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 is leading policy and advocacy efforts to expand the adoption, coverage, and access to clinically validated digital therapeutics (DTx). By engaging directly with federal officials and submitting comments on proposed rules and regulations, DTA is ensuring the interests of members and the patients they serve are considered in policy decisions that will impact the industry. Learn more about these efforts and read DTA’s recent regulatory comments in the News section of the DTA website.
  • 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

Harmonizing DTx evaluation criteria: With the ‘DTx Value Assessment & Integration Guide’, DTA is engaging with payors, policymakers, clinicians, and other healthcare decision makers (HCDMs) to inform the development of DTx-specific evaluation criteria. The Guide provides a framework to use in assessing baseline information about DTx products, their value, and their impact in real-world settings. This first ever industry framework for the evaluation and implementation of digital therapeutics will help streamline the process of bringing safe and effective digital therapeutics into clinical use across local, regional, and national settings.

Decision makers are using this tool to assess product:

  • Clinical impact & intended use
  • Regulatory & security requirements
  • Clinical evidence evaluation
  • Economic assessment
  • DTx implementation in practice

DTA Achievements

2023
2022
2021
2020
2019
2018
2017
'23

Policymaker & Payor DTx Evaluation Toolkit

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.

'23

DTx Policy Pathways: The Evolving Scenario in Europe

This DTx Policy Report stems from the partnership between the Digital Therapeutics Alliance and Healthware Group, which aims at supporting the development of adequate and enabling Policies for Digital Medical Devices and, specifically, DTx to drive equitable access to digital health care for all.

'23

2023 DTA Inaugural Summit

The Digital Therapeutics Alliance (DTA) hosted its Inaugural Summit on June 7-9, 2023 in Washington DC. Leaders from all facets of the digital therapeutics (DTx) ecosystem, including policymakers, clinicians, and payors, have joined DTA members to discuss the challenges and opportunities of DTx integration into the healthcare system and identify optimized policy, reimbursement, and regulatory pathways to accelerate adoption.

'23

DTx Integration & Workflow Report

DTA and NCPDP brought together subject matter experts from relevant stakeholder groups to contribute to the development of this report that outlines the integration and workflow of DTx products in the healthcare system, using the patient journey—from diagnosis through treatment—as the primary focal point.

A progress report was published in August 2023 along with the Rx DTx Compendia Submission & Tracking Checklist.

'22

Published “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard”

In partnership with Curebase, DTA published, “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard”, providing a foundational set of expectations outlining the necessary clinical evidence to enable appropriate and efficient assessment reflective of the unique nature and innovation cycles of DTx products.

'22

Published the ‘DTx Value Assessment & Integration Guide’

DTA published the ‘DTx Value Assessment & Integration Guide’– A first ever industry framework to streamline the process of bringing safe and effective digital therapeutics into clinical use.

'22

Held education and advocacy event on Capitol Hill

DTA convened DTx industry leaders for an event on Capitol Hill to advocate for policy and legislation to provide better access and coverage for digital therapeutics in the US.

'22

Published DTx regulatory and reimbursement pathways

DTA published overviews of DTx regulatory and reimbursement pathways in eight countries as a part of our work to establish consistent and scalable frameworks for the assessment, integration, and adoption of DTx products.

'21

Held Targeted Feedback Period for DTx Value Assessment & Integration Guide

DTA held a targeted feedback period to inform the development of the DTx Value Assessment & Integration Guide, a standardized evaluation framework for payors, clinicians, and manufacturers. DTA engaged with over 60+ DTx industry stakeholders through three workshops, a survey, and individual interviews.

'21

Resource Partner Program

Launched a Resource Partner Program to accelerate the development and post-launch success of clinically evaluated digital therapeutics by building a best-in-class network of commercialization and product development service providers.

'21

Published DTx by Country Overviews

DTA published one-page overviews about digital therapeutics translated into the official languages of nine countries and with specific information on regulatory and product access pathways for each resource.

'21

Expanded DTx Product Library

Expanded DTx Product Library to launch public-facing campaign to raise awareness of DTx products on the market that are transforming global healthcare.

'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.

'19

DTx Product Library

DTA launched the DTx Product Library to help key stakeholders understand and differentiate digital therapeutics from the thousands of other mobile health apps that are available. The library highlights evidence-based innovative DTx products that are currently on the market and meet the definition of a DTx product and attest to aligning with industry Core Principles.

'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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