U.S. health body proposes rule boosting health data interoperability

WASHINGTON, D.C., UNITED STATES — The United States Department of Health and Human Services (HHS) recently released a new proposed rule called the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2).

Introduced through the Office of the National Coordinator for Health Information Technology (ONC), this initiative aims to advance interoperability and improve information sharing among patients, providers, payers, and public health authorities.

Building on the HTI-1 final rule

The proposed rule builds on the HTI-1 final rule, published in January 2024, by incorporating several technology and standards updates. 

These updates include capabilities for exchanging clinical images, such as X-rays, and the addition of multi-factor authentication support. 

The rule also mandates the adoption of United States Core Data for Interoperability (USCDI) version 4 by January 1, 2028, providing long-term planning clarity for the industry.

New certification criteria for health IT systems

The HTI-2 proposed rule introduces two new sets of certification criteria for health IT systems aimed at improving public health and payer operations. These criteria will be part of the ONC Health IT Certification Program.

The new certification criteria focus on using standards-based application programming interfaces (APIs) to ensure seamless data exchange between healthcare providers, public health organizations, and payers. This will enhance public health responses and support the delivery of value-based care.

The public health-oriented certification criteria were developed with the Centers for Disease Control and Prevention (CDC) to support its Data Modernization Initiative. 

Similarly, the payer-oriented criteria were created in coordination with the Centers for Medicare & Medicaid Services (CMS) to meet the technical requirements of the CMS Interoperability and Prior Authorization final rule.

Empowering patient and provider decision-making

A significant component of the HTI-2 proposed rule is the introduction of a real-time prescription benefit tool certification criterion. 

This tool is designed to empower providers and patients with transparent information on drug costs and suitable alternatives, facilitating more informed decision-making.

Clarifying data sharing regulations

The HTI-2 proposed rule continues the ONC’s efforts to clarify regulations around data sharing. It includes updates to existing exceptions and introduces a new “Protecting Care Access” exception.

The new “Protecting Care Access” exception addresses concerns about potential legal issues if an organization decides to limit the sharing of a patient’s reproductive health information in certain situations. 

This aims to protect both patients and providers by ensuring that sensitive health information is handled appropriately while maintaining compliance with data-sharing regulations.

Strengthening governance and interoperability

The proposed rule also aims to establish governance rules for the Trusted Exchange Framework and Common Agreement (TEFCA), implementing section 4003 of the 21st Century Cures Act. 

These rules are intended to enhance the framework for secure and efficient health information exchange.

HHS Secretary Xavier Becerra emphasized the administration’s ongoing efforts to expand interoperability and transparency in electronic health information. 

“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,” Becerra stated.

Public comment period and next steps

The HTI-2 proposed rule is available for review and will be published in the Federal Register in the coming days. The public will have 60 days to submit comments and feedback on the proposed rule.

Micky Tripathi, Ph.D., National Coordinator for Health Information Technology, said that the proposed rule “is a tour de force. We have harnessed all the tools at ONC’s disposal to advance HHS-wide interoperability priorities.”

The HTI-2 rule represents a significant step forward in enhancing patient engagement, information sharing, and public health interoperability in the U.S. healthcare system.