Behavioral health providers were excluded from the 2009 HITECH Act, which contributed to significant disparities in EHR adoption between mental and physical health providers. The Behavioral Health Information Technology (BHIT) Coordination Act could help remedy this, yet regulatory and societal barriers to full interoperability remain.
The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria.
Digital therapeutics (DTx) have the potential to lower healthcare costs and improve patient compliance, outcomes and access to care. In the first part of this two-article series we look at the current and potential applications for this growing sector of digital health as well as key considerations for technology developers.