Office of the National Coordinator for Health Information Technology (ONC) Issues Newsletter
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Decoding the HTI-5 Proposed Rule |
| The Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Proposed Rule aims to reduce burden on health IT developers by streamlining the ONC Health IT Certification Program (Certification Program) by removing redundant requirements, updating information blocking regulations to better promote electronic health information access, exchange, and use so that patients’ access to their data is not blocked, and advance a new foundation of AI-enabled interoperability solutions through modernized standards and certification. |
Proposed Changes to the ONC Health IT Certification Program |
| ONC proposes to remove 34 and revise 7 of the existing 60 Certification Program criteria including a revision that would reduce the scope of the § 170.315(b)(11) Decision support interventions (DSI) certification criterion to fully remove the artificial intelligence (AI) “model card” requirements. These Certification Program requirements include capabilities that are already well established in health IT products in the market, duplicative of other regulatory requirements, or impede innovation. The proposed rule additionally recommends revisions to the Assurances, Application Programming Interfaces, Attestations, Real World Testing, and Insights Conditions and Maintenance of Certification requirements. Collectively, these proposed changes are intended to reduce cost and administrative burden for health IT developers and providers. |
Strengthening the Framework for FHIR Driven Interoperability |
| The HTI 5 Proposed Rule positions ONC to reset the Certification Program’s regulatory scope and establish a stronger foundation for future Fast Healthcare Interoperability Resources® (FHIR®) based API requirements, paving the way for more creative, AI enabled interoperability solutions. While FHIR offers more flexible tools to meet emerging market needs and policy priorities, ONC acknowledges that additional development is required for certain use cases. To that effect, the Certification Program plans to prioritize FHIR based APIs that enhance automation and performance, move beyond read only interactions, and expand the availability of data that supports clinical efficiency, patient centered care, and timely reporting. |
Information Blocking |
| Several updates to existing information blocking rules have been proposed including a clarification that “access” and “use” include automated and AI driven interactions with electronic health information. They also tighten or remove elements of the Infeasibility Exception—such as eliminating the “third party seeking modification use” provision and revising or removing the “manner exception exhausted” requirement—and refine the Manner Exception to prevent its misuse in contracts that are not market rate, are adhesive, or contain unconscionable terms. Furthermore, the proposed rule recommends eliminating the TEFCA Manner Exception entirely, asserting that it is no longer necessary and may be hindering participants in the health information ecosystem. For more information on the HTI-5 Proposed Rule, please see the HTI-5 Proposed Rule Overview Fact Sheet and the HTI-5 Proposed Rule Chart of Key Provisions. |
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