Compliance deadline extended for health IT developers

The Assistant Secretary for Technology Policy and the Office of the National Coordinator for Health Information Technology have announced new enforcement discretion criteria and extended the deadline to comply with certain regulatory requirements under the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing rule, or HTI-1.

The recent government shutdown caused substantial delays in HIT developers’ ability to comply with crucial HTI-1 regulations. Developers, especially smaller ones, faced significant challenges in updating vital components. While ASTP/ONC has delayed the compliance deadline, there is still a ripple effect on compliance requirements for certain provider reimbursement programs.

With the lapse of federal appropriations, the ASTP/ONC website and its compliance testing tools were unavailable.

Health IT developers were also unable to speak to technical support staff, which left them stalled on module changes needed for compliance certification deadlines, according to Stephanie Jamison of Greenway Health, vice chair of the Electronic Health Record Association.

ASTP/ONC said it will not exercise its direct review authority that arises solely from a health IT developer not complying with the Jan. 1, 2026, HTI-1 compliance date, according to the notice posted to its website on Monday.

The agency also stated that it will not initiate enforcement actions before March 1.

Specific criteria requiring updates under HTI-1 include patient demographics and observations; family health history; transitions of care; clinical information reconciliation and incorporation; care plan; transmissions to immunization registries, public health agencies and others; application programming interfaces for patient and population services; and more.

“All of the EHRA members had teams actively working with our certification bodies to meet the deadline by the end of the calendar year,” Jamison told Healthcare IT News on Tuesday. “They were kind of flying blind.”

Anything requiring a new product certification that would go through full compliance testing, such as decision support intervention requirements, is going to be complicated, she explained.

HIT vendors also hope for clarity from the U.S. Centers for Medicare & Medicaid Services on adjustments to software certification requirements, Jamison said, noting that the Merit-based Incentive Payment System and Advanced Alternative Payment Models programs have been impacted.

“We’re hoping to see an announcement from CMS to provide that clarity for our clients,” she said.

While the time to comply with HTI-1 was always seen by the HIT industry as burdensome, the 43-day shutdown didn’t alleviate the strain, Jamison said.

For the second rule, ASTP/ONC said it planned to address new advancements for public health through certified IT requirements with provisions related to API certifications for specific use cases, including electronic prior authorization, patient engagement and care coordination.

HTI-2, released about one year ago, finalized amended information blocking regulations that included definitions related to the Trusted Exchange Framework and Common Agreement, or TEFCA, Manner Exception and made corrections to HTI-1, adding privacy and security certification requirements for algorithm-based clinical decision support tools.

However, it left unanswered questions about certifying artificial intelligence enhancements.

HTI-3 (also released in 2024) focused on criteria that aimed to improve patient care access, while HTI-4 finalized e-prescribing and prior authorization rules.

Beginning in 2027, ASTP/ONC requires providers to be able to process prior authorizations in real time during patient care encounters through health IT and supports standardized, electronic prior authorization exchange through HL7’s FHIR standard.

“There’s a lot in HTI-1 that we as a vendor community have been working on throughout the year to get over the finish line,” said Jamison. “The enforcement discretion window will help a lot, especially for our smaller members.” Healthcare IT News