HIPAA-Aligned AI for Healthcare & Life Sciences

Your Compliance Officer Will Ask About AI.
We Built the Answer.

Private AI platforms deployed inside your HIPAA-aligned, BAA-covered Azure subscription. Zero PHI or IP egress. Zero model training on your data. Mapped to HIPAA Privacy & Security Rules, 21 CFR Part 11, and ISO 13485 — same architecture that passed scrutiny at a Tier 2 defense supplier under ITAR/CMMC.

BAA Covered End-to-End

Part 11 Audit-Trail Ready

ISO 13485 QMS-Mapped

Zero PHI / IP Egress

HIPAA Privacy & Security Rules 21 CFR Part 11 & Annex 11 SOC 2 Type II Architecture

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The Healthcare & Life Sciences AI Problem

Three forces converge on every compliance officer, CIO, QA lead, and VP Regulatory Affairs in healthcare. Most conclude they can't safely use AI — and most are wrong about why.

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Consumer AI Is a Reportable Disclosure

ChatGPT, Copilot, and consumer tools transmit data to vendors that aren't BAA-covered for PHI and aren't 21 CFR Part 11 validated for regulated R&D. A clinician pasting a patient note or a scientist pasting an IND draft is a reportable disclosure under HIPAA or an IP loss under your CDA — every single time.

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Shadow AI Is Already Inside Your Walls

Your clinicians, scientists, and engineers are using AI tools right now — they just aren't telling you. Every CISO, CMIO, and Head of Compliance we talk to confirms this. The exposure is happening; the audit log doesn't exist; OCR or FDA will eventually ask.

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"AI-Enabled" SaaS Is a Black Box

Vendors layering "AI features" onto EHRs, CTMS, eQMS, and ERPs typically run inference on their infrastructure under their terms — not yours. The BAA may not reach the inference layer. The audit trail may not be tamper-proof. The validation package may not satisfy your CSV team.

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The Cost of Doing Nothing Is Now Visible

Your peers are running AI on prior auth, clinical documentation, IND drafting, complaint coding, and CER refresh today — inside their own perimeters. Doing nothing means paying for the same regulator's expectation of AI capability without any of the operational benefit.

Built for Three Healthcare Pillars — Same Architecture, Different Pain

One private AI architecture, mapped to the three healthcare regulatory regimes that actually matter: HIPAA for providers, 21 CFR Part 11 for pharma R&D, and ISO 13485 / 21 CFR 820 for medical devices. Each pillar gets a deployment that speaks its compliance language.

For Hospitals, IDNs, AMCs & Payors

Provider / Hospital

HIPAA-defensible AI inside your existing Microsoft BAA. Closes the shadow-AI exposure that every CISO knows is happening but can't prove.

Clinical documentation summarization
Prior-auth letter drafting
Claims & denial-management triage
RCM throughput automation
Patient-outreach content drafting

HIPAA Privacy HIPAA Security HITECH BAA

For Pharma, Biotech & CROs

Pharma & Biotech R&D

21 CFR Part 11 / Annex 11-defensible AI on regulated R&D data. Protects pre-IND IP and accelerates regulatory submission cycle time.

IND / NDA / BLA module drafting
Protocol & SAP authoring
CMC documentation drafting
Pharmacovigilance signal & AE narratives
Literature review at scale

21 CFR Part 11 Annex 11 ICH E6(R3) GxP

For Med Devices, IVD & SaMD

Medical Devices

21 CFR 820 / IEC 62304 / ISO 13485-defensible AI inside your QMS. Cuts 510(k) and CER cycle time without breaking the design controls.

DHF & complaint retrieval
510(k) / De Novo / PMA drafting
CER refresh under EU MDR
Complaint coding & AE narratives
CAPA root-cause pattern detection

21 CFR 820 IEC 62304 ISO 13485 EU MDR

AI That Lives Inside Your Compliance Perimeter

Your PHI, your IP, your DHF — none of it leaves your security boundary. The AI model never trains on your data. Microsoft's BAA + DPA contractually guarantee it.

Your Compliance Perimeter

Azure subscription · BAA-covered

AI Brain — your institutional knowledge

Vector Database — encrypted, no egress

Audit Trail — Part 11 / HIPAA-grade, tamper-proof

RBAC — role + study + program segregation

Source Code — you own everything

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API Boundary

Zero PHI / IP Egress

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Pre-Trained LLM

No Training on Your Data

Pre-trained on public data only

Stateless — no memory between queries

Your data never modifies the model

Microsoft BAA + DPA guarantee

US sovereign regions only

HIPAA

Privacy + Security Rules

Part 11

Electronic Records

820 / 13485

QMS & Design Controls

SOC 2

Type II Architecture

What we cover on a 30–45 minute call

Focused discovery — not a slide deck. Engineers who've deployed private AI inside Azure for ITAR/CMMC programs and translated the same architecture into HIPAA, Part 11, and ISO 13485 environments.

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Your Current Architecture Review We'll map where your data and your existing BAA / QMS sit today and identify the gaps before AI enters the picture.
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HIPAA / Part 11 / ISO 13485 Control Mapping See how AI maps clause-by-clause to the framework that matters most to your organization — built into the architecture, not bolted on.
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BAA & Audit-Log Walk-Through We'll show you exactly what your existing Microsoft BAA already covers and the audit log your OCR investigator, FDA inspector, or notified body will ask for.
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Real Deployment Walkthrough See the actual platform we built — the architecture that passed CMMC scrutiny on ITAR-controlled program data, translated to your healthcare regulatory frame.
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Non-PHI / Non-Regulated Quick-Win Roadmap Start AI on AP automation, contract analysis, or commercial-team enablement now — prove the architecture before you put PHI or regulated R&D data anywhere near it.

If this architecture can pass DIBCAC scrutiny on ITAR-controlled F-35 program data with zero AI-related findings, it can carry a HIPAA Security Rule audit, a Part 11 inspection, or a notified body's review of an ISO 13485-managed QMS.

— nBrain AI, deployed under ITAR/CMMC and translated into healthcare frameworks

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One Architecture, Three Frameworks

Each row is an architecture component. Each column is a regulatory regime. Same platform — three audit answers.

Architecture Component	HIPAA (Provider)	21 CFR Part 11 (Pharma R&D)	21 CFR 820 / ISO 13485 (Devices)
Zero retention by AI model	Privacy Rule §164.502	§11.10(a) records integrity	820.40 document control
Encryption at rest (AES-256)	Security Rule §164.312(a)(2)(iv)	Annex 11 §7.1 data security	820.30(g) design transfer
Encryption in transit (TLS 1.3)	Security Rule §164.312(e)	Annex 11 §5 data integrity	820.70 production controls
RBAC + least-privilege access	Privacy Rule "minimum necessary"	§11.10(d) authority checks	ISO 13485 §7.5.6 traceability
Tamper-proof audit logging	Security Rule §164.312(b)	§11.10(e) audit trails	820.180 records retention
Source citation on every output	Clinical-accuracy attestation	§11.10(b) record reproduction	820.30 design verification
BAA / DPA / QMS coverage	Business Associate Agreement	Annex 11 §3 supplier mgmt	ISO 13485 §7.4 purchasing
Validation / IQ-OQ-PQ artifacts	Risk Analysis §164.308(a)(1)	CSV under Annex 11 §4	IEC 62304 software lifecycle
US-only data residency	BAA territorial scope	Sponsor / CRO data sovereignty	Technical-file localization

Your CISO, QA Lead, and VP RA All Defend the Same Thing. We Built One Architecture That Carries All Three.

The HIPAA-aligned BAA architecture, the 21 CFR Part 11 control mapping, and the 21 CFR 820 / IEC 62304 / ISO 13485 mapping — already built. Grab 30–45 minutes; we'll walk your team through it.