Digital health is a fast-growing sector characterised by the use of digital technologies, either alone or in combination with physical products, to treat, diagnose, cure, mitigate and/or prevent disease or other conditions. It includes Health IT – but is not limited to it.

We subscribe to the US FDA’s definition of digital health,
which includes:

• 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.

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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.

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