Prescription Digital Therapeutics

Digital health technologies including PDTx may help address unmet needs in chronic disease management, mental healthcare, and personalised medicine. PDTx differ from general consumer health apps because they are expected to meet evidence-based standards comparable to medicines or medical devices, including clinical validation, regulatory oversight, and post-market surveillance. The policy environment for PDTx remains fragmented, with countries differing in how they classify, authorise, reimburse, and integrate them into healthcare systems. Policy gaps in PDTx can delay market entry, complicate clinical use, and limit patient access to evidence-based digital therapies. Current PDTx adoption is hindered by variation in regulatory classification, approval mechanisms for software as a medical device, reimbursement arrangements, healthcare infrastructure, interoperability, professional training, and patient access. Prescription digital therapeutics are software-based healthcare interventions intended to prevent, manage, or treat specific diseases.