Digital Therapeutics: The Next Frontier

It’s not surprising healthcare professionals are unfamiliar with or confused by the rapidly evolving digital technologies employed in medicine today. Because of their current and future revolutionary impacts on healthcare, and their complicated, expansive components, professionals are likely overwhelmed by and unable to make sense of the tangle. Still, the field is growing exponentially, with no end in sight. Therefore, a quick overview of terms, categories and specific uses of each digital healthcare category might add clarity. And, although this article focuses specifically on digital therapeutics (DTx), a tech family tree is in order.

Distinctions Among Branches of Digital Healthcare

Fundamentally, there are three branches of digital technologies in healthcare: digital health, digital medicine and DTx (Table).

Table. Digital Health, Digital Medicine and Digital Therapeutics: What’s the Difference?

Source: Altexsoft. Digital Therapeutics: How Software Can Treat Diseases, Aug. 17, 2021. Accessed at www.altexsoft.com/blog/digital-therapeutics.

Digital health pertains to the field of evidence-based digital health tools that measure and/or intervene in the service of health to support practices of medicine broadly. This includes treatment, recovery, disease prevention and health promotion. Broadly put, digital technologies track health information.

Digital medicine deals with the development of interconnected health systems to improve the use of computational technologies, smart devices, computational analysis techniques and communication media to aid healthcare professionals and their clients manage illnesses and healthcare risks to improve health and well-being. In a nutshell, it tracks health information and collects or measures health data that can be used to manage a health condition.

DTx use digital and Internet-based technologies to encourage positive and necessary changes in patient behavior. These web- and design-based applications allow patients and providers to collaborate outside of a clinic or hospital. DTx products, prescribed by a healthcare provider, use the best possible software to offer evidence-based therapeutic interventions that can prevent, manage and treat a wide variety of physical, mental and behavioral conditions. DTx allow medical providers to track, collect, measure and interpret health data and make treatment changes based on real-time health information. In other words, DTx are a combination of each branch of digital technologies used in healthcare, making it the most well-rounded medical technological field.^1,2

DTx are expected to benefit the development of medical products, including pharmaceuticals. Innovations in DTx such as electronic sensors, computing platforms and information technology offer opportunities for clinicians to collect clinical trial data directly from patients. Portable DTx are worn, implanted, swallowed or placed in an environment that allows data collection from patients who are at home or in otherwise remote locations apart from clinical settings.³

Specific DTx Characteristics

Beyond identifying the branches of digital healthcare, there’s also the task of precisely deciphering DTx characteristics. DTx are even more accurately identified by the following components:4

• They have been designed and produced using quality best practices.
• They engage end users in product development and usability processes.
• They incorporate patient privacy and security protections.
• They apply product deployment, management and maintenance best practices.
• They publish trial results inclusive of clinically meaningful outcomes in peer-reviewed journals.
• They are authorized by a regulatory body as required to support product claims of risk, efficacy and intended use.
• They have made medical claims appropriate to clinical evaluation and regulatory status.

Freedom for Patients, Improved Resources for Providers

With a more specific description, perhaps it’s easier to see just how valuable and innovative the most emergent branch in digital healthcare really is. For the first time, patients’ healthcare treatments and decisions — not simply their data to collect and interpret — are put in patients’ own hands, which providers oversee. And when patients and providers utilize DTx, they may access an ever-growing range of tools. This includes wearables that monitor heart health or glucose levels. Other DTx can improve musculoskeletal performance and chronic pain by using a smartphone camera to guide patients through physical therapy. Additional DTx treatment possibilities still in the works include but are not limited to management, treatment and prevention of atopic dermatitis, substance abuse disorders, sleep disorders and even cancer. In such scenarios, DTx devices are providing patients’ performance information to healthcare workers. Some DTx will even help people decrease or better manage mental conditions such as anxiety, depression, insomnia, bipolar disorder and attention deficit hyperactivity disorder. For mental health conditions, artificial intelligence and DTx are a powerful combination that will offer people with such illnesses more power and hope. For the sake of illustration, consider this powerful combination being a means to reduce negative thoughts and behavior. Theoretically, improvement might only take 12 weeks, with one or two 30-minute sessions a week.³

DTx also offer a route beyond traditional medicine that provides more flexibility and innovation for providers with fewer obstacles such as making appointments, reducing travel time and costs and managing health conditions that limit patients’ mobility. DTx improve not only patients’ physical health, but their mental health through the empowerment they obtain. Being personally involved in their own healthcare choices offers patients “buy-in,” so to speak, which often fosters motivation to be compliant with treatment and promote healing and prevention of their personal health issues.⁵

And apart from being tailored to accommodate each patients’ needs, behavior and even language, DTx provide patients privacy, confidentiality and the ease of utilizing healthcare in the comfort of their homes. Such therapeutics also break down barriers to healthcare such as distance, disabilities and lack of transportation. Thus, DTx provide more efficacy and improved healthcare management for both healthcare workers and patients.²

Providers Are Still Crucial

Even so, it’s critical to recognize that DTx do not replace healthcare providers. Medical professionals must keep a watchful eye on patients, carefully monitoring their symptoms and healthcare needs. And providers must prescribe DTx, making sure they will be a beneficial fit for each patient. Most if not all DTx, for the record, aren’t over-the-counter treatments. They require a physician’s thorough physical and/or mental examination and diagnosis. In addition, providers must administer such technologies without training and resources to refine treatment to monitor patient needs and information. In fact, DTx providers augment their ability to personalize patients’ care more frequently and with increased precision.

Providers, of course, must check the devices or therapies to ensure they are working effectively. For example, patients would continue to see their provider for regular appointments, but therapeutics could improve providers’ abilities to adjust patient treatments, medication doses and other needs according to the information gathered from the DTx. Providers need not be involved in each therapy session, however. While providers will monitor data from a DTx product or therapy prescribed for a condition such as chronic pain management, patients are able to adhere to the treatment plan on their own — perhaps through video exercises or therapy for pain management via an electronic device such as a phone or laptop.^2,4,5

U.S. Food and Drug Administration (FDA) Approval

Because the field is so broad and still so exploratory, regulatory agencies continue to be involved in clinical testing of DTx applications to demonstrate that any medical claims made about the devices are true. While FDA doesn’t typically regulate wellness applications and devices currently on the market, it does become involved when developers of new wellness apps make medical claims about their inventions. For instance, if a developer states an app can monitor exercise amount and times, there is no medical claim. But, if a developer claims their app or device can improve blood sugar levels, that medical claim requires FDA involvement. As DTx expand their uses and devices, FDA will no doubt be more involved to monitor and determine which studies and trials are required to prove such claims.³

Potential Roadblocks

As with most technologies, there are obstacles to the development of DTx. There remain, for example, challenging questions regarding how DTx will or will not be covered by insurance reimbursement. Not only does this affect patients, it is notable for providers as well. As an illustration, during a provider shortage, patient access to DTx would be limited. Regulations might also lead to FDA control, which could lead to exorbitant prices for patient access to DTx. As such, healthcare workers’ support is necessary to regulate DTx to ensure treatment is paid for by insurance companies. Unfortunately, in the majority of cases, there is yet a clear definition of and consensus for how DTx are or will be reimbursed by insurance.^3,5

Beyond financial and insurance issues, DTx are still so new and ever-changing that there is not yet a lot of buy-in from patients who have not had access to them. Nor do DTx have the marketing expertise of the tried-and-true pharmaceutical therapeutics, which people are much more prone to understand and trust. Many providers, too, might not want to test this emerging field because they are either unsure of it or are afraid of the perceived risk involved for themselves and their patients. Other providers might feel as though their role is less effective in their patients’ treatment via digital means.⁵

The Future of DTx

Despite critics and potential difficulties, interest in the field and the number of DTx available is increasing and will continue to do so. In fact, by 2020, even before the COVID-19 pandemic, investment in DTx products grew by 40 percent per year, and DTx are expected to be a global opportunity of $56 billion by 2025.⁵

Providers are increasingly seeing DTx’ potential for growth. A recent survey of healthcare executives responsible for pharmaceutical decisions found that while only 25 percent of their organizations’ formularies paid for DTx, another 45 percent were intrigued by it and expected to do so in the future. There is also a lot of opportunity for virtual first-care companies to use and improve DTx products while helping providers to further reach and improve their engagement with patients.^2,5 So, as regulatory agencies clinically test more and more devices and methods, and expand the availability and quality of DTx, providers and patients will profit professionally, physically and emotionally.

The future of the healthcare industry is clearly increasingly digital. DTx, along with the other branches under the umbrella of digital technology, are providing doctors with more information, efficiency and efficacy, and they are providing patients with more independence, privacy and comfort. Therefore, while the DTx field is still developing, it is certainly here to stay. Healthcare professionals who haven’t yet explored or taken time to understand these tools would be wise to proactively find out more about the field and examine its advantages for patients and professionals. After all, several years from now, medical clinics and offices will look different than they do today as technologies continue to work together with and for everyone. Welcome to the radical future of better health and more interconnected healthcare.