URAC Launches Health Care AI Accreditation to Set National Standards for Safe, Ethical AI in Patient Care

URAC Launches First Health Care AI Accreditation Program

URAC has launched the Health Care Artificial Intelligence Accreditation Program, the first national standard built to validate safe, ethical and equitable AI in patient care. The program gives health systems and developers a trusted framework to adopt AI without compromising clinical oversight, privacy or outcomes.

Developed with input from a 29-member Health Care AI Advisory Committee spanning delivery, digital health, policy, academia, legal compliance and patient safety, the standards reflect real-world needs across the care continuum.

Why this matters

Policy momentum favors innovation while offering limited guardrails. URAC's accreditation fills the gap with independent verification that AI is developed, deployed and monitored responsibly.

"Our accreditation can validate that the AI tools used in health care were developed to promote safe, ethical and responsible use," said Shawn Griffin, MD, President and CEO of URAC. "By creating a trusted framework, we are supporting innovation and the promise of AI to be a powerful tool in health care."

Two tracks: one for developers, one for users

• Developer Accreditation: Validates transparency, rigorous testing, bias management and responsible data handling-helping credible developers stand apart from bad actors.
• User Organization Accreditation: Provides a clear playbook for safe implementation, including clinical oversight, patient awareness, privacy protections and monitoring for errors or false findings.

"Our standards ensure that organizations not only build and test AI properly, but also disclose how systems work, monitor for false findings and guard against inappropriate bias," said Jennifer Richards, PhD, PharmD, JD, Senior Director of Product Management at URAC.

What the standards cover

• Risk Management: Model risk stratification, bias assessment and mitigation, explainability, and escalation paths for adverse events.
• Operations and Infrastructure: Data governance, privacy and security controls, access management, documentation and change control.
• Performance Monitoring and Improvement: Ongoing validation, drift and false finding surveillance, feedback loops, and timely corrective action.

Organizations can seek accreditation as a developer, a user or both.

Practical next steps for health leaders

• Inventory all AI-enabled tools in use or in the pipeline, including clinical, operational and patient-facing applications.
• Stand up cross-functional governance: clinical leadership, data science, compliance, privacy, security, legal and patient safety.
• Adopt a model risk framework and document end-to-end lifecycle controls from data sourcing to post-deployment monitoring.
• Implement human-in-the-loop review for clinically consequential outputs and set clear handoffs for escalation.
• Standardize patient notifications and disclosures, and record informed consent where appropriate.
• Align with recognized guidance such as the NIST AI Risk Management Framework and FDA expectations for AI/ML-enabled software in clinical settings (FDA SaMD AI/ML).

Who benefits

Health systems and clinics: Clear governance, safer deployments, and better clinician and patient trust.

Developers: Market signaling that your products meet transparency, bias management and testing expectations.

Patients: Greater clarity on how AI is used in their care and stronger protections for privacy and outcomes.

About URAC

URAC is an independent nonprofit accreditor with 35 years of experience advancing quality across health equity, telehealth, pharmacies, health plans and more. Its Health Care AI Accreditation offers a path to demonstrate quality, build trust and advance innovation without compromising patient safety.

Level up your team

If you are building internal AI capability to meet accreditation standards, consider structured training for clinical, data and compliance teams. Explore curated options by role at Complete AI Training.

Media Contact

Laura A. Wood
Director, Marketing, Communications and Workplace Mental Health
202-326-3968
lwood@urac.org