Notice2025-23641
Request for Information: Accelerating the Adoption and Use of Artificial Intelligence as Part of Clinical Care
Primary source
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Published
December 23, 2025
Issuing agencies
Health and Human Services Department
Abstract
The HHS Office of the Deputy Secretary in collaboration with ASTP/ONC has published this Request for Information (RFI) to seek broad public comment on what HHS can do to accelerate the adoption and use of AI as part of clinical care.
Full Text
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<title>Federal Register, Volume 90 Issue 244 (Tuesday, December 23, 2025)</title>
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[Federal Register Volume 90, Number 244 (Tuesday, December 23, 2025)]
[Notices]
[Pages 60108-60110]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23641]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
RIN 0955-AA13
Request for Information: Accelerating the Adoption and Use of
Artificial Intelligence as Part of Clinical Care
AGENCY: Office of the Deputy Secretary and Assistant Secretary for
Technology Policy (ASTP) and Office of the National Coordinator for
Health Information Technology (ONC) (collectively, ASTP/ONC),
Department of Health and Human Services.
ACTION: Request for information.
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SUMMARY: The HHS Office of the Deputy Secretary in collaboration with
ASTP/ONC has published this Request for Information (RFI) to seek broad
public comment on what HHS can do to accelerate the adoption and use of
AI as part of clinical care.
DATES: To be assured consideration, written or electronic comments must
be received at one of the addresses provided below, by February 23,
2026.
ADDRESSES: You may submit comments, identified by ``HHS Health Sector
AI RFI,'' 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 and the
Office of the National Coordinator for Health Information Technology,
Attention: Request for Information: HHS Health Sector AI RFI, Mary E.
Switzer Building,
[[Page 60109]]
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 and the Office of the National Coordinator for Health
Information Technology, Attention: HHS Health Sector AI RFI, 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 all 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: Steven Posnack, Principal Deputy
Assistant Secretary for Technology Policy, ASTP/ONC, 202-690-7151.
SUPPLEMENTARY INFORMATION:
I. Introduction
On December 4, 2025, the Department of Health and Human Services
(HHS) issued the HHS Artificial Intelligence (AI) Strategy \1\ in
response to Office of Management and Budget (OMB) Memorandum 25-21.\2\
The HHS AI Strategy represents a ``OneHHS'' approach to AI and is
primarily focused on the Department's internal interests and ambitions
to harness the transformative potential of AI and embed it into HHS's
operations, while upholding patient privacy, civil rights, and civil
liberties. Consistent with the President's artificial intelligence (AI)
Action Plan,\3\ recent Executive Orders \4\ on AI, and Office of
Management and Budget AI memoranda,\5\ the Department seeks public
feedback on the actions it can take to establish a forward-leaning,
industry-supportive, and secure approach to accelerate the adoption and
use of AI \6\ as part of clinical care. In the past 12 months, HHS
Divisions, including the Food and Drug Administration (FDA),\7\
National Institutes of Health (NIH),\8\ Centers for Medicare & Medicaid
Services (CMS),\9\ and ASTP/ONC \10\ have sought public feedback on
various aspects of AI and how it intersects with the Department's
policy interests. In this RFI we seek concrete, experience-based
feedback from those building, buying, evaluating, using, and receiving
care from AI tools that are part of clinical care as well as from those
who wish to do so but face barriers. Public feedback will inform HHS-
wide use of three different approaches: regulation, reimbursement, and
research & development. In general, HHS seeks feedback on ways in which
these approaches can be most effectively applied to support the rapid
adoption and use of AI in clinical care, to foster public trust and
confidence in modern technology solutions, to reduce uncertainty that
impedes AI innovation, and to align federal incentives so that AI is
deployed in ways that enhance productivity, reduce burden, lower health
care costs, and improve health outcomes for patients, caregivers, and
communities.
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\1\ <a href="https://www.hhs.gov/press-room/hhs-unveils-ai-strategy-to-transform-agency-operations.html">https://www.hhs.gov/press-room/hhs-unveils-ai-strategy-to-transform-agency-operations.html</a>.
\2\ <a href="https://www.whitehouse.gov/wp-content/uploads/2025/02/M-25-21-Accelerating-Federal-Use-of-AI-through-Innovation-Governance-and-Public-Trust.pdf">https://www.whitehouse.gov/wp-content/uploads/2025/02/M-25-21-Accelerating-Federal-Use-of-AI-through-Innovation-Governance-and-Public-Trust.pdf</a>.
\3\ <a href="https://www.whitehouse.gov/wp-content/uploads/2025/07/Americas-AI-Action-Plan.pdf">https://www.whitehouse.gov/wp-content/uploads/2025/07/Americas-AI-Action-Plan.pdf</a>.
\4\ <a href="https://www.ai.gov/#resources-anchor">https://www.ai.gov/#resources-anchor</a>.
\5\ See: <a href="https://www.whitehouse.gov/wp-content/uploads/2025/02/M-25-21-Accelerating-Federal-Use-of-AI-through-Innovation-Governance-and-Public-Trust.pdf">https://www.whitehouse.gov/wp-content/uploads/2025/02/M-25-21-Accelerating-Federal-Use-of-AI-through-Innovation-Governance-and-Public-Trust.pdf</a> and <a href="https://www.whitehouse.gov/wp-content/uploads/2025/02/M-25-22-Driving-Efficient-Acquisition-of-Artificial-Intelligence-in-Government.pdf">https://www.whitehouse.gov/wp-content/uploads/2025/02/M-25-22-Driving-Efficient-Acquisition-of-Artificial-Intelligence-in-Government.pdf</a> and <a href="https://www.whitehouse.gov/wp-content/uploads/2025/12/M-26-04-Increasing-Public-Trust-in-Artificial-Intelligence-Through-Unbiased-AI-Principles-1.pdf">https://www.whitehouse.gov/wp-content/uploads/2025/12/M-26-04-Increasing-Public-Trust-in-Artificial-Intelligence-Through-Unbiased-AI-Principles-1.pdf</a>.
\6\ For purposes of this RFI, ``artificial intelligence'' is
defined to be consistent with OMB Memorandum M25-21, which follows
the meaning provided in Section 238(g) of the John S. McCain
National Defense Authorization Act for Fiscal Year 2019. See section
5 of M25-21 for additional detail.
\7\ FDA Request for Public Comment: Measuring and Evaluating AI-
enabled Medical Device Performance in the Real-World <a href="https://www.fda.gov/medical-devices/digital-health-center-excellence/request-public-comment-measuring-and-evaluating-artificial-intelligence-enabled-medical-device">https://www.fda.gov/medical-devices/digital-health-center-excellence/request-public-comment-measuring-and-evaluating-artificial-intelligence-enabled-medical-device</a>.
\8\ NIH Request for Information: Inviting Comments on the NIH
Artificial Intelligence Strategy <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-117.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-117.html</a>.
\9\ CMS Request for Information on Artificial Intelligence
Technologies for Improving Health Care Outcomes and Service Delivery
<a href="https://www.cms.gov/digital-service/artificial-intelligence-demo-days">https://www.cms.gov/digital-service/artificial-intelligence-demo-days</a>.
\10\ CMS and ASTP/ONC Request for Information: Health Technology
Ecosystem <a href="https://www.federalregister.gov/documents/2025/05/16/2025-08701/request-for-information-health-technology-ecosystem">https://www.federalregister.gov/documents/2025/05/16/2025-08701/request-for-information-health-technology-ecosystem</a>.
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II. Solicitation of Public Comments
Regulation
As the nation's principal health regulator, HHS helps shape the
environment in which AI for clinical care is developed, evaluated, and
deployed. HHS seeks to establish a regulatory posture on AI that is
well understood, predictable, and proportionate to any risks presented
to enable rapid innovation while protecting patients and the
confidentiality of their identifiable health information, and
maintaining public trust. We seek feedback on how current HHS
regulations impact AI adoption and use for clinical care.
Reimbursement
HHS's payment policies and programs have massive effects on how
health care is delivered in the United States, often times with
unintended consequences. Hypothetically, if a payer is taking financial
risk for the long-term health and health costs of an individual, that
payer will have an inherent incentive to promote access to the highest-
value interventions for patients. Under government designed and
dictated fee-for-service regimes, however, coverage and reimbursement
decisions are slow. Rarely does covering new innovations reduce net
spending; and waste, fraud, and abuse is difficult to prevent, often
times leading to massive spending bubbles on concentrated items or
services that are not commensurate with the value of such products.
Given the inherent flaws in legacy payment systems, we seek to ensure
that the potential promises of AI innovations are not diminished
through inertia and instead such payment systems are modernized to meet
the needs of a changing healthcare system. We seek feedback on payment
policy changes that ensure payers have the incentive and ability to
promote access to high-
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value AI clinical interventions, foster competition among clinical care
AI tool builders, and accelerate access to and affordability of AI
tools for clinical care.
Research & Development
HHS supports one of the world's largest health research ecosystems,
catalyzing innovation to supplement the market. By enabling applied AI
research & development, care delivery research and implementation
science, as well as AI entrepreneurship in health care, we can better
translate AI technologies from concept to clinical use. We seek input
on ways in which HHS may invest in research & development (including
public-private partnerships and cooperative research and development
agreements (CRADAs)) to integrate AI in care delivery and create new,
long-term market opportunities that improve the health and wellbeing of
all Americans.
Specific Questions
In addition to the general requests for information above regarding
AI regulation, reimbursement, and research & development, HHS seeks
input on the following specific questions:
1. What are the biggest barriers to private sector innovation in AI
for health care and its adoption and use in clinical care?
2. What regulatory, payment policy, or programmatic design changes
should HHS prioritize to incentivize the effective use of AI in
clinical care and why? What HHS regulations, policies, or programs
could be revisited to augment your ability to develop or use AI in
clinical care? Please provide specific changes and applicable Code of
Federal Regulations citations.
3. For non-medical devices, we understand that use of AI in
clinical care may raise novel legal and implementation issues that
challenge existing governance and accountability structures (e.g.,
relating to liability, indemnification, privacy, and security). What
novel legal and implementation issues exist and what role, if any,
should HHS play to help address them?
4. For non-medical devices, what are the most promising AI
evaluation methods (pre- and post-deployment), metrics, robustness
testing, and other workflow and human-centered evaluation methods for
clinical care? Should HHS further support these processes? If so, which
mechanisms would be most impactful (e.g., contracts, grants,
cooperative agreements, and/or prize competitions)?
5. How can HHS best support private sector activities (e.g.,
accreditation, certification, industry-driven testing, and
credentialing) to promote innovative and effective AI use in clinical
care?
6. Where have AI tools deployed in clinical care met or exceeded
performance and cost expectations and where have they fallen short?
What kinds of novel AI tools would have the greatest potential to
improve health care outcomes, give new insights on quality, and help
reduce costs?
7. Which role(s), decision maker(s), or governing bodies within
health care organizations have the most influence on the adoption of AI
for clinical care? What are the primary administrative hurdles to the
adoption of AI in clinical care?
8. Where would enhanced interoperability widen market
opportunities, fuel research, and accelerate the development of AI for
clinical care? Please consider specific data types, data standards, and
benchmarking tools.
9. What challenges within health care do patients and caregivers
wish to see addressed by the adoption and use of AI in clinical care?
Equally, what concerns do patients and caregivers have related to the
adoption and use of AI in clinical care?
10. Are there specific areas of AI research that HHS should
prioritize to accelerate the adoption of AI as part of clinical care?
a. Are there published findings about the impact of adopted AI
tools and their use clinical care?
b. How does the literature approach the costs, benefits, and
transfers of using AI as part of clinical care?
III. Paperwork Reduction Act
In accordance with the implementing regulations of the Paperwork
Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), and OMB
guidance, 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.
IV. Response to Comments
Due to the large number of public comments that we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this request for
information.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-23641 Filed 12-19-25; 8:45 am]
BILLING CODE 4150-45-P
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</html>Indexed from Federal Register on December 23, 2025.
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