Toward governance of artificial intelligence in pediatric healthcare
Felix Richter, Emma Holmes, Florian Richter, Katherine Guttmann, Son Q. Duong, Sandeep Gangadharan, Eric Schadt, Hojjat Salmasian, Bruce D. Gelb, Benjamin S. Glicksberg
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.