Advancing DTx

Improving Clinical and Health Economic Outcomes

As the leading international organization on digital therapeutic thought leadership and education, DTA is dedicated to providing patient, clinicians, payors, and policymakers with the necessary tools to evaluate and utilize DTx products. DTA’s members – including organizations dedicated to manufacturing, evaluating, supporting, and utilizing DTx products in clinical practice – work to enable expanded access to DTx products to improve clinical and health economic outcomes.

Current Initiatives

DTA is proud to advance digital therapeutics globally by:

Pandemic-Related Efforts

  • Covid-related efforts: During 2020, DTA petitioned international government bodies to provide their citizens with access to clinically-validated digital therapeutic products. DTA communicated with governments in Australia, Europe, Middle East, and North America through letters and publications written in Arabic, English, French, German, and Spanish.
  • Member company efforts: DTA member companies continue to be dedicated to ensuring the manufacture and support of high-quality digital therapeutics that improve healthcare delivery during this challenging time. Many DTA members are also engaged in the development of pharmaceuticals, medical devices, technology platforms, and general digital health products. We are proud to represent each of these companies as they serve their communities in a variety of ways.

European Efforts

  • Common European definition of a DTx: Frameworks for evaluating DTx products are expanding around Europe. While most include a baseline set of requirements for digital health technologies, there are still areas of divergence. This creates additional hurdles for companies that would hope to take a unified approach to entering European markets. To begin aligning these frameworks, DTA is developing a Coalition Letter that drives consensus on the utility of DTx products and agreement on the official definition of a DTx (including compliance with MDR and GDPR).

North America Efforts

  • Public policy campaign: DTA’s “Urgent Access” initiative aims to further expand patient access to clinically evaluated digital therapeutics. DTA’s legislative and regulatory proposals intend to provide new therapeutic options for patients with critical unmet needs during this pandemic. This multi-pronged effort includes a public policy campaign in the United States to accelerate access to digital therapeutics for vulnerable populations.
  • Addressing disparities and public health concerns: Individuals living in rural and underserved settings encounter challenges that others may not regularly experience. DTA’s report “Digital Therapeutics: Reducing Rural Health Inequalities,” calls for Medicare and Medicaid to leverage evidence-based digital therapeutics (DTx) to address critical gaps in care for underserved populations, regardless of whether disparities are based on patient age, language, culture, income, disease state, or geography.

Payor Efforts

  • DTx Product Value Assessment Guide: DTA is working to develop a framework for healthcare decision makers enabling them to better understand, evaluate, and implement digital therapeutics. More details will be provided in Summer 2021.

DTA Achievements

2020
2019
2018
2017
'20

Published Rural Health Paper

DTA published the report “Digital Therapeutics: Reducing Rural Health Inequalities,” that calls for Medicare and Medicaid to leverage evidence-based digital therapeutics to address critical gaps in care for underserved populations, regardless of whether disparities are based on patient age, language, culture, income, disease state, or geography.

'20

Covid-19 DTx Public Campaign

Executed a media and public campaign to raise awareness of DTx products and their effectiveness in improving clinical and economic outcomes during and beyond Covid-19. Highlighted member company contributions.

'20

International DTx Response to COVID-19

DTA petitioned governmental bodies within countries to provide their citizens access to DTx products during and after the pandemic.

'20

U.S. Payor Advisory Board

Launched a Payor Advisory Board to more intentionally engage healthcare decision makers in DTA’s work to consistently assess and demonstrate the value of digital therapeutics.

'19

Differentiated Digital Therapeutics

DTA collaborated with three other organizations to outline the landscape of digital health products available to end users and clinicians. This Digital Health Industry Categorization outlines how products making higher-risk medical claims must undergo greater levels of clinical evidence and regulatory oversight.

'19

Established the DTx Code of Ethics

DTA member companies collaborated with fellow leaders in the healthcare industry to develop a DTx Industry Code of Ethics. This Code demonstrates DTA Member Companies’ dedication to developing and bringing DTx products to market in a responsible way.

'19

Clinician Advisory Group

DTA launched a Clinician Advisory Group with physicians, psychologists, nurses, and pharmacists from multiple countries to provide insight on priority projects and initiatives.

'19

Increased Visibility for DTx

DTA staff participated in 100+ events and presentations around the world to raise awareness of DTx products and their effectiveness in improving clinical and economic outcomes.

'19

Developed Industry Best Practices

DTA published a series of Best Practices that DTx products could utilize to demonstrate alignment with industry core principles and ensure robust product design, evaluation, and intervention delivery.

'18

Developed the Official DTx Definition

DTA published a foundational report that provided the official industry definition of a DTx product, in addition to the ten industry core principles to which all DTx products must adhere. DTA also developed a risk-based categorization of DTx product claim types.

'18

Identified Existing DTx Coverage Pathways

Through DTA’s Work Groups, DTA began to map current pathways related to product regulatory oversight and coverage within the United States and select European countries.

'17

Founded in October 2017

The Digital Therapeutics Alliance was founded as a non-profit trade association with the purpose of transforming global healthcare by advancing digital therapeutics to improve clinical and economic outcomes.

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