Understanding DTx

What is a DTx?

Digital therapeutics (DTx) are health softwares intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health.

The resources on this page are designed to help patients, clinicians, policymakers, and payors better understand DTx products:

Digital Health Technology Landscape Download PDF

The digital health landscape encompasses a broad range of technologies, with each serving a specific purpose. Although some digital health technologies (DHTs) are used for wellness, medication adherence, monitoring, or patient diagnosis, others like digital therapeutics, use software to directly treat, manage, or prevent a disease or disorder. It is important to identify which DHT best meets end users’ needs and expectations. This resource provides a high-level overview of the types of DHTs that are currently used across the healthcare ecosystem.

Understanding DTx Products

DTx products – a subset of DHTs – provide patients, caregivers, and clinicians with new therapeutic options to support, improve, or replace the current standards of care for a wide range of diseases and disorders.

Digital therapeutics are recognized as medical devices and therefore are subject to a variety of internationally recognized standards, and national and local regulations. DTx products should also adhere to all core industry principles in order to demonstrate product safety, efficacy, quality, patient centricity, privacy, and ongoing clinical impact.

What is a Digital Therapeutic?

Digital therapeutics (DTx) are health softwares intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health.

DTx products incorporate advanced technology best practices relating to design, clinical evaluation, usability, and data security. They are certified or cleared by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use.

Digital therapeutics empower patients, clinicians, and payors with intelligent and accessible tools for addressing a wide range of conditions through high-quality, safe, and effective data-driven interventions.

How are DTx products different from other DHTs?

Per industry standards, digital therapeutic products should adhere to these foundational principles:

  1. Incorporate design, manufacturing, and quality best practices.
  2. Engage end users in product development and usability processes.
  3. Incorporate patient privacy and security protections.
  4. Apply product deployment, management, and maintenance best practices.
  5. Publish trial results inclusive of clinically meaningful outcomes in peer-reviewed journals.
  6. Be reviewed and cleared or certified by regulatory bodies as required to support product claims of risk, efficacy, and intended use.
  7. Make claims appropriate to clinical evaluation and regulatory status.
  8. Collect, analyze, and apply real-world evidence and/or product performance data.

Is This Product a DTx? Download PDF

Given the proliferation of products available to patients, caregivers, and clinicians for use in healthcare, it can be difficult for end users to determine which products are digital therapeutics versus other types of DHTs. This flowchart helps healthcare decision makers and end users understand which products qualify as a digital therapeutic.

Where Do Digital Therapeutics Fit into Healthcare? Download PDF

Digital therapeutics play an important role in the healthcare ecosystem alongside clinician-delivered care, pharmaceuticals, and other non-DTx medical devices. This diagram provides a snapshot of a complex ecosystem and lists various types of interventions available for patient monitoring, diagnosis, treatment decisions, and ongoing care.

Demystifying DTx

The future of patient care will unquestionably include software-based products that generate and deliver medical interventions directly to patients to treat, manage, and prevent diseases and disorders. To fully realize digital therapeutics’ value and impact across all health settings, it is important to provide clarity on common questions about how DTx products fit in the broader digital health continuum and how to distinguish between DTx products and other DHTs.

Just as medications serve different purposes, so do digital health products. Each digital health technology has a different purpose — such as health and wellness apps, digital diagnostics, remote monitoring, clinical support tools, and digital therapeutics.

An increasing number of apps are being called a digital therapeutic on the basis that they are digital products and used in a healthcare environment. However, to truly qualify, all DTx products should align with the industry’s definition and core principles (shown above).

Although patients may sometimes download the shell of a DTx product from an app store, they typically gain full access to the product’s content after they receive an authorization code from a clinician, payor, employer, or other entity and enter it into the product.

DTx products are provided to patients in a variety of ways, including:

  • Formal prescription (Rx) from a qualified clinician
  • Clinician referral for a non-prescription DTx product
  • Direct authorization by an employer or payor for a non-prescription DTx product
  • ‘Authorized clinical protocol’ established by a HCDM to authorize automatic patient access when necessary qualification requirements are met
  • ‘Clinically-validated screening tool’ that patients utilize to determine whether they qualify for the therapy
  • ‘Over-the-counter’ model where no form of third-party authorization is necessary

Individual countries often set different requirements for which products require a formal prescription.

While most digital health apps do not require clinical evidence, DTx products do. Digital therapeutics must complete multiple levels of clinical evidence, including trial results inclusive of clinically meaningful outcomes that are published in peer-reviewed journals. Additional forms of evidence may include the generation of real-world data, product performance data, real-world evidence, and health economic outcomes.

DTx products utilize a variety of mechanisms to deliver their clinical impact, including, but not limited to:

  • Behavioral therapy ƒ
  • Biofeedback
  • Cognitive training
  • Neurological stimulation
  • Physiologic stimulation
  • Software-determined medication dose modification ƒ
  • Software-directed disease management
  • Software-led clinical rehabilitation

Digital therapeutics are reviewed and cleared by regulatory bodies as required to support product claims of risk, efficacy, and intended use. Regulatory bodies in different regions and jurisdictions may set varying levels of regulatory and market authorization requirements for digital therapeutics based on the product’s intended use and level of risk.

DTx products are generally recognized as medical devices in jurisdictions with relevant regulatory frameworks. According to the level of claims each DTx product is making and its associated level of risk, DTx products must submit to the necessary regulatory requirements that are set in place for the device.

DTx products incorporate patient privacy and security protections according to each region and jurisdiction they are used within. Regulations that protect patient privacy and data rights include Health Insurance Portability and Accountability Act (HIPAA) in the United States and General Data Protection Regulation (GDPR) in Europe.

Additionally, types of third-party certifications that DTx products may undergo to protect the security of each product include ISO/IEC 27001, HITRUST, and SOC 2.

DTx products are designed to deliver a therapy that is appropriate to patient needs and must therefore be appropriately engaging. Just as medications are used for specific durations and purposes, DTx products must be used according to product requirements in order to deliver the optimal therapeutic intervention at the right time, and for the right duration. Given their role in clinical therapy, digital therapeutics are not used in the same manner as non-clinical platforms, such as social media, gaming, and entertainment sites.

DTx products that have undergone service design processes in advance of and during clinical evaluations are able to more seamlessly integrate into the appropriate real-world environments. DTx products must meet the needs of patients, clinicians, and other end users during each phase of product use.

In clinical practice, DTx products do not require daily oversight and input from clinical teams. Clinicians, should they want access to this data in line with patient privacy requirements, are typically given access to dashboards that provide insights on patient trends and insights developed over specific periods of time.

Clinician payment continues to grow in the United States and Europe. In the U.S., clinicians may use various CPT codes to account for the time they spend educating and onboarding patients, prescribing DTx products, and conducting necessary follow up efforts. In Germany and France, for example, clinicians are increasingly receiving payment for their direct engagement with digital health technologies as payment models move toward quarterly payments to optimize patient visits.

Digital therapeutics support clinicians in the delivery of high-quality patient care by extending clinicians’ ability to care for patients, addressing existing gaps in care, and providing new therapy options for previously un- or undertreated conditions.

Digital therapeutics introduce an entirely new degree of product scalability and patient access. Payors and policymakers are now able to deliver care to entire populations that have previously been outside the reach of traditional care – either due to geographic limitations, cultural and language boundaries, well-documented disparities, or health condition severity. Patients who have previously not received care now have the opportunity to receive personalized therapeutic interventions based on their specific needs and abilities, in an engaging way, with familiar languages and cultural references, in the privacy and safety of their own environment, with access to actionable insights that convey patient movement toward clinical improvement, and often through the use of patient-owned smartphones or devices.

DTx products are able to deliver interventions, collect patient-generated data, and display necessary insights using a variety of internet connection types, including: intermittent WiFi access, sustained basic internet access, and broadband internet access.

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