Preparing for your first clinical AI governance audit
A practical guide to what auditors expect, what evidence to have ready, and the governance gaps that cause the most problems during review.
Dr Reabal Najjar
Founder & CEO
Regulatory updates, governance guides, and industry analysis.
A practical guide to what auditors expect, what evidence to have ready, and the governance gaps that cause the most problems during review.
Dr Reabal Najjar
Founder & CEO
RANZCR Chapter 9 sets binding AI governance standards for radiology. Section-by-section breakdown with compliance tips for practice directors.
Australian medical indemnity insurers are adjusting risk models for AI use. What this means for radiology practices and why governance documentation is becoming a coverage issue.
The TGA's regulatory framework for AI as Software as a Medical Device is complex. A practical breakdown of what applies to your practice and what is the vendor's responsibility.
Coroner inquiries, insurer expectations, and AHPRA obligations when AI-assisted radiology decisions go wrong. What to document and why.
Medical indemnity insurers are quietly adjusting risk models for AI. Five governance gaps that raise red flags during underwriting.
Dr Reabal Najjar
Founder & CEO
A 30/60/90-day guide to establishing AI governance for practices starting from zero. Prioritised by risk.
Dr Reabal Najjar
Founder & CEO
A step-by-step guide to creating a risk register for your practice AI tools, aligned with ISO 14971 and CAIOS Domain 02.
What CAIOS is, the 5 governance domains, and why existing frameworks like ISO 42001 fall short for clinical AI.
After auditing a dozen AI tools across four practices, patterns emerged. Here are the most common compliance gaps and how to close them.
Two frameworks, different scopes. We compare CAIOS and ISO 42001 to help you understand which applies to your practice.
Download our CAIOS-aligned governance policy template. Customise it for your practice in under an hour.
Moirai Team
Clinical AI Governance
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