Digital Therapeutics

When your medicine is an app on your phone

Many believe digital therapeutics—medical treatments that have digital components or digital only formats—have the potential to help patients prevent, manage or treat a wide range of physical, mental and behavioral conditions. As these treatments become a reality they could create opportunities to strengthen current clinical treatments and disease management options for patients with diabetes, asthma, heart disease, substance abuse and other serious conditions.

As with the emergence of any new therapy, considerations around safety and quality are essential to achieving scale and delivering positive health outcomes. Medicines in the U.S. must meet certain legally established standards for quality before they can be sold. Many of these quality standards are developed by the U.S. Pharmacopeia (USP) and are enforced, under law, by the U.S. Food and Drug Administration (FDA). But digital therapeutics are not regulated like medicines, they are considered medical devices, which meet other standards, including some by USP.

Quality standards for digital therapeutics present a new set of challenges that will require insights and expertise from regulators, software engineers and designers, healthcare providers and others. USP is tapping into the knowledge and experience of experts in the field to understand the potential quality and safety gaps that exist and identify ways to assess quality in order to help protect patients. Quality standards will be an important tool to establish trust in these new therapies. That trust will open the door for physicians and patients to begin taking advantage of these cutting-edge treatments and realizing the benefits they can offer.