Bench Talk

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“Doctor, doctor, it hurts when I do this..” “Did you download the app for it?” Before too 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 blog 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 future is ripe with potential for medical technology— and a better, connected patient experience is at its center.

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 (Figure 1). Digital technologies will transform the healthcare system in the coming years.

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, 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

Figure 1: Improving lives by bringing more advanced care closer to home is possible with digital electronics solutions. (Source: metamorworks/Shutterstock.com)

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.

Digital therapeutics (DTx) uses clinically evaluated software 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.

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 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

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.