Webinar Proceedings: AI Healthcare Compliance - CMS Requirements & Governance Guide

AI Governance in Healthcare: Understanding CMS AI Healthcare Compliance Requirements

Dr. Greenhill, gave a comprehensive webinar and shared with a number of healthcare leaders the reality that AI healthcare compliance isn't a future concern—it's a present reality.

With approximately 90% of hospitals already using at least one AI-enabled technology, and the average hospital deploying five to ten AI systems, the regulatory landscape has shifted dramatically. The December 4, 2025 release of the HHS AI Strategy under the Trump Administration marks a pivotal moment, projecting a 70% increase in AI implementations across federal healthcare operations in 2025. CMS surveyors are now actively asking about AI governance during hospital surveys, making immediate action essential for compliance.

The webinar outlined how existing CMS Conditions of Participation already apply to AI systems, even without specific AI regulations. Key compliance areas include Patient Rights (§482.13) requiring transparency when AI influences care decisions, Quality

Assessment and Performance Improvement (§482.21) mandating validation and ongoing monitoring, Medical Records (§482.24) requiring practitioner verification of AI-generated content, and Medical Staff (§482.28) extending competency requirements to AI tool usage. CMS's February 2024 guidance made clear that while AI can assist decision-making, it cannot replace individualized clinical judgment, and algorithms must consider individual patient circumstances rather than relying solely on population-level data.

Dr. Greenhill provided attendees with a practical 30-day action plan focused on immediate implementation: conducting a comprehensive AI inventory in week one, designating oversight structures in week two, risk-stratifying systems and identifying validation gaps in week three, and drafting governance frameworks in week four.

The presentation emphasized that hospitals must validate AI systems in their own environments with their patient populations, conduct ongoing performance monitoring including bias assessments across demographic groups, and integrate AI oversight into existing QAPI programs. With CMS taking a measured approach that applies current standards rather than creating new ones, organizations that establish systematic governance now will be well-positioned as regulatory expectations continue to evolve.

View Webinar on Youtube @ https://www.youtube.com/@CIHQ-ARSPARTNERS/videos

Need Help With AI Governance and CMS Compliance?

Navigating the complex landscape of AI governance in healthcare requires specialized expertise and practical guidance. SmartSigma AI helps healthcare organizations develop comprehensive AI governance frameworks, conduct system inventories and risk assessments, establish validation protocols, and prepare for CMS surveys. Whether you're just beginning your AI governance journey or need to strengthen existing programs, our team can provide the strategic support and technical assistance you need to ensure compliance and protect patient safety. Contact us at admin@smartsigmaai.com to discuss how we can help your organization build a robust, CMS-compliant AI governance program.