Security & Compliance Overview
Effective Date: August 4, 2024
We take patient data and device security seriously. This is your central hub for all things related to IntuBlade's security, privacy, and compliance posture.
Security Overview
- •AES-256 end-to-end encryption (device ↔ app ↔ cloud)
- •Signed firmware, secure boot, tamper-evident logs
- •Role-based access control, SSO/SCIM support
- •Third-party penetration testing and ongoing threat monitoring
- •Device logs and video storage can remain fully local or push securely to AWS
Compliance Overview
- •FDA-compliant Class I device
- •Built on ISO 13485 and 21 CFR 820
- •UDI tracking, post-market surveillance, and internal QA
- •HIPAA-aligned infrastructure and safeguards
- •Business Associate Agreement (BAA) applies automatically to HIPAA Cloud accounts
- •Data Processing Agreement (DPA) available upon request
Deployment Options
- •On-device only (air-gapped)
- •Hybrid (local video, cloud metadata – AWS us-west-2)
- •Fully cloud with secure video sync to encrypted S3