Healthcare AI.
Safe.
The observability layer for clinical LLMs. Know exactly where AI is safe, where it creates liability, and prove compliance to auditors — automatically.
Built for compliance with
Avg. time to compliance verdict
vs. weeks of manual legal review
Frameworks covered
6+
HIPAA · EU AI Act · SOC 2
Risk categories
40+
Bias · PHI · Safety · BAA
Radiology triage AI — Safe to Deploy
FDA 510(k) cleared · HIPAA compliant · Low risk
Do you know if your AI
is safe to deploy?
73% of health systems are piloting AI. Almost none have a formal process to assess risk, verify compliance, or prove safety to auditors.
Is this AI workflow safe for our patients?
Is our AI vendor actually HIPAA compliant?
How do we prove AI safety to our board?
Where could AI make care worse undetected?
LumeOps answers all of these — automatically.
Three modules.
One source of truth.
Governance, risk, and compliance in one workflow — no spreadsheets, no manual work.
Instant verdicts on any AI workflow.
Input any healthcare workflow. Get Safe / Risky / Prohibited in seconds — backed by live FDA, HIPAA, and EU AI Act databases.
- Regulatory citations for every verdict
- Department-specific risk profiles
- Batch analysis for procurement
// AI Use Case Classifierconst result = await lumeops.classify({workflow: "sepsis-prediction-model",dept: "critical-care",});// ✓ Response{ verdict: "REQUIRES_REVIEW",
risk: "HIGH",
regulation: "FDA SaMD — 21 CFR 880",
trail_id: "LO-2024-00847"
}
Every major framework.
One platform.
LumeOps maps your AI controls to every regulatory framework that matters.
HIPAA
Privacy & Security Rules + BAA validation
EU AI Act
High-risk classification + conformity
SOC 2 Type II
Trust Services Criteria mapping
FDA 21 CFR
SaMD classification + 510(k) guidance
CMS
Reimbursement & safety documentation
HL7 FHIR
Interoperability compliance
The regulatory clock is ticking
2024
FDA AI/ML SaMD action plan finalized
2025
EU AI Act obligations take effect
2026
Full EU enforcement — healthcare audits begin
2027+
CMS links reimbursement to AI safety docs
Simple, transparent
pricing.
14-day free trial. No credit card required.
Starter
For startups and small clinics
- 50 use case assessments
- 5 vendor risk scans
- HIPAA mapping
- PDF reports
Professional
For growing health systems
- Unlimited assessments
- Unlimited vendor scans
- HIPAA + SOC 2 + EU AI Act
- Compliance Evidence Vault
- API access + advisor
Enterprise
For large health systems & payers
- Everything in Pro
- Custom frameworks
- SSO + integrations
- On-premise option
- Dedicated team
Early access pricing locked in permanently for founding customers.
Get ahead of the
governance curve.
Join healthcare organizations securing their AI before the EU AI Act enforcement deadline.
14-day free trial · No credit card · Unsubscribe anytime