Las Vegas – A new era of health data accessibility is dawning in the United States, with federal regulators signaling a firm stance against practices that hinder the seamless exchange of patient information. The Department of Health and Human Services (HHS) is preparing to enforce rules designed to prevent “information blocking,” a practice that has long been criticized for stifling innovation and potentially compromising patient care. This enforcement includes the possibility of revoking IT certifications for developers found to be obstructing data flow, a move that could have significant financial repercussions.
Dr. Thomas Keane, the Assistant Secretary for Technology Policy and National Coordinator for Health Information Technology, announced the impending actions at the 2026 HIMSS conference. The Office of the National Coordinator for Health Information Technology (ONC), under Dr. Keane’s leadership, is initiating the process of issuing notices of nonconformity to IT developers participating in the agency’s health IT certification program. This marks the first substantial enforcement effort since Congress prohibited information blocking nearly a decade ago. The move underscores a commitment to realizing the full potential of interoperability, a cornerstone of modern healthcare policy.
What is Information Blocking and Why Does it Matter?
Information blocking refers to practices by healthcare providers, health IT developers, and health information exchanges that unreasonably limit the access, exchange, or employ of electronic health information. These practices can range from outright refusal to share data to implementing technologies that make data exchange unnecessarily tricky or expensive. The 21st Century Cures Act, enacted in 2016, mandated the ONC to establish standards and certification criteria to promote interoperability and prohibit information blocking. The goal is to empower patients with greater control over their health data and to facilitate more coordinated, efficient, and effective healthcare delivery.
The implications of information blocking are far-reaching. Limited data exchange can hinder medical research, delay diagnoses, and lead to preventable medical errors. It can also create barriers to care for patients seeking second opinions or transferring between providers. It can stifle innovation in the health IT sector by preventing developers from building new tools and applications that leverage the power of shared data. The current push for enforcement reflects a growing recognition that overcoming these obstacles is crucial for improving the overall health of the nation.
Consequences for Non-Compliance: Certification Loss and Financial Penalties
The stakes for IT developers found to be engaging in information blocking are high. The ONC can revoke a developer’s health IT certification, a significant blow to their reputation and market access. Crucially, losing certification can also trigger the loss of financial incentives offered by the Centers for Medicare & Medicaid Services (CMS). These incentives, often provided to customers of certified technology, represent a substantial revenue stream for developers. The ONC is collaborating with the CMS to ensure that these incentive payments are withheld from companies found to be in violation of information blocking rules.
While the health IT certification program is voluntary, certification is often a prerequisite for participation in various federal and state programs. This creates a strong incentive for developers to comply with information blocking regulations. The HHS Office of Inspector General (OIG) has the authority to levy fines of up to $1 million per instance of information blocking, as Dr. Keane pointed out. He emphasized the broad interpretation possible under the law, stating, “What’s great about the law is it doesn’t say exactly what an instance constitutes. So, in theory, the penalties could be quite large.”
A Phased Approach to Enforcement and Corrective Action
The ONC is adopting a phased approach to enforcement, prioritizing education and collaboration before resorting to punitive measures. Developers who receive notices of nonconformity will have the opportunity to respond and present their case. If the ONC determines that a developer is not in compliance, it will work with the company to develop a corrective action plan. Certification will only be revoked as a last resort, after a vendor fails to adhere to the requirements of the corrective action plan.
This approach reflects a desire to foster a culture of compliance rather than simply imposing penalties. Dr. Keane underscored the importance of open communication and collaboration, stating, “No one — not a doctor, not a hospital, not an EHR vendor — should be able to hoard health information for their own gain. It’s bad for patients, bad for innovation, and, quite frankly, bad for business.” The emphasis on a collaborative process aims to ensure that developers understand their obligations and have the opportunity to address any shortcomings.
Understanding the Role of Dr. Thomas Keane
Dr. Thomas Keane, currently serving as the ninth National Coordinator for Health Information Technology, brings a unique blend of medical and technical expertise to his role. According to HHS.gov, he previously served as a Senior Advisor to the Deputy Secretary of HHS and was an administrator of the COVID-19 Provider Relief Fund, as well as leading the AHRQ National Nursing Home COVID Action Network. His background includes experience as a finite element software developer and enterprise software engineer before transitioning to a career in interventional radiology. This diverse experience positions him well to navigate the complex challenges of health IT interoperability.
Key Takeaways
- Increased Enforcement: The HHS is actively enforcing regulations to prevent information blocking in the health IT sector.
- Certification at Risk: IT developers found in violation of information blocking rules could lose their health IT certification.
- Financial Implications: Loss of certification can lead to the loss of CMS incentive payments for developers and their customers.
- Collaborative Approach: The ONC is prioritizing a phased enforcement approach, offering developers opportunities to correct non-compliant practices.
- Patient Empowerment: The ultimate goal is to empower patients with greater control over their health data and improve the quality of care.
The ongoing efforts to promote interoperability and prevent information blocking represent a significant step forward in modernizing the U.S. Healthcare system. By fostering a more open and collaborative exchange of health data, regulators hope to unlock new opportunities for innovation, improve patient outcomes, and create a more efficient and equitable healthcare landscape. The next key development will be the publication of detailed findings from the initial notices of nonconformity issued by the ONC, expected in the coming months. This will provide further clarity on the specific practices being targeted and the level of enforcement to be expected.
What are your thoughts on the new enforcement measures? Share your comments below, and let’s continue the conversation about the future of health data exchange.
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