Digital Therapeutics Alliance establishes foundational definition, industry core principles

Digital Therapeutics Alliance

The Digital Therapeutics Alliance (DTA) released a comprehensive report to provide an overview of the digital therapeutics (DTx) industry and establish the definition of a digital therapeutic. Core principles and best practices related to the design, manufacture, clinical validation, and regulatory oversight of these products are also featured.

The organization defines digital therapeutics (DTx) as a new category of medical interventions that combine patient-centric technologies with evidence-based medicine to deliver highly personalized care. Digital therapeutics present patients, healthcare providers, and payers with evidence-based technologies that have the ability to elevate medical best practices, address unmet medical needs, expand healthcare access, and improve clinical and health economic outcomes.

“The integration of digital therapeutics into healthcare is no longer a theoretical conversation. As an Alliance, we are focused on building a strong foundation for this rapidly growing industry,” Megan Coder, DTA Executive Director, said in a statement. “We are committed to empowering patients, healthcare providers, and payers with engaging and accessible tools that deliver meaningful clinical outcomes across a broad spectrum of physical, mental, and behavioral disorders.”

Digital therapeutics 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 incorporate advanced technology best practices and are validated by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use.

Over the coming months, DTA will further develop best practices and frameworks that directly support the design, validation, utilization, and regulatory oversight of digital therapeutics across multiple cultures, languages, and national borders.

The Digital Therapeutics Alliance organization aims to broaden the understanding, adoption, and integration of clinically-validated digital therapeutics into healthcare through education, advocacy, and research. It envisions enabling broad access to high quality, evidence-based digital therapeutics for patients, healthcare providers, and payers in order to improve clinical and health economic outcomes.