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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.
Richter et al. (Thu,) studied this question.