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

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

The Proposed HTI-2 Regulation is designed to further promote interoperability and encourage nationwide information sharing among patients, providers, payers, and public health authorities. It aims to do so through two new sets of criteria under the ONC Health IT Certification Program, among other provisions.

The new proposed certification rules focus on interoperability between providers and public health authorities and payers, respectively.

Both sets of criteria place a strong emphasis on standards-based APIs to enable streamlined end-to-end interoperability between data exchange partners.

The Public Health IT Certification Criteria were developed in collaboration with the Centers for Disease Control and Prevention to support the ongoing Data Modernization Initiative.

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

Other components of ONC’s HTI-2 proposal:

  • Technology and standard updates that build on the HTI-1 final ruleranging from the ability to exchange clinical images (e.g. X-rays) to the support of multi-factor authentication.

  • Requires implementation of USCDI version 4 by January 1, 2028.

  • Amendments to certain “exceptions” to the ONC information blocking regulations, aimed at covering additional practices recently proposed by stakeholders, such as a new “Protection of Access to Care” exception, which would cover practices an actor engages in under certain circumstances to reduce the risk of legal exposure resulting from information sharing.

  • Establishing a number of new TEFCA governance rules, including requirements to implement Section 4003 of the 21st Century Cures Act.

The proposed HTI-2 regulations are intended to continue and supplement the final HTI-1 regulations, which were published earlier this year.

That rule — Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing — focused on AI effectiveness and also on strengthening the foundation for four key ONC priorities, as Micky Tripathi, national coordinator for health IT, 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 the appropriate use of digital health tools.

The proposed HTI-2, meanwhile, takes a broader and more expansive look at the information-sharing ecosystem, with provisions like the certification criterion for real-time prescription benefit tools, which help health care providers and patients make more informed decisions, compare drug costs and find appropriate alternatives. And other parts of HTI-2 seek to advance steps HHS has already taken to strengthen privacy rules — including for those seeking or providing legitimate reproductive care.

“The proposed HTI-2 rule is a tour de force. We have used all the tools at ONC’s disposal to advance HHS-wide interoperability priorities,” Tripathi said in a July 10 statement. “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 worked to expand interoperability and improve transparency when it comes to electronic health information,” HHS Secretary Xavier Becerra added. “Now we’re building on that work to ensure that the entire system supporting patients and providers uses the best available technology in a safe and responsible way.”

Mike Miliard is Editor-in-Chief of Healthcare IT News
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