ONC Outlines Health IT Certification Tips for 2015 Edition Cures Update

The 2015 Edition Cures Update made several changes to the ONC Health IT Certification Program, including new functionalities and requirements establishing the Conditions and Maintenance of Certification.

Most certified health IT developers must update their certified Health IT Modules by December 31, 2022.

Certified health IT developers with API technology certified to the § 170.315(g)(8) Application Access- data category request criterion must update their product(s) to the § 170.315(g)(10) Standardized API for patient and population services criterion.

“If certified health IT developers face challenges with successfully testing to § 170.315(g)(10), they should communicate with their ONC Authorized Certification Body (ONC-ACB) as soon as possible and work with them to successfully test with an ONC Authorized Testing Lab (ONC-ATL) by the deadline,” Laura M. Urioste of ONC wrote in the blog post.

Certified health IT developers with Modules certified to § 170.315(g)(8) that do not intend to update their Health IT Modules to § 170.315(g)(10) should engage their ONC-ACB to change their product listings on the Certified Health IT Product List (CHPL).

“Any actions by a certified health IT developer after December 31, 2022, to reduce the scope of an applicable Health IT Module’s certification once it is non-compliant is prohibited (§ 170.523(o)) and could result in Certification Program consequences (such as a certification ban (§170.581(a)(1)(ii)-(iv))),” the post noted.

Suppose a certified health IT developer has not updated or changed its product certifications or certified to § 170.315(g)(10) and provided its upgraded API technology to users by the end of the year. ONC may initiate a Direct Review for non-compliance with the API Maintenance of Certification requirement in that case.

ONC may also require the developer to submit and complete a Corrective Action Plan (CAP) that meets the conditions and return to compliance with the Certification Program requirements.

While participation in the Certification Program is voluntary, not complying with Certification Program requirements can negatively impact end users’ ability to meet the standards of other HHS programs.

Such initiatives include the Promoting Interoperability (PI) and Merit-based Incentive Payment System (MIPS) programs administered by CMS or participation in various Alternative Payment Models (APMs) in 2023.

For instance, eligible hospitals and clinicians participating in these programs need to use certified API technology and enable patients to access all the data elements included as part of the United States Core Data for Interoperability (USCDI) version 1 through (e)(1) certified Health IT Modules.

“Certified health IT developers who allow their products to fall out of conformity and compliance with the Certification Program put their products and their participation in the Certification Program at risk, resulting in providers being unable to meet CMS requirements,” Urioste concluded.