Security & Compliance Overview

Effective Date: 8/4/2024

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) available upon request

  • 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

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FAQ Highlights

Where is patient data stored?
AWS us-west-2 by default. Local and on-prem options available.

Can I run this offline?
Yes. All core functions run without internet, including lens-clearing spray and video capture.

Who controls data retention?
You do. Retention windows can be set from 7 days to 7 years. Default is 7 years.