◆ Knowledge Hub
The definitive library
on AI governance in healthcare.
Whitepapers, regulatory guides, case studies and expert analysis. Built for the teams who have to get AI right the first time.
◆ Featured
EU AI Act Article 72: The Complete Compliance Framework for Healthcare AI Systems
Post-market surveillance is now mandatory for high-risk AI in healthcare. This whitepaper breaks down every obligation, maps them to technical controls, and shows how SENTINEL automates compliance across jurisdictions — EU, UAE, Brazil and FDA.
46 compliance controlsmapped to Art. 72 obligations
5 jurisdictions coveredEU · UAE · Brazil · FDA · ISO 42001
Audit-ready templatesEvidence checklists and report formats
Cost of non-compliance€30M / 6% global turnover analysis
◆ Whitepapers & Reports
Deep-dive technical
and regulatory research.
Whitepaper
Feb 2026
Hallucination in Clinical AI: Detection, Measurement and Automated Prevention
How unverified AI outputs reach clinicians, why standard LLM guardrails fail in medical contexts, and how multi-layer evidence validation eliminates the risk.
18 min read · 24 pages
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Report
Jan 2026
State of AI Governance in Healthcare 2026: Global Regulatory Landscape
Analysis of 12 regulatory frameworks across EU, MENA, LATAM and North America. Where is enforcement highest, what is the cost of delay, and what early movers are gaining.
25 min read · 38 pages
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Whitepaper
Dec 2025
Pathological Correlation in AI-Assisted Diagnostics: The Missing Layer
Why clinical AI that stops at the hypothesis is incomplete. The case for macro-micro pathological correlation as a standard of care — and how HARVEX+ implements it.
14 min read · 19 pages
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◆ Regulatory Guides
Compliance made
actionable.
Jurisdiction-by-jurisdiction breakdowns written by compliance engineers, not lawyers. Practical checklists you can use today.
| Framework | Jurisdiction | Key Obligation | Status | Guide |
|---|---|---|---|---|
| EU AI Act Art. 72 | European Union | Post-market surveillance, incident reporting, bias monitoring | Available | Download → |
| CFM 2.454/2026 | Brazil | Physician accountability, AI output transparency, patient consent | Available | Download → |
| UAE DOH AI Framework | UAE / MENA | Clinical AI certification, DHA approval pathway, audit requirements | Available | Download → |
| FDA SAMD Guidance | United States | Software as Medical Device classification, PMS, 510(k) pathway | Q2 2026 | Notify me |
| ISO 42001 | Global | AI management system standard, risk assessment, continual improvement | Q2 2026 | Notify me |
| LGPD + HIPAA | Brazil / US | PII handling in AI contexts, data subject rights, breach notification | Available | Download → |
◆ Case Studies
Real governance.
Real outcomes.
How leading healthcare AI teams used SENTINEL and HARVEX+ to achieve compliance, reduce risk and accelerate clinical adoption.
Case Study
2026
Regional Hospital Network — EU AI Act Compliance in 6 Weeks
A 14-hospital network with 23 active AI models needed full Art. 72 compliance before enforcement date. How SENTINEL achieved it without disrupting clinical workflows.
8 min read
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Case Study
2026
Oncology Clinic — 34% Improvement in Diagnostic Accuracy with HARVEX+
How structured pathological correlation and adversarial AI debate changed the diagnostic process for a high-volume oncology practice — and what the numbers showed after 90 days.
10 min read
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Case Study
2025
MedTech Vendor — DHA Certification Achieved with SENTINEL Post-market Audit
An AI radiology vendor entering the UAE market needed DHA approval. SENTINEL provided the audit trail, incident documentation and bias monitoring required for certification.
7 min read
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◆ Blog
Insights from the
governance front line.
Blog
Mar 6, 2026
Why "AI approved by a doctor" is not a compliance strategy
The CFM 2.454 and EU AI Act both require continuous monitoring — not a one-time human sign-off. Here is what that means in practice for clinical AI teams.
5 min read
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Blog
Feb 28, 2026
The €30M question: what AI non-compliance actually costs a hospital
Breaking down the full cost of an EU AI Act violation — fines, reputational damage, contract loss, and clinical liability. The math that every CIO should see before deferring compliance.
6 min read
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Blog
Feb 14, 2026
Dubai is becoming the world's first AI-safe healthcare market. Here's why that matters.
The UAE DOH is moving faster than the EU on AI certification requirements. First movers in the Gulf will have a regulatory template that travels to 30+ markets.
7 min read
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Blog
Jan 30, 2026
Confidence scores are not enough: why clinical AI needs adversarial validation
A single AI model giving a confidence score of 94% is not the same as two models debating the diagnosis with DOI-backed evidence. The difference in patient outcomes is significant.
8 min read
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Blog
Jan 15, 2026
What OpenEvidence got right — and what the next generation must fix
OpenEvidence reached $12B doing search-only, US-only, ad-supported. The governance layer was missing. Elyara picks up where it stopped.
9 min read
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Guide
Jan 5, 2026
How to audit your hospital's AI systems before the regulator does
A practical 5-step framework for healthcare IT and compliance teams to assess AI risk exposure — before enforcement arrives. Includes a downloadable checklist.
11 min read
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