Digital Therapeutics: When Apps Become Medicine
By: Rachel Slaughter-Thury
Digital therapeutics have moved from novelty toward clinical practice. Unlike ordinary wellness apps, these programs deliver software-based interventions intended to manage or treat disease.[1] The U.S. Food and Drug Administration (“FDA”) recognizes that software functions can qualify as medical devices regardless of the platform on which they run.[2] Its De Novo database includes reSET for substance-use disorder and EndeavorRx for attention-deficit/hyperactivity disorder.[3] These products highlight the legal dilemma: an app can resemble a game while functioning as regulated treatment.[4]