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.
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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.
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.
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.
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.
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.
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.
HIPAA-defensible AI inside your existing Microsoft BAA. Closes the shadow-AI exposure that every CISO knows is happening but can't prove.
21 CFR Part 11 / Annex 11-defensible AI on regulated R&D data. Protects pre-IND IP and accelerates regulatory submission cycle time.
21 CFR 820 / IEC 62304 / ISO 13485-defensible AI inside your QMS. Cuts 510(k) and CER cycle time without breaking the design controls.
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.
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.
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.
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 |
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.
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