Collaboration to expand existing DirectTrust programs by establishing a new accreditation program for efficacy and data privacy and security for digital therapeutics applications and platforms

WASHINGTON, DC – June 6, 2024 – DirectTrust®, a non-profit healthcare industry alliance focused on furthering trust in healthcare data exchange through standards, accreditation, and other services, and Digital Therapeutics Alliance (DTA) today announced a collaborative partnership that will provide accreditation for efficacy, data privacy and security for digital therapeutics applications and platforms (DTx).

Through this strategic partnership, DTA and DirectTrust will develop a program set to expand existing DirectTrust programs that provide independent assessment of health apps for privacy, security, and transparency, as well as interoperability compliance with regulations and best practices. DirectTrust will administer the program, while DTA will lead the criteria development.

“This collaboration will add to DirectTrust’s growing suite of programs designed to assess the diverse digital health app and platform market,” said Scott Stuewe, DirectTrust President and CEO. “Our Health App program evaluates privacy and security, while the CARIN Code of Conduct for Consumer-Facing Applications assesses transparency and data use outside of HIPAA. Additionally, our UDAP™ programs validate effective, scalable connections to national health networks using the FHIR® standard. With the creation of this new accreditation to assess clinical efficacy for Digital Therapeutics, organizations will be able to select the program(s) that are appropriate for their business models.”

Over the past six years, DTA has produced collaborative and validated assets to define and assess DTx products, which will serve as the foundation for program assessment criteria. These assets include a Product Library that incorporates the industry core principles; DTx Value Assessment and Integration Guide; along with the clinical evidence paper “Setting the Stage for a Fit-for-Purpose DTx Evidentiary Standard.”

“As the digital therapeutics industry grows, an increasing number of U.S. clinicians, provider systems, health plans, employers, and patients are evaluating how to best incorporate DTx products into their care plans to provide the highest quality of care,” said Andy Molnar, CEO, DTA. “With an overwhelming number of products touting a wide range of clinical rigor, it is critical that we set a high bar to build trust. In order to achieve this, DTA and DirectTrust are partnering to establish a rigorous accreditation program  specific to DTx products that will build upon DirectTrust’s established, and widely adopted, Privacy and Security accreditation program.”

The new program is slated to launch later this year following DirectTrust’s standard procedures of developing proposed criteria and publishing those criteria for a 60-day public comment period.

Call for DirectTrust Criteria Council Sub-Group Members

To establish and codify the criteria to be used for this new program, a focus group comprised of key stakeholders with expertise and interest in clinical efficacy will be established as a subgroup of the DirectTrust Criteria Council. Any interested constituent is welcome to apply to the Criteria Council. Because this group will convene to collaborate on criteria related to Digital Therapeutics accreditation, representation from health care organizations, condition-specific advocacy groups, and digital therapeutics companies is highly encouraged. Already committed to participate in the effort are active participants in the Digital Therapeutics Alliance community including payer representatives Mark Rakowski of Children’s Community Health Plan, Nick Dougerty from Mass General Brigham Health Plan, Jon Vecchiet from OscarHealth, and Jeff Dunn representing Cooperative Benefits Group.

Stakeholders with an interest in participating as a beta organization for accreditation, or in joining the Criteria Council subgroup can complete the form on the DirectTrust website at, or email [email protected].

DirectTrust’s accreditation and certification programs are governed by the organization’s Electronic Healthcare Network Accreditation Commission (EHNAC). DirectTrust criteria for each of its accreditation programs sets the stakeholder and program specific foundational requirements for assessing an organization’s ability to meet/align with federal and state healthcare reform mandates such as HIPAA/HITECH, 21st Century Cures Act, TEFCA and other mandates and best practices like NIST SP 800-53 800-171, and 800-63, for healthcare organizations focusing on the areas of trust, privacy, security, cybersecurity, breach handling, confidentiality, best practices, procedures, and assets.