Protecting Healthcare's
AI Future. Works.
LumeOps is the observability layer for clinical LLMs — the AI governance platform that tells healthcare organizations exactly where AI is safe, where it creates liability, and proves compliance to auditors automatically.
@LumeOps·Building the observability layer for clinical LLMs
AI Use Case Classifier
Instant Safe / Risky / Prohibited verdicts with full regulatory citations.
Risk Surface Scanner
Bias, PHI leakage, and patient safety failure mode detection.
Compliance Evidence Vault
Auto-generated audit trails mapped to HIPAA, SOC 2, and EU AI Act.
Built for compliance with
Healthcare AI is moving fast.
Governance is not.
Every hospital buying an AI tool faces the same impossible questions with no reliable way to answer them before something goes wrong.
of health systems are actively piloting AI
but most have no formal governance process in place
average HIPAA breach cost in 2024
AI misuse is an emerging attack and liability vector
EU AI Act enforcement begins
healthcare AI is classified as high-risk by default
Questions every healthcare CIO is asking right now
None of them have easy answers — until now.
“Can we use AI for this patient workflow?”
Nobody knows without months of legal review.
“Is this AI vendor HIPAA compliant?”
BAAs exist, but technical controls go unverified.
“How do we prove AI safety to our board?”
Manual documentation that takes weeks to compile.
“Where could AI make patient care worse?”
Bias and failure modes are invisible until they are not.
LumeOps answers every one of these — automatically.
Three modules. One source of truth.
LumeOps integrates governance, risk assessment, and compliance documentation into a single workflow — no spreadsheets, no manual work.
AI Use Case Classifier — Live Preview
Try it yourselfFor illustration. All verdicts cite live FDA, HIPAA, and EU AI Act sources. Consult your compliance officer.
AI Use Case Classifier
Input any healthcare workflow. Our LLM — trained on FDA guidance, HIPAA technical safeguards, EU AI Act healthcare annexes, and CMS policy — returns a Safe / Risky / Prohibited verdict in seconds with full regulatory citations.
- Verdicts backed by live regulatory database
- Department-specific risk profiles
- PDF report generation for stakeholders
- Batch analysis for vendor procurement
// AI Use Case Classifier
const result = await lumeops.analyze({
workflow: "sepsis-prediction-model",
department: "critical-care",
vendor: "vendor-name",
});
// Response
{
verdict: "REQUIRES_REVIEW",
risk_level: "HIGH",
regulation: "FDA SaMD — 21 CFR 880",
audit_trail_id: "LO-2024-00847"
}
Risk Surface Scanner
Point LumeOps at any AI vendor, model, or integration. We surface algorithmic bias risks, PHI data leakage vectors, model failure modes, and patient safety edge cases that your legal team would miss.
- Bias detection across patient demographics
- Data flow and PHI exposure mapping
- Vendor Business Associate Agreement review
- Failure mode and safety impact analysis
// Risk Surface Scanner
const result = await lumeops.analyze({
workflow: "sepsis-prediction-model",
department: "critical-care",
vendor: "vendor-name",
});
// Response
{
verdict: "REQUIRES_REVIEW",
risk_level: "HIGH",
regulation: "FDA SaMD — 21 CFR 880",
audit_trail_id: "LO-2024-00847"
}
Compliance Evidence Vault
Every assessment, scan, and decision automatically generates audit-ready documentation. Map your AI controls to HIPAA, SOC 2 Type II, EU AI Act, and CMS requirements — export everything your auditors need.
- Auto-generated control mappings
- Timestamped decision audit trails
- One-click auditor export packages
- Continuous compliance monitoring
// Compliance Evidence Vault
const result = await lumeops.analyze({
workflow: "sepsis-prediction-model",
department: "critical-care",
vendor: "vendor-name",
});
// Response
{
verdict: "REQUIRES_REVIEW",
risk_level: "HIGH",
regulation: "FDA SaMD — 21 CFR 880",
audit_trail_id: "LO-2024-00847"
}
Every major framework. One platform.
LumeOps maps your AI use cases and controls to the regulatory frameworks that matter — so you are never caught off guard by an audit.
HIPAA
Health Insurance Portability and Accountability Act
- Privacy Rule mapping
- Security Rule technical safeguards
- Breach notification requirements
- BAA validation for AI vendors
EU AI Act
European Union Artificial Intelligence Act
- High-risk AI classification
- Conformity assessment support
- Human oversight documentation
- Post-market monitoring
SOC 2 Type II
Service Organization Control 2
- Trust Services Criteria mapping
- Availability and security controls
- Vendor risk management
- Evidence collection automation
FDA 21 CFR
Software as a Medical Device (SaMD)
- SaMD classification guidance
- 510(k) pre-submission support
- Quality Management System
- Post-market surveillance
Why act now
The regulatory pressure on healthcare AI is escalating fast.
2024
FDA finalizes AI/ML-based SaMD action plan
2025
EU AI Act obligations take effect for high-risk systems
2026
Full EU AI Act enforcement — healthcare AI audits begin
2027+
CMS reimbursement linked to AI safety documentation
Transparent pricing. No surprises.
Start with a free trial. Scale as your AI governance needs grow. No setup fees, no hidden costs.
Starter
For digital health startups and small clinics evaluating AI tools.
- 50 AI use case assessments/month
- Risk Surface Scanner — 5 vendors/month
- HIPAA compliance mapping
- PDF report generation
- Email support
Professional
For mid-sized health systems and health IT vendors deploying AI.
- Unlimited use case assessments
- Risk Surface Scanner — unlimited
- HIPAA + SOC 2 + EU AI Act mapping
- Compliance Evidence Vault
- Audit-ready export packages
- API access
- Dedicated compliance advisor
Enterprise
For large health systems, payers, and enterprise health IT vendors.
- Everything in Professional
- Custom regulatory framework support
- SSO and enterprise integrations
- White-label report branding
- On-premise deployment option
- SLA-backed uptime guarantee
- Dedicated implementation team
All plans include a 14-day free trial. No credit card required.
Early access pricing locked in for life for founding customers.
Get ahead of the
AI governance curve.
Join healthcare organizations and health IT vendors getting early access to LumeOps before the EU AI Act enforcement deadline.
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