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Accepted for/Published in: Journal of Medical Internet Research

Date Submitted: Jul 16, 2025
Date Accepted: Nov 6, 2025

The final, peer-reviewed published version of this preprint can be found here:

Collaborative and Cooperative Hospital “In-House” Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values

Schönfelder A, Eberlein-Gonska M, Hülsken-Giesler M, Jovy-Klein F, Kather JN, Kohoutek E, Lennefer T, Liebert E, Lipprandt M, Mathias R, Muti HS, Obergassel J, Reibel T, Rösler U, Schneider M, Schlicht L, Schlieter H, Schmieding M, Schweingruber N, Sedlmayr M, Strametz R, Susec B, Wekenborg MK, Weicken E, Weitz K, Diehl A, Gilbert S

Collaborative and Cooperative Hospital “In-House” Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values

J Med Internet Res 2026;28:e80754

DOI: 10.2196/80754

PMID: 41608759

PMCID: 12902763

Collaborative and cooperative hospital in-house medical device development and implementation in the AI age: the EURAID-framework compatible with European values

  • Anett Schönfelder; 
  • Maria Eberlein-Gonska; 
  • Manfred Hülsken-Giesler; 
  • Florian Jovy-Klein; 
  • Jakob Nikolas Kather; 
  • Elisabeth Kohoutek; 
  • Thomas Lennefer; 
  • Elisabeth Liebert; 
  • Myriam Lipprandt; 
  • Rebecca Mathias; 
  • Hannah Sophie Muti; 
  • Julius Obergassel; 
  • Thomas Reibel; 
  • Ulrike Rösler; 
  • Moritz Schneider; 
  • Larissa Schlicht; 
  • Hannes Schlieter; 
  • Malte Schmieding; 
  • Nils Schweingruber; 
  • Martin Sedlmayr; 
  • Reinhard Strametz; 
  • Barbara Susec; 
  • Magdalena Katharina Wekenborg; 
  • Eva Weicken; 
  • Katharina Weitz; 
  • Anke Diehl; 
  • Stephen Gilbert

ABSTRACT

The last years have seen an acceleration in the development and uptake of AI systems by ‘early adopter’ hospitals. This transformation has raised concerns among healthcare providers about impacts on professional roles, patient care, and the real priorities of change drivers. The pace of AI-enabled digital transformation in the EU may be slowed by structural factors, the caution of professional organisations, and strict regulation. How can positive AI-enabled digital transformation be carried out in EU healthcare, aligned with European values, while avoiding the risk of falling behind, missing out on the digital health dividend of better care, greater efficiency, and global competitiveness? In response, we explore the co-development of a narrow purpose ‘in-house’ AI system, developed through multi stakeholder collaboration as an introductory step toward bridging the AI implementation gap in real-world clinical settings. This example is then expanded to address the broader challenges associated with complex, multi-agent AI systems. Based on multi-stakeholder workshops and a perspective that spans all stakeholders, we propose a practical, multimodal framework for human-centric transformation based on agreed values.


 Citation

Please cite as:

Schönfelder A, Eberlein-Gonska M, Hülsken-Giesler M, Jovy-Klein F, Kather JN, Kohoutek E, Lennefer T, Liebert E, Lipprandt M, Mathias R, Muti HS, Obergassel J, Reibel T, Rösler U, Schneider M, Schlicht L, Schlieter H, Schmieding M, Schweingruber N, Sedlmayr M, Strametz R, Susec B, Wekenborg MK, Weicken E, Weitz K, Diehl A, Gilbert S

Collaborative and Cooperative Hospital “In-House” Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values

J Med Internet Res 2026;28:e80754

DOI: 10.2196/80754

PMID: 41608759

PMCID: 12902763

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