What are examples of digital medicine products?

Digital medicine products are evidence-based tools that support the practice of medicine.

Measurement products include digital biomarkers (e.g., using a vocal biomarker to track change in tremor for a Parkinson’s patient), electronic clinical outcome assessments (e.g., a electronic patient-reported outcome survey), and tools that measure adherence and safety (e.g., a wearable sensor that tracks falls). 

Intervention products include digital therapeutics and connected implantables (e.g., an insulin pump). Digital therapeutics deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes1.

Combination products both measure and intervene. For example, continuous glucose monitors (CGMs) for diabetics share patient data automatically with their doctor’s office using a companion app. The level of human involvement may vary in the cycle between measurement and intervention - say, when a doctor diagnoses an abnormal heart condition from an EKG reading off a smartphone. Over time, this cycle may become more closed-loop, with less need for human intervention in response to routine changes. More recently, the development of the “artificial pancreas” has combined the CGM with an insulin pump and a computer-controlled algorithm that allows the system to automatically adjust the delivery of insulin to reduce high blood glucose levels (hyperglycemia) and minimize the incidence of low blood glucose (hypoglycemia)2.