ArticleBMC medical informatics and decision making2022
A FHIR has been lit on gICS: facilitating the standardised exchange of informed consent in a large network of university medicine.
Article in BMC medical informatics and decision making, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Common data models and data standards for tabular health data: a systematic review.BMC medical informatics and decision making · 2025Pooled it
- Implementing informed consent in federated medical research: a blueprint designed to safeguard data subject rights in Germany.Journal of translational medicine · 2026Article
- Safeguarding patient privacy in eHealth systems: Bridging theory and practice through a scoping review and healthcare survey.PLOS digital health · 2026Article
- Health disparities and selection bias in obtaining broad consent in a general practitioner setting.Frontiers in medicine · 2025Article
- The benefits of fully electronic consent management and consent collection via a tablet PC in supporting time-critical pandemic research-an example from a NAPKON COVID-19 project.Frontiers in digital health · 2025Article
- Information Mode-Dependent Success Rates of Obtaining German Medical Informatics Initiative-Compliant Broad Consent in the Emergency Department: Single-Center Prospective Observational Study.JMIR medical informatics · 2024Observational
- The University Medicine Greifswald's Trusted Third Party Dispatcher: State-of-the-Art Perspective Into Comprehensive Architectures and Complex Research Workflows.JMIR medical informatics · 2024Article
- On-site electronic consent in pediatrics using generic Informed Consent Service (gICS): Creating a specialized setup and collecting consent data.PLOS digital health · 2024Article
- Bias in obtaining broad consent in a German general practice? - Preliminary results from a cross-sectional study.Journal of family medicine and primary care · 2024Article
- Uncovering Harmonization Potential in Health Care Data Through Iterative Refinement of Fast Healthcare Interoperability Resources Profiles Based on Retrospective Discrepancy Analysis: Case Study.JMIR medical informatics · 2024Article
- Pediatric Consent on FHIR.Applied clinical informatics · 2024Article
- Transforming Clinical Information Systems: Empowering Healthcare through Telemedicine, Data Science, and Artificial Intelligence Applications.Yearbook of medical informatics · 2023Review
Corrections and comments
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Authors and funding
16 authors.
Funding
Abstract
backgroundThe 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.
methodsBased 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.
resultsA 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.
conclusionsThis 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.
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