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.
60 Day Comment Period Open
The DTx Criteria Council has published the first draft of the DTx Accreditation Criteria. The open comment period opened on September 23 and ends on November 22, 2024. Read the DTx Accreditation Criteria here.
A key update for 2025 is the inclusion of the criteria for the new Digital Therapeutics program. A subgroup of the DirectTrust Criteria Council has established and codified proposed criteria of the new program which will be published for a 60-day public comment period. Public comment is critical in creating a robust set of criteria, so we encourage everyone submit feedback by November 22, 2024.
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