As the digital therapeutics industry grows, an increasing number of U.S. clinicians, provider systems, health plans, employers, and patients are evaluating whether or not to incorporate a DTx product into their care plan. In order to establish trust in products, DTA and DirectTrust are partnering to establish an accreditation program specific to DTx products that will build upon DirectTrusts’ established Privacy and Security accreditation program by adding a layer for product efficacy.
The Digital Therapeutic program is an add on to the Health App accreditation. Specifically, the program is for those who desire to demonstrate compliance with efficacy, data privacy, and security requirements for digital therapeutics applications and platforms (DTx). This program is administered by DirectTrust.
Call for Criteria Council
To establish and codify the criteria to be used for this new program, a clinical 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. Representation from health care organizations, condition-specific advocacy groups, and digital therapeutics companies is highly encouraged.
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 bit.ly/DTDTx, or email Admin@DirectTrust.org.