Healthcare AI with PHI redaction inline.
Providers, payers, and healthcare SaaS are deploying copilots fast. Regulators haven't slowed down either. ShadowIQ is built to keep PHI out of generative AI — without slowing clinicians.
Summary
ShadowIQ for Healthcare provides HIPAA-compliant AI governance with inline PHI redaction, HITRUST CSF alignment, FDA Software as a Medical Device (SaMD) controls, and cryptographic evidence for healthcare AI including clinical copilots, payer workflows, and health-tech SaaS.
Your healthcare stack, under one control plane.
You've heard this one before.
- Clinician copilots exposed to PHI no one tracked.
- FDA SaMD risk classification for LLM-backed features.
- 42 CFR Part 2 scope when AI touches SUD records.
- Prior-authorization AI under state scrutiny (CA AB 3030).
Three moves.
- 118 HIPAA identifiers, inline.
Context-aware PHI detection. Redact, tokenize, or deny before the model sees it. Zero PHI egress in production deployments.
- 2BAA-native routing.
Policy routes PHI-tagged workloads only to BAA-signed providers. Azure OpenAI (BAA), Bedrock (BAA), Anthropic Enterprise, Vertex (BAA) — each fenced.
- 3FDA-ready lifecycle.
Predetermined Change Control Plan (PCCP) templates, version control, performance monitoring per FDA's AI/ML action plan.
Numbers, not adjectives.
ShadowIQ integrates with what you already run.
We speak the compliance languages you do.
- HHS OCR (HIPAA)
- FDA
- ONC
- CMS
- 42 CFR Part 2
- State AGs
- HITRUST Alliance
“We went from 'should we let clinicians use AI' to 'here are the five approved assistants' in three months — and zero PHI has left the network.”
Asked, answered, sourced.
Yes, on Growth and Enterprise plans. We route PHI-tagged traffic only to sub-BAA-signed providers, and we produce signed BAA-compliance attestations for your quarterly audits.
Part 2 data gets a higher-sensitivity classification. Redaction is stricter, providers are further restricted, and the audit trail includes Part 2-specific attestations.
Yes. We produce the Predetermined Change Control Plan (PCCP), performance monitoring data, and change log in the format FDA review divisions expect. Customers have cleared 510(k) updates in 120 days.
Keep going.
Your 30-minute demo. A signed audit trail by the end of it.
We'll wire ShadowIQ into one live workload, block a prompt injection in real time, and hand you a cryptographic receipt — before the meeting ends.