SENTINEL / HARVEX+ / GOVERNANCE
Elyara
Health AI Governance
The first company dedicated exclusively to AI governance in healthcare. SENTINEL monitors medical AI in production. HARVEX+ powers the complete clinical journey. 19 AI professionals, 8 medical verticals, ~8,800 curated evidence documents. From the consultation room to the patient’s home.
SENTINEL
HARVEX+
GOVERNANCE
SENTINEL
Central Product
Post-market monitoring
of medical AI.
1,300+ AI devices authorized by FDA, 75-80% in radiology. Less than 2% have RCT evidence. 5% have adverse events. No company offers continuous monitoring as a service. SENTINEL is the independent auditor that hospitals and regulators need.
- Performance Drift — detects accuracy degradation over time
- Demographic Bias — unequal performance by group (Fitzpatrick V-VI)
- Data Drift — input distribution changes without recalibration
- Regulatory Compliance — continuous EU AI Act Art. 72 monitoring
- Adverse Events — AI-linked incidents tracked and reported
- Model Transparency — auditable decision explainability
- Elyara Gateway — every AI call passes through 9 mandatory checkpoints
- Kill Switch — instant shutdown at platform, product, or system level
- PII Protection — zero tolerance, blocked before reaching any agent
- Transparency Card — DOIs, confidence score, curation type on every response
How SENTINEL governs every AI response
Request
platform sends intent
Gateway
auth + PII + kill switch
Confidence
≥0.85 full / 0.60 partial / <0.60 block
KB + LLM
curated evidence + AI
Audit
DOI + trace + cost
Response
governed + explainable
Every response carries a Transparency Card: DOIs, confidence score, curation type, human intervention flag. EU AI Act Art. 13 compliant.
SENTINELGOVERNANCE
4 Layers of Guardrails
Elyara doesn’t sell AI.
Elyara governs AI.
The system NEVER generates medical content from the LLM alone. All clinical information comes from the curated KB or real-time search (marked as uncurated). The LLM organizes, classifies, and presents — it does not invent. No verifiable DOI = claim removed.
Confidence Gate
≥0.85: full response with DOI. 0.60–0.84: partial + disclaimer. <0.60: BLOCK + Gap Protocol activates. Every claim scored before delivery.
Gap Protocol
When the KB has no answer: Curator searches PubMed/Cochrane in real-time → Indexer classifies by GRADE → Compliance validates DOIs → Gap filled in 24h.
Transparency Card
Every response includes: documents used (DOIs), confidence score, indexation date, curation type, and whether human intervention occurred. EU AI Act Art. 13.
Anti-Hallucination
Architectural, not prompt-based. All medical info comes from curated KB or real-time search. The LLM organizes — never invents. No DOI = removed.
Calibrated Confidence
Most competitors hide when they don’t know. Elyara does the opposite — turns limitation into trust signal. “If it tells me when it doesn’t know, I can trust when it does.”
◆ Infrastructure Guardrails
Elyara Gateway
9 mandatory checkpoints on every AI call. Auth, rate limit, kill switch, PII scan, LLM dispatch, response audit, cost tracking. No bypass possible.
Kill Switch
Shut down any AI process instantly. Platform-level, product-level, or system-wide. Seconds, not minutes. Core governance is the last to stop.
PII Protection
Every payload scanned. Regime A/B: PII is blocked with HTTP 422. Regime C: warned. Output PII is always masked. Zero tolerance.
◆ Clinical Assurance
Explainability Trail
Why did the AI say this? Every output carries sources, confidence, validation path, and DOI references. Built for the clinician, not the developer.
Drift & Fairness
Continuous monitoring detects silent degradation and demographic bias. AI dermatology failing on dark skin? SENTINEL catches it before it harms patients.
Citation Enforcement
Every clinical response requires PubMed, Cochrane, or guideline references with GRADE classification. Gateway rejects responses without verifiable citations.
HARVEX+
Clinical Intelligence Ecosystem
From transcription to slide.
From office to home.
HARVEX+ is the entry point of the Elyara ecosystem. 6 clinical moments powered by specialized AI agents — Zeus for anamnesis, Cecília for confirmatory hypothesis, Isadora for adversarial debate, and a dedicated Pathology agent for macro-micro correlation.
☤ 6 CLINICAL MOMENTS
The Complete Journey
Each moment of the clinical journey has dedicated AI agents with governance guardrails. From real-time streaming transcription to continuous home care.
- 01 Consultation — Zeus: real-time anamnesis streaming, dynamic checklist, red flags
- 02 Hypothesis — Cecília (confirmatory) + Isadora (adversarial), DOI on every claim
- 03 Procedure — Physician (human), guided macroscopic registration
- 04 Pathological Confirmation — Macro-micro correlation, unexpected findings
- 05 Study Room — Socratic preceptor, 5 layers, competency profile
- 06 Continuous Care — Navigator Nurse + Nutrition via WhatsApp + wearables
★ PATHOLOGICAL CONFIRMATION
World-first Innovation
When the pathology report arrives, HARVEX+ triggers new analysis. Appendix was appendicitis? Could be carcinoid (1-2%). Gallbladder? Incidental adenocarcinoma. Each result triggers: reclassification, conduct adjustment, referrals, and Study Room material.
Appendix
Gallbladder
Thyroid (Bethesda)
Breast (HER2, Ki-67)
Uterus (Sarcoma)
Colon (Adenoma)
Prostate
Skin (Melanoma)
✎ STUDY ROOM — 5 LAYERS
Medical Education Engine
Every real case becomes a learning opportunity. Anonymized dossier, Socratic preceptor using Cecília vs Isadora debate, personalized quizzes with DOI, pathology module, and 6-domain competency profile with spaced repetition.
Evidence Dossier
Socratic Preceptor
Personalized Quiz
Pathology Module
Competency Profile
📚 KNOWLEDGE BASE
6 Curated Bases — ~8,800 Docs
PostgreSQL + pgvector (1536 dims). Every document classified by department, vertical, jurisdiction, and urgency. Embeddings enable semantic search across the entire corpus. Schema integrates pathology data (WHO, ENETS, Bethesda classifications) with clinical evidence.
KB-Regulatory ~500
KB-Scientific ~6,000
KB-Pathology ~1,800
KB-Engineering ~300
KB-Market ~200
KB-Internal (growing)
◆ HARVEX+ Integration: every real consultation feeds KB-Internal. Pathological confirmations calibrate agents. Gap Protocol fills lacunas in 24h. The KB grows stronger with every clinical interaction.
SENTINELHARVEX+GOVERNANCE
AI Team v3 — 19 Professionals
19 AI professionals.
$3K/month vs $220K human.
Organizational structure that mirrors a real human team. 6 departments, 19 specialized AI professionals operating the entire ecosystem. 98.6% cost reduction. Same coverage, 24/7 availability.
ENGINEERING (6)
CTO, Architect, Backend, Frontend, DevOps, QA
System design, development, deployment, and quality assurance. The technical backbone that builds and maintains the entire infrastructure.
Always active. Core infrastructure never sleeps.
COMPLIANCE (3)
Head Compliance, Regulatory Analyst, Assessor
EU AI Act, FDA, DHA Dubai, ANVISA compliance. Continuous regulatory monitoring across 4 jurisdictions. Every response audited.
Activated on every clinical output. Zero tolerance for non-compliance.
COMMERCIAL (3)
Head BD/Sales, Market Analyst, Growth Marketer
Pipeline management, competitive intelligence, content strategy. Market analysis across Dubai, EU, and LATAM regions.
Activated by business events. Zero cost in standby.
LIBRARY (3)
Curator, Indexer, Agent Trainer
Curator scans 200+ sources/day. Indexer generates embeddings (pgvector 1536 dims). Agent Trainer analyzes patterns and updates prompts. The KB backbone.
KPI: >70% relevance, <4h latency for critical publications, >5% monthly improvement.
PRODUCT (2)
Product Manager, Data Scientist
Roadmap definition, metrics tracking, AI monitoring, and data-driven decisions for the entire ecosystem.
Continuous monitoring. Metrics drive every product decision.
OPERATIONS (2)
COO / Chief of Staff, Scrum Master
Daily briefings, cross-department coordination, process optimization, and sprint management across all 6 departments.
Daily standups. Weekly retrospectives. Continuous improvement.
SENTINEL
8 Medical Verticals
Eight verticals.
Documented risks.
SENTINEL monitors AI across 8 medical verticals. Each has specific risks, documented failures, and regulatory requirements. One governance layer for all.
01
Radiology
X-ray, CT, MRI, mammography reading. 75-80% of all FDA-authorized AI devices. Risks: drift with equipment changes, demographic bias.
75-80%
02
Cardiology
ECG, arrhythmias, echo, cardiovascular risk. Risks: false positives in atrial fibrillation, alert fatigue in clinical settings.
~10%
03
Pathology
Digital histopathology, cancer detection. Risks: lab-to-lab variation, staining drift, interpretation inconsistencies.
Growing
04
Ophthalmology
Diabetic retinopathy, glaucoma, AMD screening. Risks: performance varies by ethnicity, image quality dependency.
Stable
05
Dermatology
Melanoma, skin lesions. The most documented case of racial bias in AI — Fitzpatrick V-VI underperformance.
Emergent
06
Oncology
Screening, prognosis, dosimetry. Errors are lethal. Highest regulatory risk category across all jurisdictions.
High risk
07
Emergency
Triage, sepsis, clinical deterioration. Heterogeneous populations, temporal pressure, life-or-death decisions.
Critical
08
Mental Health
NLP in psychiatry, therapeutic chatbots. Extreme privacy requirements, cultural bias, vulnerability of patients.
Emergent
HARVEX+SENTINEL
The Flywheel
Every consultation makes
the system stronger.
HARVEX+ is the entry point. Every real clinical interaction feeds back into the ecosystem — improving agents, filling KB gaps, and calibrating SENTINEL. A virtuous cycle no competitor can replicate.
01
Doctor transcribes in HARVEX+
Real-time streaming via Zeus generates structured clinical case with red flags and checklist.
↓
02
Case feeds Study Room
Anonymized dossier becomes learning material. Socratic preceptor generates questions and simulations with DOI.
↓
03
Pathology confirms or refutes
When the AP report arrives, agents recalibrate. Diagnostic reclassification, conduct adjustment, new referrals.
↓
04
Usage reveals KB gaps
Every confidence score <0.60 triggers the Gap Protocol. Curator fills the lacuna within 24h. Each “I don’t know” makes the system stronger.
↓
05
Feedback improves agents
Approved/rejected responses train the Agent Trainer. Prompt updates, A/B testing, >5% monthly improvement on all KPIs.
↓
06
Anonymized data reveals patterns
Gaps by specialty, region, and vertical. Intelligence feeds SENTINEL monitoring and partner insights.
⟳
BUSINESS MODEL
Products & Revenue
6 revenue streams.
One ecosystem.
SENTINEL Enterprise
Hospitals, AI manufacturers, regulators
Annual contract per monitored device. Post-market surveillance as a service. The product regulators need.
Revenue: per device/year
HARVEX+ Transcription
Doctors, clinics
Real-time streaming transcription with Zeus. Structured clinical output. The entry point to the ecosystem.
Revenue: SaaS monthly/doctor
HARVEX+ Clinical Intelligence
Premium doctors
Cecília (confirmatory) + Isadora (adversarial) debate. DOI on every claim. Pathological correlation.
Revenue: premium add-on
HARVEX+ Study Room
Doctors + students + residents
5-layer medical education from real cases. Socratic preceptor, quizzes with DOI, competency profile, CME certification.
Revenue: SaaS education
HARVEX+ Continuous Care
Clinics, hospitals (B2B)
Navigator Nurse + Nutrition via WhatsApp + wearables. From the office to the patient’s home.
Revenue: per active patient/month
Anonymized Data
Pharma, research, medical societies
Clinical insights by specialty, region, and vertical. Gaps, patterns, and trends from real consultations.
Revenue: licensing
MARKET
Competitive Analysis
Adjacent markets,
not overlapping.
OpenEvidence = Google for doctors. Consensus = Google Scholar with AI. UpToDate = encyclopedia. Elyara/SENTINEL = digital ANVISA for medical AI + complete clinical ecosystem.
OpenEvidence
AI medical search (40% US doctors)
$12B valuation. No governance, no pathology, no education, ad-supported. PhD in finance from Harvard — not a clinician.
Gap: search only, no monitoring, no clinical workflow
Consensus
Academic search (220M papers)
Generic, no healthcare focus, no clinical workflow, no governance layer. Indexes papers but doesn’t audit AI.
Gap: no clinical context, no governance
UpToDate
Static medical reference ($499/yr)
Gold standard for decades. But it doesn’t interact, doesn’t debate, doesn’t monitor AI, doesn’t learn from cases.
Gap: static, no AI monitoring, no debate
Nuance / DAX
Transcription (Microsoft)
Industry leader in clinical transcription. But zero clinical intelligence — only transcribes, doesn’t analyze or govern.
Gap: transcription only, no intelligence
ResearchRabbit
Visual literature mapping
Beautiful paper discovery. No generative AI, no clinical decisions, no patient care, no monitoring.
Gap: discovery only, no clinical action
Elyara / SENTINEL
Health AI Governance + Clinical Ecosystem
Monitoring + transcription + clinical debate + pathological confirmation + education + continuous care. Built by a surgeon at the bedside.
Complete ecosystem. No competitor covers this.
SENTINELGOVERNANCE
Regulatory Strategy
4 jurisdictions.
SENTINEL is the answer.
EU
EU AI Act (2024/1689)
Art. 72: mandatory post-market monitoring for high-risk AI. Medical AI classified as high-risk. SENTINEL is the compliance solution.
→
US
FDA AI/ML Framework
510(k) + PCCP + Good Machine Learning Practice. Independent auditing as a service for manufacturers and hospitals.
→
UAE
DHA AI Governance Policy
Dubai Health Authority standards for healthcare AI. Regulatory sandbox + capital. Dubai-first go-to-market strategy.
→
BR
PL 2338/2023 + ANVISA
AI regulation under construction. Early mover advantage in LATAM. Birthplace of DOC+ and HARVEX+.
→
SENTINELROADMAP
Timeline to Unicorn
From MVP to $1B.
2026–2029.
OpenEvidence reached $12B doing a fraction: search only, US only, ad-supported. Elyara does the complete ecosystem: governance + transcription + clinical debate + pathological confirmation + education + continuous care. Global-first.
W1-6
Infrastructure + KB
PostgreSQL/pgvector + 8,800 curated documents across 6 knowledge bases. Foundation layer.
2026
W7-10
Clinical Agents
Zeus + Cecília + Isadora + Pathology operational. The clinical brain comes alive.
2026
W11-14
Study Room
5 layers with pathology module. Every real case becomes a learning opportunity.
2026
W15-18
Continuous Care
Navigator Nurse + wearables + WhatsApp integration. From office to home.
2026
W19-24
SENTINEL MVP
Monitoring of 1 vertical (Radiology). First independent AI auditor for hospitals.
2026
Q4
Go-to-Market Dubai
Pitch DHA + first contracts in the Gulf. Regulatory sandbox + strategic capital.
2026
H1
EU + LATAM Expansion
EU AI Act compliance + ANVISA early mover. Two continents, one governance layer.
2027
H2
Proprietary Models
Fine-tuning with real HARVEX+ clinical data. The moat no competitor can replicate.
2027-28
★
Unicorn
$1B+ valuation. Global health AI governance standard.
2029
The governance layer is ready.
What will you monitor with it?
Talk to our team about SENTINEL for your hospital or HARVEX+ for your clinical practice.