Monday, July 15, 2024

Public Health Interoperability Enhanced by HHS Proposal of HTI-2 Rule for Improved Patient Engagement and Information Sharing

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Public health interoperability is at the forefront as the U.S. Department of Health and Human Services (HHS), through the Office of the National Coordinator for Health Information Technology (ONC), has released the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule for public comment. This HTI-2 proposed rule is designed to advance interoperability and enhance information sharing among patients, healthcare providers, payers, and public health authorities.

HHS Secretary Xavier Becerra emphasized the Biden-Harris Administration’s commitment to expanding interoperability and improving transparency in electronic health information. He stated, “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.”

Public Health Interoperability Prioritized in HTI-2 Rule, Says National Coordinator Micky Tripathi

Micky Tripathi, Ph.D., the national coordinator for health information technology, called the HTI-2 proposed rule a comprehensive effort to advance HHS-wide interoperability priorities. He expressed eagerness to review public comments and engage with the health IT community in the forthcoming months.

The HTI-2 proposed rule introduces two groundbreaking sets of new certification criteria. These criteria are designed to enable health IT for public health and health IT for payers to be certified under the ONC Health IT Certification Program. These criteria focus heavily on standards-based application programming interfaces (APIs) to improve end-to-end interoperability between data exchange partners, such as healthcare providers, public health organizations, and payers.

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

Additionally, the HTI-2 proposed rule includes several technology and standards updates building on the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule published in January 2024. These updates range from the capability to exchange clinical images (e.g., X-rays) to the addition of multi-factor authentication support.

Public Health

Public Health Enhanced by HTI-2 Rule: USCDI Version 4 Adoption and New Real-Time Prescription Benefit Tool Proposed

The rule also proposes requiring the adoption of United States Core Data for Interoperability (USCDI) version 4 by January 1, 2028, to provide industry longer-term planning clarity. Moreover, the rule proposes implementing section 119(b)(3) of the Consolidated Appropriations Act, 2021 by including a new, real-time prescription benefit tool certification criterion. This tool would empower providers and patients to make more informed decisions by comparing patient-specific drug costs and suitable alternatives.

ONC’s commitment to further clarifying the information blocking regulations continues with the HTI-2 proposed rule. It includes revisions to certain information blocking “exceptions” to address additional scenarios recently identified by the regulated community. The rule also proposes a new “Protecting Care Access” information blocking exception, addressing concerns about potential information blocking consequences if an entity chooses to limit sharing a patient’s reproductive health care information in certain circumstances. This proposal builds on other key steps HHS has taken to strengthen patient and provider privacy, especially for those seeking or providing lawful reproductive care.

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The HTI-2 proposed rule also includes the establishment of certain Trusted Exchange Framework and Common Agreement™ (TEFCA™) governance rules, which implement section 4003 of the 21st Century Cures Act. These governance rules aim to ensure standardized and secure exchange of health information across different networks, enhancing the interoperability framework in the healthcare system.

In conclusion, the HTI-2 proposed rule by HHS marks a significant step toward enhancing public health interoperability, patient engagement, and information sharing. By introducing new certification criteria, technology updates, and clarifying information blocking regulations, the proposed rule aims to create a more integrated, efficient, and transparent healthcare system.

The HHS and ONC’s efforts reflect a commitment to leveraging technology to improve patient care and ensure that healthcare providers have the tools they need to operate effectively in a rapidly evolving digital landscape. Public comments and engagement with the health IT community will be crucial in refining and implementing these proposals to achieve the desired outcomes in health data interoperability and patient care.


Resource: Health and Human Services, July 10, 2024

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