New Generation of Healthcare
Digital therapeutic solutions consist of patient-facing disease management and direct treatment applications. Many of these products include clinical assessment and outcomes tracking tools, clinician monitoring dashboards, and HIPAA-compliant data storage. When integrated into clinical practice, physicians and other healthcare providers prescribe these programs just as they do any other medication or prescription.
DTx products undergo rigorous clinical testing through randomized clinical trials and real world pilots to demonstrate their safety and efficacy. Unlike general digital health apps, these tools are used by patients and healthcare providers to improve and facilitate the delivery of patient care. Therefore, if a DTx solution is used as a medical device, it undergoes a thorough review and regulatory clearance process by federal agencies such as the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA).