Digital Therapeutics: Patient, Heal Thyself

Article By : Paul Golata, Mouser Electronics

The future is ripe with potential for medical technology—and a better, connected patient experience is at its center.

Physician, Heal Thyself

The saying, “Physician, Heal Thyself,” was employed even before Alexander the Great (356–323BC) spearheaded his conquest into Western Asia and Persia, spreading Greek civilization, language, thought, culture, and ideals (Hellenism) around the Mediterranean and the Persian Gulf. The Greek dramatist and father of tragedy, Aeschylus (525–455 BC), rightly—or perhaps wrongly—is credited with employing what would become a general maxim. From Prometheus Bound, this concept would become distilled to the proverbial “Physician, Heal Thyself.” The medical word “therapeutic” also traces back to the Greek, to the word therapeutikos, meaning “to attend” or “to treat.” In the informational age of computers, the proverb might need to be updated to “Patient, Heal Thyself.”

Doctor, Doctor

“Doctor, doctor, it hurts when I do this… “Did you download the app for it?” Before long, this may be the response from your doctor to many common health issues such as abnormal heart rhythm, depression, and Parkinson’s. Applications, together with wearable or ingestible sensors, will provide data for a variety of concerns for medical professionals to follow up on. This article examines a relatively new area of medicine known as Digital Therapeutics (DTx) and how software and wearables can work together to keep us healthy.

The Digital Health Technology Landscape

The future is ripe with potential for medical technology—and a better, connected patient experience is at its center. Improving lives by bringing more advanced care closer to home is possible with digital electronics solutions.

Technological development in analytical computation, data storage, and artificial intelligence (AI) makes advanced analytics more practical. In the form of wearable medical devices, smartphones, and smart watches, personalized hardware allows consumers to exchange digital information with their medical providers. Significantly, research data indicates that there is increasing evidence that digital therapies and interventions improve human flourishing. Digital therapeutics also implies a level of speed, convenience, and lack of human contact desired by today’s consumers. Digital technologies will transform the healthcare system in the coming years.

What developments have been happening in the medical electronics sector? What technologies are in the pipeline? How are technology suppliers helping manufacturers improve their processes? All this, and more, in this month’s In Focus series.

Digital Therapeutics is only one section among the digital health technology landscape. This digital landscape is expanding quickly for digital health in a wide variety of sectors beyond digital therapeutics, including:

– Devices, sensors, and wearables: Wearable and wireless devices, biometric sensors, diagnostic products

– Health Information Technology (HIT): Electronic medical record systems, electronic prescribing and order entry, consumer health and information technology (IT) applications

– Mobile health (mHealth): Wellness, fitness trackers, and nutrition applications; consumer health information; medication adherence applications

– Personalized healthcare: patient-reported outcomes, predictive analytics, clinical decision support

– Telehealth: telemedicine virtual visits, remote patient monitoring, at-distance care programs

Solutions across the digital health ecosystem work synergistically to support excellent patient outcomes. Large-scale enterprise systems and support provide a platform for healthcare systems, clinics, and enterprise settings. Clinician services and support utilize HIT and telehealth to improve care and workflow. Patient-facing wellness and support in the form of devices, sensors, wearables, and mHealth help capture, store, or transmit health data. Patient-facing diagnostic and monitoring solutions get employed to diagnose, guide diagnoses, or actively monitor patients.

The Digital Therapeutics Alliance

The Digital Therapeutics Alliance (DTA) has defined the concept of digital therapeutics. DTA is a medical industry organization with a vision for transforming global healthcare by advancing digital therapeutics to improve clinical and health economic outcomes. The mission of the DTA is to broaden the understanding, adoption, and integration of clinically-evaluated digital therapeutics with patients, clinicians, payors, and policymakers through education, advocacy, and cross-industry collaboration.

Digital Therapeutics Defined

DTA maintains that Digital Therapeutics (DTx) is a method to provide evidence-based therapeutic interventions to patients to prevent, manage, or treat a medical disorder or disease. DTx is utilized independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. DTx products incorporate advanced technology best practices relating to design, clinical evaluation, usability, and data security. DTx products are reviewed and cleared or certified by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use. Digital therapeutics empower patients, clinicians, and payers with intelligent and accessible tools for addressing a wide range of conditions through high-quality, safe, and effective data-driven interventions.

Foundational Principles of DTx Products

DTA promotes the idea that DTx products should be developed and designed with all of the following principles in mind and as a goal:

• Prevent, manage, or treat a medical disorder or disease

• Produce a medical intervention that is driven by software

• Incorporate design, manufacture, and quality best practices

• Engage end-users in product development and usability processes

• Incorporate patient privacy and security protections

• Apply product deployment, management, and maintenance best practices

• Publish trial results inclusive of clinically meaningful outcomes in peer-reviewed journals

• Be reviewed and cleared or certified by regulatory bodies as required to support product claims of risk, efficacy, and intended use

• Make claims appropriate to clinical evaluation and regulatory status

• Collect, analyze, and apply real-world evidence and product performance data

DTx Product Categories

DTA has grouped DTx into three (3) product categories. These categories are distinguished by the overall goal, whether it be treatment, management, or improvement of a health function (Table 1).

Table 1: Digital therapeutics (DTx) product categories. (Source: Digital Therapeutics Alliance)

Value of DTx Products

DTx products—using evidence-based, clinically evaluated technologies—have the ability to:

• Optimize clinical and health economic outcomes

• Deliver high-quality therapies to underserved populations

• Quickly scale and be accessible through patient-owned devices

• Offer at-home convenience and privacy

• Transform how patients understand, manage, and engage in their healthcare

• Extend clinicians’ ability to care for patients

• Support healthcare teams in settings with varying degrees of health care infrastructure

• Lower overall costs of care

Patients and Caregivers: New Effective Therapy Options

Digital therapeutics are clinically proven to treat, manage, and prevent a wide range of diseases and disorders using software-based technologies (Figure 1). DTx products deliver medical interventions directly to patients or integrate with other digital health technologies, medications, or in-person therapies to:

• Improve patient health

• Deliver a highly engaging and user-friendly experience

• Provide meaningful results and insights on personalized goals and outcomes

• Quickly scale and be accessible via smartphones and tablets

• Ensure patient safety and privacy protection

Figure 1: A caregiver with a patient. DTx enables new and effective therapies to be delivered from the caregiver to the patient. (Source: fizkes/Shutterstock.com)

Clinicians: Trustworthy and Effective Therapy Options

DTx products represent a category of evidenced-based therapeutic technologies that support clinicians in delivering high-quality patient care (Figure 2). These products address a range of disease states and provide a wide variety of software-based interventions. DTx products are used independently or in concert with other medical therapies to:

• Directly impact disease-state measures and clinical outcomes

• Expand access to safe, confidential, and effective medical treatments

• Provide therapies for previously un- or undertreated conditions

• Extend clinicians’ ability to care for patients

• Maximize patient engagement

• Close gaps in care

• Lower overall healthcare costs

Figure 2: Clinicians like that DTx delivers trustworthy and effective therapy options. (Source: Pressmaster/Shutterstock.com)

Because of their easy accessibility, a record of improving outcomes, ability to integrate into care management workflows, delivery of real-world insights, and increased reimbursement by payors, DTx products are becoming critically important tools for clinicians and their care teams.

Policymakers: Developing Legislation and Regulations

Policymakers at the local, national, and regional levels face many important questions about the regulatory recognition of DTx products and legislative actions necessary to enable public payor coverage and patient access (Figure 3). Building on the ease of product scalability and access through patient-owned devices, DTx products can more easily reach high-risk, rural, and underserved communities that often lack access to healthcare services even during the best of times.

Figure 3: Policymakers shape legislation and regulations for digital healthcare, including DTx. (Source: Andrina Rissanen/Shutterstock.com)

Payors: Clinical and Financial Value

The global pandemic has exposed the challenges payors face in delivering accessible, high-quality care outside of traditional office-based visits (Figure 4). Payors are now considering additional options for best meeting patient needs and closing gaps in care with non-traditional approaches. By combining technology and evidenced-based medicine, DTx products offer patients access to therapies that address a wide range of conditions, enabling payors to:

• Reduce the overall cost of care

• Enhance, support, and optimize current medical treatments

• Optimize patient engagement

• Improve provider network efficiency

• Support value- and outcomes-based care initiatives

• Expand care delivery outside of traditional clinic settings

• Improve member experience and satisfaction

Figure 4: Medical payors, including insurance companies, the government, and corporations, are developing ways to improve population health management and value-based care initiatives. (Source: zimmytws/Shutterstock)

Insights and information collected by digital technologies are easily integrated within care management workflows to provide payors with valuable insights that support population health management and value-based care initiatives.

Conclusion

Digital Therapeutics provides evidence-based therapeutic interventions to patients to prevent, manage, or treat a medical disorder or disease. Software, medical wearables, smartphones, and other electronic medical devices work together to fight and cure human disease. Medical professionals will continue to pursue the development of more ways to improve their patient’s total well-being by incorporating digital therapeutics to provide healthcare. The world of tomorrow includes patients working with their healthcare providers to, cooperatively, Heal Thyself.

About the Author

Paul Golata joined Mouser Electronics in 2011. As a Senior Technology Specialist, Paul contributes to Mouser’s success through driving strategic leadership, tactical execution, and the overall product-line and marketing directions for advanced technology related products. He provides design engineers with the latest information and trends in electrical engineering by delivering unique and valuable technical content that facilitates and enhances Mouser Electronics as the preferred distributor of choice. Before joining Mouser Electronics, Paul served in various manufacturing, marketing, and sales related roles for Hughes Aircraft Company, Melles Griot, Piper Jaffray, Balzers Optics, JDSU, and Arrow Electronics. He holds a BSEET from the DeVry Institute of Technology (Chicago, IL); an MBA from Pepperdine University (Malibu, CA); an MDiv w/BL from Southwestern Baptist Theological Seminary (Fort Worth, TX); and a PhD from Southwestern Baptist Theological Seminary (Fort Worth, TX).

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