Toward governance of artificial intelligence in pediatric healthcare.

Richter, Felix; Holmes, Emma; Richter, Florian; Guttmann, Katherine; Duong, Son Q; Gangadharan, Sandeep; Schadt, Eric E; Salmasian, Hojjat et al. · NPJ Digit Med · 2025

review · Level V

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Abstract

AI is transforming healthcare, yet pediatric adoption remains limited and governance is underdeveloped. We review existing frameworks and identify pediatric-specific gaps: insufficient stakeholder engagement, developmentally appropriate consent/assent, limited bias mitigation, and unclear accountability. An analysis of FDA-cleared pediatric SaMDs shows radiology dominance while other specialties lag. We call for a pediatric-centric governance approach emphasizing transparency, inclusive participation, equitable data practices, and rigorous post-deployment monitoring to ensure safe, responsible integration.