Digital Medicine
Also known as: SaMD, Digital Health, Health IT
Healthcare innovations delivered primarily through software — spanning regulated SaMD (requiring FDA or CE clearance) and non-regulated tools such as AI diagnostics, remote monitoring, telehealth, and digital therapeutics.
Full Definition
Digital Medicine solutions are characterized by software-based delivery, subscription or per-patient transaction models, and software-scale gross margins. Within Digital Medicine, SaMD (Software as a Medical Device) is the regulated subset — requiring FDA clearance or authorization equivalent to a physical device. Non-device Digital Medicine tools — wellness apps, clinical decision support software below the SaMD threshold, and telehealth platforms — carry a lower or absent regulatory burden. The H-BMC addresses Digital Medicine separately from HealthTech where their commercial dynamics differ — particularly in regulatory classification, reimbursement establishment, and the economics of software gross margins.