HTI-2 proposed rule includes new certification criteria for payer and public health IT

HTI-2 proposed rule includes new certification criteria for payer and public health IT

The Office of the National Coordinator for Health Information Technology on Wednesday published its long-awaited Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability proposed rule for public comment.

The HTI-2 proposed rule is designed to further advance interoperability and boost nationwide information sharing among patients, providers, payers, and public health authorities. It aims to do that with two new sets of criteria under the ONC Health IT Certification Program, among other provisions.

The new proposed certification rules are focused on interoperability between providers and public health agencies and payers, respectively.

Both sets of criteria maintain a big focus on standards-based APIs to enable more streamlined end-to-end interoperability between data exchange partners.

The health IT for public health-oriented certification criteria were developed in tandem with the Centers for Disease Control and Prevention  to support its ongoing Data Modernization Initiative.

Meanwhile, proposed payer-focused health IT certification rules were developed in coordination with the Centers for Medicare and Medicaid Services to support technical requirements included in the CMS Interoperability and Prior Authorization final rule.

Among other components of ONC’s HTI-2 proposal:

  • Technology and standards updates that build on the HTI-1 final rule, ranging from the capability to exchange clinical images (e.g., X-rays) to the addition of multi-factor authentication support.

  • Requiring the adoption of USCDI version 4 by January 1, 2028.

  • Adjustments to certain “exceptions” to the ONC information blocking regulations, with the aim of covering additional practices that have recently been suggested by stakeholders – such as a new “Protecting Care Access” exception, which would cover practices an actor takes in certain circumstances to reduce its risk of legal exposure stemming from sharing information.

  • Establishing some new TEFCA governance rules, including requirements that implement section 4003 of the 21st Century Cures Act.

The HTI-2 proposed rule is available in full at It will soon be published in the Federal Register, after which it will be available for public comment for 60 days.

The HTI-2 proposed rule is designed to build on and complement the HTI-1 final rule, which was published earlier this year.

That rule – Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing – was focused on AI efficacy, and also around bolstering foundations for four key ONC priorities, as National Coordinator for Health IT Micky Tripathi noted when the proposed HTI-1 rule was first unveiled in 2023: building the digital foundation of health record information; making interoperability easy; promoting information sharing and ensuring proper use of digital health tools.

The proposed HTI-2, meanwhile, takes a broader and more expansive view of the information sharing ecosystem, with provisions such real-time prescription benefit tool certification criterion, which help providers and patients to make more informed decisions, comparing the cost of drugs and finding suitable alternatives. And other portions of HTI-2 seek to advance steps HHS has already taken to strengthen privacy rules – including for those seeking or providing lawful reproductive care.

“The HTI-2 proposed rule is a tour de force. We have harnessed all the tools at ONC’s disposal to advance HHS-wide interoperability priorities,” said Tripathi in a statement on July 10. “As always, we look forward to reviewing public comments and engaging with the health IT community in the weeks and months ahead.”

“The Biden-Harris Administration has been working to expand interoperability and improve transparency when it comes to electronic health information,” added HHS Secretary Xavier Becerra. “Now we are building on that work to ensure that the entire system that supports patients and providers utilizes the best technology available in a safe and responsible way.”

Mike Miliard is executive editor of Healthcare IT News
Email the writer:
Healthcare IT News is a HIMSS publication.

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