Digital Therapeutics Alliance Launches Policymaker & Payor DTx Evaluation Toolkit to Accelerate Global Digital Therapeutic Understanding and Adoption


Digital Therapeutics Alliance (DTA) is announcing the launch of the Policymaker & Payor DTx Evaluation Toolkit, a comprehensive set of resources to enable global healthcare and digital technology leaders to broaden the understanding, adoption, and integration of clinically evaluated digital therapeutics (DTx) into healthcare.

According to ISO, digital therapeutics “generate and deliver software-based medical interventions to patients to treat or alleviate a disease or disorder”. DTx products additionally provide clinicians and payors with robust opportunities to enhance clinical and health economic outcomes for patients and populations.

As part of its core mission, DTA continues to convene healthcare decision makers, end users, and industry leaders to develop a strong foundation for how patients and caregivers access and utilize digital therapeutics. This Toolkit originated through the work of the DTx Policy Coalition, which launched in June 2022, and provides clarity for healthcare decision makers responsible for evaluating and implementing DTx in real-world settings.

Components included in this Toolkit include:

  • Foundation setting materials, such as the Digital Health Technology (DHT) ecosystem categorization, ISO’s official definition of a DTx, and DTx intended uses and mechanisms of impact.
  • DTx assessment guides, covering product clinical and economic impact, privacy, security, usability, and evidence requirements.
  • Implementation resources that feature DTx market access pathways, prescription vs. non-prescription status, and integration considerations. 

In an increasingly fragmented landscape of differing product requirements and expectations within and across national jurisdictions, this Toolkit represents a first step toward enabling policymakers, payors, and manufacturers to harmonize baseline requirements and scale therapies across populations.

To that end, the Toolkit is equipped with an explanation of the benefits and challenges associated with developing and implementing DTx in clinical care, and provides education on the evaluation processes and metrics for assessing clinical benefits, risks, and patient preferences.

Through advocacy, education, and cross-industry collaboration, the Policymaker & Payor DTx Evaluation Toolkit will provide greater insight on the development and integration of DTx into healthcare, in an effort to ultimately improve patient outcomes and benefit global healthcare.

“Digital therapeutics will undoubtedly become a critical part of patient care. With the appropriate frameworks and pathways, this is the first treatment modality that can equitably scale across global healthcare settings to deliver personalized, high quality, impactful healthcare,” said Megan Coder, Chief Policy Officer of DTA. “The Policymaker & Payor DTx Evaluation Toolkit offers decision makers a full spectrum approach to understanding the complexities of DTx value assessment, legal and regulatory guidelines, and implementation, in addition to optimizing the impact of DTx therapies on patient care.”

These tools are free and open access, available to all: DTx Evaluation Toolkit – Digital Therapeutics Alliance.

About DTA

As the leading global authority on the evolution of digital health technology, Digital Therapeutics Alliance (DTA) is a 501(c)(6) non-profit trade association of industry leaders and stakeholders dedicated to the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors to improve clinical and health economic outcomes. As the leading international organization on digital therapeutic thought leadership and education, DTA provides the digital health ecosystem with the necessary tools to define, evaluate, and utilize DTx products.

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