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

Humans Electronic Health Records COVID-19 Software Informed Consent
Consent management FHIR Informed Consent Medical data management Patient rights

Journal

BMC medical informatics and decision making
ISSN: 1472-6947
Titre abrégé: BMC Med Inform Decis Mak
Pays: England
ID NLM: 101088682

Informations de publication

Date de publication:
19 12 2022
Historique:
received: 03 11 2021
accepted: 09 12 2022
entrez: 19 12 2022
pubmed: 20 12 2022
medline: 22 12 2022
Statut: epublish

Résumé

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. 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. 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. 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.

Sections du résumé

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.

Identifiants

DOI: 10.1186/s12911-022-02081-4 PMID: 36536405 PMC: PMC9762638
pubmed: 36536405
doi: 10.1186/s12911-022-02081-4
pii: 10.1186/s12911-022-02081-4
pmc: PMC9762638
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

335

Subventions

Organisme : Bundesministerium für Bildung und Forschung
ID : 01KX2021
Organisme : Bundesministerium für Bildung und Forschung
ID : 01ZZ1803A
Organisme : Bundesministerium für Bildung und Forschung
ID : 01ZZ1801M

Informations de copyright

© 2022. The Author(s).

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Auteurs

Martin Bialke (M)

Institute for Community Medicine, Department Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17475, Greifswald, Germany. martin.bialke@uni-greifswald.de.
ORCID: 0000-0001-6888-9086

Lars Geidel (L)

Institute for Community Medicine, Department Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17475, Greifswald, Germany.

Christopher Hampf (C)

Institute for Community Medicine, Department Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17475, Greifswald, Germany.
ORCID: 0000-0002-4557-4783

Arne Blumentritt (A)

Institute for Community Medicine, Department Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17475, Greifswald, Germany.

Peter Penndorf (P)

Institute for Community Medicine, Department Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17475, Greifswald, Germany.
ORCID: 0000-0002-6761-3878

Ronny Schuldt (R)

Institute for Community Medicine, Department Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17475, Greifswald, Germany.

Frank-Michael Moser (FM)

Institute for Community Medicine, Department Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17475, Greifswald, Germany.

Stefan Lang (S)

Gefyra GmbH, Otto-Hahn-Str. 9, 48161, Münster, Germany.

Patrick Werner (P)

MOLIT Institute Heilbronn, Im Zukunftspark 10, 74076, Heilbronn, Germany.

Sebastian Stäubert (S)

Institute for Medical Informatics, Statistics and Epidemiology (IMISE), Leipzig University, Härtelstr. 16-18, 04107, Leipzig, Germany.
SMITH Consortium of the German Medical Informatics Initiative, Leipzig, Germany.

Hauke Hund (H)

GECKO Institute, Heilbronn University of Applied Sciences, Max-Planck-Str. 39, 74081, Heilbronn, Germany.

Fady Albashiti (F)

Medical Data Integration Center (MeDIC LMU), Hospital of the Ludwig-Maximilian-University (LMU), Marchioninistr. 15, 81377, Munich, Germany.

Jürgen Gührer (J)

Tekaris GmbH (Partner of MeDIC LMU), Elsenheimerstraße 53, 80687, Munich, Germany.

Hans-Ulrich Prokosch (HU)

Chair of Medical Informatics, Friedrich-Alexander-Universität Erlangen-Nürnberg, Wetterkreuz 15, 91058, Erlangen, Germany.

Thomas Bahls (T)

Institute for Community Medicine, Department Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17475, Greifswald, Germany.

Wolfgang Hoffmann (W)

Institute for Community Medicine, Department Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17475, Greifswald, Germany.

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