Role of Digital Therapeutics in Digital Health

Mansha Kapoor
December 28, 2023


A recent study showed that implementing wearable AI, which encompasses technologies like smartwatches equipped with AI algorithms to monitor health in real-time, could potentially save nearly 400,000 lives in Europe, leading to an annual cost savings of 200 billion EUR. 

The COVID-19 pandemic motivated the quick adoption of digital health globally, allowing healthcare access beyond traditional means. Digital platforms facilitated contact-tracing efforts and aided in containing the virus's spread. Remote care services grew overnight, enabling patients to receive essential medical guidance and support from the safety of their homes.

Rapid deployment of digital technologies like contact tracing software bridged health inequities. For digital healthcare to be effectively implemented and uniformly accessible, Digital therapeutics step in for sharing knowledge, collaborating on IP, and knowledge transfer.

Digital health has revolutionized how healthcare is delivered, and individuals manage their well-being. This umbrella term encompasses various technological tools and platforms to enhance healthcare outcomes. It includes personalized patient care, expanded access to healthcare via mobile applications, and the utilization of advanced algorithms for disease diagnosis.

Digital health, digital medicine, and digital therapeutics are terms used within digital healthcare technology. Digital health is an umbrella term for technology for improving health and healthcare. It has fitness tracking apps to telemedicine and remote patient monitoring within its ambit. Digital medicine and digital therapeutics are more specific and focus on diagnosing, treating, and preventing diseases using technology.

It is digital therapeutics that power digital healthcare. The technology to diagnose, treat, and prevent diseases includes wearable devices monitoring vital signs, AI-driven disease diagnosis, 3D printing for personalized medical equipment, evidence-based interventions preventing, managing, and treating medical disorders using digital sensors, wearables, VR, and AI devices. 

Digital therapeutics specifically leverages technology for disease treatment. Its applications range from wearable devices administering medication and monitoring health indicators to using virtual reality for therapies like anxiety or PTSD treatments.

These technologies have rapidly advanced healthcare, promising improved care quality, increased accessibility, and reduced costs. 

DTx, in particular, offers evidence-based behavioral treatments online, making healthcare more accessible and effective through technology. It ensures top-tier standards in design, clinical support, usability, and data security.

Scope of Digital Health

The World Health Organization (WHO) defines digital health in its Digital Health Strategy (2020-2025) as using digital technologies and data to enhance health outcomes, improve health system performance, and empower individuals to make informed decisions about their health and well-being. It also emphasizes transparency, accessibility, scalability, replicability, interoperability, privacy, security, and confidentiality.

Digital health is growing exponentially, incorporating mobile health (mHealth) apps, wearable devices, telemedicine, electronic health records, and artificial intelligence (AI). It saves lives, enhances efficiency, and introduces innovative healthcare amalgamations. AI powers The Internet of Medical Things (IoMT) to combine medical devices with IT systems. They enable diverse applications like telemedicine, disease control, and user-level data collection through smart sensors.

COVID-19 accelerated the adoption of telehealth, showcasing how technology aids virtual care. Notably, smartphone-connected pacemakers, highlighted by Cleveland Clinic, exemplify how mobile apps transmit crucial health data securely to patients and their doctors, improving insights and care.

mHealth has seen growth in its user base, fueled by the pandemic. Wearables, straddling the line between consumer and medical devices, now feature advanced health monitoring capabilities like heart rate variability and continuous glucose monitoring.

Blockchain-based EMRs aim to expedite data access, enhance quality, and ensure interoperability in patient information, capitalizing on blockchain's security and scalability.

AI streamlines healthcare tasks, from patient monitoring to medical imaging, automating labor-intensive processes and augmenting decision-making. Digital twins, modeling devices, and patients demonstrate how AI replicates real-world conditions.

Augmented reality (AR) finds application in education, surgical visualization, and disease simulation, integrating digital information into real-time environments.

The advent of big data in healthcare, drawing from diverse systems and applications, poses opportunities and challenges. Healthcare systems must harness technologies capable of managing, storing, and analyzing vast and complex healthcare data to extract actionable insights.

According to Healthgrades, healthcare big data encompasses collecting, analyzing, and utilizing vast and intricate consumer, patient, physical, and clinical data. We talk about data often processed through machine learning algorithms to derive meaningful insights. Despite challenges such as volume, velocity, variety, and veracity, technology adoption is crucial to extract actionable insights.

Advantages of Big Data in Healthcare

1. Reducing Medication Errors:

Software analyzing patient records detects inconsistencies between health and prescriptions, alerting healthcare professionals and patients to potential errors.


2. Enhancing Preventive Care:

Big data aids in identifying frequent emergency room visitors, enabling proactive measures to prevent recurrent visits.


3. Accurate Staffing:

Predictive analysis assists hospitals and clinics in anticipating admission rates and optimizing staff schedules for better operational efficiency.

Role of Digital Therapeutics in Integrated Health Ecosystems:

Advancements in healthcare technology, particularly in Artificial Intelligence (AI), Deep Learning, and wearable health monitoring, have revolutionized data collection for doctors. This transformation yields valuable insights, prompting a noticeable shift in healthcare priorities. Patients are increasingly seeking digitally-driven solutions that offer personalized, on-demand care. Likewise, healthcare providers seek digital tools to facilitate real-time patient monitoring and enhanced patient engagement. Payers aim for solutions that detect risks and minimize overall costs, while pharmaceutical companies strive to elevate the quality of care. For many, the solution lies within digital therapeutics. Digital therapeutics address many clinical issues amidst the growing emphasis on cost-effective and preventive care solutions. 

Chronic conditions stand as the primary cause of worldwide fatalities, presenting a unique set of hurdles in their management. These obstacles encompass issues like ensuring adherence to medications, facilitating self-management, adjusting to lifestyle changes, and behavioral adaptations, all while necessitating personalized care, continuous monitoring, and treatment modifications (as seen in conditions like diabetes).

Digital therapeutics (DTx) present a promising solution. These evidence-driven interventions, powered by top-notch software programs, aim to prevent, manage, or treat various medical conditions. They hold the potential to tackle these challenges effectively by expanding treatment choices available to both patients and healthcare professionals. Furthermore, DTx offers novel pathways for accessing healthcare.

DTx encompasses a diverse array of forms and indications that have already demonstrated significant effectiveness, including:

1. Mobile applications designed to support diabetes management.

2. Game-based treatments tailored for attention deficit hyperactivity disorder (ADHD).

3. Platforms based on cognitive behavioral therapy for handling depression, anxiety, and insomnia.

These interventions receive certification from regulatory bodies to validate product claims regarding safety, efficacy, and intended use. Often requiring a prescription, they are distinct from other digital health technologies—such as wellness and support tools—due to their delivery of therapeutic interventions. These DTx solutions strictly adhere to rigorous regulatory standards and necessitate the publication of robust trial data, affirming their effectiveness in treating, managing, or preventing disorders. In contrast, other digital health technologies might not deliver therapeutic interventions, instead focusing on tasks like data tracking or providing educational content without being grounded in evidence-based interventions.

How Does DTx Work?

The rise of digital therapeutics (DTx) is a groundbreaking innovation in healthcare, which is expected to reach a $28.66 billion market value by 2030. This form of digital health solutions offers evidence-based software interventions to manage medical conditions, empowering patients in their treatment decisions. DTx targets chronic diseases like diabetes, hypertension, and mental health disorders, aiming to improve patient behavior and health outcomes through remote monitoring and tailored interventions.

DTx differs from other digital health innovations by its software-driven, evidence-backed, disease-preventing, and managing capabilities. It's transforming medication adherence through reminders, substituting medications with sensory stimuli, and even assisting in substance addiction treatment. The industry is witnessing a surge in investments, reshaping regulatory structures and treatment approaches.

These therapies focus on conditions often inadequately addressed by traditional healthcare systems, presenting relatively cost-effective treatments. Their ability to drive behavioral change at scale is notable, especially in lifestyle interventions for conditions like diabetes. Additionally, DTx is making strides in mental health treatment, utilizing cognitive-behavioral therapy (CBT) digitally for depression, anxiety, substance abuse, and more.

Improving medication adherence remains a core aspect of DTx. Innovations include AI-driven robots for nudging medication intake and ingestible sensors that monitor and record patients' responses to medication, transmitting data to healthcare providers. Furthermore, virtual reality (VR) technology is finding its place in DTx, particularly in exposure therapy for Post-Traumatic Stress Disorder (PTSD) and exploration of other mental health domains like anxiety, phobias, and addiction.

In essence, DTx represents a transformative shift in digital healthcare delivery, addressing unmet needs and offering innovative solutions for managing various health conditions through technology-driven interventions.

Trends in Digital Therapeutics

Digital therapeutics (DTx) have gained recognition for enhancing medication adherence and driving behavioral change. Approved by the FDA, these solutions target diabetes, obesity, cardiovascular issues, mental health, hypertension, and insomnia. The Digital Therapeutics Alliance (DTA) defines DTx as evidence-based interventions delivered through high-quality software to treat or prevent diseases.

The prevalence of chronic diseases globally has led to a demand for comprehensive disease management. In North America, the DTx market is predicted to grow at a CAGR of 30.7% from 2023 to 2032 due to increased chronic care spending, venture funding, and supportive government initiatives.

Critical trends in DTx clinical research include evidentiary standards, trial design considerations, AI integration, patient adoption, and evidence generation for DTx solutions.

1. Evidentiary Standard:

The DTA outlined foundational principles in 2022, defining the clinical evidence necessary for efficient DTx assessment by regulatory bodies like the FDA.

2. DTx Trials vs. Drug Trials:

DTx trials necessitate clinical verification akin to pharmaceuticals but have shorter development periods and lower costs. Challenges include rapid software updates, access barriers like digital literacy, and patient engagement crucial for success.

3. Trial Design:

Similar to drug development, DTx faces challenges in patient recruitment, data quality, and timelines. However, its digital nature makes it suitable for decentralized trials and poses unique technical security concerns.

4. AI and ML:

Assessing AI/ML-based DTx safety and efficacy is complex due to potential biases in training datasets concerning diverse patient populations.

5. Integrated Offerings:

Companies combining DTx with other therapies, like Orexo's opioid use disorder treatment, face regulatory complexities during joint development.

6. Patient Adoption:

Studies explore factors influencing patient acceptance of DTx, emphasizing perceived usefulness and ease of use, shaping the framework for future clinical trials' focus.

DTx's potential in healthcare is immense, but addressing challenges in evidence generation, trial design, and patient acceptance remains pivotal for their widespread adoption and impact.


In embracing the transformative potential of digital healthcare, it's clear that the future of medicine is already upon us, albeit unevenly distributed. The convergence of advanced technologies like machine learning, wearables, and telehealth has accelerated due to recent global events, offering immense promise in improving patient care.

However, while these innovations hold great potential, several crucial considerations demand attention. Ensuring the effective assessment and thoughtful integration of new technologies into healthcare practices is vital. Unifying diverse data sources into comprehensive care records is essential for their optimal use. Equally important is ensuring that these digital tools are accompanied by appropriate clinical support, benefitting patients without overwhelming clinicians with increased workload.

As we navigate this shift, it's evident that clinicians, traditionally seen as repositories of knowledge, face a daunting challenge in keeping up with the explosion of medical information and treatment complexities. The solution lies in transitioning from authoritative dispensers of knowledge to skilled interpreters of algorithm-generated recommendations fueled by the latest evidence, genomics, and additional data sources.

This transformation demands a fundamental shift in skill set, from mere knowledge acquisition to adept communication. The future demands that clinicians leverage digital tools as interpreters and patients work at mitigating their technological poverty in this new era of healthcare.

Mahalo Health stands at the forefront of digital healthcare, blending traditional healing methods with cutting-edge technology. As a comprehensive platform, it offers personalized solutions, integrating telemedicine, data-driven insights, and patient-centric tools. With a focus on holistic wellness, it revolutionizes healthcare by empowering individuals to take charge of their well-being anytime, anywhere. Contact us for a demo today!

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