Clinical Evaluation of Artificial Intelligence-Enabled Interventions

Artificial intelligence (AI) health technologies are increasingly available for use in real-world care. This emerging opportunity is accompanied by a need for decision makers and practitioners across healthcare systems to evaluate the safety and effectiveness of these interventions against the needs of their own setting. To meet this need, high-quality evidence regarding AI-enabled interventions must be made available, and decision makers in varying roles and settings must be empowered to evaluate that evidence within the context in which they work. This article summarizes good practices across four stages of evidence generation for AI health technologies: study design, study conduct, study reporting, and study appraisal.