Expert Urges ONC to Strengthen FHIR Rules

Josh Mandel of Microsoft Health and SMART Health IT shared formal comments on the proposed HTI-5 rule. He urged the ONC to retain FHIR metrics, mandate Real World Testing for EHI export capabilities, and ensure AI agents have proper accessibility to patient data.

- The "HTI" rules from the Office of the National Coordinator for Health IT (ONC) aim to improve the access, exchange, and use of electronic health information. The recently finalized HTI-1 rule establishes transparency requirements for AI and algorithms used in certified health technology, requiring developers to disclose how their tools are maintained, known risks, and how they are used. A subsequent proposal, HTI-2, focuses on patient engagement, information sharing, and public health interoperability. - Real World Testing is a requirement under the ONC Health IT Certification Program designed to verify that certified health IT continues to function as intended in operational clinical settings, especially regarding interoperability and data exchange. Health IT developers must submit annual plans outlining how they will test their systems' performance in real-world scenarios, such as the successful export of a single patient's complete electronic health information (EHI) without developer assistance. - For ICU nurses transitioning to informatics, critical care experience is highly valuable as it provides a deep understanding of clinical workflows, data needs, and the high-stakes decision-making environment that health IT systems must support. This background is essential for optimizing EHRs and developing clinical decision support tools that are genuinely helpful and not a source of frustration for frontline staff. - Common complaints from nurses about EHRs include physician-centric design, excessive clicks and redundant data entry, poor mobile access, and a general sense that the systems increase their documentation burden and take time away from direct patient care. A survey of ICU nurses found that higher satisfaction with the EHR was associated with higher self-reported well-being, while dissatisfaction with the time spent on EHR tasks was linked to increased stress. - To transition into nursing informatics, an RN with a BSN can pursue the American Nurses Credentialing Center (ANCC) board certification in Informatics Nursing (NI-BC). Eligibility typically requires a combination of practice hours in informatics nursing (1,000-2,000 hours in the last 3 years) and potentially graduate-level coursework in informatics. - Epic Systems, a major EHR vendor, initially opposed federal data-sharing rules due to concerns about patient privacy and third-party apps but now supports the regulations after material improvements were made. The company is actively working to comply with ONC standards, including releasing application programming interfaces (APIs) to support the United States Core Data for Interoperability (USCDI) v3 ahead of the federal deadline. - The ONC's rules are advancing the adoption of the United States Core Data for Interoperability (USCDI), a standardized set of health data classes and elements. The HTI-1 final rule establishes USCDI v3 as the new baseline standard starting January 1, 2026, which expands the data elements available for exchange to help address health equity and disparities. - The push for greater AI transparency in the HTI-1 rule requires developers of clinical decision support tools to provide "nutrition label" style information about their algorithms. This allows clinical users to better assess the fairness, validity, and safety of the tools, a key concern in high-acuity settings like the ICU where biased or flawed algorithms could lead to patient harm.

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