For the 565 million people worldwide struggling with mental health issues, and the billions more who love and support them, a recent decision made by the Food and Drug Administration (FDA) offers encouragement and hope. The agency has cleared a novel new software designed to be integrated directly into, or used alongside, existing media — video games, mobile apps, and more — to treat mental health conditions (see Figure 1). The clearance marks a significant step forward in the rapidly evolving field of digital therapeutics (DTx), bringing potentially life-changing mental health treatments directly to the place where people already spend time — with media.

What Is a Digital Therapeutic (DTx)?

Fig. 1 - Media and entertainment companies can embed or use DeepWell technology adjacent to their products.

Digital therapeutics encompass evidence-based software programs designed to prevent, manage, or treat medical conditions (see Figure 2). While they have been around for years, the excitement of this new field was long overshadowed by the numerous hurdles and challenges in bringing DTx devices to market, gaining adoption, and driving compliance. The DTx industry has also suffered from excessive hype, coupled with failure to meet expectations, and a resulting lack of funding and government support. Fortunately, recent advancements appear to have DTx poised to finally live up to its promises.

The basic construct of DTx involves a device for sensing patient vitals and/or directing therapeutic intervention, using AI-enabled software, and either a software or human-led support mechanism to suggest suitable interventions from collected data.

Making DTx Compliance Compelling

The DTx method of therapy has proven to be very effective when patient adherence is high; unfortunately, on average, only 10 percent of patients engage with their digital therapeutic devices after the first week of treatment.

Patient compliance has long been a major issue when considering how to make an effective and accessible digital therapeutic treatment, and certainly a big part of why DTx has struggled to take hold. Even if a developer can create a clinically proven, reimbursable, functional therapy (no easy feat), it’s rendered useless if the patient won’t engage with it.

Fig. 2 - FDA-approved DeepWell DTx SDK provides biostimulation that improves coping and resilience by reducing stress and hypertension.

Human beings simply aren’t wired for longitudinally taking care of themselves; we engage with the things that we find interesting and intrinsically motivating. Simply knowing that something is “good for us” isn’t a catalyst for changing our behavior. An effective therapy must be something a patient wants to do because it is compelling, and not merely because it is recommended.

A Novel Approach

The FDA recently cleared DeepWell’s software development kit (SDK), allowing commercially popular games and other immersive media using the SDK to be incorporated into over-the-counter DTx treatments for stress and hypertension. For the last four years, DeepWell DTx has explored what new treatments for mental and physical health could come from leveraging the therapeutic value of media in digital therapeutics.

There are approximately 3.3 billion active video game players globally, a population that has risen by one billion in the last eight years, and the games themselves, when properly delivered, have resulted in considerable mental health benefits. The convenience of this therapeutic medicine model cannot be overlooked. By accessing an enormous group of people where they are willingly and happily spending their time, and giving them tailored, immersive experiences in a safe, controlled, and familiar environment, the likelihood of consistent engagement with digital therapies within media becomes comparatively high.

Hundreds of studies have shown the enormous therapeutic value of video games and other immersive media, especially for addressing mental health issues. Yet previous attempts to create effective DTx treatments have focused on therapy first and engagement second, often resulting in experiences that quickly become tedious and are soon abandoned.

How the New Software Is Different

DeepWell’s software differentiates itself by providing existing video game and media developers with a cleared development kit that can be seamlessly integrated into their products. When this happens, the resulting application becomes a Class 2 medical device, which allows direct marketing claims, clear therapeutic value communicated to the consumer, and access to additional revenue streams.

Throughout the integration of its SDK into media, DeepWell manages all compliance requirements for the newly minted DTx device, allowing developers to focus on their core competencies — creating compelling media that people want to return to, again and again.

Patients can then have a much more approachable, welcoming, and immersive experience. Rather than requiring users to download, learn, and dedicate time to a standalone app, the therapy is delivered in the context of familiar and well-loved media, allowing for the subtle delivery of therapy during an activity most patients are familiar with and enjoy.

Interpreting the 2025 CMS Codes for Digital Therapeutics

The introduction of new CMS (Centers for Medicare and Medicaid Services) codes in 2025 will play a pivotal role in shaping the future of DTx. These codes will determine the reimbursement landscape for digital therapeutic interventions, potentially accelerating or hindering widespread adoption of these technologies. While the specifics remain ambiguous, the potential for broader insurance coverage could be transformative, making DTx accessible to a much wider patient population.

In recognition of the significant amount of time it can take for reimbursement to emerge and become practically applicable in the marketplace, DeepWell DTx chose to pursue an over-the-counter clearance. The impending CMS codes are expected to address pharmaceutical-like distribution but do not provide enough financial incentives that are typically needed to fund and drive this type of model. All reimbursement must start somewhere, but it is clear that DTx will need to rely on consumer spending and more traditional code stacking to achieve a financially viable distribution model.

What Does the Future Hold for DTx Technology?

The recent FDA decision represents a pivotal moment in the evolution of mental health treatment. The development of effective DTx will be vital for addressing the current mental health emergency. In 2024 alone, there has been a close to 40 percent increase in people seeking mental healthcare. In a system that is already overtaxed and financially overburdened, the promise of DTx may be to provide innovative, accessible, and affordable treatments to address the growing need.

DTx technology has the potential to transform access to care and dramatically improve outcomes for millions. Fast-tracking DTx delivered via media and allowing the content to be updated without additional FDA clearance is efficient, which suits the current financial reality of both the DTx market and the rising cost of treating a global mental health pandemic.

The fundamentals of DTx have been clinically proven to be powerful sources of low-cost, accessible, effective interventions. The impact of the upcoming CMS codes remains to be seen but, with continued innovation and collaboration, the future of DTx to transform mental healthcare is bright.

This article was written by Ryan Douglas, founder and board member at DeepWell DTx, Seattle, WA. A noted expert and innovator in the fields of mental health, artificial intelligence, and surgical robotics, Douglas has been on the front line of major paradigm shifts in healthcare for nearly 20 years. For more information, visit here  .