“Digital therapeutics” vs. “Mental health apps”: A growing debate on standards, regulation and efficacy

The efficacy of Mental Health Apps (pharmaforum): In January, PLOS Digital Health published a study which claimed that there’s “sparse” data to support the efficacy of most mental health apps. In their meta-analysis of published studies, the authors found universal deficiencies and concluded that there’s no convincing evidence that app-based interventions deliver meaningful outcomes. Without digging further, one might think the current case for digital therapeutics is weak. I reviewed all 14 meta-analyses included in the study and found the analysis to be accurate, but incomplete. These analyses focused exclusively on wellness and smoking cessation apps, bypassing a category of digital therapeutics regulated by the FDA that make scientifically validated claims using sound research … A meta-analysis focused on DTx products, like Big Health’s Sleepio, Pear’s reSET, Orexo’s Deprexis, and Happify Health’s Happify, would reach different conclusions… In 2017, pioneering DTx companies created the Digital Therapeutics Alliance (DTA), a 501(c)(6) non-profit trade association focused on providing patients, clinicians, payors, and policymakers with the necessary tools to evaluate and utilize PDTs and NPDTs. One of their primary initiatives was to develop core principles to which all DTx companies should adhere. These include making claims that are appropriate for the level of clinical evaluation, and following required regulatory processes to support product claims. ...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Brain/ Mental Health Technology & Innovation Big Health digital health digital therapeutics Digital Therapeutics Alliance DTx FDA Happify Health mental health apps mental illness meta-analysis Orexo PEAR PLOS Digital Health Source Type: blogs