In May 2022, the Digital Therapeutics Alliance released a report titled DTx Value Assessment & Integration Guide. This new report provides a framework for how health care decision-makers can assess emerging digital therapeutics, including information that should be considered when evaluating digital therapies, and a benchmark system to compare prescription digital therapeutics. The report also addresses the differences between wellness apps and prescription digital therapies. As explained in the report, patient wellness apps are products like fitness, meditation, and lifestyle apps that capture, transmit, or store health data, such as an individual’s heart rate or daily step count. Wellness apps are not required to be clinically tested and cannot be used as a clinical intervention to treat a disease or disorder.
Meanwhile, prescription digital therapeutics are medical interventions that use software to treat, manage, or prevent a disease or disorder. Prescription digital therapeutics also incorporate patient privacy and security protections; publish trial results inclusive of clinically meaningful outcomes in peer-reviewed journals; and are cleared by the Food and Drug Administration (FDA). To learn more about Aimed Alliance’s work to expand access to and coverage of prescription digital therapies, please click here.