Proposed HTI-2 Regulation Includes New Certification Criteria for Payers and Public Health IT

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

WHY IT MATTERS
The HTI-2 proposed rule is designed to further promote interoperability and enhance information sharing across the country between patients, providers, payers, and public health agencies. The rule aims to do so with two new sets of criteria under the ONC Health IT Certification Program, among other provisions.

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

Both sets of criteria focus heavily on standards-based APIs to enable more streamlined, comprehensive interoperability between data exchange partners.

The public health-focused health IT certification standard was developed in tandem with the Centers for Disease Control and Prevention to support the ongoing Data Modernization Initiative.

Meanwhile, proposed payer-focused health IT certification rules have been developed in collaboration with the Centers for Medicare & Medicaid Services to support the technical requirements contained in CMS’s Interoperability and Prior Authorization final rule.

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

• Technology and standards updates based on the HTI-1 final rule range from the ability to exchange clinical images (e.g., X-rays) to adding support for multi-factor authentication.

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

• Adjusting certain “exceptions” to ONC’s information blocking regulations, intended to include additional activities recently proposed by stakeholders — such as the new “Protecting Access to Care” exception, which would cover activities a party takes in certain circumstances to reduce the risk of legal action arising from information sharing.

• Establishes several new TEFCA regulatory rules, including requirements to implement section 4003 of the 21st Century Cures Act.

The HTI-2 proposed rule is available in full at healthit.gov/proposedrule. The rule will be published in the Federal Register soon, and then open for public comment for 60 days.

THE BIGGER TREND
The HTI-2 proposed rule is designed to build on and supplement the HTI-1 final rule, published earlier this year.

That rule — Health Data, Technology, and Interoperability: Certification Program Updates, Algorithmic Transparency, and Information Sharing — focuses on the effectiveness of AI and also centers around strengthening the foundation for ONC’s four key priorities, as National Coordinator for Health IT Micky Tripathi noted when the proposed HTI-1 rule was first announced for 2023: building a digital foundation for health record information, facilitating interoperability, promoting information sharing, and ensuring appropriate use of digital health tools.

Meanwhile, the proposed HTI-2 takes a broader, more inclusive view of the information-sharing ecosystem, with provisions like criteria for certifying real-time prescribing-benefit tools that help providers and patients make more informed decisions, compare drug costs, and find appropriate alternatives. And other parts of HTI-2 seek to leverage steps HHS has taken to strengthen privacy rules—including for those seeking or providing legitimate reproductive care.

ON PROFILE
“The HTI-2 proposed rule is a tremendous accomplishment. We have leveraged every tool available to ONC to advance interoperability priorities across HHS,” Tripathi said 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 worked 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 supports patients and providers using the best available technology in a safe and responsible manner.”

Mike Miliard is executive editor of Healthcare IT News
Email the author: [email protected]
Healthcare IT News is a publication of HIMSS.