Prescription Digital Therapeutics: The Future of Digital Health Solutions

Prescription Digital Therapeutics: The Future of Digital Health Solutions

AI Health Tech Med Tech

The global market for prescription digital therapeutics (PDT) is expected to grow to $17.16 billion by 2030. This growth is mainly due to the affordability of digital health technology for both healthcare providers and patients, as well as the increasing use of smartphones in both developed and developing countries.

In this article, we’ll describe PDT, its applications, benefits, and challenges.

Contents

What Are Prescription Digital Therapeutics?

Prescription digital therapeutics (PDTs) are a new class of medical interventions that leverage software to treat, manage, or prevent diseases and disorders. Unlike typical health apps, PDTs require a prescription from a healthcare provider and are subject to rigorous regulatory scrutiny.

According to the U.S. Food and Drug Administration (FDA), prescription digital therapeutics are medical devices, also called Software as a Medical Device (SaMD). The FDA review of prescription digital therapeutics is the same as the process the FDA uses to review medical devices. 

Definition and key characteristics of PDTs

PDTs are software-based treatments delivered through mobile devices, designed to address the behavioral and psychological aspects of various health conditions. These digital tools are developed based on scientific evidence and aim to provide therapeutic benefits comparable to traditional medical treatments (Phan et al., 2023). 

Source: Avalere

Examples of prescription digital therapeutics developers

This chart from Blue Matter Consulting (2023) lists 154 PDT companies.

Source: Blue Matter

How PDTs differ from wellness apps and other digital health tools

While wellness apps focus on general health and fitness, PDTs are designed to treat specific medical conditions. PDTs undergo clinical trials, and are subject to stringent regulatory processes to ensure they meet high standards of safety and effectiveness. This regulatory oversight differentiates PDTs from other digital health tools, which may not require such rigorous evaluation.

The PDT regulatory framework 

The FDA plays a critical role in the approval of PDTs. These therapeutics must demonstrate clinical efficacy and safety through rigorous trials before receiving FDA clearance. This process ensures that PDTs meet the same standards as traditional pharmaceuticals, providing healthcare providers and patients with confidence in their use (Phan et al., 2023).

The Science Behind Prescription Digital Therapeutics

PDTs are grounded in scientific research and evidence-based practices to ensure their effectiveness in treating various health conditions.

Evidence-based approaches used in PDTs

PDTs incorporate evidence-based approaches to help patients change their behaviors and manage symptoms effectively, such as: 

For instance, CBT-based PDTs can help identify and change negative thought patterns, improving mental health outcomes. A study on a PDT for opioid use disorder found it improved retention in treatment by 76% at 12 weeks compared to treatment as usual (Brezing & Brixner, 2022). 

Clinical trials and efficacy studies supporting PDTs

Lab worker

Clinical trials are essential for validating the efficacy of PDTs. These studies assess the therapeutic outcomes of PDTs compared to traditional treatments. 

For example, trials have shown PDTs can be effective in managing substance use disorders and chronic insomnia, providing real-world evidence of their clinical benefits (Brezing & Brixner, 2022).

Applications of Prescription Digital Therapeutics

PDTs offer promising solutions across a range of medical conditions, providing tailored interventions for diverse patient needs.

Mental health conditions

Therapist and patient talking on couch

PDTs are increasingly used to treat mental health disorders such as depression, anxiety, schizophrenia, and post-traumatic stress disorder (PTSD). In a randomized controlled trial, a PDT for depression reduced symptoms by 45.6% compared to 17.4% with usual treatment (Phan et al., 2023).

These digital tools provide accessible and scalable interventions, often with CBT techniques to help patients manage symptoms and improve their quality of life.

Chronic diseases

For chronic conditions like diabetes and hypertension, PDTs offer personalized management strategies. They enable continuous monitoring and data analysis, facilitating timely adjustments to treatment plans and improving patient outcomes (Phan et al., 2023).

A PDT for type 2 diabetes led to a 1.1% reduction in HbA1c levels after 6 months in a clinical trial (Phan et al., 2023).

Substance use disorders and addiction treatment

Woman sitting with hands clasped

PDTs are particularly effective in treating substance use disorders, offering structured programs that support recovery. They provide patients with tools to manage cravings and develop healthier coping mechanisms, contributing to sustained recovery. 

A couple of examples:

  • Research with 1,758 patients using a PDT for substance use disorder showed 64.1% abstinence at 12 months (Brezing & Brixner, 2022).
  • A PDT for alcohol use disorder resulted in 63% of patients reducing heavy drinking days compared to 32% receiving standard treatment (Rassi-Cruz et al., 2022).

Neurological disorders

Conditions such as ADHD and insomnia can benefit from PDTs, which offer targeted interventions to manage symptoms and improve daily functioning. For instance, PDTs for insomnia often include sleep hygiene education and relaxation techniques to enhance sleep quality.

Benefits of Prescription Digital Therapeutics

PDTs offer numerous advantages that enhance patient care and healthcare delivery.

Improved accessibility to treatment

PDTs make healthcare more accessible by providing treatments that can be delivered remotely via mobile devices. This is particularly beneficial for individuals in underserved areas or those with mobility challenges, ensuring they receive timely care.

Personalized and adaptive interventions

PDTs can be tailored to individual patient needs, offering adaptive interventions that evolve based on real-time data. This personalization enhances treatment effectiveness and patient satisfaction (Phan et al., 2023).

Real-time data collection and analysis

The ability to collect and analyze data in real-time allows healthcare providers to monitor patient progress continuously. PDTs can collect patient data continuously, providing 1440 data points per day compared to 1-4 from traditional in-person visits. This facilitates early detection of issues and enables proactive adjustments to treatment plans, improving overall outcomes (Phan et al., 2023).

Reduced healthcare costs

By providing effective and scalable interventions, PDTs have the potential to reduce healthcare costs. They can decrease the need for in-person visits and hospitalizations, making them a cost-effective alternative to traditional treatments. For example, an economic analysis estimated PDTs could save $2,150 per patient per year for opioid use disorder treatment (Brezing & Brixner, 2022).

Challenges and Limitations of PDTs

Despite their benefits, PDTs face several challenges that must be addressed to maximize their potential.

Doctor showing a patient an app in green

Federal regulation lags behind software development

Digital therapeutics (DTx) are mobile medical apps that use new tech like artificial intelligence (AI) and virtual reality (VR). They’re always changing, with new versions coming out every few months, which makes them hard to regulate. 

A problem with a DTx app could hurt someone’s health, so to keep DTx safe for consumers without stopping progress, software companies need to self-regulate–find ways to reduce risks and follow ethical rules on their own to help patients and build trust with their doctors.

One way to self-regulate is to involve clinicians in app development. Doctors know what patients need and can spot potential problems. But surprisingly, most health apps are made without input from medical experts. A study found only 20% of health apps included input from health professionals during development (Rassi-Cruz et al., 2022). 

Data privacy and security concerns

The collection and storage of sensitive health data raise significant privacy and security concerns. Ensuring robust data protection measures is crucial to maintaining patient trust and compliance with regulations (Phan et al., 2023).

Integration with existing healthcare systems

Integrating PDTs into existing healthcare infrastructures can be complex. Seamless integration is necessary to ensure that PDTs complement traditional treatments and fit within the broader healthcare ecosystem.

Patient adherence and engagement

Black man using his blood pressure monitor at home

Maintaining patient engagement with PDTs can be challenging. 

For example, take mental health apps that use CBT or provide feedback through wearables like smartwatches. While helpful, these apps often aren’t covered by insurance, and patients may pay out-of-pocket. They often give up if they don’t see quick results. 

Ensuring that patients adhere to prescribed digital therapies is essential for achieving desired outcomes, requiring strategies to enhance motivation and commitment. Pharmacists can help by encouraging patients to stick with the apps and complete all modules (Pharmacy Times, 2024).

Reimbursement and insurance coverage issues

Securing reimbursement for PDTs remains a hurdle, as insurance companies may be hesitant to cover these relatively new treatments. Establishing clear guidelines and demonstrating cost-effectiveness may help overcome this barrier.

The Future of Prescription Digital Therapeutics

The future of PDTs is promising, with advancements in technology and expanding applications poised to enhance their impact on healthcare.

overlay with doctor and pill bottle

Emerging technologies such as artificial intelligence and machine learning are set to revolutionize PDTs. These innovations can enhance personalization and predictive capabilities, improving treatment outcomes and patient experiences.

Potential for combination therapies

Combining PDTs with traditional treatments offers a holistic approach to healthcare. This synergy can enhance therapeutic outcomes by addressing multiple aspects of a patient’s condition, providing comprehensive care (Phan et al., 2023).

Expanding applications in preventive care and wellness

PDTs hold potential for preventive care by identifying and addressing health risks early. Their application in wellness can promote healthier lifestyles and prevent the onset of chronic diseases, contributing to improved public health.

Conclusion

In digital health, PDTs offer promising avenues for improving patient outcomes, increasing access to care, and potentially reducing healthcare costs. While challenges remain, the growing body of evidence supporting PDTs suggests that they will play an increasingly important role in the future of healthcare delivery. 

As patients, healthcare providers, and policymakers alike embrace these innovative tools, we can look forward to a more personalized, accessible, and effective approach to managing a wide range of health conditions.

References

Bashran, E. (2024). Prescription Digital Therapeutics: Devices. HealthAffairs. Retrieved from

https://www.healthaffairs.org/doi/10.1377/hlthaff.2024.00159

Brezing, C. A., & Brixner, D. I. (2022). The Rise of Prescription Digital Therapeutics In Behavioral Health. Journal of Behavioral Health; 11(4), 1-10. doi: 10.1007/s12325-022-02320-0 

Global Prescription Digital Therapeutics (PDTx) Market – Industry Trends and Forecast to 2030. (2023). Data Bridge Market Research. Retrieved from https://www.databridgemarketresearch.com/reports/global-prescription-digital-therapeutics-dtx-market

Liesch, J., Volgina, D. Nessim, C., Murphy, D., & Samson, C. (2023). Blue Matter Consulting. Retrieved from https://bluematterconsulting.com/prescription-digital-therapeutics-us-market-outlook-2023/

Phan, P., Mitragotri, S., & Zhao, Z. (2023). Digital therapeutics in the clinic. Bioengineering & Translational Medicine; 8(4), e10536. doi:10.1002/btm2.10536. 

Prescription Digital Therapeutics Bring New Treatments to Healthcare. (2021). Avalere Health. Retrieved from https://avalere.com/insights/prescription-digital-therapeutics-bring-new-treatments-to-healthcare

Prescription Digital Therapeutics for Mental Health: Effectiveness, Challenges, and Future Trends. (2024). Pharmacy Times. Retrieved from https://www.pharmacytimes.com/view/prescription-digital-therapeutics-for-mental-health-effectiveness-challenges-and-future-trends

Rassi-Cruz, M., Valente, F., & Caniza, M. V. (2022). Digital therapeutics and the need for regulation: How to develop products that are innovative, patient-centric and safe. Diabetology & Metabolic Syndrome; 14. doi.org/10.1186/s13098-022-00818-9 

Wang, C. Lee, C. & Shin, H. (2023). Digital therapeutics from bench to bedside. npj Digital Medicine; 6(1), 1-10. doi.org/10.1038/s41746-023-00777-z

The Future of Telehealth: Trends and Predictions for 2025 and Beyond

The Future of Telehealth: Trends and Predictions for 2025 and Beyond

AI Health Tech Med Tech

In 2020, the COVID-19 pandemic sparked a 78% uptick in telehealth usage. As we look to the future, telehealth is poised to become an integral part of healthcare delivery. 

This article explores the exciting innovations and trends that will shape the future of telehealth, promising to enhance patient care, improve accessibility, and streamline healthcare operations.

To understand the future of telehealth, we first need to look at the new technologies that are changing how we provide care.

Contents

Emerging Technologies in Telehealth

The future of telehealth is closely tied to advancements in technology. Several cutting-edge innovations are set to reshape virtual care in the coming years.

Artificial intelligence and machine learning in diagnostics

Phone with chatbot conversation

AI and machine learning (ML) can analyze large amounts of medical data to assist healthcare providers in making more accurate diagnoses and treatment recommendations.

For example, AI-powered diagnostic tools can examine medical images like X-rays or MRIs and flag potential issues for review by human doctors. 

AI chatbots are also being developed to conduct initial patient screenings and triage. These chatbots can ask patients about their symptoms and medical history, then direct them to appropriate care options whether that’s a virtual doctor visit, in-person visit, or emergency services.

Internet of Medical Things for remote patient monitoring

The Internet of Medical Things (IoMT) refers to connected medical devices and applications that can collect and transmit health data. This technology enables continuous remote monitoring of patients’ vital signs and other health metrics.

Some examples of IoMT devices include:

5G networks enabling real-time, high-quality video visits

The rollout of 5G networks dramatically improves the quality and reliability of video-based telehealth services. 5G offers much faster data speeds and lower latency compared to 4G networks.

In fact, 5G technology can reduce video latency to less than 2 milliseconds, enabling real-time interaction during virtual doctor visits comparable to in-person visits.

For telehealth, this means:

  • Higher-quality video and audio for virtual visits

  • The ability to transmit large medical files like MRIs quickly

  • More reliable connections in rural or remote areas

  • Support for bandwidth-intensive applications like augmented reality

Take a look at a diagram that shows how connected medical devices interoperate across different systems (Deloitte, 2021).

How connected medical devices interoperate across different systems
Source: Deloitte

Virtual and augmented reality applications in telemedicine

Virtual reality (VR) and augmented reality (AR) have exciting potential applications in telehealth:

For instance, a 2018 study in the Journal of Visualized Experiments found that VR-based physical therapy for stroke patients greatly improved upper limb function compared to conventional therapy (Choi & Paik, 2018).

While technology is important, telehealth’s real strength is in making specialized care available to more people.

Expanding Access to Specialized Care

One of telehealth’s greatest promises is improving access to specialized medical care, especially for underserved populations.

Telepsychiatry bridging the mental health treatment gap

Mental health care has long suffered from accessibility issues, with many areas facing severe shortages of psychiatrists and therapists. Telepsychiatry is helping to bridge this gap.

A 2016 study in the World Journal of Psychiatry found that telepsychiatry was as effective as in-person care for treating depression, with the added benefit of increased patient satisfaction and engagement (Hubley et al., 2016).

Telepsychiatry is particularly valuable for:

  • Rural communities with few local mental health providers

  • Patients with mobility issues or transportation barriers

  • People seeking specialized treatments not available locally

  • Those who prefer the privacy and convenience of at-home care

Remote visits with specialists for rural and underserved areas

Telehealth is bringing specialized medical expertise to areas that previously had little or no access. This includes:

  • Remote dermatology visits using high-resolution images

  • Virtual neurology assessments for stroke patients

  • Tele-oncology services for cancer patients in rural areas

School-based telehealth programs improving pediatric care

School-based telehealth programs are emerging as a powerful tool for improving children’s health, especially in underserved communities. These programs typically involve:

Halterman et al (2017) found that school-based telehealth programs reduced emergency department visits and improved asthma outcomes for children in rural communities.

Virtual second opinions from leading medical experts

Telehealth is making it easier for patients to get second opinions from top specialists, regardless of geographic location. This can be particularly valuable for complex or rare conditions.

Several major medical centers now offer formal virtual second opinion programs. For example, the Mayo Clinic’s eConsults program provides written second opinions from Mayo Clinic specialists based on a review of medical records and test results.

Telehealth is also changing how we approach personalized care and monitoring for patients.

Personalized Medicine and Remote Monitoring

The integration of telehealth with other digital health technologies is enabling more personalized and proactive care.

Wearable devices for continuous health tracking

Monitor attached to back of a woman's left shoulder

Wearable devices like smartwatches and fitness trackers are increasingly being used for medical monitoring. These devices can track:

  • Heart rate and rhythm

  • Blood oxygen levels

  • Sleep patterns

  • Physical activity levels

  • Stress indicators

This continuous data collection allows for more comprehensive health monitoring between doctor visits.

Monitoring services are poised to continue incredible growth over the next several years, as depicted in the following chart (Gupta, 2024).

Source: Appinventiv

AI-powered predictive analytics for early intervention

By analyzing data from wearables, electronic health records (EHRs), and other sources, AI algorithms can predict health risks and recommend early interventions.

Some applications can help clinicians to:

  • Predict heart attacks or strokes based on subtle changes in vital signs

  • Identify patients at risk of developing diabetes

  • Forecast mental health crises based on behavioral patterns

Genomics and telehealth integration for tailored treatments

genetic markers

The combination of telehealth and genomic medicine is opening up new possibilities for personalized treatment plans. Patients can now receive genetic counseling and testing remotely, with results informing tailored treatment recommendations.

For example, pharmacogenomic testing can help determine which medications are likely to be most effective for a particular patient based on their genetic profile. 

Remote medication management and adherence monitoring

Poor medication adherence is a major challenge in healthcare, contributing to worse health outcomes and increased costs. Telehealth-enabled medication management tools can help by:

  • Sending reminders to take medications

  • Tracking medication usage through smart pill bottles or ingestible sensors

  • Allowing remote adjustments to medication regimens

  • Providing education about medications and potential side effects

As telehealth grows, we need to update the rules and regulations that guide its use.

Regulatory Landscape and Telehealth Adoption

Law books and scales with plant and shield

The rapid growth of telehealth has prompted significant regulatory changes, with more likely to come as the technology continues to evolve.

Evolving reimbursement policies for virtual care

One of the biggest barriers to telehealth adoption has been inconsistent reimbursement policies. However, the COVID-19 pandemic led to significant policy changes:

  • Medicare expanded coverage for telehealth services.

  • Many private insurers increased telehealth coverage.

  • Some states mandated payment parity between in-person and virtual visits.

As we move forward, key questions include:

  • Will expanded telehealth coverage become permanent?

  • How will reimbursement rates for virtual care compare to in-person visits?

  • What types of telehealth services will be covered?

Data privacy and security considerations in telehealth

medical papers and stethoscope

The growth of telehealth raises important questions about patient data privacy and security. Key concerns include ways to:

  • Ensure secure transmission of sensitive medical information

  • Protect patient data stored in telehealth platforms

  • Maintain privacy during video visits

Healthcare providers and telehealth companies must comply with regulations like HIPAA in the U.S.

Licensing and cross-state practice regulations

Traditionally, healthcare providers have been limited to practicing in states where they hold a license. This poses challenges for telehealth, which can easily cross state lines.

Some recent developments include:

  • The Interstate Medical Licensure Compact, which streamlines licensing for doctors in multiple states

  • Temporary waivers of state licensing requirements during the COVID-19 pandemic

  • Proposals for a national telemedicine license

Global telehealth initiatives and international cooperation

People around a globe

Telehealth has the potential to improve healthcare access globally, particularly in developing countries with limited medical infrastructure.

Some notable international telehealth initiatives include:

  • The World Health Organization’s Global Strategy on Digital Health

  • The European Union’s eHealth Network

  • The African Alliance of Digital Health Networks

Even with its many benefits, telehealth faces challenges that we must tackle to make it work for everyone.

Overcoming Challenges in Telehealth Implementation

While telehealth offers tremendous potential, several challenges must be addressed to ensure its effective and equitable implementation.

Addressing the digital divide and ensuring equitable access

The “digital divide” the gap between those who have access to technology and those who don’t poses a significant challenge for telehealth adoption.

Key issues include:

  • Lack of broadband internet access in rural areas

  • Limited digital literacy among some patient populations

  • Affordability of devices needed for telehealth

Potential solutions include:

  • Government initiatives to expand broadband access

  • Programs to provide telehealth-enabled devices to underserved populations

  • Digital literacy training for patients

Training healthcare providers in virtual care best practices

Many healthcare providers lack formal training in delivering care via telehealth. This can lead to suboptimal patient experiences and outcomes.

Key areas for provider training include:

  • Effective communication in virtual settings

  • Conducting remote physical exams

  • Managing technical issues during visits

  • Ensuring patient privacy and data security

Integrating telehealth with existing healthcare systems

For telehealth to reach its full potential, it needs to be seamlessly integrated with existing healthcare systems and workflows. This includes:

  • Integrating telehealth platforms with EHRs

  • Developing protocols for when to use telehealth vs. in-person care

  • Ensuring continuity of care between virtual and in-person visits

  • Adapting billing and administrative processes for telehealth

Health providers are set to invest heavily in virtual health applications in the next 5 to 10 years, as shown in the following chart (Gupta, 2024).

Source: Appinventiv

Managing patient expectations and building trust in virtual care

For many patients, telehealth represents a significant shift in how they receive care. Building trust and managing expectations is crucial for successful adoption.

Key considerations include how to:

A recent Health Information National Trends Survey found that 70% of U.S. adults with recent telehealth visits used audio-video, and 75% felt their telehealth visits were as good as in-person care (Spaulding et al., 2024). 

Conclusion

As technology advances and adoption grows, we can expect more personalized, accessible, and efficient care. However, success will depend on addressing challenges such as the digital divide and regulatory hurdles. 

By embracing AI and other technological innovations, we can create a healthcare system that truly meets the needs of patients in the digital age. Patients, providers, and policymakers must work together to shape this exciting future of healthcare.

References

Choi, H., & Paik, J. (2018). Mobile Game-based Virtual Reality Program for Upper Extremity Stroke Rehabilitation. Journal of Visualized Experiments: JoVE; (133). doi.org/10.3791/56241

Deloitte. (2021). Medtech and the Internet of Medical Things: How connected medical devices are transforming health care. Retrieved from https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-medtech-iomt-brochure.pdf

General FAQs About the Compact. (n.d.). Interstate Medical Licensure Compact. Retrieved from https://www.imlcc.org/faqs/

Gupta, D. (2024). 7 Telemedicine Trends Shaping the Future of Healthcare. Appinventiv. Retrieved from https://appinventiv.com/blog/top-telehealth-trends/

Halterman, J. S., Tajon, R., Tremblay, P., Fagnano, M., Butz, A., Perry, T., & McConnochie, K. (2017). Development of School-Based Asthma Management Programs in Rochester, NY Presented in Honor of Dr. Robert Haggerty. Academic Pediatrics; 17(6), 595. doi.org/10.1016/j.acap.2017.04.008 

Hubley, S., Lynch, S. B., Schneck, C., Thomas, M., & Shore, J. (2016). Review of key telepsychiatry outcomes. World Journal of Psychiatry, 6(2), 269–282. doi.org/10.5498/wjp.v6.i2.269

Marley, R. (2021). 8 key trends driving the future of telehealth. Healthcare Transformers. Retrieved from https://healthcaretransformers.com/digital-health/current-trends/future-of-telehealth/

More care close to home. (2024). MayoClinic. Retrieved from https://www.mayoclinic.org/about-mayo-clinic/care-network/more-care-close-to-home

Spaulding, E. M., Fang, M., Chen, Y., Commodore-Mensah, Y., Himmelfarb, C. R., Martin, S. S., & Coresh, J. (2024). Satisfaction with Telehealth Care in the United States: Cross-Sectional Survey. Telemed J E Health. 2024 Jun;30(6):1549-1558. doi:10.1089/tmj.2023.0531