Key Technologies in the Digital Therapeutics Arena

July 31, 2023 - Amid the ongoing digitization of healthcare, digital therapeutics (DTx) have gained popularity, with providers and payers increasingly offering these software-based therapies to patients.

According to the Digital Therapeutics Alliance, DTx "deliver to patients evidence-based therapeutic interventions that are driven by high quality software programs to treat, manage, or prevent a disease or disorder." The alliance also noted that the interventions are provided independently or alongside medications, devices, and other therapies.

The DTx market is booming, according to a recent report from Grand View Research. The report shows that the market was valued at $5.09 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 26.6 percent from 2023 to 2030. While there have been some cautionary tales, like the Pear Therapeutics bankruptcy, companies continue to push ahead, making acquisitions and publishing clinical trial results.

DTx typically fall into three categories depending on their primary purpose: to treat a disease, to manage a condition, and to improve a health function. In each category, the therapy must "deliver a therapeutic intervention and use clinical endpoints to support product claims," the alliance states. 

Here, mHealthIntelligence takes a deep dive into the key technologies that enable the delivery of DTx interventions:

MHEALTH APPLICATIONS

Perhaps the most common solution used to deliver DTx, mobile apps are user-friendly and customizable. Health-related apps typically have health-tracking, care support, and data-sharing capabilities, making them a popular mode of healthcare delivery in the past few decades.

DTx companies often use mHealth apps to deliver their interventions. For instance, DTx provider Dariohealth offers its services primarily through an app, aiming to help patients manage metabolic conditions, like diabetes and hypertension, musculoskeletal conditions, and behavioral health issues. Through the app, Dariohealth users gain access to health coaches, assessments, education, and personalized exercise plans.  

Another DTx provider, Omada Health, focuses on musculoskeletal and chronic obstructive pulmonary disease (COPD) care, providing customizable physical therapy, automated feedback, and access to medical providers through its app.

Using mHealth apps can make DTx more accessible and cost-effective, as most Americans now have smartphones.

Further, unlike the direct-to-consumer mHealth apps proliferating on app stores, DTx products must undergo a rigorous Food and Drug Administration (FDA) validation and approval process, which includes providing evidence of a clinical association between the software output and the targeted clinical condition.

WEARABLE DEVICES

The use of wearable devices has been growing steadily in the healthcare industry, particularly following the onset of the COVID-19 pandemic. This is largely because of their popularity among healthcare consumers. A Deloitte consumer survey, which polled 2,005 US consumers in the first quarter of 2022, revealed that 70 percent of wearable owners said the devices helped improve their fitness and health. Another 55 percent said they share their data with their healthcare providers.

There is also an expanding body of clinical evidence backing wearables use in healthcare. For instance, a study published in JAMA Network Open this year found that hospitalized patients using wearables had improved physical activity levels and physical functioning compared to those receiving standard care.

Numerous DTx providers leverage wearables to deliver their interventions. For instance, MEDRhythms uses a combination of sensors, software, and music with neuroscience to help improve mobility and functional outcomes among those with neurologic injury and disease. The intervention includes patients clipping sensors to their shoes and putting on headphones streaming music. The sensors collect baseline gait data and transmit them to an app that uses algorithms to assess the data and provide individualized clinical interventions for the patient.

Another company that leverages wearable devices is h2o Therapeutics. The company offers Parky, a prescription remote patient monitoring app that patients can access through their Apple Watch. The app uses the Movement Disorder API, an Apple tool, to track Parkinson's disease symptoms, such as tremor and dyskinesia episodes.

TELEHEALTH TOOLS

Telehealth services boomed during the COVID-19 pandemic. Although usage has fallen from pandemic highs, nearly half of the respondents to a survey conducted this year said they had participated in telehealth appointments in the last 12 months.

Thus, numerous DTx interventions include a telehealth component. Virta Health, a DTx provider focused on reversing diabetes and prediabetes, and supporting weight loss, offers provider-led care through its platform. Users receive daily support from a dedicated health coach as well as access to physicians and nurse practitioners.

Over the course of the pandemic and following the end of the public health emergency (PHE), telebehavioral healthcare has remained immensely popular. One estimate shows that these services have increased 45-fold since the onset of the pandemic.  

Curio, a DTx company offering behavioral healthcare, provides access to personalized health coaching and a network of providers. The company's suite of products offers behavioral therapy programs for women across a range of life experiences, including pregnancy, postpartum, and menopause.

Similarly, Lark Health offers access to a digital coach, who is available 24/7. The company aims to help people build healthy habits, such as eating well, quitting tobacco, and reducing stress. Through its solution, Lark Health provides food, activity, sleep, and weight coaching. 

VIRTUAL REALITY/AUGMENTED REALITY

Healthcare stakeholders are increasingly turning to virtual and augmented reality (VR/AR) solutions to improve patient care. Some popular use cases for VR/AR include pain management, pediatric diagnostics, neurological disorder treatments, and postoperative rehabilitation, according to the Food and Drug Administration. 

As the clinical evidence backing VR/AR use in healthcare grows, providers are scaling efforts through the creation of new centers and conducting clinical trials. Earlier this year, the Centers for Medicare and Medicaid Services (CMS), for the first time, established a unique Healthcare Common Procedure Coding System (HCPCS) Level II code for a virtual reality program.

Several DTx providers have incorporated VR/AR into their products. BehaVR is one such provider. The company's VR-based intervention aims to support mental wellness, anxiety regulation, pain management, addiction recovery, and maternal health. Through a VR headset, users can access various programs based on Cognitive Behavior Therapy (CBT) techniques that aim to build resilience.  

Another company, AppliedVR, provides interventions for pain management through VR. The company's RelieVRx program, previously known as EaseVRx, became the first FDA-authorized in-home VR treatment for pain relief in 2021. The self-guided program offers eight-week VR sessions that last an average of six minutes a day. The sessions provide pain management education on techniques such as body awareness and pain distraction.

ARTIFICIAL INTELLIGENCE

AI is making an undeniable mark in the healthcare industry. The technology and its subsets, including machine learning (ML), are widely used across clinical care areas for risk prediction, treatment recommendations, and diagnosis. It is also used to ease administrative and operational burdens, such as clinical documentation.

In the DTx industry, AI is used in numerous ways as well. Woebot, which creates relational technologies to support mental healthcare, uses AI and natural language processing to provide users with CBT, Interpersonal Psychotherapy (IPT), and Dialectical Behavioral Therapy (DBT). The solution engages in conversations and conducts check-ins with users, suggesting therapeutic tools and resources to meet their mental health needs.

Cognoa also uses AI to deliver its intervention. The company's solutions collect and analyze children's social, behavioral, executive functioning, and language data to support early diagnosis of developmental disorders. Currently, its autism diagnostic solution is FDA-approved. This solution requires users to answer a few multiple-choice questions about their child and upload videos. An AI algorithm assesses the data and provides insights to providers, helping them make an informed autism diagnosis. The company is also developing solutions to support care for speech-language issues, Attention-Deficit/Hyperactivity Disorder (ADHD), and anxiety among children. 

GAMIFICATION TECHNOLOGY

Amid the digital transformation of healthcare, video game technologies are being tapped to deliver clinical interventions. Numerous healthcare providers have turned to these technologies to improve clinical outcomes and patient experience, including Children's Hospital of Philadelphia and C.S. Mott Children’s Hospital.

In the DTx arena, several companies provide solutions underpinned by gamification technologies. For example, Akili Interactive's EndeavorOTC and EndeavorRx are immersive video game treatments that aim to improve attention and focus among adults and children with ADHD. The games target areas of the brain through challenges to enhance cognitive function and help patients better manage distractions. EndeavorRx became the first FDA-authorized prescription video game treatment for children in 2020.

Another DTx provider leveraging video game technology to deliver clinical interventions is Deepwell DTx. The company's solutions aim to treat mental health issues through games that engage and challenge users while also creating a community. The video games are being developed by a team of game industry and medical experts and will debut this year.

Amblyotech also utilizes video game technology to treat amblyopia, more commonly known as 'lazy eye.' The company's software provides a dichoptic display in which each eye is presented with a different image using a proprietary algorithm. This encourages cooperation between the eyes, with both eyes working together to view a complete image. Novartis acquired the company in 2020, announcing plans to collaborate with the Research Institute of the McGill University Health Centre and Ubisoft Entertainment SA to continue product development.