Evaluation Frameworks for Clinical AI Incorporating Validation Strategies, Real-World Applicability, and Ethical Principles: Scoping Review
Abstract
Background: AI shows substantial potential in health care; however, the absence of standardized evaluation frameworks limits its safe and effective clinical implementation because of inconsistent validation requirements and fragmented ethical principles. Existing guidelines vary in structure, methodological rigor, and ethical integration, creating uncertainty.
Objective: This study aimed to systematically map, characterize, and critically analyze existing evaluation frameworks for clinical AI, focusing on three core dimensions: methodological rigor, validation strategies (internal validation, including reporting of technical and clinical performance; external validation, including real-world applicability), and alignment with the United Nations Educational, Scientific and Cultural Organization (UNESCO) AI ethical considerations.
Methods: A scoping review was conducted following PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Six databases (PubMed, Embase, BVS, EBSCOhost, ProQuest, and Sage) and the Enhancing the Quality and Transparency of Health Research Network were searched without language or date restrictions up to February 2026. Eligible documents included peer-reviewed papers, gray literature, and organizational guidelines describing evaluation or reporting frameworks for clinical AI. Editorials, commentaries, and conference abstracts lacking a clearly defined evaluative framework or clinical…
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