Information technology (IT), or the use of devices such as computers to handle electronic data, has existed for decades, but it has only recently become accessible to many Americans in a health care context. The federal government has tasked the Office of the National Coordinator for Health Information Technology (ONC) with developing a nationwide health IT framework that is interoperable, equitable, and accessible to all Americans for the use and exchange of health information. ONC’s mission is to systemically improve the American people’s health “through the access, exchange, and use of data.” ONC is a staff division within the Office of the Secretary for the U.S. Department of Health and Human Services (HHS). Organization and Programs ONC’s activities are unified by two objectives. First, ONC endeavors to “advanc[e] the development and use of health IT capabilities.” Second, ONC strives to “establish ... expectations for data sharing.” ONC comprises two offices under an overarching Immediate Office of the National Coordinator (IO): the Office of Programs and Implementation (OPI) and the Office of Standards, Certification, and Analysis (OSCA). The IO broadly leads and advances the interoperability of health information efforts and coordinates related policies and programs across HHS and other agencies. OPI is responsible for health IT policy and rulemaking activities domestically and globally, the coordination of related efforts with stakeholders, establishment and analysis of health IT policies to promote health and human services initiatives, and support for the Health Information Technology Advisory Committee (HITAC). OSCA executes selected provisions of relevant acts, coordinates stakeholders to implement and advance nationwide interoperability for health and human services initiatives, leads the development of testing and resource tools to promote the interoperability of optimized health IT, administers the ONC Health IT Certification Program (Certification Program), and leads ONC’s technical interoperability interests and investments. Selected Focus Areas ONC broadly coordinates nationwide health IT and electronic health information (EHI) exchange efforts. ONC initiatives involve multiple ongoing endeavors, including the following key activities: Interoperability. Many of ONC’s activities center on advancing interoperability. Under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA; P.L. 114-10), interoperability is defined as the “ability of two or more health information systems or components to exchange clinical and other information and to use the information that has been exchanged using common standards as to provide access to longitudinal information for health care providers in order to facilitate coordinated care and improved patient outcomes.” Practically, interoperability means that different health ITs can “speak” with one another seamlessly. Interoperability in health care, particularly of electronic health records (EHRs), presents myriad potential benefits, including increased safety, efficacy, and personalization of clinical care, as well as enhanced accessibility to individual health information to improve the management and coordination of care. ONC organizes interoperability efforts nationwide. Trusted Exchange. ONC’s Trusted Exchange Framework and Common Agreement (TEFCA) went live in December 2023. TEFCA is an ONC initiative designed to create a baseline governance, legal, and technical framework for a nationwide, interoperable network-of-networks capable of securely and seamlessly exchanging health information. Under TEFCA, authorized health data can be shared with health care providers, patients, public health agencies, and payers. Data exchanged through TEFCA may be transmitted for multiple reasons, including facilitating treatment, payment, health care operations, public health, government benefits determination, and individual access to services. TEFCA is a voluntary initiative available to participants across the country. Certification Program. Begun in 2010, the Certification Program is an initiative under which health IT developers may voluntarily obtain certification for their health IT products. The Certification Program incentivizes conformity across EHR systems through a combination of evolving standards, implementation specifications, and certification criteria adopted by the HHS Secretary. This conformity is meant to promote interoperability through access, exchange, and use of EHI, especially through open application programming interfaces (APIs). An API is a tool that, in part, allows multiple software applications to communicate with one another and share information, regardless of how each of the applications was designed. Information Blocking. An efficient health care system relies on the sharing of EHI among authorized parties. Activities that interfere with, or are likely to interfere with, the lawful access, exchange, or use of EHI are considered information blocking under the 21st Century Cures Act (Cures Act; P.L. 114-255). Per the Cures Act, actors, including health care providers, health information networks or health information exchanges, and health IT developers of certified health IT, are forbidden from practices constituting information blocking. However, pursuant to direction in the Cures Act, ONC has, via rulemaking, identified exceptions to the information blocking prohibition. Regulated actors who commit information blocking may be subject to civil money penalties and other disincentives. Authorities The position of National Coordinator for Health Information Technology within the HHS Office of the Secretary was created by President George W. Bush via Executive Order (EO) 13335. The Office of the National Coordinator for Health Information Technology (originally ONCHIT) was then legislatively mandated under the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act; P.L. 111-5) to promote the creation of a national health IT infrastructure capable of electronic data use and exchange. Much of ONC’s duties and related authorities are outlined under Title XXX of the Public Health Service Act (PHSA, as amended; 42 U.S.C. §§300jj-300jj-52), as originally added by the HITECH Act. ONC’s duties were further augmented and amended by the Medicare Access and CHIP Reauthorization Act (MACRA; P.L. 114-10) in 2015 and the Cures Act in 2016. Under MACRA, ONC was delegated the task of promoting EHR system interoperability. Under the Cures Act, key ONC initiatives and powers were authorized, including conditions and maintenance of certification requirements for the Certification Program, the creation of TEFCA, the formation of HITAC, and the identification of reasonable and necessary activities not constituting information blocking. In response to the COVID-19 pandemic, ONC was charged under President Biden’s Executive Order 13994, issued on January 21, 2021, with advising the HHS Secretary on gaps in public health information systems. (EO 13994 was later rescinded by President Trump under EO 14236 on March 14, 2025.) In July 2024, HHS was reorganized and ONC’s authority was expanded to include technology, data, and artificial intelligence (AI) policy and strategy oversight for the department; this expansion also resulted in the renaming of ONC to the Assistant Secretary for Technology Policy (ASTP)/ONC. This reorganization was later reversed in April 2026, at which time the staff division reverted to ONC and resumed its narrower focus on nationwide health IT interoperability and data liquidity through health IT policy, standards, and certification. A concomitant press release noted that ONC will continue to lead coordination regarding AI use in clinical care. Regulations ONC administers many regulations, sometimes in conjunction with the Centers for Medicare & Medicaid Services (CMS). Most of ONC’s regulations address topics such as interoperability, information blocking, and the Certification Program. Among the primary regulations ONC implements are its Cures Act Final Rule, as well as an ongoing series of final rules under the title Health Data, Technology, and Interoperability (HTI). The HTI rules address topics related to the Certification Program, algorithmic (including AI) transparency, information sharing, patient engagement, and public health interoperability, among others. Selected Policy Considerations Information Blocking In a July 2026 data report, ONC reported receiving 2,279 possible claims of information blocking to its Report Information Blocking Portal (Portal) since April 5, 2021. Reasons for continued information blocking, despite heightened ONC enforcement efforts, may in part reflect a lack of stakeholder understanding regarding how information-blocking measures interface with other regulations. Data also indicate that cases of perceived information blocking may be underreported by those experiencing it. ONC has noted ongoing work to encourage such reporting and educate the public about what constitutes information blocking. In past budget materials, ONC has requested that HHS be authorized to create an advisory opinion process to issue binding opinions to actors about whether a specific action, if undertaken, would constitute information blocking. TEFCA Because TEFCA is meant to function as a network-of-networks and is voluntary to join, its success hinges in large part on the number of parties who choose to participate. ONC has stated that current barriers to TEFCA include a lack of trust amongst participants and transparency in oversight. ONC recently announced steps to strengthen TEFCA oversight by contracting with Alliance Global Tech, Inc. (AGT), for audit, review, and compliance support services. Additionally, recent survey data indicate that some parties remain unaware of TEFCA, including 13% of nonfederal acute care hospitals surveyed in 2025. To bolster TEFCA participation, ONC previously suggested that technical assistance and grants may enable uncommitted parties to join and make ongoing investments in the initiative. Certification Program Given the rapid nature of health IT development, ONC has expressed an ongoing interest in modernizing the Certification Program. It has in part endeavored to do so through deregulatory action, including via the HTI-5 Proposed Rule issued in December 2025. This proposed rule would, in part, remove or revise over half of the current certification criteria under the Certification Program, including those related to privacy, security, and AI transparency. ONC writes that such revisions would decrease burden and costs and better support health IT innovation. While stakeholders are generally supportive of modernization and burden reduction, some are concerned that deregulation is premature and suggest retaining current certification criteria, especially those related to privacy, security, and AI transparency. Depending on the portions of HTI-5 finalized, some stakeholders have requested that ONC conduct impact assessments for removed or revised certification criteria to ensure deregulation has its intended effect.
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