FDA's ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience

https://www.fda.gov/drugs/drug-safety-and-availability/fdas-istand-pilot-program-accepts-submission-first-artificial-intelligence-based-and-digital-health?utm_medium=email&utm_source=govdelivery FDA's ISTAND Pilot Program Accepts Submission of First Artificial Intelligence-based and Digital Health Technology for Neuroscience FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) recently accepted a new submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. This submission is the first artificial intelligence-based and digital health technology-based project and the first project in neuroscience to be accepted into ISTAND. Launched in 2020, ISTAND aims to support the development of novel drug development tools (DDTs) to be used in regulatory applications for new medical products. The program opens opportunities for DDTs that do not fit into established pathways for evaluation and application such as for biomarkers and clinical outcome assessments. The accepted letter of intent (LOI) submission is for an automated depression and anxiety severity measurement tool utilizing multiple behavioral and physiological indices of depression in a machine learning (ML) model to derive clinician-reported outcomes for depression and anxiety based on the Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) scores. This LOI represents both a digital health technology (DHT) and artificial intelligence (AI)/ML, both important areas of focus for FDA.