DirectTrust and the Digital Therapeutics Alliance announced this week that they'll work together on an accreditation program designed to test the efficacy and security of digital-therapeutic apps and platforms.

WHY IT MATTERS
Together, two groups will partner up to establish an assessment regimen that will build on existing DirectTrust programs that provide independent assessment of health apps for safety and transparency, privacy protections, compliance with interoperability regs and best practices, and more, according to DTA, which is holding its annual summit this week.

The aim is 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," said Digital Therapeutics Alliance CEO Andy Molnar.

DirectTrust, meanwhile, already has an array of programs designed to assess the vast and hugely diverse digital-health app and platform market.

"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," said Scott Stuewe, president and CEO of DirectTrust. "Additionally, our UDAP programs validate effective, scalable connections to national health networks using the FHIR standard."

DTA will take lead on criteria development for the new program – which is expected to launch later this year – while DirectTrust will administer it.

A focus group comprising stakeholders with expertise and interest in clinical efficacy will be also be stood up as a subgroup of the DirectTrust Criteria Council, and anyone interested in applying Criteria Council or participating as a beta organization for accreditation is encouraged to visit the DirectTrust website or to email admin@directtrust.org.

THE LARGER TREND
In recent years, DTA has produced an array of collaborative, validated assets to define and assess DTx products. Those frameworks – such as the product library incorporating industry core principles and the DTx Value Assessment and Integration Guide – will serve as the foundation for the new program-assessment criteria.

DTA also points stakeholders to the recent clinical-evidence paper "Setting the Stage for a Fit-for-Purpose DTx Evidentiary Standard."

Digital therapeutics are proving their worth, in at-home and provider settings, and offering novel approaches to managing an array of conditions, including ADHD, generalized anxiety, multiple sclerosis and many others.

DTA, meanwhile, has been working to ensure the efficacy of those myriad apps and tools, while working to encourage that technology developers keeps a focus on health equity.

Among its many recent initiatives, meanwhile, DirectTrust has been focused on interoperability use cases such as its secure cloud fax standard.

ON THE RECORD
"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 Molnar. "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."

"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," added Steuwe.

Mike Miliard is executive editor of Healthcare IT News
Email the writer: mike.miliard@himssmedia.com
Healthcare IT News is a HIMSS publication.