The HTI-2 proposed rule introduces significant updates to enhance healthcare technology and interoperability. Building on the HTI-1 final rule, HTI-2 aims to improve patient engagement and data sharing to create a more integrated, efficient, and secure health IT ecosystem. As a result, its proposed requirements accelerate critical health IT initiatives focused on advancing interoperability and data transfer efficacy amongst key healthcare stakeholders. By understanding and preparing for these changes, organizations can identify the necessary resources and functional developments needed to achieve HTI-2 compliance, reducing the risk of last-minute complications that could jeopardize their ONC health IT certified status.
Let’s explore the major developments introduced by the HTI-2 proposed rule and their implications for the healthcare industry.
Advancement of the CMS Electronic Prior Authorization Initiative
The HTI-2 proposed rule closely aligns with the Centers for Medicare & Medicaid Services (CMS) Electronic Prior Authorization (ePA) requirements, aiming to streamline the prior authorization process by promoting an electronic workflow. It enhances the ePA process by standardizing data elements, ensuring timely responses, reducing administrative burdens, and supporting advanced decision support tools. This alignment fosters a more efficient and transparent process, easing the workload on healthcare providers and accelerating patient access to necessary treatments and medications.
A critical mandate that supports this initiative is the (g)(34) requirement (effective date January 1st, 2027), which aims to streamline the prior authorization process by enabling early coverage discovery, utilizing standardized documentation templates, and integrating automated workflows into clinical practices. These efforts are designed to enhance the efficiency and transparency of managing prior authorization requests. By implementing these electronic processes, the healthcare system is expected to see substantial efficiency improvements, leading to reduced delays and better patient outcomes.
Improve Public Health Data Modernization
Marking a significant advance in public health data modernization, the HTI-2 proposed rule has established a diverse set of health IT certification criteria that support the Centers for Disease Control and Prevention’s (CDC) ongoing data modernization initiative. Some of these requirements include improved electronic case reporting, enhanced laboratory data exchange, bidirectional data exchange and support for public health analytics. By setting robust standards and certification criteria, the rule enables more efficient and accurate data exchange between public health agencies and healthcare providers. These improvements are expected to strengthen public health infrastructure, making intervention more agile and effective. This will ensure that critical health data is accessible when and where it is needed, ultimately leading to better public health outcomes and a more resilient healthcare system.
Major Updates to Technology and Standards
The HTI-2 proposed rule introduces several crucial updates aimed at enhancing interoperability and security within health IT systems. Among these updates is the ability to exchange clinical images, such as X-rays, which will significantly improve communication and collaboration among healthcare providers. The rule also requires the implementation of multi-factor authentication, a vital enhancement for strengthening the security of health information systems. The rule mandates the adoption of United States Core Data for Interoperability (USCDI) version 4 by January 1, 2028, giving the industry clear direction for long-term planning. However, developers are not required to wait until the deadline; they can implement this standard earlier through the Standards Version Advancement Process (SVAP), which allows for adoption anytime between now and 2028. This four-year window provided by the HTI-2 Proposed Rule gives developers the freedom to preemptively participate in a change that’s primed to integrate and secure their health IT environment, ultimately leading to improved care and data management efficiency.
Empower Real-Time Prescription Benefit Tools
The HTI-2 proposed rule introduces a new certification criterion for real-time prescription benefits, which could substantially boost the effectiveness of drug selection in healthcare technology. These tools empower both providers and patients by offering transparent information on drug costs, enabling them to compare patient-specific drug prices and available alternatives. This transparency facilitates more informed decision-making, allowing providers to consider cost-effective options without compromising care quality. By integrating real-time prescription benefit tools into health IT systems, the HTI-2 proposed rule seeks to elevate the overall efficiency and effectiveness of healthcare delivery, ultimately contributing to better health outcomes.
Clarifies Information Blocking Regulations
Reinforcing the ONC’s commitment to clarifying information blocking regulations, the HTI-2 proposed rule includes revisions to certain exceptions to address new scenarios identified by the regulated community. Among these updates is the “Protecting Care Access” exception, which tackles the complexities of sharing reproductive health care information. This new exception provides specific guidelines for entities that choose to limit the sharing of sensitive information, ensuring privacy concerns are adequately addressed. This proposal builds on other key steps taken by the U.S. Department of Health and Human Services (HHS) to strengthen privacy protections for patients and providers, especially those involved in lawful reproductive care. By updating existing information blocking exceptions, the HTI-2 proposed rule intends to improve privacy for both patients and providers, ensuring responsible and secure handling of health information. These changes demonstrate a commitment to protecting sensitive health data while maintaining the necessary flow of information within the healthcare ecosystem, ultimately fostering trust and compliance within the industry.
In Summary
The HTI-2 proposed rule aims to create a more efficient, secure, and patient-centered healthcare system by enhancing interoperability, security, engagement, and data sharing. These changes are designed to establish a more integrated and effective health IT ecosystem, ultimately improving care and public health response. The importance of these developments cannot be overstated, as they lay the foundation for a more connected and transparent healthcare system. Saying that, organizations must stay informed and prepare for these regulatory changes to ensure they maintain ONC compliance without losing sight of their broader enterprise goals.