The long-awaited enforcement of regulations designed to ensure the seamless flow of health information is gaining momentum, according to Dr. Thomas Keane, the Assistant Secretary for Technology Policy and National Coordinator for Health Information Technology. For years, the promise of interoperability – the ability of different health IT systems to exchange and leverage electronic health information – has been hampered by what’s known as “information blocking.” Now, the Department of Health and Human Services (HHS) is signaling a more aggressive stance, referring potential violations to the Office of Inspector General (OIG) for investigation.
This shift marks a significant step toward realizing the goals of the 21st Century Cures Act, landmark legislation passed in 2016. The Act explicitly prohibited information blocking, aiming to empower patients, facilitate care coordination and advance medical research. But, nearly a decade after its passage, the government had yet to impose any penalties or accept concrete enforcement actions. The delay stemmed, in part, from perceived ambiguities within the Act itself, making it challenging for regulators to pursue allegations of wrongdoing. It wasn’t until 2023 that HHS finalized penalties for health IT vendors, and another year passed before punishments were announced for healthcare providers.
The issue of information blocking centers on practices by health IT developers, health information exchanges, and healthcare providers that intentionally hinder the access, exchange, or use of electronic health information. These practices can range from imposing unreasonable costs for data access to outright refusing to share information, ultimately impeding patient care and innovation. The ASTP/ONC, the agency leading this effort, views robust enforcement as critical to fostering a more connected and efficient healthcare ecosystem. The goal is to create a system where patient data flows freely and securely, enabling better-informed decisions and improved health outcomes.
Complaints Mount, Investigations Begin
The ASTP/ONC has been collecting reports of potential information blocking through a public-facing complaint portal since 2021. To date, the agency has received more than 1,500 allegations, demonstrating the widespread concern over this issue. Dr. Keane revealed during a Senate subcommittee hearing that the agency has begun sharing these complaints with the HHS’ Office of Inspector General (OIG), triggering formal investigations. The OIG, responsible for detecting and preventing fraud, waste, and abuse within HHS programs, has the authority to impose significant financial penalties and pursue legal action against violators.
The potential consequences for information blocking are substantial. For health IT developers and networks, fines can reach up to $1 million per violation. The ASTP/ONC also has the authority to terminate certifications, effectively barring companies from participating in key health IT programs. Healthcare providers found to be engaging in information blocking could face financial penalties, including the loss of Medicare payments. These measures are intended to send a clear message that information blocking will not be tolerated.
The current administration’s commitment to enforcement follows a period of increased scrutiny and warnings. Last fall, HHS signaled an impending crackdown on information blocking, pledging to deploy “all available authorities” to investigate potential violations. In February 2026, the ASTP/ONC began issuing notices to health IT developers accused of information blocking, initiating a process that could lead to corrective action plans or further investigation by the OIG. This proactive approach represents a significant departure from the previous, more passive stance.
Navigating the Complexities of the 21st Century Cures Act
The 21st Century Cures Act aimed to modernize healthcare by promoting interoperability and patient access to their own health data. However, the implementation of the Act has been complex, and the definition of “information blocking” has been subject to interpretation. The HHS initially faced challenges in pursuing enforcement actions due to the perceived vagueness of the Act’s language.
To address these concerns, HHS finalized rules in 2023 establishing specific penalties for health IT vendors and, in 2024, for healthcare providers. These rules clarified the types of actions that constitute information blocking and outlined the enforcement mechanisms available to the agency. The penalties include financial fines, certification termination, and Medicare payment adjustments. The finalized rules were published after a period of public comment and stakeholder engagement, reflecting a collaborative effort to refine the regulations.
The Role of TEFCA and National Interoperability
The push for information blocking enforcement coincides with the growing momentum of TEFCA, the Trusted Exchange Framework and Common Agreement. TEFCA is a set of standards and protocols designed to establish a national network for exchanging health information. As of February 2026, TEFCA has facilitated the exchange of nearly 500 million health records, demonstrating its potential to transform healthcare interoperability.
According to HHS, leveraging technology and artificial intelligence (AI) within TEFCA is also aimed at lowering costs and reducing administrative burdens. The success of TEFCA is inextricably linked to the enforcement of information blocking regulations. If health IT systems continue to restrict data sharing, the full benefits of TEFCA will not be realized. The ASTP/ONC views TEFCA and information blocking enforcement as complementary strategies for achieving a more connected and efficient healthcare system.
A Collaborative Approach to Compliance
Despite the potential for significant penalties, Dr. Keane emphasized that the ASTP/ONC is taking a collaborative approach to compliance. “We work with the assumption at ASTP that everybody wants to be a fine actor in the market,” he stated during the Senate hearing. When the agency identifies potential instances of information blocking, it first informs the affected parties, discusses the concerns, and offers guidance on how to correct the issues. Only if these efforts fail to resolve the problem will the agency issue a formal notice of nonconformity and refer the case to the OIG.
This approach reflects a recognition that many instances of information blocking may be unintentional or stem from misunderstandings of the regulations. By prioritizing education and collaboration, the ASTP/ONC hopes to encourage voluntary compliance and minimize the require for punitive measures. However, the agency is prepared to take strong action against those who deliberately obstruct the flow of health information.
What’s Next?
While Dr. Keane declined to comment on the status of specific cases referred to the OIG, the agency’s increased focus on enforcement is undeniable. The ASTP/ONC will continue to monitor complaints, issue notices of nonconformity, and work with the OIG to investigate potential violations. The next key checkpoint will be the release of the OIG’s findings from its ongoing investigations, which are expected in the coming months.
The Senate Health, Education, Labor and Pensions committee has expressed its support for robust enforcement, with Senator Roger Marshall (R-Kan.) stating, “I do think we need to start holding some of these companies accountable.” This bipartisan support suggests that the pressure to address information blocking will continue to mount.
The ongoing efforts to enforce information blocking regulations represent a critical step toward realizing the full potential of interoperability and transforming the American healthcare system. By ensuring that health information flows freely and securely, HHS aims to empower patients, improve care coordination, and drive innovation.
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