Despite the increased popularity of Digital Therapeutics and Digital Medicines, there is still ambiguity around their definitions. This infographic provides clarity and defines the Digital Healthcare Space.
Digital Therapeutics (DTx)
Evidence-based digital solutions making direct therapeutic (and frequently drug-like) claims and regulated by the FDA, usually as Software-as-a-Medical Device (SaMD).
A broader category of digital solutions that may treat, diagnose or help to manage a disease or condition, and that may or may not require regulatory oversight. A product specifically designed to work alongside a pharmaceutical product could fall into this category.
A broad and all-encompassing term for all the ways digital is directly being deployed within healthcare. Normally it is not assumed that digital health products directly treat or diagnose disease. Examples include electronic health records (EHR), telemedicine, and mobile health.