An important paper co-authored by Duke Health AI Evaluation & Governance Program’s Nicoleta Economou, PhD, and Michael Pencina, PhD, recently published in NPJ Digital Medicine discusses leveraging a Quality Management System (QMS) for AI/ML development intended for healthcare. The authors explain how a tailored QMS framework can bridge the AI translation gap, ensuring safe, ethical, and effective incorporation into patient care. This approach can accelerate the translation of AI research into practical clinical applications, prioritizing patient safety and fostering trust in healthcare innovation.