CHAI Governance Framework
The Coalition for Health AI's governance guidelines address responsible AI in clinical and operational healthcare settings. As a CHAI partner, Trustible's platform reflects the CHAI Responsible AI Guide's requirements.
CHAI's AI Governance Playbook Domains
AI Policy
A formal AI policy with leadership approval, a defined governance scope, and an assigned policy owner.
Organizational Structures
Governance committees and escalation paths with named recipients, defined triggers, and authority to suspend tools.
Organizational Resources
The datasets, infrastructure, model cards, monitoring tools, and human expertise AI systems depend on.
Responsible Lifecycle Management
Governance across the full AI lifecycle, from intake and evaluation through deployment and retirement.
Risk and Impact Assessments
Structured pre-deployment and ongoing review of patient safety and technology risk.
Responsible Data Management
Handling of protected health information and other data in compliance with applicable law.
Third-Party Management
Oversight of vendor and embedded AI, including approval and monitoring processes.
Education, Training, and Feedback
Ongoing training and feedback pathways for clinical and operational staff working with AI.
Regulatory Context
FDA AI/ML SaMD
AI systems that meet the definition of a medical device require FDA clearance or approval, with post-market monitoring requirements.
ONC Health IT Certification
AI embedded in certified health IT products may be subject to ONC transparency and non-discrimination requirements.
HIPAA
AI systems processing protected health information must comply with HIPAA's Privacy and Security Rules.
State AI Legislation
An expanding set of state laws impose specific requirements on health-related AI applications.
How Trustible Supports CHAI Alignment
CHAI FAQs
Voluntary. CHAI is a nonprofit coalition, not a regulatory body, and its Responsible AI Guide for Healthcare carries no legal enforcement mechanism of its own. That said, it's widely endorsed across the healthcare industry, developed with input from health systems, AI developers, patient advocates, and researchers, and increasingly treated as the practical governance baseline regulators and health system partners expect to see. The binding requirements in healthcare AI come from elsewhere: FDA clearance for AI that meets the SaMD definition, HIPAA for anything touching protected health information, and a growing set of state laws. CHAI's value is in translating principles that those regulations only partially address, clinical validation, health equity, ongoing monitoring, into a structured governance process. Trustible is a CHAI partner, and our platform operationalizes CHAI's guidelines alongside the FDA, HIPAA, and state requirements that do carry legal weight.