Best Practice Guidelines for Bioethical Use of Medical AI in Healthcare. An eDelphi Consensus Exercise

Abstract Introduction Medical Artificial Intelligence (MAI) is transforming healthcare but raises significant ethical concerns. Despite emerging principles and regulations, to our knowledge, no standardized clinical bioethics framework exists to guide MAI practice. Objective This Delphi study sought global expert agreement on ethical challenges, principles, guidelines, and practical tools for MAI use. Method A four-round international eDelphi study, conducted under ACCORD and DELPHISTAR guidance, engaged multidisciplinary stakeholders identified through systematic review and targeted recruitment. Preliminary items were evidence-derived and iteratively refined. Consensus (≥ 80% agreement across two rounds) was predefined. Surveys were anonymized and randomized. Ethical approval and protocol registration were secured before study initiation. Results The panel included 53 participants from 21 countries. Survey rounds started November 2025 and ended February 2026. 170 items were considered. 132 reached consensus. Items were classified into bioethical issues, values, principles, solutions, a checklist for clinicians, and report markers for risk management. Discussion This study produced clinician-focused practice guidelines for the bioethical use of MAI. Ethical components aligned with prior literature, while no new bioethical principles met consensus. Limitations included geographic imbalance and stakeholder representation. Recommendations emphasized human responsibility, governance, and practical implementation tools. Conclusion This Delphi consensus provides practical, ethics-based guidance for the responsible integration of MAI into clinical practice and institutional governance.