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HHS Confirms Active Enforcement of Information Blocking Rules
At a Thursday hearing, the Senate Health, Education, Labor and Pensions (HELP) Committee heard testimony from Thomas Keane, M.D., M.B.A., Assistant Secretary for Technology Policy and National Coordinator for Health Information Technology (ASTP/ONC) on the HHS’s efforts to make improvements in health and care through the access, exchange, and use of data.
“My top priority is fostering greater data liquidity in the U.S. health care system so that patients and their clinicians are in the driver’s seat. I see how modern data standards, combined with artificial intelligence (AI), can make health care more affordable, accessible, and can support improved health outcomes,” explained Keane.
It has been a decade since the 21st Century Cures Act was enacted in 2016. Key provisions of the act have been implemented, such as the establishment of the Trusted Exchange Framework and Common Agreement (TEFCA) for nationwide health information exchange across health information networks. TEFCA Exchange began in earnest in January 2024, and 11 Qualified Health Information Networks have now signed up and been vetted to facilitate data exchange. More than 70,000 locations nationwide are connected, and the exchange of more than 400 million health records is now supported. While TEFCA has yet to reach its full potential, when that happens, a healthcare provider will be able to access a patient’s full health history, regardless of the electronic health record system where that information is stored.
While the technology exists to support the seamless exchange of health data, information does not always flow unimpeded. At the hearing, HELP Committee members expressed frustration that health data is being blocked by healthcare providers, developers of certified health IT, and health information networks and exchanges. The 21st Century Cures Act prohibited information blocking; however, it took until 2023 to finalize the financial penalties for developers of health IT, and another year to finalize the financial penalties for healthcare providers, and penalties have yet to be imposed for information blocking.
At the hearing, Keane confirmed that the federal government is taking action against entities engaged in information blocking. Since the HHS launched its information blocking complaint portal, more than 1,500 complaints have been filed alleging information blocking, the majority of which were filed by patients. Keane confirmed that ASTP/ONC has started actively enforcing its information blocking rules. A major enforcement initiative was launched in September 2025, targeting noncompliance, which allocated additional resources to support investigations and hold entities accountable for blocking the sharing of electronic health information. In the Fall of last year, the HHS warned developers, providers, and health information exchanges that it announced that it would start cracking down on information blocking.
Since then, ASTP/ONC has been working closely with the HHS Office of Inspector General to ensure that bad actors face meaningful consequences for information blocking, and in February this year, ASTP/ONC sent notices to developers of certified health IT about potential non-conformity under the ONC Health IT Certification Program, requesting information and explanations about non-conformity issues. Should information blocking be confirmed, health IT developers could face penalties of up to $1 million per violation, while providers could be prevented from receiving Medicare payments.
Keane explained that ASTP/ONC is collaborating with the Federal Trade Commission (FTC), Department of Justice (DoJ), and state governments to identify potential anti-competitive business practices and other practices that are preventing the seamless exchange of health information. ASTP/ONC is also continuing to work with providers, health information networks, and health IT developers to improve understanding of what constitutes information blocking and the steps they must take to ensure compliance with the law.
“In [the] not-so-distant future, an individual with multiple chronic conditions can keep all their health information in one secure digital place and share it instantly with a new provider, a caregiver, or a trusted app—no matter where they live or where they receive care,” Keane said.
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