卫生与公众服务部定版HTI-5健康信息技术去监管规则：预计节省逾15亿美元合规成本
华盛顿——美国卫生与公众服务部（HHS）下属的国家卫生信息技术协调员办公室（ONC）10月26日发布 HTI-5 终局规则，正式名称为《健康数据、技术与互操作性：ONC 释放繁荣的去监管行动》。HHS 表示，该规则预计可节省超过15亿美元的监管成本。
据 HHS 介绍，HTI-5 终局规则大幅减轻参加 ONC 健康信息技术认证计划的健康信息技术开发商的行政负担，使开发商能把腾出的资源用于改善患者与临床医生的使用体验。该规则与特朗普总统的第14192号行政令《通过去监管释放繁荣》和第14267号行政令《减少反竞争监管壁垒》相衔接。
卫生与公众服务部长 Robert F. Kennedy, Jr. 表示：「美国的医生和患者需要更好的技术，而不是更多来自华盛顿的文书工作。特朗普政府正在取消耗费超过15亿美元、阻碍创新的不必要监管。我们要让美国的健康技术创新者解放出来，去打造更好的工具、降低成本，并帮助医生把更多时间花在照顾患者上。」
国家卫生信息技术协调员 Tom Keane 表示：「通过 HTI-5，我们采取了果断行动，大幅降低开发商的行政合规负担，让他们能把更多时间用于开发改善互操作性、自动化水平和美国民众医疗服务的解决方案。」
HHS 表示，按照《2026年联邦监管与去监管行动统一议程》，ONC 计划继续通过改善电子健康信息的获取、交换与使用，应对慢性病、增加市场竞争并降低医疗成本。后续提案预计将通过采用标准、进一步更新认证计划以支持应用程序接口（API）的扩展用途及潜在后续技术、以及有针对性的认证条件，推进互操作性和电子健康信息共享。HHS 同时表示，公众就 HTI-5 拟议规则中信息阻断相关提案提交的意见仍在审议之中，是该部持续处理和消除信息阻断工作的一部分。
HHS Finalizes HTI-5 Health IT Deregulatory Rule Projected to Save More Than $1.5 Billion
WASHINGTON — The Office of the National Coordinator for Health Information Technology (ONC) at the U.S. Department of Health and Human Services (HHS) on October 26 released the HTI-5 final rule, formally titled Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity. The rule is projected to save more than $1.5 billion in regulatory costs.
According to HHS, the HTI-5 final rule significantly reduces administrative burdens for health IT developers participating in the ONC Health IT Certification Program, freeing resources that developers can apply toward enhancing user experiences for patients and clinicians. The rule aligns with President Trump's Executive Order 14192, Unleashing Prosperity Through Deregulation, and Executive Order 14267, Reducing Anti-Competitive Regulatory Barriers.
"American doctors and patients need better technology, not more Washington paperwork," said HHS Secretary Robert F. Kennedy, Jr. "The Trump Administration is eliminating unnecessary regulations that cost more than $1.5 billion and hold back innovation. We are freeing America's health technology innovators to build better tools, lower costs, and help doctors spend more time caring for patients."
"Through HTI-5, we have taken decisive action to significantly lower the administrative compliance burden for developers so that they can spend more of their time developing solutions that improve interoperability, automation, and better healthcare for Americans," said Tom Keane, M.D., National Coordinator for Health IT.
HHS said that, as outlined in the 2026 Unified Agenda of Federal Regulatory and Deregulatory Actions, ONC intends to continue addressing chronic disease, increasing market competition, and lowering healthcare costs by improving the access, exchange, and use of electronic health information. Future proposals are expected to advance interoperability and electronic health information sharing through standards adoption, additional updates to the Certification Program to support expanded uses of application programming interfaces (APIs) and potential successor technologies, and targeted conditions of certification. Comments submitted in response to the HTI-5 proposed rule's information blocking proposals remain under consideration as part of HHS' ongoing efforts to address and eliminate information blocking, the department said.
来源：GSM·美国（原文链接）
图片来源：图：医生在诊室使用电脑处理电子健康记录（资料图）。Shixart1985，CC BY 2.0，经维基共享资源。 / A physician using a computer for electronic health records in her office (file image). Shixart1985, CC BY 2.0, via Wikimedia Commons.
