Unlocking the Potential of Digital Health Therapeutics: FDA-Approved Solutions for Modern Healthcare

Digital health therapeutics (DTx), applications increasingly powered by AI and/or machine learning, are on the rise and promise to increase access to healthcare, provide real-time monitoring of health data, improve patient engagement and adherence to treatment, and reduce healthcare costs.

What Are Digital Health Therapeutics?

DTx are evidence-based therapeutic interventions driven by software and technology to prevent, manage, or treat medical disorders and diseases. Unlike general wellness apps or fitness trackers, digital therapeutics deliver clinical outcomes and are often subject to regulatory oversight and the FDA’s medical review pathways. That requires clinical trials and evidence of safety and efficacy. These products also increase patient access to care, as most only require a smartphone or digital device. The goal of the FDA’s Digital Health Center of Excellence,¹ which regulates DTx, is to “empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.” The FDA’s Digital Health Advisory Committee² provides input as to proposed guidances, regulation, or approvals of DTx.

Do All Digital Health Therapeutics Require a Prescription?

Digital health products include a wide array of technologies such as step counters, symptom trackers, and telemedicine platforms. According to IQVIA’s Digital Health Trends 2024 report,³ there are now more than 103 digital diagnostics available, many of which are aided by AI and/or machine learning. Some of these DTx require a prescription while others do not. DTx that do not require a prescription include wellness apps, which may offer meditation guidance, diet trackers, or nutrition tips. These products are typically considered low-risk and do not make claims about treating, curing, or preventing diseases.

DTx that may require a prescription and treat or manage specific conditions are regulated by the FDA and must prove their efficacy to be approved, much like traditional pharmaceuticals or medical devices. One example is the use of DTx for insomnia and other sleep disorders,⁴ which have been shown to demonstrate clinically meaningful improvements in sleep outcomes.

Examples of Digital Health Therapeutics

DTx have the potential to treat various conditions, including chronic diseases, mental health disorders, and neurological conditions. The following is a list of selected examples that are FDA-approved to treat various conditions, from opioid use disorders to pediatric ADHD. These products are regulated as medical devices and are prescribed by healthcare providers:

• reSET® and reSET-O®: prescription DTx for the treatment of substance use disorder and opioid use disorder, respectively. These apps deliver three forms of treatment via mobile devices to help patients manage their recovery.
• BlueStar®: a DTx for people with type 1 and type 2 diabetes that provides personalized AI-powered coaching, educational content, and real-time feedback based on blood glucose data.
• EndeavorRx®: the first prescription video game to treat pediatric ADHD (in children ages 8-17), demonstrating improvements in attention function through interactive gameplay.
• Somryst: the first and only prescription DTx that delivers effective, first-line treatment for adults with chronic insomnia.
• Nightware: the first and only prescription DTx that improves sleep in adults, 22 years old and older, with Nightmare Disorder or nightmares related to PTSD.

The following are just a few examples of non-prescription DTx:

• Headspace: evidence-based meditation and mindfulness tools, sleep resources, mental health coaching.
• Happify: a digital program based on positive psychology, mindfulness, and cognitive behavioral therapy techniques for stress and mental well-being.
• Noom: behavior change platform with customized plans that harnesses the power of psychology and biology for weight-loss results that last.
• Sleepio: a digital therapeutic intended for the improvement of poor sleep and the management of Insomnia Disorder in adults, aged 18 years and older, as an adjunct to their usual medical care.
• mySugr: diabetes management app that helps with logging blood sugar, meals, and activity.

These solutions can be used in combination with traditional care but, in some cases, they may serve as standalone interventions. The evidence-based approach of DTx regulation by the FDA ensures that patients and providers can trust the effectiveness and safety of these digital tools.

Benefits of Digital Health Therapeutics

Accessibility and Scalability

Digital therapeutics can be accessed via smartphones, tablets, or computers, making access more equitable⁵ – this becomes much easier for patients across different geographies, who may have issues securing transportation, and for areas that experience provider shortages. This accessibility is especially important for individuals in rural or underserved areas, and for those with mobility challenges. DTx address these issues as they can be distributed instantly and updated remotely, making them inherently scalable, with the ability to reach large patient populations.

Real-Time Monitoring and Feedback

Many DTx platforms integrate with sensors, wearables, or smartphone features to collect real-time health data. This enables timely feedback for patients and healthcare providers, allowing for rapid intervention if problems arise. For chronic conditions like diabetes⁶ or asthma,⁷ real-time data can help fine-tune treatments and prevent complications.

Improved Patient Engagement and Adherence

DTx solutions often use interactive interfaces, games, reminders, and personalized feedback to engage patients. These features encourage patients to stick with their treatment plans, leading to higher adherence rates compared to some traditional interventions. Recent studies have looked at developing an ideal design for a dashboard that can track and improve medication or treatment nonadherence⁸ and adaptations that may be needed for use in clinical environments.⁹

Potential for Cost Savings in Healthcare

By improving adherence, enabling early intervention, and reducing the need for in-person visits, digital therapeutics can help lower healthcare costs. They have the potential to reduce hospital admissions, emergency room visits, and overall disease burden. Approvals and reimbursements of these clinical tools³ are increasing.

Summary

Digital health therapeutics are evidence-based, FDA-regulated software or devices designed to prevent, manage, or treat medical conditions. They are fundamentally different from general wellness apps as they require clinical validation and often a prescription. DTx have many benefits, which include increased accessibility, features like real-time monitoring, interactive engagement, and the potential to improve adherence and reduce healthcare costs. The clinical evidence of effectiveness of the apps is growing, supported by evidence from many recently published studies.¹⁰

Jackie Orabone, PhD
Senior Scientific Director

Jackie helps clients prepare for FDA Advisory Committee meetings by combining her scientific expertise and research knowledge in immunology with medical communications agency experience. Connect with Jackie on LinkedIn.

References

1. US Food and Drug Administration. Digital Health Center of Excellence. https://www.fda.gov/medical-devices/digital-health-center-excellence.
2. US Food and Drug Administration. FDA Digital Health Advisory Committee. https://www.fda.gov/medical-devices/digital-health-center-excellence/fda-digital-health-advisory-committee.
3. IQVIA Inc. Digital Health Trends 2024—Implications for Research and Patient Care. Dec 12, 2024. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/digital-health-trends-2024.
4. Madeo G, et al. The increasing use of digital therapeutics of insomnia and other sleep disorders: a systematic review. Eur J Public Health. 2023;33(suppl 2):ckad160.1212. doi: 10.1093/eurpub/ckad160.1212.
5. Shaw J, et al. Digital health and equitable access to care. PLOS Digit Health. 2024;3(9):e0000573. doi: 10.1371/journal.pdig.0000573.
6. Akturk HK, Bindal A. Advances in diabetes technology within the digital diabetes ecosystem. J Manag Care Spec Pharm. 2024;30(10-b suppl):S7-S20. doi: 10.18553/jmcp.2024.30.10-b.s7.
7. Kaplan A, et al. The emerging role of digital health in the management of asthma. Ther Adv Chronic Dis. 2023;14:20406223231209329. doi: 10.1177/20406223231209329.
8. Faisal S, et al. Designing a real-time medication intake and adherence dashboard: features, functionality, and data display to meet the needs of patients, care partners and healthcare providers. J Med Syst. 2025;49(1):58. doi: 10.1007/s10916-025-02189-w.
9. Schwartz DG, et al. Apps don’t work for patients who don’t use them: Towards frameworks for digital therapeutics adherence. Health Policy Technol. 2024;13(2):100848: doi: 10.1016/j.hlpt.2024.100848
10. IQVIA Inc. Digital Health Trends 2021—Innovation, Evidence, Regulation, and Adoption. Jul 22, 2021. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/digital-health-trends-2024.