Checklist Approach to Developing and Implementing AI in Clinical Settings: Instrument Development Study.

Background: The integration of artificial intelligence (AI) in health care settings demands a nuanced approach that considers both technical performance and sociotechnical factors.

Objective: This study aimed to develop a checklist that addresses the sociotechnical aspects of AI deployment in health care and provides a structured, holistic guide for teams involved in the life cycle of AI systems.

Methods: A literature synthesis identified 20 relevant studies, forming the foundation for the Clinical AI Sociotechnical Framework checklist. A modified Delphi study was then conducted with 35 global health care professionals. Participants assessed the checklist's relevance across 4 stages: "Planning," "Design," "Development," and "Proposed Implementation." A consensus threshold of 80% was established for each item. IQRs and Cronbach α were calculated to assess agreement and reliability.

Results: The initial checklist had 45 questions. Following participant feedback, the checklist was refined to 34 items, and a final round saw 100% consensus on all items (mean score >0.8, IQR 0). Based on the outcome of the Delphi study, a final checklist was outlined, with 1 more question added to make 35 questions in total.

Conclusions: The Clinical AI Sociotechnical Framework checklist provides a comprehensive, structured approach to developing and implementing AI in clinical settings, addressing technical and social factors critical for adoption and success. This checklist is a practical tool that aligns AI development with real-world clinical needs, aiming to enhance patient outcomes and integrate smoothly into health care workflows.