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In this proposed rule we use the term digital mental health treatment (DMHT) device to include the term digital CBT we used in prior rulemaking and in general to refer to software devices cleared by the Food and Drug Administration (FDA) that are intended to treat or alleviate a mental health condition, in conjunction with ongoing behavioral health care treatment under a behavioral health treatment plan of care, by generating and delivering a mental health treatment intervention that has a demonstrable positive therapeutic impact on a patient's health

One of Health Secretary Robert F

Lastly, an OTP must meet additional conditions as the Secretary may find necessary to ensure the health and safety of individuals being furnished services under such program and the effective and efficient furnishing of such services