Key Takeaways:

• Digital therapeutics are a new software-enabled method of care delivery.
• Physicians are prescribing apps for their patients, although many are
• available over the counter.
• These connected health tools can work in tandem with medication or alone.

“Download this app and call me in the morning.” Believe it or not, your primary care physician might be saying this—or something like it—in the near future.

That’s because a new era of personalized medicine has arrived, and doctors’ orders are evolving with it. Rather than simply recommending traditional medication or therapies, health care providers are increasingly prescribing digital health apps, mobile devices and other tech-enhanced tools to help their patients manage a range of chronic conditions—including diabetes, anxiety, migraines and insomnia.

It’s all part of a movement toward digital therapeutics, or DTx, a market that some analysts predict will grow to $18 billion by 2028.

Given that, it’s a good bet that digital therapeutics will play a role in your life at some point. With that in mind, here’s a closer look at these tech-based solutions—their potential benefits, some important issues to consider and insights on whether they could make sense for you.

A new category of health care

In many ways, DTx is a new category of medicine that enables health care providers to use software to treat and manage—and even help prevent, in some cases—a range of diseases and disorders. The technology-enabled tools can be used on their own or in concert with more traditional medications and therapies, depending on patient needs, according to the Digital Therapeutics Alliance, a trade group.

Some DTx watchers are calling it a development that will fundamentally disrupt health care and how we deal with the chronic conditions so many of us experience during our lives. With “effective and scalable” non-pharmaceutical interventions such as these digital tools—most focused on enabling behavior modifications and establishing new, healthier habits—DTx could “reduce or even eliminate the demand for medications,” according to one report.

These new software-based interventions are expected to be a key part of a wider movement across the health care industry toward more holistic health and wellness—one that, not surprisingly, has been accelerated due to COVID-19. During the pandemic, patients by necessity became familiar with telemedicine and other forms of virtual health care. Expanding to remote patient monitoring, wearable devices and other tech-enhanced solutions will likely be a natural next step for many of us.

Three main types of DTx

So that’s the big picture. But what exactly do these digital therapeutics do to make our lives better? That depends on the specific tools and situations, of course. These therapeutics run the gamut from behavioral intervention software and gamification tools to medication adherence apps, wearable devices and even ingestible sensors.

To help make sense of this emerging world, the Digital Therapeutics Alliance has categorized DTx in three main ways according to their primary purpose:

1. Digital therapeutics designed to treat disease

In general, treatment-focused digital therapeutics aim to do just that: treat disease or other acute conditions, most often alongside more traditional medical interventions. An app itself can’t cure cancer, of course, but an oncology-focused software program might offer patients a convenient way to track daily vital signs or other biomarkers. That, in turn, can give their physicians more complete insights into their experience of the disease—and, ideally, help chart a more personalized path to treatment. Another tech tool might offer insights to help patients deal with specific psychological aspects of having a serious illness.

At the moment, there are DTx products for a wide variety of clinical use cases—including Alzheimer’s and dementia, asthma, congestive heart failure, obesity, and more. Not surprisingly, they can work in widely different ways. Some track vitals and daily health data. Some work in concert with sensors or other wearables to measure biometric information. Others offer cognitive behavioral therapy to overcome unhealthy patterns in thought and behavior, or multimedia education tools tailored for patient groups from teens to the elderly.

Some of the leading apps have been studied in multiple clinical trials, with results that suggest they have helped reduce an adverse effect or improved a health outcome by a meaningful percentage. Example: One tool designed to help with substance abuse disorder has—in conjunction with outpatient therapy—more than doubled abstinence rates among all patients and improved rates of retention by 20 percent.

Another example of a treatment-focused DTx is an app for helping patients with chronic obstructive pulmonary disease by crunching data from a sensor connected to their inhalers—giving them insights into their breathing patterns that help them adjust and stick with their treatment regimens.

2. Digital therapeutics designed to manage a chronic condition

These are the tech health tools created to help people manage issues such as diabetes, obesity, back pain, insomnia and other serious but not necessarily life-threatening conditions.

Consider, for example, prescription software that gives patients aged 22 and older a nine-week course of cognitive behavioral therapy for improving behaviors, routines and disruptive thoughts that are preventing them from getting a good night’s sleep. As part of its treatment plan, the app focuses on specific areas such as stimulus control and cognitive restructuring. To complement the CBT insights offered by the app, patients also keep a daily sleep diary.

When used as instructed, and in combination with clinical care, the app helped drive a 45 percent reduction in the time it took users to fall asleep and a 52 percent reduction in the time spent awake at night.

Another example of a software tool for chronic condition maintenance is a program that targets migraines with a smartphone app that connects with a wearable neuromodulation unit. It can be activated by the patient at the onset of a headache and deliver 45 minutes of a “tingling” treatment designed to ease and shorten symptoms.

3. Digital therapeutics designed to improve overall health and wellness

The products in the previous two categories often are available only by prescription. But digital therapeutics tailored toward general health and wellness can often be downloaded over the counter via the App Store or Google Play.

An example of this category is an app-based program that seeks to reduce the symptoms of overloaded nervous systems both at work and at home. The 12-week course uses text, video and audio to teach strategies and problem-solving techniques—helping users learn emotional regulation and reduce anxiety stemming from overwork. It sets goals to achieve over the course of its 45-to-60-minute courses, tracking progress across several thematic areas. Eight randomized controlled trials of the tool showed lasting reduction of stress levels by an average of 33 percent.

Other examples of prescription-free health and wellness apps include those designed to deliver smartphone-based cognitive behavioral therapy and address adolescent-specific depression.

Issues to consider

As miraculous and magical as some of this might sound, it’s important to realize that digital therapeutics aren’t meant to be cure-alls. As noted, they’re usually designed to supplement more comprehensive clinical treatment programs—especially those dealing with more severe medical conditions.

And in all cases, it’s vital to talk with your physician or care provider if you’re thinking about using any of these apps—even ones that don’t require a prescription. To understand why, consider the sleep therapy app mentioned earlier. Because of its specific treatment plan, patients with mental disorders exacerbated by sleep restrictions (including bipolar disorder and schizophrenia), obstructive sleep apnea or other conditions aren’t appropriate candidates.

One key issue to consider if you’re new to DTx is basic digital literacy. These leading-edge therapeutic tools are designed for patients who are equipped with good Wi-Fi and are familiar with smartphones and the apps that populate them. That might make them relevant for you, but perhaps not your elderly parents—or those with limited English proficiency or without reliable broadband.

Additionally, security and privacy are two key, intertwined concerns. Given that hospitals and health systems are often in hackers’ crosshairs, it’s important to tread cautiously with how sensitive health information is logged and shared on these apps.

For example, DTx apps—many of which enable communication between patients and their care teams—should not be used by clinicians to communicate with patients about emergency medical issues, nor should patients share emergent information via these tools. For patient safety, it’s important that such high-stakes communications about potentially high-acuity conditions take place in a clinical setting—not via something downloaded from an app store.

Finally, pay close attention to the clinical efficacy and safety of this emerging technology. As noted above, many digital therapeutic apps have been studied with rigorous clinical trials to prove their effectiveness—but not all of them have been as carefully vetted. The U.S. Food and Drug Administration has increasingly paid attention to the DTx space in recent years—notably with the Digital Health Center of Excellence it launched in 2020—but the fact is, the app ecosystem is evolving so rapidly that regulation can still be something of a gray area.

To use or not to use?

One obvious question is whether you (or someone you know) may be a good candidate for digital therapeutics.

Given the rapid growth of this emerging field of health care, it’s likely that you’ll find “there’s an app for that.” Consider, for example, that there are DTx offerings designed to address ADHD, diabetes, IBS, back pain and other musculoskeletal issues, insomnia, PTSD, asthma, COPD, depression, and anxiety. For consumers with those or other conditions who might be curious about trying a new approach to managing their health in consultation with their physicians, such software-based approaches might have a role to play.

That said, digital therapeutics don’t exist for every medical condition. And not every patient is interested in incorporating cutting-edge tools into their care regimens—nor are they tech-savvy enough to do so effectively. DTx apps only work when used as designed and in close collaboration with trained caregivers. Ultimately, these tools are meant to be used in tandem with other connected devices or sometimes as part of intensive cognitive behavioral therapies. Simply put, some of us just aren’t interested in going down those roads.

Conclusion

We all want to not only live for a long time but also remain healthy during those years so we can enjoy a life of significance. Increasingly, it seems, digital therapeutics will be among the medical resources we can tap to manage and potentially improve our health so we can live our best life and have the impact we desire. The upshot: It makes sense to keep your eye on these ever-evolving tools for better health.

 

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