Last updated June 11, 1:47 p.m.
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."
Stuewe said this is DirectTrust's first program that includes a clinical evaluation component. A criteria council that includes digital therapeutics experts will establish the clinical criteria, potentially based on international frameworks for DTx that are already established in places like Germany and the United Kingdom.
DirectTrust already uses some international standards such as the European Union’s privacy framework, the General Data Protection Regulation (GDPR), to be able to point to an external source of truth when validating a product. That practice will continue, given that the digital therapeutics market is the most global of any healthcare technology market DirectTrust has worked in, Stuewe said.
DTA is also working to create a standard for DTx with the International Organization for Standardization (ISO), which will likely factor into the DirectTrust assessment once it is finalized.
DTx companies that receive accreditation will be issued digital badges through Credly that will be active for two years. DirectTrust will use its established pricing model.
Unlike artificial intelligence models used in healthcare, Stuewe said DirectTrust feels confident about launching into the DTx space. He said it's a narrow enough application of health technology with just hundreds of companies, as opposed to thousands in the AI space. The accrediting body might add AI in the future once there are more regulations in place by the federal government.
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.