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Background: Despite the touted potential of artificial intelligence (AI) and machine learning (ML) to revolutionize health care, clinical decision support tools, herein referred to as medical modeling software (MMS), have yet to realize the anticipated benefits. One proposed obstacle is the acknowledged gaps in AI translation. These gaps stem partly from the fragmentation of processes and resources to support MMS transparent documentation. Consequently, the absence of transparent reporting hinders the provision of evidence to support the implementation of MMS in clinical practice, thereby serving as a substantial barrier to the successful translation of software from research settings to clinical practice.

Objective: This study aimed to scope the current landscape of AI-and ML-based MMS documentation practices and elucidate the function of documentation in facilitating the translation of ethical and explainable MMS into clinical workflows.

Methods: A scoping review was conducted in accordance with PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. PubMed was searched using Medical Subject Headings key concepts of AI, ML, ethical considerations, and explainability to identify publications detailing AI-and ML-based MMS documentation, in addition to snowball sampling of selected reference lists. To include the possibility of implicit documentation practices not explicitly labeled as such, we did not use documentation as a key concept but as an inclusion criterion. A 2-stage screening process (title and abstract screening and full-text review) was conducted by 1 author …