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[166] SAMHSA has adopted the International Organization for Standardization's definition of DTx as health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient's health. [167] SAMHSA also notes that DTx may be used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. Given nationwide behavioral health workforce shortages combined with increasing demand for behavioral health care services, some Medicare beneficiaries may have limited access to these services

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