Co-design of a trustworthy AI-based prognostic tool for predicting patient outcome in acute stroke
Abstract This paper reports a descriptive, process-oriented case study of the application of Z-Inspection®, an ethically aligned co-design methodology, in the early design phase of an artificial intelligence (AI) system for healthcare. The methodology was applied within the Horizon Europe project VALIDATE [1], which develops and validates a prognostic clinical decision support system (CDSS) to support treatment decisions in acute ischaemic stroke. An interdisciplinary team of Z-Inspection® experts, AI developers, and clinical stakeholders jointly identified ethical, legal, and technical issues relevant to the planned system. The assessment resulted in 22 ethical issues, 12 dilemmas, 18 risks, and 48 derived requirements, each mapped to the European Commission’s trustworthy AI principles. The identified issues, dilemmas, risks, and derived requirements constitute the primary findings of this descriptive case study and document how general trustworthy-AI principles were translated into context-specific technical, clinical, governance, and organisational requirements. By documenting the process and publishing the complete requirements, the study provides a detailed case for critical scrutiny and potential uptake in other healthcare AI projects, though its transferability and scalability remain to be established in further studies.
Authors
- Megan Coffee (ORCID: https://orcid.org/0000-0002-4581-111X)
- Boris Düdder (ORCID: https://orcid.org/0000-0002-0241-7729)
- Elizabeth Hofvenschioeld (ORCID: https://orcid.org/0000-0002-3418-6144)
- Marta Rubiera (ORCID: https://orcid.org/0000-0001-8100-9477)
- Adam Hilbert (ORCID: https://orcid.org/0000-0003-3447-5453)
- Jesmin Jahan Tithi (ORCID: https://orcid.org/0000-0002-2861-8393)
- Roberto V. Zicari (ORCID: https://orcid.org/0000-0003-2792-9162)
- Pedro A. Moreno-Sánchez (ORCID: https://orcid.org/0000-0003-3987-1789)
- Vince I. Madai (ORCID: https://orcid.org/0000-0002-8552-6954)
- Francesco Di Tano
- Susanne Bonekamp (ORCID: https://orcid.org/0000-0001-9681-5973)
- Malte von Tottleben (ORCID: https://orcid.org/0000-0002-2012-9376)
- L.A. Cappellini (ORCID: https://orcid.org/0000-0001-7604-5625)
- Giorgio Colangelo (ORCID: https://orcid.org/0000-0003-2454-9076)
- Andréane Sabourin Laflamme
- John D. Kelleher (ORCID: https://orcid.org/0000-0001-6462-3248)
- Dietmar Frey (ORCID: https://orcid.org/0000-0001-5407-2331)
- Giovanni Sartor (ORCID: https://orcid.org/0000-0003-2210-0398)
- Roberta Calegari (ORCID: https://orcid.org/0000-0003-3794-2942)
- Cathrine K. T. Bui
- Gabriele Pluktaite
- Tess Buckley
- Ingo Werren
- Emma Moorhead
- Pedro Kringen (ORCID: https://orcid.org/0009-0008-1197-4296)
- Magnus Westerlund
- Renee Wurth
Institutions
- University of Copenhagen (DK)
- Humanitas University (IT)
- Intel (United States) (US)
- Université de Sherbrooke (CA)
- Seoul National University (KR)
- Seoul National University of Education (KR)
- Arcada University of Applied Sciences (FI)
- Trinity College Dublin (IE)
- Heidelberg University (DE)
- Ibero-American Institute (DE)
- Høyskolen Kristiania (NO)
- University Hospital Heidelberg (DE)
- Vall d'Hebron Institut de Recerca (ES)
- Tecnalia (ES)
- Vall d'Hebron Hospital Universitari (ES)
- empirica - Communication and Technology Research (DE)
- Association of Child Psychotherapists (GB)
- Berlin Institute of Health at Charité - Universitätsmedizin Berlin (DE)
- Oldham Council (GB)
- New York University (US)
- Reutlingen University (DE)
- Columbia University (US)
- Charité - Universitätsmedizin Berlin (DE)
- European University Institute (IT)
- University of Bologna (IT)
Publication Details
- Journal
- AI and Ethics
- Published
- 2026-09-14
- DOI
- https://doi.org/10.1007/s43681-026-01337-3
- Primary Topic
- Acute Ischemic Stroke Management
- Type
- article
- Field-Weighted Citation Impact
- 0.00