HEALTH INFORMATION TECHNOLOGY
Digital Therapeutics An emerging field BY MEGAN CODER, PHARMD, MBA, AND CHRISTINA NYQUIST
A
s COVID-19 continues to impact health systems, lessons learned to date can assist in determining how to navigate ongoing challenges, and could lead to improvements in addressing ever-increasing levels of chronic disease, mental health, and opioid abuse. To build a stronger and more holistic health ecosystem, it is critical that technologies such as telehealth and remote monitoring become foundational components—along with the emerging field of digital therapeutics.
Defining DTx Still in a relatively early stage of formation, digital therapeutics (DTx) are a subcategory of digital health technologies that deliver therapeutic interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a disease or disorder. DTx provide patients, caregivers, and clinicians with access to new models of remote and on-demand care, with evidence-based treatment delivered through personal devices such as smartphones and tablets. DTx products must comply with ten rigorous patient-centered core principles and best practices (https://tinyurl.com/mp-dtx-best-practices) to
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ensure product integrity, user-centered designs, patient privacy, and validated clinical outcomes via randomized controlled trials and real-world evidence. All products claiming to be a digital therapeutic must: • Prevent, manage, or treat a medical disorder or disease. • Produce a medical intervention that is driven by software. • Incorporate design, manufacture, and quality best practices. • Engage end users in product development and usability processes. • Incorporate patient privacy and security protections. • Apply product deployment, management, and maintenance best practices. • Publish trial results inclusive of clinically meaningful outcomes in peer-reviewed journals. • Be reviewed and cleared or certified by regulatory bodies as required to support product claims of risk, efficacy, and intended use. • Make claims appropriate to clinical evaluation and regulatory status. • Collect, analyze, and apply real world evidence and/or product performance data. Many DTx products are used in concert with other devices, medications, or therapies to optimize patient care and health outcomes, while others may be used independently. Collectively these treatment options yield distinct, additive benefits to patients’ physical, mental, and behavioral health. In the United States, private insurers, pharmacy benefits managers, and employers are increasingly embracing digital therapeutic technologies to improve patient outcomes. As a result of observations from the COVID pandemic, three important things present expanded opportunities for digital therapeutics.
Underlying health disparities have resulted in unequal impacts. Minority populations in the United States have suffered from the COVID19 pandemic disproportionately. The Black community has the highest age-adjusted mortality rate in the United States from COVID, estimated at 3.8 times the rate for White populations. Native American and Hispanic populations experience similar disparities with estimated mortality rates 3.2 times and 2.5 times, respectively, that of White populations.
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The unacceptable impacts of COVID-19 on minorities parallels longstanding, well-documented health disparities within these communities. Using diabetes as an example, the rate of disease in Black adults is 60% higher than White adults, with Hispanics being 1.4 times more likely than White adults to die from diabetes. In the U.S., Native Americans account for the highest rate of diabetes, with one in six individuals receiving this diagnosis, and in some tribes as many as 60% of adults having Type 2 diabetes.
