Compliance with Clinical Guidelines and AI-Based Clinical Decision Support Systems: Implications for Ethics and Trust.

Artificial intelligence (AI) is gradually transforming healthcare. However, despite its promised benefits, AI in healthcare also raises a number of ethical, legal and social concerns. Compliance by design (CbD) has been proposed as one way of addressing some of these concerns. In the context of heal...

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Publicado en:Science & Engineering Ethics Vol. 31; no. 6; pp. 1 - 20
Autores principales: Pardoux, Éric, Kerasidou, Angeliki
Formato: Artículo
Publicado: Springer Nature Dec2025
Materias:
Acceso en línea:Ver este registro en EBSCOhost
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        atl: Compliance with Clinical Guidelines and AI-Based Clinical Decision Support Systems: Implications for Ethics and Trust.
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          Pardoux, Éric
          Kerasidou, Angeliki
        affil:
          https://ror.org/02feahw73 Aix Marseille Université, CNRS, EFS, ADES, Marseille, France
          https://ror.org/02wmc6m46 IHRIM, CNRS & ENS Lyon, Lyon, France
          https://ror.org/022psxk94 CNRS, Maison Française d’Oxford, Oxford, UK
          https://ror.org/052gg0110 The Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK
      su:
        Clinical decision support systems
        Medical ethics
        Design techniques
        Artificial intelligence & ethics
        Medical decision making
        Sociotechnical systems
        Artificial intelligence
        Medical protocols
      sug:
        subj:
          Clinical decision support systems
          Medical ethics
          Design techniques
          Artificial intelligence & ethics
          Medical decision making
          Sociotechnical systems
          Artificial intelligence
          Medical protocols
      keyword:
        Clinical guidelines
        Compliance
        Design
        Ethics
        Trust
      ab: Artificial intelligence (AI) is gradually transforming healthcare. However, despite its promised benefits, AI in healthcare also raises a number of ethical, legal and social concerns. Compliance by design (CbD) has been proposed as one way of addressing some of these concerns. In the context of healthcare, CbD efforts could focus on building compliance with existing clinical guidelines (CGs), given that they provide the best practices identified according to evidence-based medicine. In this paper we use the example of AI-based clinical decision support systems (CDSS) to theoretically examine whether medical AI tools could be designed to be inherently compliant with CGs, and implication for ethics and trust. We argue that AI-based CDSS systematically complying with CGs when applied to specific patient cases are not desirable, as CGs, despite their usefulness in guiding medical decision-making, are only recommendations on how to diagnose and treat medical conditions. We thus propose a new understanding of CbD for CGs as a sociotechnical program supported by AI that applies to the whole clinical decision-making process rather than just understanding CbD for CGs as a process located only within the AI tool. This implies taking into account emerging knowledge from actual clinical practices to put CGs in perspective, reflexivity from users regarding the information needed for decision-making, as well as a shift in the design culture, from AI as a stand-alone tool to AI as an in-situ service located within particular healthcare settings.
      pubtype: Academic Journal
      doctype: Article
      src: R
    language: English
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