Digital Medicine

Digital Medicine covers software-based products used in the prevention, diagnosis, monitoring, and treatment of disease. Examples include software that analyzes medical images or physiological signals to support diagnosis, clinical decision support that guides clinicians in treatment, remote patient monitoring, telehealth platforms, and digital therapeutics that deliver treatment directly. Digital Medicine is also one of the GAITS Solution Types.

Regulation depends on the intended use and the claims made, not on the technology. Software intended to diagnose, treat, or prevent a disease is generally regulated as software as a medical device (SaMD) and requires clinical evidence. In the United States, some clinical decision support software that does not analyze images or signals falls outside device regulation when the clinician can independently review the basis for each recommendation.

Software intended only to maintain or encourage a healthy lifestyle, such as a fitness or sleep-tracking app, is treated as a general wellness product and is not regulated as a medical device, provided it makes no claim to diagnose, treat, or prevent a disease. A wellness product that adds a disease claim becomes subject to device regulation.

Digital Medicine solutions typically use subscription or per-patient transaction models and carry software-scale gross margins. Reimbursement and integration into clinical workflow are frequent barriers. The H-BMC addresses Digital Medicine separately from HealthTech where their commercial dynamics differ.