The Pharmacovigilance of Digital Therapeutics (DTX): Developing A New Safety Framework

Digital therapeutics (DTx) are one of the novel and outstanding advancements in the health care, changed the way we treat and manage health conditions by using software as a form of medicine. From managing chronic diseases to supporting mental health, these tools offer new possibilities for personalized and accessible care. But just like traditional medicines, digital therapeutics must be safe, effective, and reliable. That’s where pharmacovigilance comes in the process of monitoring and managing potential risks or adverse effects. However, tracking the safety of digital tools is different from monitoring drugs. It involves keeping an eye on software errors, data privacy concerns, unexpected user experiences, and clinical outcomes that may not be immediately obvious. As DTx continue to evolve, so must the systems that ensure their safety. In this review article we have discussed how pharmacovigilance is adapting to the digital age, highlighting the need for smarter monitoring, updated regulations, and stronger collaboration between developers, clinicians, and regulators to protect patients and build trust in this growing field.