On July 10, 2024, the Office of the National Coordinator for Health Information Technology (ONC) announced the release of the highly anticipated Health Data, Technology, and Interoperability (HTI-2) proposed rule. This game-changing proposal aims to significantly advance interoperability and improve information sharing among patients, providers, payers, and public health authorities. Let's dive into the key aspects of this transformative rule.

Expanding Certification Criteria

The HTI-2 rule introduces two new sets of certification criteria:

• Public Health IT: This will enable health IT systems used in public health to be certified under the ONC Health IT Certification Program.
• Payer IT: Similarly, health IT systems used by payers can now be certified, promoting better data exchange between healthcare stakeholders.

Both sets focus heavily on standards-based APIs to improve end-to-end interoperability.

Stakeholders Impacted by Requirements

Here are the key entities required to comply with different aspects of the rule:

• Health IT Developers: Must update their Health IT Modules to meet new rules, like USCDI v4, by January 1, 2028.
• Healthcare Providers: Need to use certified health IT that follows the new rules for sharing information.
• Public Health Agencies: Will get better public health data systems and are involved in the improvements.
• Health Plan/Payers: Must make sure their data follows FHIR standards and USCDI v4. They also need to test and validate that their APIs meet the new rules and work well in their environment.

Technology and Standards Updates

Building on the HTI-1 final rule, the proposal includes updates ranging from the capability to exchange clinical images (like X-rays) to adding multi-factor authentication support. It also requires the adoption of United States Core Data for Interoperability (USCDI) version 4 by January 1, 2028.

Information Blocking Regulations

The rule proposes adjustments to certain "exceptions" in the information blocking regulations. Notably, it introduces a new "Protecting Care Access" exception, which would cover practices an actor takes to reduce the risk of legal exposure stemming from sharing information in certain circumstances.

TEFCA Governance Rules

The proposal establishes certain Trusted Exchange Framework and Common Agreement (TEFCA) governance rules, implementing section 4003 of the 21st Century Cures Act. The requirements include things like codifying definitions of terms to clarify how the information blocking rule applies to TEFCA participants.

FHIR API Certification

The rule proposes several new API certification criteria aligned with the Centers for Medicare and Medicaid Services (CMS) requirements from the CMS Final Rule (0057) Advancing Interoperability and Improving Prior Authorization. The proposed rule would advance the certification of the following APIs required for use in 0057

• Patient Access API
• Provider Access API
• Payer-to-Payer API
• Prior Authorization API
• Provider Directory API

These APIs aim to improve the exchange of clinical, coverage, and prior authorization information.

ePrescribing and Real-Time Prescription Benefit

The rule updates ePrescribing standards and introduces a new Real-Time Prescription Benefit certification criterion. These changes will modernize electronic prescribing and improve transparency in medication costs and coverage for patients.

Bulk Data Enhancements

ONC proposes to adopt the latest version of the HL7 FHIR Bulk Data Access implementation specification, which will improve support for application developers and enable better data exports for patient cohorts.

Conclusion

The HTI-2 proposed rule is a big step forward for healthcare interoperability. By focusing on standard APIs, better data exchange, and fixing key problems in the healthcare system, ONC is making healthcare more connected, efficient, and focused on patients.

While the HTI-2 proposed rule sets new standards, smart health plans and EHR vendors should see this as a chance for innovation and standing out. Here are some key points to consider:

Better Patient Experience

• Create user-friendly interfaces that help patients access and understand their health information, like prior authorization status and real-time benefit details.
• Develop patient-facing tools using the new APIs to offer personalized health insights and advice.

Operational Efficiency

• Go beyond basic compliance to redesign workflows that make the most of the new interoperability features, potentially lowering administrative costs and boosting staff productivity.
• Invest in advanced analytics to gain insights from the increased data flow, which can improve risk assessment and care management.

Supporting Value-Based Care

• Use improved data exchange to better support value-based care initiatives, like better care coordination and tracking outcomes.

Competitive Edge

• Health plans should think about using these new capabilities to offer more attractive and personalized insurance products.
• EHR vendors should focus on creating a more open platform that easily integrates with a wide range of third-party applications.

As the industry looks at these proposed changes, there will be many discussions and feedback that will shape the final rule. Stay tuned for more updates as this important proposal moves through the process. If you’d like to discuss how this proposed rule and other policies might impact your organization, reach out to me at kim.boyd@pocp.com. Our Regulatory Resource Center Team is dedicated to policy and works collaboratively with other POCP experts to help clients with their technology and interoperability strategy, ensuring a complete view, deep understanding, and actionable strategies.