What is a digital therapeutic? 2019-05-21T03:15:05+00:00

What Is A Digital Therapeutic?

_ Digital therapeutics are evidence-based therapeutic interventions driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. Not every app or technology in health care is a digital therapeutic.

A New Category of Medicine

Digital therapeutics (DTx) deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.

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

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

Case Study: How Digital Therapeutics Relate to Digital Health

Product Categories

Digital therapeutics form an independent category of evidence-based products within the broader digital health landscape. Digital therapeutics are distinguished from other digital health categories through their primary function of delivering software-generated therapeutic interventions directly to patients to prevent, manage, or treat a medical disorder or disease.

Similar to the way that digital therapeutics represent a distinct subset of products under the broader digital health category, there are also distinct types of products under the digital therapeutic umbrella, all of which are based on the level of risk associated with a product’s claim or claims.

Required Components of a DTx

The direct delivery of personalized treatment interventions to patients places digital therapeutics in a unique position, one full of additional responsibility and promise. Given the diversity of interventions being delivered by digital therapeutics and the types of disease states addressed, it is important for all products to adhere to industry-adopted core principles and best practices.

Core principles all digital therapeutics must adhere to:

  • Prevent, manage, or treat a medical disorder or disease
  • Produce a medical intervention that is driven by software, and delivered via software or complementary hardware, medical device, service, or medication
  • 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 approved by regulatory bodies as required to support product claims of risk, efficacy, and intended use
  • Make claims appropriate to clinical validation and regulatory status
  • Collect, analyze, and apply real world evidence and product performance data

DTx Product Case Studies

The types of interventions being delivered by digital therapeutic products across the industry are as diverse as the disease states being addressed.

Examples of digital therapeutic products developed by DTA Member Companies may be found on the Product Case Study page. This list will continue to be updated with additional member company products that have advanced through the pipeline development process and are aligned with DTA’s core principles.

Access Product Case Studies