AI Governance for Patient-Critical Software
When AI assists in developing medical device software, diagnostics, or clinical systems, regulatory accountability is non-negotiable. ByteVerity provides the governance infrastructure to prove AI followed your policies—before a single line of code was generated.
The Regulatory Reality
FDA, EMA, and global regulators are scrutinizing AI in medical device software. IEC 62304 requires documented software development processes. 21 CFR Part 11 demands audit trails with electronic signatures. When AI assists development, you need proof it followed your controls.
Detection-based approaches fail here. You can't tell regulators "we think the AI followed our policy." You need cryptographic evidence.
Regulatory Frameworks We Address
21 CFR Part 11
Electronic Records & Signatures
- Cryptographic signatures on all policy decisions
- Tamper-evident audit trails with timestamps
- Access controls enforced before AI generation
IEC 62304
Medical Device Software Lifecycle
- Documented inputs for AI-assisted development
- Traceability from requirements to implementation
- Change control with hermetic context snapshots
HIPAA
Protected Health Information
- Zero-knowledge architecture—no PHI exposure
- Crown Jewels zones for PHI-handling code
- Audit logs for access control compliance
EU MDR / AI Act
Medical Device & AI Regulation
- Human oversight via CISO-signed policies
- Risk management with zone-based controls
- Transparency via decision reasoning in logs
Healthcare AI Development Scenarios
From SaMD to clinical decision support—governance for every use case.
Software as Medical Device
AI assisting diagnostic algorithm development with frozen context snapshots for reproducibility.
Clinical Decision Support
Pre-generation enforcement ensures AI cannot modify patient-facing logic without approval.
EHR & Data Systems
Crown Jewels protection for PHI-handling code paths. Zero-knowledge governance.
Hermetic Generation for Regulated Industries
Layer 3 — Context Snapshots
For FDA submissions and regulatory audits, you need more than proof of policy compliance. You need reproducibility—the ability to show exactly what context AI used when generating code.
Avarion's Hermetic Generation freezes the exact context (source files, dependencies, documentation) before AI generates. Every output can be reproduced from the same inputs. Auditors verify the Merkle-hashed context, not your explanations.
Ready for FDA-Ready AI Governance?
See how Avarion provides the governance infrastructure healthcare organizations need for AI-assisted development.