Prescription Digital Therapeutics: When Software Is The Active Ingredient

By Shauna Swanson, Regulatory Scientist

With smartphones now ubiquitous, interest has increased in digital health solutions such as telemedicine platforms and apps used to track symptoms or medication usage. In recent months, the COVID-19 pandemic has only accelerated the adoption of these technologies. While many digital health products are unregulated, prescription digital therapeutics (PDTs) are regulated by the FDA as medical devices.