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

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.

Pediatric Consent on FHIR

“…Our literature review yielded 68 papers, seven of which were relevant. 12 15 22 23 24 25 26 The remaining four papers were retrieved using snowballing. 10 11 14 27 We indicated if an attribute was introduced/used before in the literature for the retrieved papers.…”

“…13 Based on stakeholder dialogue, Bialke et al and Lin et al identified ethical, legal, and administrative reasons why patients must give explicit consent to medical treatment. 14,15 Both studies identified major required consent components-such as treatment information, consent, and signature and mapped them into the FHIR Consent Resource to demonstrate its suitability to support the exchange of electronic consent.…”

“…Note: For each attribute, cardinality, definition and source (consent forms and/or state law) are provided.Applied Clinical Informatics Vol 15. No.…”

Consent Management System on Patient-Generated Health Data

“…Previous studies [2][3][4][5] have demonstrated how various software solutions can be applied to obtain patients' digital and paper-based informed consent when the FHIR standard for managing consent has been insufficient [3,5] or has been limited to the exporting of consent definitions previously defined [4].…”

Transforming Clinical Information Systems: Empowering Healthcare through Telemedicine, Data Science, and Artificial Intelligence Applications

“…The remaining cluster 4 (in yellow) also (Fast Healthcare Interoperability Resources) context in our selection. This year, a contribution by Bialke et al [13] on the topic of standardized exchange of informed consent in an extensive network of university medicine made it into the best paper selection. The authors discuss the use of FHIR in facilitating the exchange of informed consent and provide insights into the potential implications of using FHIR for informed consent in the field of university medicine.…”