Proposed Rule2026-01866
Request for Information: Diagnostic Imaging Interoperability Standards and Certification
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Published
January 30, 2026
Issuing agencies
Health and Human Services Department
Abstract
This request for information (RFI) seeks input from the public regarding the potential adoption of diagnostic imaging technical standards and certification criteria for health information technology (IT) under the ONC Health IT Certification Program (Certification Program) to better enable the access, exchange, and use of diagnostic images by health care providers and patients. Responses to this RFI will be used to inform potential future rulemaking.
Full Text
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<title>Federal Register, Volume 91 Issue 20 (Friday, January 30, 2026)</title>
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[Federal Register Volume 91, Number 20 (Friday, January 30, 2026)]
[Proposed Rules]
[Pages 4054-4057]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-01866]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Part 170
RIN 0955-AA11
Request for Information: Diagnostic Imaging Interoperability
Standards and Certification
AGENCY: Assistant Secretary for Technology Policy (ASTP)/Office of the
National Coordinator for Health Information Technology (ONC)
(collectively, ASTP/ONC), Department of Health and Human Services
(HHS).
ACTION: Request for information.
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SUMMARY: This request for information (RFI) seeks input from the public
regarding the potential adoption of diagnostic imaging technical
standards and certification criteria for health information technology
(IT) under the ONC Health IT Certification Program (Certification
Program) to better enable the access, exchange, and use of diagnostic
images by health care providers and patients. Responses to this RFI
will be used to inform potential future rulemaking.
DATES: To be assured consideration, written or electronic comments must
be received at one of the addresses provided below, by March 16, 2026.
ADDRESSES: You may submit comments, identified by RIN 0955-AA11, by any
of the following methods (please do not submit duplicate comments).
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
<bullet> Federal eRulemaking Portal: Follow the instructions for
submitting comments. Attachments should be in Microsoft Word, Microsoft
Excel, or Adobe PDF; however, we prefer Microsoft Word. <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
<bullet> Regular, Express, or Overnight Mail: Department of Health
and Human Services, Assistant Secretary for Technology Policy/Office of
the National Coordinator for Health Information Technology, Attention:
Request for Information: Diagnostic Imaging Interoperability Standards
and Certification, Mary E. Switzer Building, Mail Stop: 7033A, 330 C
Street SW, Washington, DC 20201. Please submit one original and two
copies.
<bullet> Hand Delivery or Courier: Assistant Secretary for
Technology Policy/Office of the National Coordinator for Health
Information Technology, Attention: Request for Information: Diagnostic
Imaging Interoperability Standards and Certification, Mary E. Switzer
Building, Mail Stop: 7033A, 330 C Street SW, Washington, DC 20201.
Please submit one original and two copies. (Because access to the
interior of the Mary E. Switzer Building is not readily available to
persons without federal government identification, commenters are
encouraged to leave their comments in the mail drop slots located in
the main lobby of the building.)
Inspection of Public Comments: All comments received before the
close of the comment period will be available for public inspection,
including any personally identifiable or confidential business
information that is included in a comment. Please do not include
anything in your comment submission that you do not wish to share with
the general public. Such information includes, but is not limited to: a
person's social security number; date of birth; driver's license
number; state identification number or foreign country equivalent;
passport number; financial account number; credit or debit card number;
any personal health information; or any business information that could
be considered proprietary. We will post comments that are received
before the close of the comment period at <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Docket: For access to the docket to read background documents or
comments received, go to <a href="http://www.regulations.gov">http://www.regulations.gov</a> or the Department
of Health and Human Services, Assistant Secretary for Technology
Policy/Office of the National Coordinator for Health Information
Technology, Mary E. Switzer Building, Mail Stop: 7033A, 330 C Street
SW, Washington, DC 20201 (call ahead to the contact listed below to
arrange for inspection).
FOR FURTHER INFORMATION CONTACT: Michael Lipinski, Office of Policy,
Assistant Secretary for Technology Policy/Office of the National
Coordinator for Health Information Technology, 202-690-7151.
SUPPLEMENTARY INFORMATION:
I. Purpose
Diagnostic images, including, but not limited to, radiographic,
photographic, and video images produced by light, radiation, sound
waves, or magnetic resonance, are critical to supporting care in a
variety of health care settings and are routinely used by health care
providers to help determine a patient's course of treatment.\1\
Diagnostic images are often stored in systems external to an electronic
health record (EHR),\2\ such as picture archiving and communication
systems (PACS), vendor neutral archives (VNAs), and other imaging
platforms. While health care providers (e.g., radiologists,
ophthalmologists, dermatologists, and pathologists) who work within the
same organization generally have direct access to the
[[Page 4055]]
diagnostic images obtained by the organization, access to such images
by health care providers from outside the organization can be
nonexistent, inconsistent, and highly dependent on several technical,
operational, and organizational factors. In some cases, organizations'
vendors use proprietary formats that impede exchange and external
access by ``outside'' providers. In other cases, outside providers are
denied access to full-resolution Digital Imaging and Communications in
Medicine[supreg] (DICOM[supreg]) files, and are instead given access to
low resolution, incomplete, or inferior (e.g., encapsulated PDF) images
through web-based viewers. They may also be denied access to prior
imaging studies. In addition, originating organizations frequently
refuse to securely electronically transmit diagnostic images despite
the source organization's technical capability to do so. Ultimately,
the burden to ``exchange'' these images is placed on the patient or
their caregiver. In such instances, patients too are often unable to
access their own imaging directly or with a patient-facing application
(app). Consequently, patients and their caregivers are left to carry
around physical media (e.g., CDs and DVDs), or printed images and
reports, from provider to provider. These outcomes are far from ideal,
particularly due to the quality of the images and even sometimes due to
the lack of provider hardware to view the images stored on CDs and
DVDs.
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\1\ For purposes of this RFI, ``treatment'' generally means the
provision, coordination, or management of health care and related
services among health care providers or by a health care provider
with a third party, consultation between health care providers
regarding a patient, or the referral of a patient from one health
care provider to another. See 45 CFR 164.501.
\2\ For purposes of this RFI, an electronic health record (EHR)
generally means health IT certified under the Certification Program
that would meet the criteria of the Qualified EHR definition (42
U.S.C. 300jj).
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Enhanced access to diagnostic images can improve care and health
outcomes, decrease the need for duplicative imaging tests, and reduce
costs within the United States (U.S.) health care system. Therefore, we
seek comments on whether the adoption of technical standards and/or
certification criteria for health IT would improve the access,
exchange, and use of diagnostic images for both providers and patients.
II. Regulatory Background
On March 7, 2012, the Secretary of HHS issued a proposed rule with
request for comments titled ``Health Information Technology: Standards,
Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology, 2014 Edition; Revisions to the
Permanent Certification Program for Health Information Technology'' (77
FR 13832) (2014 Edition Proposed Rule), which proposed new and revised
standards, implementation specifications, and certification criteria.
In the 2014 Edition Proposed Rule, we proposed certification to the
2014 Edition ``imaging'' certification criterion (Sec. 170.314(a)(12))
without use of the DICOM standard but requested comments on using the
standard (77 FR 13838). We also proposed to require EHR technology that
would be certified to the 2014 Edition ``view, download, and transmit
to 3rd party'' (VDT) certification criterion (Sec. 170.314(e)(1)) to
be capable of enabling images formatted according to the DICOM standard
to be downloaded and transmitted to a third party (77 FR 13839 and
13840).
On September 4, 2012, the Secretary published a final rule titled
``Health Information Technology: Standards, Implementation
Specifications, and Certification Criteria for Electronic Health Record
Technology, 2014 Edition; Revisions to the Permanent Certification
Program for Health Information Technology'' (77 FR 54163) (2014 Edition
Final Rule). In the 2014 Edition Final Rule, we adopted an ``image
results'' certification criterion (without the DICOM standard) to
support the Medicare and Medicaid EHR Incentive Programs (now referred
to as the Medicare Promoting Interoperability Program and the Merit-
based Incentive Payment System Promoting Interoperability performance
category) requirement, also known as the Meaningful Use or ``MU Stage 2
Objective'' requirement. The MU Stage 2 Objective required eligible
clinicians, hospitals, and critical access hospitals to have access to
imaging results and information through Certified EHR Technology (77 FR
54172 and 54173). The associated MU Stage 2 Objective certification
criterion required a Health IT Module to be capable of indicating the
availability of a patient's images and narrative interpretations and
enable access to those images and narrative interpretations. We stated
that the requirements of the certification criterion could be met via
the capability to directly link to images stored in the EHR system or
by providing a context-sensitive link to an external application which
provided access to images and their related narrative. We also stated
in the 2014 Edition Final Rule that the use of the DICOM standard (or
any other imaging standards) was unnecessary to meet the functional
requirement expressed in the image results certification criterion (77
FR 54172 and 54173). Instead, we reiterated our understanding, stated
in the 2014 Edition Proposed Rule, that the adoption of standards was
unnecessary to enable users to electronically access images and their
narrative interpretations, as required by this certification criterion
(77 FR 13838). Further, in the 2014 Edition Final Rule, after
considering the comments received and the complexity and potential
burden identified by commenters, we removed the requirement that images
be made available for download and transmission to a third party as
part of the VDT certification criterion (77 FR 54183).
On February 26, 2014, the Secretary published a proposed rule
titled ``Voluntary 2015 Edition Electronic Health Record (EHR)
Certification Criteria; Interoperability Updates and Regulatory
Improvements'' (79 FR 10880) (Voluntary Edition Proposed Rule). The
proposed rule proposed a voluntary edition of certification criteria
that was designed to enhance interoperability, promote innovation, and
incorporate ``bug fixes'' to improve upon the 2014 Edition (79 FR
10880). In the proposed rule, we contemplated improvements that could
be made to the VDT certification criterion in Sec. 170.314(e)(1) for
the ``2017 Edition'' (79 FR 10907). We requested public comments on
whether we should again propose (in the future) to require that images
be part of this certification criterion. More specifically, we
requested comment on: (1) whether images for patients need to be of
diagnostic quality; (2) whether they should be viewable and
downloadable, but not required to be transmitted; and (3) whether
cloud-based technology could allow for a link to the image to be made
accessible (79 FR 10907). On September 11, 2014, a final rule was
published titled ``2014 Edition Release 2 Electronic Health Record
(EHR) Certification Criteria and the ONC HIT Certification Program;
Regulatory Flexibilities, Improvements, and Enhanced Health Information
Exchange'' (79 FR 54430) (2014 Edition Release 2 Final Rule), which did
not include any updates to the VDT certification criterion related to
diagnostic imaging (79 FR 54439 and 54465).
On March 30, 2015, the Secretary of HHS published a proposed rule
titled ``2015 Edition Health Information Technology (Health IT)
Certification Criteria, 2015 Edition Base Electronic Health Record
(EHR) Definition, and ONC Health IT Certification Program
Modifications'' (80 FR 16804) (2015 Edition Proposed Rule). In the 2015
Edition Proposed Rule, we proposed to maintain the image results
certification criterion (80 FR 16822). While some commenters supported
this proposal, we ultimately removed the image results certification
criterion in the 2015 Edition Final Rule (80 FR 62602), published
October 16, 2015, because the associated CMS EHR Incentive Programs
[[Page 4056]]
objective (now referred to as Promoting Interoperability objectives)
was removed and no longer required technological support (80 FR 62683).
On August 5, 2024, we published a proposed rule titled ``Health
Data, Technology, and Interoperability: Patient Engagement, Information
Sharing, and Public Health Interoperability'' (89 FR 63498) (HTI-2
Proposed Rule) to revise the certification criteria adopted in Sec.
170.315(b)(1), (e)(1), (g)(9), and (g)(10) to include new certification
requirements to support access, exchange, and use of diagnostic images
via imaging links. On December 29, 2025, the Secretary published a
withdrawal notice titled ``Health Data, Technology, and
Interoperability: Patient Engagement, Information Sharing, and Public
Health Interoperability; Withdrawal'' (90 FR 60602) (HTI-2 Proposed
Rule Withdrawal Notice) to withdraw the remaining proposals that were
not finalized from the HTI-2 Proposed Rule, including our proposed
revisions to the certification criteria adopted in Sec. 170.315(b)(1),
(e)(1), (g)(9), and (g)(10).
ASTP/ONC's joint Request for Information (RFI) with the Centers for
Medicare & Medicaid Services (CMS) (90 FR 21034), published May 16,
2025, sought input from the public regarding the market of digital
health products for Medicare beneficiaries as well as the state of data
interoperability and broader health technology infrastructure.
Responses to the RFI covered a broad range of topics, including ways to
increase patient access to effective digital capabilities needed to
inform health decisions and increase data availability for health care
providers and patients. Among these comments were the identification of
challenges specific to the access, exchange, and use of diagnostic
images, including: (1) a fragmented ecosystem where diagnostic image
exchange is manual, burdensome, and unreliable; (2) continued reliance
on physical media (such as CDs and DVDs), which is generally
inefficient, not secure, and presents barriers to timely care; and (3)
lack of patient access to their own diagnostic images through modern,
application programming interface (API)-driven tools.
III. Solicitation of Public Comments
The access, exchange, and use of diagnostic images is crucial for
timely and accurate diagnosis, leading to better patient outcomes and
lower treatment costs. As we evaluate the best and least burdensome
ways to support the access, exchange, and use of electronic health
information (EHI), including diagnostic images, through the adoption of
standards and the certification of health IT under the Certification
Program, we invite public comment to help us further explore how we can
achieve these goals for the purpose of accessing, exchanging, and using
diagnostic images.
We encourage interested parties to share their responses for as
many of the questions below as possible. The questions are not intended
for a specific audience but are meant to solicit feedback from multiple
individuals and groups. To aid in our understanding of submitted
responses, please prioritize clarity and conciseness and annotate your
responses with question label(s) (for example, PM-1).
A. Transition From Physical Media to Electronic Access, Exchange, and
Use
We acknowledge there are certain outlying use cases and
circumstances where access via physical media may be more appropriate
than internet-based access to diagnostic images (e.g., locations with
inadequate internet capabilities). However, we believe the health care
ecosystem's continued default to physical media and the slow shift from
this practice is due to a combination of limited investment in image
exchange standards, business practices that silo images within systems,
and a lack of policy drivers to reinforce a shift to electronic access
and exchange of diagnostic images.
Ultimately, the status quo creates a perfect storm of
administrative burden, unnecessary costs, and uncoordinated care for
providers and patients alike. For example, health care providers often
rely on imaging to evaluate how well treatments are working. When a
health care provider assumes the care of a new patient, access to prior
imaging from outside facilities is a key component for accurate
treatment planning. However, patients may not always have physical
media (e.g., CDs and DVDs) or access to online diagnostic images to
share with their providers. In time-sensitive situations, this lack of
access may result in delayed or inappropriate treatment or unnecessary
health care costs through duplicative testing.
PM-1. What barriers do patients experience with electronic access
to diagnostic images? Are there examples today where patients can
successfully access, exchange, and use diagnostic images outside of a
particular hospital or network system without use of physical media?
PM-2. What existing policies do you believe limit or interfere with
diagnostic image access, exchange, and use? What policies would you
introduce to accelerate the transition to electronic, standards-based
diagnostic image access and exchange and to reduce the practice of
imaging silos that impede electronic access, exchange, or use of
diagnostic images?
<bullet> PM-2A. What other policy or financial barriers do
providers face in accessing diagnostic images from outside facilities?
For example, are there concerns about compliance with health care
facility policies or procedures (e.g., security or overall policies on
data sharing outside the facility), state laws, or malpractice
liability?
<bullet> PM-2B. What technical/interoperability concerns exist,
such as compatibility between systems, authorization issues from
external sources, or issues with the provenance of diagnostic images?
PM-3. What technical, operational, and policy approaches can best
support health care providers in transitioning from physical media
(e.g., CDs and DVDs) to secure, electronic exchange-based methods for
sharing diagnostic images outside of their operating environment/health
care organization system? If possible, please be detailed in your
response.
PM-4. Do health care providers and/or patients (including patient-
facing apps) need access to the full resolution diagnostic images
stored in PACS or is a reference image (e.g., a DICOM image rendered as
a JPEG) sufficient for clinical decision-making and use by health care
providers and patients? Does this vary by clinician specialty or by
type(s) of care provided to the patient? Please feel free to elaborate
with rationale.
PM-5. Do health care providers and/or patients need access to
quantitative parameters \3\ derived from images for clinical decision-
making and use by providers and patients? Please feel free to elaborate
with rationale.
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\3\ Quantitative parameters are numerical measurements that
describe specific (e.g., physical, anatomical, or functional)
properties. We have received information that quantitative image
parameters are being manually entered into EHRs due to the lack of
standards adoption.
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B. Standards and Certified Health IT Functionality
The Certification Program \4\ is a voluntary program under which
health IT developers can obtain ONC certification for their health IT
products that meet certain requirements. Requirements for certification
are established by standards,
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implementation specifications, and certification criteria adopted
through rulemaking by the Secretary of HHS. The Certification Program
supports the availability of certified health IT for use by health care
providers under other federal, state, and private programs.
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\4\ For more information, see <a href="https://www.healthit.gov/topic/certification-ehrs/certification-health-it">https://www.healthit.gov/topic/certification-ehrs/certification-health-it</a>.
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Health IT developers often rely on custom interfaces and
connections for individual customer (e.g., health care provider)
systems resulting in incompatibilities between different health IT
developers' technology platforms. For example, survey findings suggest
that although many U.S. children's hospitals have electronic image-
sharing platforms, substantial challenges in radiologic image sharing
persist, primarily due to ongoing reliance on CDs and the lack of
interoperability between existing image-sharing platforms.\5\
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\5\ <a href="https://link.springer.com/article/10.1007/s00247-022-05474-9">https://link.springer.com/article/10.1007/s00247-022-05474-9</a>.
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SC-1. What technical approaches are currently in use to enable
access and/or exchange of diagnostic images between health care systems
and health information networks? To what extent are these methods based
on standards (e.g., DICOM, DICOMweb<SUP>TM</SUP>, FHIR[supreg],
IHE[supreg] XDS-I, IHE[supreg] XCA-I) versus proprietary or custom
integrations?
SC-2. What metadata and other information is currently associated
with diagnostic images for purposes of access and exchange, including
images exchanged using different standards and custom integrations?
Please feel free to elaborate on the use of artificial intelligence
tools in adding metadata to images and additional information to
accompany an image.
SC-3. What technical barriers, such as proprietary interfaces or
ambiguous standards, limit the access, exchange, and use of diagnostic
images across health IT systems (including by patient-facing apps), and
should existing technical standards be further modified (please
identify the standard)?
SC-4. How do certified health IT and/or EHRs enable or facilitate
access, exchange, and use of diagnostic images today? Specifically, do
EHRs play an active role in diagnostic image exchange, or is the
functionality primarily driven by imaging systems such as PACS and
VNAs?
SC-5. Should ASTP/ONC update the Certification Program to support
the access, exchange, and use of diagnostic images? For example, an
image access requirement could be added to the existing VDT
certification criterion or additional imaging data elements could be
included in the United States Core Data for Interoperability
(USCDI).\6\
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\6\ <a href="https://www.healthit.gov/isp/united-states-core-data-interoperability-uscdi">https://www.healthit.gov/isp/united-states-core-data-interoperability-uscdi</a>.
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SC-6. Should there be a focus on particular, individual diagnosis
and treatment use cases (e.g., ocular imaging)? Are there specific
requirements that need to be considered for use cases in other fields?
SC-7. Could image management systems, such as PACS and VNAs, be
certified to specific certification criteria that would improve
interoperability between these systems and EHRs and make access to
diagnostic images available to ``outside'' providers and patients
(including patient-facing apps)? What standards and capabilities should
these certification criteria include?
SC-8. Beyond or absent the certification of health IT to specific
technical standards, what diagnostic image-related standards should
ASTP/ONC adopt on behalf of HHS to improve interoperability and health
IT alignment? \7\
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\7\ <a href="https://www.healthit.gov/topic/hhs-health-it-alignment-program">https://www.healthit.gov/topic/hhs-health-it-alignment-program</a>.
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SC-9. Are there unique privacy and security concerns related to the
access, exchange, and use of diagnostic images that may not exist with
other types of health information?
SC-10. Would further development and adoption of the SMART[supreg]
Imaging Access draft specification \8\ help address the access,
exchange, and use of diagnostic images, as well as any specific privacy
and security concerns related to such access, exchange, and use?
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\8\ <a href="https://github.com/sync-for-science/imaging">https://github.com/sync-for-science/imaging</a>.
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IV. Collection of Information Requirements
In accordance with the implementing regulations of the Paperwork
Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), and OMB
guidance, we believe this general solicitation is exempt from the PRA.
Facts or opinions submitted in response to general solicitations of
comments from the public, published in the Federal Register or other
publications, regardless of the form or format thereof, provided that
no person is required to supply specific information pertaining to the
commenter, other than that necessary for self-identification, as a
condition of the agency's full consideration, are not generally
considered information collections and therefore not subject to the
PRA.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2026-01866 Filed 1-29-26; 8:45 am]
BILLING CODE 4150-45-P
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