitaetsmedizin.de/gecco-data-set (2021). Accessed 03 Aug 2021.
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    1. Intersoft consulting. Art. 6 General Data Protection Regulation, Lawfulness of processing. https://gdpr-info.eu/art-6-gdpr/ Accessed 01 Mar 2018.

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