The COVID-19 Data Exchange Platform of the German University Medicine

Prokosch, Hans‐Ulrich; Bahls, Thomas; Bialke, Martin; Eils, Jürgen; Fegeler, Christian; Gruendner, Julian; Haarbrandt, Birger; Hampf, Christopher; Hoffmann, Wolfgang; Hund, Hauke; Kampf, Marvin; Kapsner, Lorenz A.; Kasprzak, Piotr; Kohlbacher, Oliver; Krefting, Dagmar; Mang, Jonathan M.; Marschollek, Michael; Mate, Sebastian; Müller, Armin; Praßer, Fabian; Saß, Julian; Semler, Sebastian C.; Stenzhorn, Holger; Thun, Sylvia; Zenker, Sven; Eils, Roland

doi:10.3233/shti220554

Cited by 28 publications

(35 citation statements)

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“…Within all these institutions, databases and registers have been created in preparation for evidence synthesis in future pandemics, which are helpful for potential decision-making (e.g. CEOsys [15], NAPKON [16], CODEX [17] [18], STAKOB [19]).…”

Section: Discussionmentioning

confidence: 99%

Informed consent and trial prioritization for human subject research during the COVID-19 pandemic. Stakeholder experiences and viewpoints

Weigold

Schorr

Faust

et al. 2022

Preprint

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Background: Very little is known about the practice-oriented challenges and mitigation strategies for effective and efficient translation of informed consent and study prioritization in times of a pandemic. This stakeholder interview study aimed to identify the full spectrum of challenges and mitigation strategies for informed consent and study prioritization in a pandemic setting. Methods: We performed semi-structured interviews with German stakeholders involved in human subject research during the COVID-19 pandemic. We continued sampling and thematic text analysis of interview transcripts until thematic saturation of challenges and mitigation strategies was reached. Results: We conducted 21 interviews with investigators, oversight bodies, funders and research support units. For the first topic informed consent we identified three main categories: consent challenges, impact of consent challenges on clinical research, and potential response strategies for consent challenges. For the second topic prioritization of trials, we identified two main categories: need for prioritization of clinical studies and potential response strategies for prioritization of clinical studies. All main categories are further specified with subcategories. A supplementary table provides original quotes from the interviews for all subcategories. Discussion: Mitigation strategies for challenges with informed consent and study prioritization partly share common ground. High quality procedures for study prioritization, for example, seem to be a core mitigation strategy in dealing with informed consent challenges. Especially in a research environment with particularly high uncertainty regarding potential treatment effects and further limitations for valid informed consent should the selection of clinical trials be very well justified from a scientific, medical, and ethics viewpoint.

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Section: Discussionmentioning

confidence: 99%

Informed consent and trial prioritization for human subject research during the COVID-19 pandemic. Stakeholder experiences and viewpoints

Weigold

Schorr

Faust

et al. 2022

Preprint

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“…In close cooperation between WG Consent and the Technology, Methods, and Infrastructure for Networked Medical Research e. V. (TMF), the already approved MII Broad Consent (MII BC) [14] was extended for NUM by a NUM-specific consent module (version 1.6f ) [15]. This supplementary module (called Z-module) grants patients the opportunity to decide on their own responsibility (1) whether their data may be transmitted to the central platform CODEX for the purpose of COVID-19 and pandemic research, in order to then be used for research in conformity with the GDPR, and (2) may even be transferred to countries in which the European Commission did not explicitly confirm a suitable level of data protection, yet ("unsecure third countries" [16]).…”

Section: A Broad Consent Promotes Broad Researchmentioning

confidence: 99%

“…The Federal Ministry of Education and Research of Germany (BMBF) is funding a national network of university medicine (NUM) to support COVID-19 and pandemic research at national level. Within the NUM project “COVID-19 Data Exchange Platform” (CODEX), as one of several funded projects of NUM, a nationwide standardised infrastructure is to be established that supports the storage and provision of COVID-19 research datasets in a data protection-compliant manner [ 1 , 2 ].…”

Section: Introductionmentioning

confidence: 99%

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

Bialke

Geidel

Hampf

et al. 2022

BMC Med Inform Decis Mak

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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.

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“…To tackle the COVID-19 challenges, the Bundesministerium für Bildung und Forschung has initiated the network of university medicine hospitals, which has launched 13 different projects, for example, to coordinate action plans and diagnostic and therapeutic strategies and to provide a comprehensive COVID-19 data exchange (CODEX) platform [ 7 , 8 ]. Decentralized data collection within the CODEX project was based on the German Corona Consensus Data Set (GECCO), a data set specifically designed to collect data on patients with COVID-19 for research [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

The Architecture of a Feasibility Query Portal for Distributed COVID-19 Fast Healthcare Interoperability Resources (FHIR) Patient Data Repositories: Design and Implementation Study

Gruendner¹,

Deppenwiese²,

Köhler³

et al. 2022

JMIR Med Inform

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Background An essential step in any medical research project after identifying the research question is to determine if there are sufficient patients available for a study and where to find them. Pursuing digital feasibility queries on available patient data registries has proven to be an excellent way of reusing existing real-world data sources. To support multicentric research, these feasibility queries should be designed and implemented to run across multiple sites and securely access local data. Working across hospitals usually involves working with different data formats and vocabularies. Recently, the Fast Healthcare Interoperability Resources (FHIR) standard was developed by Health Level Seven to address this concern and describe patient data in a standardized format. The Medical Informatics Initiative in Germany has committed to this standard and created data integration centers, which convert existing data into the FHIR format at each hospital. This partially solves the interoperability problem; however, a distributed feasibility query platform for the FHIR standard is still missing. Objective This study described the design and implementation of the components involved in creating a cross-hospital feasibility query platform for researchers based on FHIR resources. This effort was part of a large COVID-19 data exchange platform and was designed to be scalable for a broad range of patient data. Methods We analyzed and designed the abstract components necessary for a distributed feasibility query. This included a user interface for creating the query, backend with an ontology and terminology service, middleware for query distribution, and FHIR feasibility query execution service. Results We implemented the components described in the Methods section. The resulting solution was distributed to 33 German university hospitals. The functionality of the comprehensive network infrastructure was demonstrated using a test data set based on the German Corona Consensus Data Set. A performance test using specifically created synthetic data revealed the applicability of our solution to data sets containing millions of FHIR resources. The solution can be easily deployed across hospitals and supports feasibility queries, combining multiple inclusion and exclusion criteria using standard Health Level Seven query languages such as Clinical Quality Language and FHIR Search. Developing a platform based on multiple microservices allowed us to create an extendable platform and support multiple Health Level Seven query languages and middleware components to allow integration with future directions of the Medical Informatics Initiative. Conclusions We designed and implemented a feasibility platform for distributed feasibility queries, which works directly on FHIR-formatted data and distributed it across 33 university hospitals in Germany. We showed that developing a feasibility platform directly on the FHIR standard is feasible.

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The COVID-19 Data Exchange Platform of the German University Medicine

Cited by 28 publications

References 0 publications

Informed consent and trial prioritization for human subject research during the COVID-19 pandemic. Stakeholder experiences and viewpoints

Informed consent and trial prioritization for human subject research during the COVID-19 pandemic. Stakeholder experiences and viewpoints

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

The Architecture of a Feasibility Query Portal for Distributed COVID-19 Fast Healthcare Interoperability Resources (FHIR) Patient Data Repositories: Design and Implementation Study

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