Prescription digital therapeutics are software-generated therapeutic interventions delivered directly to patients to prevent, manage, or treat a medical disorder or disease. They are not wellness or fitness apps, wearable devices, or remote care programs.
In many ways, they are held to the same regulatory standards as a biologic or drug.
Directly treat disorders.
Have demonstrated safety and efficacy in randomized X A clinical trial is any research study to evaluate the effects on health outcomes with human participants. clinical trials .
Have labeling claims regulated by the U.S. Food and Drug Administration (FDA).
Are available by prescription only.
Prescription digital therapeutics provide patients, clinicians, and payers with novel therapy options for unmet medical needs. They can be used to enhance or support treatment.
Increase accessibility and may reduce the stigma usually associated with therapeutic treatment.
Foster engagement by integrating gaming and social technologies into therapy.
Make it easy to control quality through consistent delivery of evidence-based therapy.
Offer personalization, so treatment can be tailored to patients’ individual needs.