Advancing DTx

DTA published the final ‘DTx Integration and Workflow Report‘, the fifth and final report to be published in collaboration with DTA’s Integration and Workflow Task Group, NCPDP, and other industry stakeholders.

DTA updated the DTx regulatory and reimbursement pathway overviews for three countries: France, Germany, and United Kingdom. These pathways help policymakers and DTx manufacturers understand the current landscape of how DTx products are recognized, regulated, and funded in specific countries.

DTA announced a partnership with DirctTrust to expand existing DirectTrust programs by establishing a new accreditation program for efficacy and data privacy for digital therapeutics applications and platforms.

In partnership with the Post Graduate Institute for Medicine (PIM), DTA launched the first continuing medical education (CME) module for digital therapeutics, “Understanding the Future of Digital Therapeutics”.

DTA hosted its second annual summit on June 5-7, 2024 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.

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

Building on the DTx Integration & Workflow Report released in January 2023, an updated report was released in March 2024. This report provides more details on the workflow to integrate digital therapeutic products into the standard practice of care in the U.S, identifies gaps and pain points in the workflow, and proposes the next steps to address the pain points to optimize the experience for clinicians and patients.

DTA re-published the DTx Commercial Launch Playbook, constructed in collaboration ClearView Healthcare Partners, for South Korean DTA members.

Launching a DTx includes hundreds of activities which are often difficult to track, regardless of organizational resources. As such, this playbook is designed to provide DTA member organizations with a standard set of launch considerations to help execute a successful product launch and understand the resources necessary to launch and scale.

In collaboration with Clearview Healthcare Partners, DTA released the white paper, “DTx Commercialization Launch Playbook Case Study“.

Building upon the success of the Commercial Launch Playbook, our new white paper delves into a captivating case study with Freespira, exploring the critical success factors that drive a successful launch in the Digital Therapeutics (DTx) landscape.

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.

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.

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.

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.

DTA published the DTx Commercial Launch Playbook, constructed in collaboration ClearView Healthcare Partners for DTA members.

Launching a DTx includes hundreds of activities which are often difficult to track, regardless of organizational resources. As such, this playbook is designed to provide DTA member organizations with a standard set of launch considerations to help execute a successful product launch and understand the resources necessary to launch and scale.

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.

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.

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.

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.

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.

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.

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

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.

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.

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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.