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[43] Digital mental health tools won't see clinical [44] US Food and Drug Administration, proposed
adoption without validation, industry players say. Regulatory Framework for Modifications to
https://www.mobihealthnews.com/content/digital- Artificial Intelligence/Machine Learning (AI/ML) -
mental-health-tools-wont-see-clinical-adoption- Based software as Medical Device (SaMD):
without-validation-industry-players https://www.fda.gov/media/122535/download
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