Ethical and legal considerations influencing human involvement in the implementation of artificial intelligence in a clinical pathway: A multi-stakeholder perspective

Abstract

Introduction: TFF3 test (a minimally invasive alternative to endoscopy), where AI promises to mitigate increasing demands for pathologists' time and input. Methods: We gathered a multidisciplinary group of stakeholders, including developers, patients, healthcare professionals and regulators, to obtain their perspectives on the ethical and legal issues that may arise using this exemplar. Results: The findings are grouped under six general themes: risk and potential harms; impacts on human experts; equity and bias; transparency and oversight; patient information and choice; accountability, moral responsibility and liability for error. Within these themes, a range of subtle and context-specific elements emerged, highlighting the importance of pre-implementation, interdisciplinary discussions and appreciation of pathway specific considerations. Discussion: To evaluate these findings, we draw on the well-established principles of biomedical ethics identified by Beauchamp and Childress as a lens through which to view these results and their implications for personalised medicine. Our findings are not only relevant to this context but have implications for AI in digital pathology and healthcare more broadly.

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