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January 13 - January 14
Digital health technologies (wearable sensors, smartphone apps) have been increasingly utilized in drug delivery for intended uses such as assessment of endpoints, diagnosis of diseases, and recommendation of treatment decisions. Artificial intelligence/machine learning is routinely applied when deploying these technologies. This workshop will provide an overview of digital health regulations and provide a venue to discuss challenges and opportunities associated with lifecycles of these technologies ranging from technical/clinical development, health authority interactions, regulatory submissions, and post-approval maintenance.