A private AI platform deployed inside your own HIPAA-eligible Azure subscription, under your Microsoft BAA. PHI is never used to train public models. Mapped to the HIPAA Privacy and Security Rules, 21 CFR Part 11, and 21 CFR 820 / ISO 13485, using the same architecture we run for a Tier 2 defense manufacturer under ITAR and CMMC rules.
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The same platform is already running real work for nBrain clients in regulated industries.
These results come from nBrain clients across industries. None of them is a healthcare client, and none involves PHI.
Four forces land on every compliance officer, CIO, QA lead, and VP of Regulatory Affairs in healthcare at the same time.
ChatGPT, Copilot, and other consumer tools send data to vendors that aren't covered by a BAA for PHI and aren't validated under 21 CFR Part 11 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. The CISOs, CMIOs, and heads of compliance we talk to confirm it. The exposure is happening, the audit log doesn't exist, and OCR or FDA will eventually ask.
Vendors adding AI features to EHRs, CTMS, eQMS, and ERPs usually run inference on their own infrastructure, under their terms, not yours. The BAA may not reach the inference layer. The audit trail may not be tamper-evident. The validation package may not satisfy your computer system validation team.
Your peers are running AI on prior authorization, clinical documentation, IND drafting, complaint coding, and clinical evaluation report refreshes today, inside their own perimeters. Doing nothing means meeting the same regulator expectations without any of the operational benefit.
One private AI architecture, mapped to the three regulatory regimes that matter most in healthcare: HIPAA for providers, 21 CFR Part 11 for pharma R&D, and ISO 13485 / 21 CFR 820 for medical devices. Each deployment speaks its own compliance language.
AI you can defend under HIPAA, running inside your existing Microsoft BAA. It closes the shadow-AI exposure every CISO knows is happening but can't prove.
AI you can defend under 21 CFR Part 11 and EU Annex 11, on regulated R&D data. It protects pre-IND IP and shortens regulatory submission cycles.
AI you can defend under 21 CFR 820, IEC 62304, and ISO 13485, inside your QMS. It shortens 510(k) and clinical evaluation report cycles without breaking design controls.
Your PHI, your IP, and your design history file stay inside your security boundary. The model never trains on your data. Microsoft's BAA and data protection addendum commit to that in writing.
Covered by your BAA
Reached through endpoints you approve. No training on your data.
Each row is a part of the architecture. Each column is a regulatory regime. Same platform, three audit answers.
| Architecture component | HIPAA (providers) | 21 CFR Part 11 (pharma R&D) | 21 CFR 820 / ISO 13485 (devices) |
|---|---|---|---|
| No retention by the AI model | Privacy Rule §164.502 | §11.10(a) record 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 |
| Role-based, least-privilege access | Privacy Rule minimum necessary | §11.10(d) authority checks | ISO 13485 §7.5.6 traceability |
| Tamper-evident 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, and QMS coverage | Business associate agreement | Annex 11 §3 supplier management | ISO 13485 §7.4 purchasing |
| Validation and IQ / OQ / PQ artifacts | Risk analysis §164.308(a)(1) | Computer system validation, Annex 11 §4 | IEC 62304 software lifecycle |
| US-only data residency | BAA territorial scope | Sponsor and CRO data sovereignty | Technical file localization |
This is how the architecture lines up with each framework. It is not a legal opinion or an attestation. Under the FDA's Quality Management System Regulation, in effect since February 2026, the legacy 820 section numbers are kept here as a crosswalk; your regulatory counsel confirms the final mapping. For the clause-by-clause versions, read the HIPAA architecture whitepaper and the medical device QMS mapping.
You talk with engineers who have deployed private AI inside Azure for ITAR and CMMC programs, and who have translated the same architecture into HIPAA, Part 11, and ISO 13485 environments.
If this architecture can carry ITAR-controlled defense program data, it can carry a HIPAA Security Rule audit, a Part 11 inspection, or a notified body's review of an ISO 13485 QMS.
Prefer to pick a time directly? Book with Cary Johnson →
The HIPAA architecture, the 21 CFR Part 11 control mapping, and the 21 CFR 820 / IEC 62304 / ISO 13485 mapping are already built. Give us 30 to 45 minutes and we'll walk your team through them.
Prefer email? hello@nbrain.ai