Healthcare Standards Institute (HSI) Announces American National Standard for AI Governance in Healthcare Operations
Healthcare Standards Institute
The Healthcare Standards Institute (HSI), an ANSI Accredited Standards Developer, today announced the release of ANSI/HSI 2800:2025 Healthcare Organization Management - Artificial Intelligence (AI) Governance in Healthcare Operations, an American National Standard approved December 17, 2025.
As health systems rapidly deploy AI into patient care, revenue cycle, scheduling, documentation, diagnostics, and predictive analytics, this standard is built to help Boards and CEOs pull AI oversight out of the “IT project” bucket and treat it for what it is now: a core enterprise opportunity and risk issue. It gives organizations a practical framework to integrate AI responsibly across clinical, administrative, and operational domains, strengthen accountability and workforce readiness, and reduce legal and regulatory exposure by aligning to a clear, defensible governance model. Additionally, it supports leaders in setting an expectation that key partners and vendors meet the same bar, which includes HSI certification to this standard, so governance isn’t uneven or optional across the ecosystem. AI is too disruptive to not be governed.
“AI is now touching decisions that shape safety, quality, access, trust, liability, and financial performance of healthcare organizations,” said Dr. Veronica Edwards, HSI President. “This is a practical governance roadmap for healthcare leaders who want the benefits of AI without exposing their organizations to avoidable harm, liability, and erosion of trust.”
A clear message for Boards and CEOs: governance is not optional
ANSI/HSI 2800:2025 explicitly calls for Board of Directors oversight and CEO/executive leadership accountability for AI governance, execution, and compliance across the organization. The standard addresses the full AI lifecycle from development and procurement to deployment, monitoring, and continuous improvement, and emphasizes safeguards such as patient consent, privacy, transparency in algorithmic use, and proactive identification and mitigation of bias.
“This is about governing AI the same way healthcare governs everything else that can materially impact health outcomes and public trust,” said Don Taylor, Chairman of the HSI Foundation Standards Board. “Boards and CEOs don’t need to be technologists to lead AI…they need a governance system that makes AI accountability real.”
What the standard helps healthcare organizations do:
ANSI/HSI 2800:2025 provides structure for leaders to
• Establish accountability for AI outcomes and escalation pathways across clinical and operational use cases
• Align AI governance with regulatory expectations and reduce exposure to legal and reputational risk
• Require monitoring, auditing, and feedback loops to identify drift, unintended consequences, and safety issues over time
• Protect clinicians and staff from over-reliance on “black box” tools and from workflow harm that drives burnout
• Strengthen patient trust through transparency, meaningful consent, and appropriate opt-out pathways
• Creates a baseline of trust, transparency, and predictability across the healthcare ecosystem (health systems, clinicians, vendors, payers, and partners) by standardizing expectations for AI governance and performance, helping enable safe, accessible, value based care
Hamed Abbaszadegan, MD, MBA, Physician Executive at Stanson Health said: "Physicians have always been taught to trust, yet verify, and AI will never be full proof. Having physicians involved in the oversight process will be critical to ensuring safety for our patients.”
Availability:
ANSI/HSI 2800:2025 is available through ANSI at https://webstore.ansi.org/standards/ansi/ansihsi28002025
For information on the standard and implementation support, visit HSI at https://hsi.health
Media Contact: media@hsi.health
About Healthcare Standards Institute (HSI)
The Healthcare Standards Institute (HSI) is an ANSI Accredited Standards Developer (ASD) focused on healthcare organization management, convening experts and stakeholders to develop practical standards that support safe, effective, and trustworthy healthcare management.
Veronica Edwards
Healthcare Standards Institute
info@hsi.health
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