Understanding DTx

The products developed by DTA member companies address a wide variety of diseases and deliver an equally diverse array of interventions.

While DTA does not endorse, certify, or accredit products, we are glad to provide examples of DTx products from member companies that attest to aligning with DTx Industry Core Principles.

Visit DTA’s product library.

Digital therapeutic products must be proven effective via rigorous testing through Randomized Control Trials (RCT), ongoing real-world evidence generation, and analysis of product performance data. Clinical trial results are published in peer-reviewed journals to demonstrate that each technology:

• Is effective, safe, and credible
• Delivers clinically meaningful results
• Qualifies as a candidate for standard-of-care

Additionally, DTx products align with industry best practices which include well-established Good Clinical Practice protocols.

Digital therapeutics are regulated by national and regional agencies. DTx products adhere to similar standards of oversight as traditional medicines, which include:

• Compliance with national regulatory agencies, notified bodies, and manufacturing requirements
• Registration with the applicable product regulatory agency or notified body
• Affirmation that product claims are factual and supported by clinical validation, regulatory status, and marketing authorization
• Adherence to appropriate labeling and advertising regulations

Even though all digital therapeutics adhere to industry core principles, these products fit into three different categories based on the product’s primary purpose and type of intervention delivered to patients. While exceptions may exist, DTx products generally align with one of these three categories: treat, manage, or prevent a disease (which includes the direct improvement of a health function).

Digital therapeutics improve patient outcomes for a wide range of diseases and disorders with clinically proven technologies accessible through devices such as smartphones or personal tablets.

DTx products may expand access to proven therapies, offer treatment options for un- or undertreated conditions, and empower patients with self-management tools. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.

Additionally, real-world outcomes generated by digital therapeutics may be used to optimize outcomes at the individual patient and population levels. At the individual patient level, DTx products provide clinicians with meaningful, actionable clinical reports. At the population level, data generated by DTx products may be aggregated to track progress or compare aggregate outcomes based upon patient disease state, level of acuity, geographic location, age, gender, etc.

Compared to products that track fitness, encourage medication adherence, or monitor patient activity, DTx products deliver medical interventions directly to patients. As such, digital therapeutics undergo rigorous testing and are held to the same standards of evidence and regulatory requirements as traditional medical treatments.

Wellness and fitness apps that consumers download to their smartphones are not typically regulated, nor do they need to prove product claims by scientific testing or clinical evidence.

Patients & Caregivers – Gain access to proven technologies that are accessible, easy to use, and improve health outcomes.

Clinicians – Enhance the impact of your treatment plans to improve patient health and expand access to care.

Payors – Reduce overall medical costs, support value-based care initiatives, and improve member experience.