卫生与公众服务部向七家公司发出潜在违规函：涉非法封锁患者健康数据访问
华盛顿——卫生与公众服务部（HHS）已向七家公司发出「潜在违规」函件，指这些公司可能非法封锁了患者健康数据的访问。国家卫生信息技术协调员 Thomas Keane 上周四在新墨西哥州 Santa Fe 举行的 ADAPT 会议上披露了这一数字。
据 Nextgov 报道，Keane 没有公布收到函件的公司名称。他表示，收到函件的公司大多已对被指限制数据访问的行为作出整改，「在大多数情况下，他们会说：你说得对，我们不该这样做，我们会改变做法」。这类函件此前从未被报道过具体的发出数量。
「信息封锁」（information blocking）指妨碍患者、医疗机构等相关方获取电子健康信息的行为。2016 年底签署成法的《21 世纪治愈法案》（21st Century Cures Act）明文禁止这一做法；其后历届政府出台的配套规则规定，被认定实施信息封锁的实体每项违规最高可面临 100 万美元民事罚款。2025 年 9 月，HHS 已宣布将对非法封锁患者、医疗提供者及其他相关方信息访问的医疗实体采取「积极执法」立场。
Keane 在会上表示，其办公室正与 HHS 监察长办公室、司法部（DOJ）与联邦贸易委员会（FTC）合作执行相关规定；该办公室希望先让医疗 IT 公司及其他受监管实体理解信息封锁规则并自愿改变数据共享做法。他说：「如果不改，我们就会采取执法立场。」
与此同时，联邦医疗保险和医疗补助服务中心（CMS）正组织「问题排查」电话会，把患者、电子健康记录公司与医疗机构召集到一起，设法让患者的健康数据流动起来。CMS 副局长 Amy Gleason 表示，这类电话会迄今已举行两次，两次都成功推动了患者数据的转移。（GSM 据 Nextgov 报道）
HHS Sends Seven Potential Nonconformity Letters in Crackdown on Health Data Blocking
WASHINGTON — The Department of Health and Human Services (HHS) has issued seven letters of potential nonconformity to companies that may have illegally blocked access to health data, National Coordinator for Health Information Technology Thomas Keane said Thursday at the ADAPT conference in Santa Fe, New Mexico.
According to Nextgov, Keane did not disclose which companies received the letters. He said the companies have been able to remediate the allegations of restricted data access, and that "for the most part, folks have said, 'you know what, you're right, we shouldn't have been doing this, and we're going to change our behavior.'" The number of letters had not previously been reported.
"Information blocking" refers to practices that interfere with patients', providers' and other stakeholders' access to electronic health information. The 21st Century Cures Act, signed into law in late 2016, prohibits the practice, and later regulations spelled out penalties for entities found to have committed it, including a civil penalty of up to $1 million per violation. In September 2025, HHS said it would take an "active enforcement stance" against health care entities that illegally block access to information.
Keane told attendees his office is working with the HHS Office of Inspector General, the Department of Justice and the Federal Trade Commission to enforce the regulations, and wants health IT companies and other regulated entities to understand the rules and change their data sharing practices voluntarily. "If not, we take an enforcement posture," he said.
At the same time, the Centers for Medicare and Medicaid Services (CMS) is holding "troubleshooting calls" that bring together patients, electronic health record companies and medical providers to get patient data moving. CMS Deputy Administrator Amy Gleason said two such calls have been held so far, and both succeeded in getting patient data to move. (GSM, based on Nextgov reporting)
发布：GSM·美国（发布链接）
图片来源：图：位于华盛顿的卫生与公众服务部（HHS）总部汉弗莱大楼标识牌（2025年2月摄）。照片：G. Edward Johnson，CC BY 4.0，经维基共享资源。Photo: The sign for the U.S. Department of Health and Human Services headquarters at the Hubert H. Humphrey Building in Washington, February 2025. By G. Edward Johnson, CC BY 4.0, via Wikimedia Commons.
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