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About Prescription Digital Therapeutics

What is a Prescription Digital Therapeutic?

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.

Why choose a Prescription Digital Therapeutic?

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.

Interested in prescribing reSET-O or reSET?
Request a demo to learn more.

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