The CAIOS Standard
Clinical AI Oversight Specification — the peer-reviewed evidentiary framework for responsible AI governance in healthcare.
What is CAIOS
Evidence requirements, not guidelines.
CAIOS defines what must be provable when AI assists a clinical decision. Not guidelines — evidence requirements. It specifies the artefacts, attestations, and audit trails a practice must maintain to demonstrate responsible governance to regulators, insurers, and courts.
Five domains
The evidentiary framework
DOMAIN 01
Clinical Governance
Organisational structures, accountability frameworks, and decision-making authority for AI oversight. Defines who is responsible, how decisions are escalated, and what governance bodies must exist.
DOMAIN 02
Risk Management
Identification, assessment, and mitigation of risks arising from clinical AI deployment.
Risk matrix
DOMAIN 03
Regulatory Compliance
Alignment with TGA, RANZCR, and emerging international AI governance frameworks.
DOMAIN 04
Evidence & Audit
Immutable documentation of governance decisions, attestations, and evidentiary artefacts.
DOMAIN 05
Continuous Monitoring
Ongoing surveillance of AI system performance, drift, and compliance posture.
Development
How CAIOS was built
2023
Research begins
Systematic review of AI governance gaps in clinical radiology across Australia and New Zealand.
2024
Framework drafted
Five-domain evidentiary framework developed from clinical observation, regulatory analysis, and medicolegal precedent.
2025
Peer review & refinement
Framework refined through expert consultation, pilot testing with radiology practices, and alignment with TGA guidance.
Mar 2026
Submitted to JMIRO
CAIOS submitted for peer review to the Journal of Medical Imaging and Radiation Oncology.
“When a coroner asks how your practice governed its AI — what’s your answer?”
Court-defensible evidence
Structured artefacts that meet the evidentiary bar for medicolegal proceedings, coronial inquests, and regulatory audits.
Insurer recognition
Demonstrate governance posture to medical indemnity insurers. CAIOS-certified practices signal reduced risk.
Regulatory alignment
Pre-aligned with TGA, RANZCR Ch.9, and NHMRC frameworks. When regulation catches up, you're already compliant.
Recognised by leading bodies
Get CAIOS certified.
Formal third-party verification that your practice meets the published evidentiary standard.
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