Digital Therapeutics and Safety Monitoring
Digital therapeutics (DTx) represent a new frontier in healthcare, offering software-driven interventions for various medical conditions. This session explores the pharmacovigilance implications of DTx, including the identification, assessment, and management of software-related adverse events. Attendees will learn about regulatory expectations for safety monitoring of DTx products and how to adapt traditional pharmacovigilance systems for digital contexts. Topics include user data protection, interoperability with health records, and tracking efficacy in real-world usage. The importance of usability testing, continuous performance monitoring, and cross-functional collaboration is highlighted. Real-world case examples will showcase how companies ensure safe deployment and lifecycle management of digital therapeutics.
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