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Toward governance of artificial intelligence in pediatric healthcare.

October 30, 2025pubmed logopapers

Authors

Richter F,Holmes E,Richter F,Guttmann K,Duong SQ,Gangadharan S,Schadt EE,Salmasian H,Gelb BD,Glicksberg BS

Affiliations (12)

  • The Center for AI in Children's Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • The Mindich Child Health and Development Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • The Windreich Department of Artificial Intelligence and Human Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • The Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • Children's Hospital of Philadelphia, Philadelphia, PA, USA.
  • ArtemisAI Labs, San Diego, CA, USA.
  • The Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • The Center for AI in Children's Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA. [email protected].
  • The Mindich Child Health and Development Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA. [email protected].
  • The Windreich Department of Artificial Intelligence and Human Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA. [email protected].
  • The Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY, USA. [email protected].
  • The Hasso Plattner Institute for Digital Health at Mount Sinai, Icahn School of Medicine at Mount Sinai, New York, NY, USA. [email protected].

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.

Topics

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