Digital therapeutics (DTx) represents a collection of technologies, products, and services across healthcare and wellness. More specifically, DTx delivers evidence-based therapeutic interventions that prevent, manage, or treat medical disorders and can either supplement or supplant existing treatments for a variety of diseases and conditions. DTx differs from diagnostics, telehealth, and other digital health products, as DTx products must be approved by regulatory entities. Proof of concept is at the core of their models, as DTx products not only have to be driven and backed by evidence but must also be able to prevent and/or manage a disease or disorder.

As COVID-19 proliferated across the globe, forever changing the way we interact in both physical and digital environments, combined with a growing mental health crisis and surging prevalence of chronic conditions around the world, the DTx space is now projected to reach $56 billion by 2025. DTx has the potential to disrupt traditional pharmaceutical markets, and big pharma and medical device companies must decide whether to embrace this technology or potentially lose market share to DTx startups in a rapidly expanding market.

The Digital Therapeutics Alliance (DTA) is the leading international organization on thought leadership in the DTx space, providing patients, clinicians, and policymakers with the necessary tools to evaluate and utilize DTx products — including ethics, best practices, and product categorization. According to the DTA, 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, manufacturing, 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 claims of risk, efficacy, and intended use.
• 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 claims of risk, efficacy, and intended use;
• Make claims appropriate to clinical evaluation and regulatory status; and
• Collect, analyze, and apply real-world evidence and/or product performance data.

DTx products can eliminate many gaps in healthcare by delivering therapies on devices to which a large percentage of people have access such as smartphones and tablets and, owing to the regulatory rigor being applied to determine efficacy, patients are beginning to rely on DTx products in ways that parallel traditional care. DTx allows for increased patient access to clinically safe and effective therapies while lowering stigmas associated with traditional care, expanding patient accessibility regardless of age, language, culture, income, or geography.

The DTA adopted four categories for classifying DTx products suggesting they should do one of the following:

• Address a medical condition;
• Manage or prevent a medical disorder or disease;
• Optimize medication; or
• Treat a medical disease or disorder

The regulatory requirements for each DTx category vary depending on the purpose of the product for example, products designed to address a medical condition can go the direct-to-consumer route, whereas products developed to treat a medical disease or disorder require prescriptions. There are many companies developing DTx products to treat conditions including diabetes, hypertension, asthma, COPD, heart disease, cancer, stroke, insomnia, musculoskeletal disorders, stress, substance abuse, schizophrenia, cognitive impairments, and more. Many people suffering from these conditions are underserved due to limited or inconvenient access to healthcare; DTx can help narrow this gap.

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