We subscribe to the US FDA’s definition of digital health,
• Mobile health (mHealth)
• Health information technology (Health IT/e-health)
• Connected and wearable devices
• Telehealth and telemedicine
• Pesronalised and precision medicine
Digital Medicines and Digital Therapeutics
Digital Health is a broad category that encompasses Digital Medicine, which in turn includes Digital Therapeutics.
Different levels of claims
--> Different levels of risk
---> Different evidence requirements.
Digital Medicine: high-quality hardware or software technologies as tools for measurement and intervention of human health.
Digital Therapeutics: high-quality software (may also include hardware) to deliver evidence-based therapeutic interventions that prevent, manage, or treat a health condition.