Joint Commission (Kathryn E. Spates)

Please see the attached comments.

October 19, 2026

Kyle Diamantas, J.D.
Acting Commissioner
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852

[Docket: FDA-2026-N-7874. Submitted electronically via Regulations.gov]

Dear Acting Commissioner Diamantas:

Joint Commission appreciates the opportunity to comment on the Food and Drug
Administration’s discussion paper, Considerations for the Regulation of Generative AI-Enabled
Medical Devices: Discussion Paper and Request for Feedback.

Founded in 1951, Joint Commission’s mission is to enable and affirm the highest standards of
healthcare quality and patient safety for all. Joint Commission has programs that accredit or
certify healthcare organizations (HCOs) across the continuum of care. A variety of federal and
state government regulatory bodies, including the Centers for Medicare and Medicaid Services,
recognize and rely upon Joint Commission’s findings for Medicare or licensure purposes.

Joint Commission supports FDA’s effort to address the unique regulatory challenges posed by
Generative AI (GenAI)-enabled medical devices. AI-enabled medical devices, and AI-enabled
tools in general are transforming care for the better, while bearing new challenges that can create
patient safety risks. Joint Commission’s new voluntary AI program complements FDA’s efforts
by helping HCOs manage similar risks and opportunities in clinical care settings.

Joint Commission’s AI program, a voluntary certification for the Responsible Use of AI in
Healthcare (RUAIH), 1 gives HCOs a framework for how to adopt AI with the oversight,
accountability, and safeguards needed to promote safe, reliable, and transparent use. As FDA
considers how to regulate GenAI-enabled medical devices throughout their lifecycle, the RUAIH
certification illustrates a complementary approach to governance standards for HCOs deploying
AI in real-world settings, which includes the need to monitor the safety and performance of these
tools in proportion to the risk of harm. FDA’s guidance framework outlined in the discussion
paper, together with a framework like the one used in Joint Commission’s RUAIH certification,
provides a model to support both the product and the organization to allow patients and
providers access to AI-enabled tools.
Joint Commission, Responsible Use of AI in Healthcare Certification, https://www.jointcommission.org/enus/certification/responsible-use-of-ai-in-healthcare.
Joint Commission Comments on FDA Discussion Paper on Generative AI

Accrediting organizations (AOs) like Joint Commission can reinforce AI user review,
monitoring, and reporting of AI tool performance by promoting standardized AI governance
programs.

While FDA provides essential review of AI-enabled medical devices, many GenAI-enabled tools
used within a healthcare system may fall outside of that jurisdiction, such as non-device clinician
decision support tools; even those that are FDA-approved may require organization-level
governance once they are deployed. Joint Commission believes this distinction underscores the
complementary roles of FDA oversight and the health and safety requirements that AOs assess as
part of their survey processes. For example, FDA approves MRI scanners, and AOs have
standards and survey processes needed for imaging safety. HCOs still need safety frameworks
when GenAI-enabled tools are implemented within healthcare delivery. Importantly, Joint
Commission does not validate or inspect specific AI tools or their development. Local
governance frameworks like those contemplated by the voluntary RUAIH certification provide
HCOs with a means to manage AI-enabled tools that may enter a healthcare provider’s
ecosystem. As part of the voluntary RUAIH certification, organizations conduct ongoing
monitoring of the safety and performance of AI tools appropriate to the risk categorization of the
tool and track, investigate, and report AI-related safety events.

Joint Commission is happy to serve as a resource on how GenAI-enabled medical devices are
being used in clinical care settings or to discuss how voluntary certification programs like
RUAIH can complement FDA’s work and role.

Please do not hesitate to contact me, Rehana Gubin, Senior Director, Public Policy, at (202) 7836655 or rgubin@jointcommission.org, or Patrick Ross, Associate Director, Public Policy, at
(202) 783-6655 or pross@jointcommission.org.

Sincerely,

Kathryn E. Spates
Executive Vice President, Public Policy & Government Relations

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