The Digital Therapeutics Alliance announced Thursday morning it will launch an accreditation program through DirectTrust to dispel disillusion about the products and companies. The Digital Therapeutics Alliance will soon launch an accreditation program for digital therapeutics products through DirectTrust, which contracts with a slew of payers. Payers, especially the Centers for Medicare and Medicaid Services (CMS), have been hesitant to cover the products because of key DTx companies that announced bankruptcy last year, like Pear Therapeutics. Andy Molnar, CEO of the Digital Therapeutics Alliance, announced this morning at the organization's annual conference that it will begin to accredit digital therapeutics products to help build confidence in the industry. Through the collaborative partnership, DTA will establish criteria for evaluating efficacy of digital therapeutics products and DirectTrust will utilize existing standards for privacy, security and interoperability of the devices.
"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," Molnar said in a statement.
DirectTrust is an authorized HITRUST assessor and an accreditor for numerous healthcare policies, frameworks and programs.
The partnership will expand DirectTrust's existing programs. "This collaboration will add to DirectTrust's growing suite of programs designed to assess the diverse digital health app and platform market," Scott Stuewe, DirectTrust President and CEO said in a statement. "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."
Molnar said the accreditation program will be an arduous process and not a pass or fail program.
DTA is recruiting for DirectTrust Criteria Council Sub-Group Members that will help establish efficacy criteria that is specific to DTx products.