The Office of the National Coordinator for Health Information Technology (ONC)
March 17, 2023
The Office of the National Coordinator for Health Information
Technology (ONC)
Information technology (IT), or the use of devices like
Trusted Exchange. In January 2022, ONC published the
computers for the handling of electronic data, has existed
first versions of its Trusted Exchange Framework and
for decades, but has only recently become accessible to
Common Agreement (TEFCA), documents meant to
many Americans in a health care context. The federal
establish minimum acceptable interoperability standards.
government has tasked the Office of the National
Specifically, the Common Agreement delineates
Coordinator for Health Information Technology (ONC)
infrastructure and governing approaches for basic
with developing a framework for and implementing
information sharing across all health networks. In turn, the
widespread adoption of information technology in health
Trusted Exchange Framework enumerates aspirational
care to create an interoperable, equitable, and accessible
principles for trust policies and practices across health
system for all Americans. ONC’s mission is to systemically
information networks.
improve the American people’s health “through the access,
exchange, and use of data.” ONC is a staff division within
United States Core Data for Interoperability (USCDI).
the Office of the Secretary for the Department of Health
The USCDI is “a standardized set of health data classes and
and Human Services (HHS).
constituent data elements for nationwide, interoperable
health information exchange.” Required data include
Organization and Programs
clinical notes, allergies and intolerances, laboratory results,
All of ONC’s organizational efforts are unified by two
and medications. Adhering to the USCDI is a mandatory
objectives. First, ONC endeavors to “[a]dvanc[e] the
condition for health IT stakeholders seeking certification
development and use of health IT capabilities.” Second,
under the ONC Health IT Certification Program. The third
ONC strives to “[e]stablish ... expectations for data
version of the USCDI was released in January of 2022, with
sharing.” ONC comprises four offices: the Immediate
a fourth version expected in July 2023.
Office of the National Coordinator (Immediate Office), the
Office of the Chief Operating Officer, the Office of Policy,
ONC Health IT Certification Program (Certification
and the Office of Technology. The Immediate Office and
Program). Begun in 2010, the Certification Program is an
the Office of the Chief Operating Officer lead agency-wide
initiative under which health IT developers may voluntarily
support through leadership, management, and advisory
obtain health IT certification. The Certification Program
activities. The Office of Policy is responsible for
incentivizes baseline conformity across electronic health
developing policies in accordance with pertinent statutes
record (EHR) systems through a combination of evolving
and executive orders. The Office of Technology provides
standards, implementation specifications, and certification
coordination, and technical and program support.
criteria issued by the HHS Secretary. This conformity is
meant to promote interoperability through access,
Focus Areas
exchange, and use of electronic health information (EHI),
ONC offices broadly conduct activities related to health IT
especially through the use of open application programming
standards, certification, and exchange. Across these ONC
interfaces (APIs).
efforts, there are multiple ongoing key activities:
Information Blocking. The expectation in health care is
Interoperability. Advancing interoperability is at the core
that EHI be shared amongst authorized parties. When an
of many of ONC’s activities. According to the Healthcare
actor engages in activities that interfere with, or are likely
Information and Management Systems Society,
to interfere with, the access, exchange, or use of EHI, this is
interoperability is defined as the “ability of different
considered information blocking under the Final Rule
information systems, devices and applications (systems) to
promulgated under the 21st Century Cures Act (Cures Act;
access, exchange, integrate and cooperatively use data in a
P.L. 114-255). Per this rule, actors, including health care
coordinated manner, within and across organizational,
providers, health information networks or health
regional and national boundaries, to provide timely and
information exchanges, and health IT developers of
seamless portability of information and optimize the health
certified health IT, are forbidden from practices constituting
of individuals.” Interoperability in health care presents
information blocking. ONC has, however, identified eight
myriad potential benefits, including increasing clinical
exceptions to the information blocking prohibition.
safety, promoting health equity, and speeding public health
Regulated actors who violate the information blocking rule
emergency responses. ONC organizes interoperability
may be subject to civil monetary penalties.
efforts nationwide.
Health Information Exchange (HIE). Through its
standards work, ONC promotes electronic HIE, allowing
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The Office of the National Coordinator for Health Information Technology (ONC)
for the secure exchange of appropriate health information
Interoperability and Patient Access Final Rule (85 Federal
between individuals, caregivers, and clinicians. HIE is vital
Register 25510, 2020). Notably, under the Cures Act Final
to interoperability and can reduce medical errors and costs
Rule, ONC implemented information blocking provisions
related to readmissions, incorrect prescriptions,
and specified eight exceptions to information blocking. In
misdiagnoses, and duplicative testing. There are presently
turn, under CMS’s final rule, ONC is responsible for aiding
three primary modes of HIE: directed, query-based, and
CMS in the implementation of foundational interoperability
consumer mediated.
standards to better protect patient privacy and security.
Health Information Technology Advisory Committee
Funding
(HITAC). Established by the Cures Act and subject to the
From FY2009 through FY2023, ONC has been funded by
Federal Advisory Committee Act, HITAC is an ONC
the Labor, Health and Human Services, Education, and
advisory body that recommends policies, standards,
Related Agencies Appropriations Act, either via annual
implementation specifications, and certification criteria to
discretionary appropriations or directed transfers. (In
the National Coordinator for Health Information
FY2020 and FY2021, ONC received additional funds from
Technology. HITAC concentrates its efforts on design and
the Coronavirus Aid, Relief, and Economic Security Act
use of technologies that advance health equity and support
[CARES Act; P.L. 116-136], American Rescue Plan Act
public health, interoperability, privacy and security, and
[P.L. 117-7], and Consolidated Appropriations Act [CAA],
patient access to information. HITAC has contained
2021 [P.L. 116-260].) Annual funding for ONC between
numerous task forces and workgroups, organized as
FY2014 and FY2023 has ranged between roughly $60
subcommittees, since its inception. HITAC builds upon,
million and $66 million per year. In FY2024, the
and has replaced, two committees that existed prior to the
President’s budget request for ONC is $104 million. This
enactment of the Cures Act.
proposed increase is to enable ONC to build upon previous
digital advancements and focus on continued progress in
Authorities
policy development, standards, certification, and
The position of National Coordinator for Health
interoperability.
Information Technology within the HHS Office of the
Secretary was created by President George W. Bush via
Select Policy Considerations
Executive Order 13335. The Office of the National
Coordinator for Health Information Technology (originally
Determination of Information Blocking Practices
ONCHIT) was then legislatively mandated under the Health
What precisely constitutes information blocking is often
Information Technology for Economic and Clinical Health
difficult to discern; in guidance, ONC has stated it will
Act of 2009 (HITECH Act; P.L. 111-5) to promote the
approach events on a case-by-case basis. In its FY2023
creation of a national health information technology
budget materials, ONC requested HHS authorize the
infrastructure capable of electronic data use and exchange.
creation of an advisory opinion process capable of issuing
Much of ONC’s duties and related authorities are outlined
binding opinions to requestors about whether a specific
under Title XXX of the Public Health Service Act (PHSA,
practice may violate information blocking provisions.
as amended) [42 U.S.C. §300jj et. seq.], as originally added
by the HITECH Act.
Balancing Access with Safety
The information blocking rule has created controversy
ONC’s duties were further augmented and amended by the
amongst stakeholders regarding rapid patient access to
Medicare Access and CHIP Reauthorization Act (MACRA;
potentially distressing health information without
P.L. 1114-10) in 2015 and the Cures Act in 2016. Under
contextual and interpretive information. Some physicians
MACRA, ONC was delegated the task of promoting EHR
argue that exceptions to the rule are too narrow, and that
system interoperability. Under the Cures Act, key ONC
doctors may be required to divulge test results before being
initiatives and powers were authorized, including
able to provide context to patients. Conversely, HHS
conditions of maintenance and certification for the HIT
counters that instant access to test results empowers
certification program, the creation of TEFCA, the formation
patients.
of HITAC, and identifying reasonable and necessary
activities not constituting information blocking. Most
Interoperability Shortcomings and COVID-19
recently, in response to the COVID-19 pandemic, ONC was
COVID-19 highlighted the importance of rapid information
charged under President Joseph R. Biden, Jr.’s Executive
exchange between public health entities and clinics. It also
Order 13994, published on January 21, 2021, with advising
revealed current gaps in interoperability. ONC has been
the HHS Secretary on gaps in public health information
working with the Centers for Disease Control and
systems.
Prevention (CDC) to advance public health data
interoperability through the Data Modernization Initiative,
Regulations
among other efforts. Congress has encouraged ONC to
ONC administers many regulations, sometimes in
collaborate with state-based health data utilities to better
conjunction with the Centers for Medicare & Medicaid
prepare for future public health threats (H.Rept. 117-96).
Services (CMS). Most of ONC’s regulations address topics
including meaningful use, interoperability, information
Nora Wells, Analyst in Health Policy
blocking, and the Certification Program. Among the
primary regulations ONC enforces are its Cures Act Final
IF12352
Rule (85 Federal Register 25642, 2020), as well as CMS’s
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The Office of the National Coordinator for Health Information Technology (ONC)
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