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    <IdentifierUrn>urn:nbn:de:0183-25gmds1316</IdentifierUrn>
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      <Title language="en">A Secure Architecture for Deploying Machine Learning Models in Distributed Healthcare Settings</Title>
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          <Lastname>H&#252;ning</Lastname>
          <LastnameHeading>H&#252;ning</LastnameHeading>
          <Firstname>Simon</Firstname>
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          <Affiliation>Institute of Medical Informatics, Medical Faculty of RWTH Aachen University, Aachen, Germany</Affiliation>
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          <Affiliation>Institute of Medical Informatics, Medical Faculty of RWTH Aachen University, Aachen, Germany</Affiliation>
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          <Affiliation>Institute of Medical Informatics, Medical Faculty of RWTH Aachen University, Aachen, Germany</Affiliation>
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          <Lastname>Majeed</Lastname>
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          <Firstname>Raphael W.</Firstname>
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          <Affiliation>Institute of Medical Informatics, Medical Faculty of RWTH Aachen University, Aachen, Germany</Affiliation>
          <Affiliation>Department of Internal Medicine, Universities of Giessen and Marburg Lung Center (UGMLC), Member of the German Center for Lung Research (DZL), Gie&#223;en, Germany</Affiliation>
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          <Lastname>Bienzeisler</Lastname>
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          <Firstname>Jonas</Firstname>
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          <Affiliation>Institute of Medical Informatics, Medical Faculty of RWTH Aachen University, Aachen, Germany</Affiliation>
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          <Corporatename>German Medical Science GMS Publishing House</Corporatename>
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        <Address>D&#252;sseldorf</Address>
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    <SubjectGroup>
      <SubjectheadingDDB>610</SubjectheadingDDB>
      <Keyword language="en">privacy-preserving machine learning</Keyword>
      <Keyword language="en">research data management</Keyword>
      <Keyword language="en">electronic health records</Keyword>
      <Keyword language="en">privacy</Keyword>
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    <DatePublishedList>
      <DatePublished>20251103</DatePublished>
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    <Language>engl</Language>
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      <AltText language="de">Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung).</AltText>
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      <Meeting>
        <MeetingId>M0631</MeetingId>
        <MeetingSequence>131</MeetingSequence>
        <MeetingCorporation>Deutsche Gesellschaft f&#252;r Medizinische Informatik, Biometrie und Epidemiologie</MeetingCorporation>
        <MeetingName>70. Jahrestagung der Deutschen Gesellschaft f&#252;r Medizinische Informatik, Biometrie und Epidemiologie e. V. (GMDS)</MeetingName>
        <MeetingTitle></MeetingTitle>
        <MeetingSession>PS 5: IT-Infrastruktur 1</MeetingSession>
        <MeetingCity>Jena</MeetingCity>
        <MeetingDate>
          <DateFrom>20250907</DateFrom>
          <DateTo>20250911</DateTo>
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    <ArticleNo>Abstr. 302</ArticleNo>
    <Fundings>
      <Funding fundId="01VSF23017">Gemeinsamer Bundesausschuss</Funding>
      <Funding fundId="01KX2121">Bundesministerium f&#252;r Bildung und Forschung (BMBF)</Funding>
      <Funding fundId="01KX1319A">Bundesministerium f&#252;r Bildung und Forschung (BMBF)</Funding>
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      <MainHeadline>Text</MainHeadline><Pgraph><Mark1>Introduction:</Mark1> This work presents a proposed architecture that enables the secure deployment of machine learning (ML) models in distributed healthcare environments. ML models are typically developed in centralized environments, but their deployment in healthcare occurs in decentralized, highly protected clinical environments. Sensitive patient data must be protected from unauthorized access, requiring strict isolation and limiting external data connections <TextLink reference="1"></TextLink>. ML environments must accommodate heterogeneous hardware and different ML frameworks, which makes deployment complex. Scalability remains an issue, as decentralized systems must efficiently handle growing datasets and computational demands.   </Pgraph><Pgraph>The AKTIN Network operates a decentralized infrastructure for the standardized collection and local storage of routine emergency care data across German hospitals, the AKTIN infrastructure <TextLink reference="2"></TextLink>. Data remains on-site and is queried via a federated model, ensuring full institutional control and compliance with data protection regulations <TextLink reference="3"></TextLink>. In the context of the KlimaNot project, machine learning models are developed based on data collected within the AKTIN infrastructure and analyzed together with weather data. To enable their deployment and use, our objective is to draft a conceptual framework that allows these models to be executed locally at participating hospitals while safeguarding data privacy and information security. </Pgraph><Pgraph> </Pgraph><Pgraph><Mark1>State of the art:</Mark1>  Privacy in clinical ML is commonly framed by the Five Safes model <TextLink reference="1"></TextLink>. Approaches like the Personal Health Train enable distributed computing, while the UK Health Data Research Alliance provides a guideline to implement a trusted research environment in which ML models can be deployed <TextLink reference="4"></TextLink>, <TextLink reference="5"></TextLink>. However, these frameworks do not address scalable, continuous on-premises model deployment in routine care settings, nor do they include mechanisms for institution-level model approval and integration into operational IT. </Pgraph><Pgraph> </Pgraph><Pgraph><Mark1>Concept and implementation:</Mark1> We propose a modular, privacy-preserving architecture for local ML inference using the AKTIN data warehouse as a trusted source. The Architecture Communication Canvas serves as a tool to communicate and document architecture. The system is implemented as a Trusted Research Environment under the Five Safes framework. After being reviewed and approved by local IT and medical staff, models are executed in containerized local environments. They access data exclusively through a dedicated loader and remain fully isolated from raw patient data. The design supports heterogeneous infrastructures and is evaluated within the KlimaNot project as a scalable solution for secure ML deployment in routine care and research.  </Pgraph><Pgraph> </Pgraph><Pgraph><Mark1>Lessons learned:</Mark1> The Five Safes framework enables secure ML inference in decentralized healthcare. Our architecture shows that local, container-based execution is feasible, but real-world analysis revealed challenges that hospitals require flexible infrastructure support, model validation must be locally approved by IT and clinical staff, and data access must be tightly controlled via dedicated loaders. Ensuring reproducibility and scalability requires container registries and version control. Detailed technical and procedural aspects will be addressed in a forthcoming full paper. </Pgraph><Pgraph> </Pgraph><Pgraph><Mark1>Acknowledgement:</Mark1> Funding by the G-BA Innovationsfonds (01VSF23017) and the German Federal Ministry of Education and Research and Network of University Medicine &#8220;NUM 2.0&#8221; (01KX2121), &#8220;AKTIN&#64;NUM&#8221; (01KX1319A).</Pgraph><Pgraph>The authors declare that they have no competing interests.</Pgraph><Pgraph>The authors declare that an ethics committee vote is not required.</Pgraph></TextBlock>
    <References linked="yes">
      <Reference refNo="1">
        <RefAuthor>Desai T</RefAuthor>
        <RefAuthor></RefAuthor>
        <RefTitle>Five safes: designing data access for research</RefTitle>
        <RefYear>2016</RefYear>
        <RefJournal>Economics Working Paper Series</RefJournal>
        <RefPage>28</RefPage>
        <RefTotal>Desai T, et al. Five safes: designing data access for research. Economics Working Paper Series. 2016;1601:28.</RefTotal>
      </Reference>
      <Reference refNo="2">
        <RefAuthor>Ahlbrandt J</RefAuthor>
        <RefAuthor></RefAuthor>
        <RefTitle>Balancing the need for big data and patient data privacy - an IT infrastructure for a decentralized emergency care research database</RefTitle>
        <RefYear>2014</RefYear>
        <RefJournal>Stud Health Technol Inform</RefJournal>
        <RefPage>750-4</RefPage>
        <RefTotal>Ahlbrandt J, et al. Balancing the need for big data and patient data privacy - an IT infrastructure for a decentralized emergency care research database. Stud Health Technol Inform. 2014;205:750-4.</RefTotal>
      </Reference>
      <Reference refNo="3">
        <RefAuthor>Bienzeisler J</RefAuthor>
        <RefAuthor></RefAuthor>
        <RefTitle>Implementation report on pioneering federated data access for the German National Emergency Department Data Registry</RefTitle>
        <RefYear>2025</RefYear>
        <RefJournal>npj Digit Med</RefJournal>
        <RefPage>94</RefPage>
        <RefTotal>Bienzeisler J, et al. Implementation report on pioneering federated data access for the German National Emergency Department Data Registry. npj Digit Med. 2025;8:94.</RefTotal>
      </Reference>
      <Reference refNo="4">
        <RefAuthor>Hubbard T</RefAuthor>
        <RefAuthor></RefAuthor>
        <RefTitle></RefTitle>
        <RefYear>2020</RefYear>
        <RefBookTitle>Trusted Research Environments (TRE) Green Paper</RefBookTitle>
        <RefPage></RefPage>
        <RefTotal>Hubbard T, et al. Trusted Research Environments (TRE) Green Paper. Zenodo; 2020.</RefTotal>
      </Reference>
      <Reference refNo="5">
        <RefAuthor>Beyan O</RefAuthor>
        <RefAuthor></RefAuthor>
        <RefTitle>Distributed analytics on sensitive medical data: the personal health train</RefTitle>
        <RefYear>2020</RefYear>
        <RefJournal>Data Intell</RefJournal>
        <RefPage>96-107</RefPage>
        <RefTotal>Beyan O, et al. Distributed analytics on sensitive medical data: the personal health train. Data Intell. 2020;2(1-2):96-107.</RefTotal>
      </Reference>
    </References>
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