HHS Proposes HTI-2 Rule to Expand Horizon for Interoperability

July 10, 2024
The Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule implements provision of the 21st Century Cures Act

On July 10, The U.S. Department of Health and Human Services (HHS), through the Office of the National Coordinator for Health Information Technology (ONC), released the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule for public comment.

In a press release this Wednesday, HHS explained that the “HTI-2 proposed rule has two sets of new certification criteria designed to enable health IT for public health as well as health IT for payers to be certified under the ONC Health IT Certification Program.” “These new certification criteria, which would improve public health response and advance the delivery of value-based care, focus heavily on standards-based application programming interfaces to improve end-to-end interoperability between data exchange partners,” the release stated.

In a press conference on Wednesday, Micky Tripathi, Ph.D., National Coordinator for Health Information Technology, shared, “We've been working really hard on making parts of our healthcare delivery value chain and public health value chain more and more electronic.”

“We need to be able to think of this as one health IT ecosystem because that's how healthcare happens,” Tripathi said. “It doesn't make sense for us to have silos separating public health information from provider and clinical information from payer information.”

According to Tripathi, expanding the voluntary certification requirements to include public health IT systems is one of the improvements under the draft rule. Another element is voluntary certification requirements for payer Application Programming Interfaces (APIs). Certifications require automation and electronic mechanisms for prior authorizations, Tripathi explained.

“Systems that go through that certification process will be able to interoperate with the provider organizations, as well as have standard approaches for patients to access their information,” Tripathi added. He explained that developing more advanced capabilities with APIs will allow for automated data sending for others authorized to receive patient information with Electronic Health Record (EHR) systems.

“We want to keep the industry moving forward on the best use of API-based capabilities to support everyone's needs,” Tripathi stated. “Another aspect of the Fire API work in expanding the capabilities of interoperability is supporting the scalability of Fire APIs. Fire API is now required for all certified EHR systems across the ecosystem, which covers 97 percent of hospitals and over 80 percent of ambulatory provider organizations,” Tripathi noted.

ONC is working with the Trusted Exchange Framework and Common Agreement (TEFCA) to support fire API exchange. Instead of a manual process, Tripathi said, “You can have many apps that can connect to EHR systems in a much more seamless way.”

Tripathi explained that voluntary certification requirements for the payer side of APIs and introducing requirements for EHR vendors and the provider side would address patient concerns about prior authorization. Real-time benefits checks and access to imaging are other areas that would benefit patients.

Tripathi mentioned that additional requirements related to multi-factor authentication (MFA) are proposed to address cybersecurity concerns.

“The Biden-Harris Administration has been working to expand interoperability and improve transparency when it comes to electronic health information,” said HHS Secretary Xavier Becerra in a statement, adding, “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.”

According to the press release, “The health IT for public health-oriented certification criteria were developed in tandem with the Centers for Disease Control and Prevention (CDC) to support its ongoing Data Modernization Initiative. Similarly, the health IT for payer-oriented certification criteria were developed in coordination with the Centers for Medicare & Medicaid Services (CMS) to support technical requirements included in the CMS Interoperability and Prior Authorization final rule (89 FR 8758).”

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