Cybersecurity & Data Privacy

Build secure-by-design into your AI medical product from the first sprint: SBOM, vulnerability monitoring, healthcare-specific regulatory constraints integrated rather than bolted on.

Overview

Healthcare cybersecurity is not just a compliance overlay. It is a design constraint that propagates through architecture, dependencies, deployment, and customer interactions. Late retrofits are expensive and rarely complete.

We bring the right discipline early: secure-by-design principles applied to your architecture, SBOM for every component, vulnerability monitoring instrumented from the start, and a regulatory roadmap that anticipates the 2025 FDA premarket cybersecurity expectations.

Our Process

  1. 1

    Threat modeling

    STRIDE / PASTA applied to your architecture.

  2. 2

    Secure-by-design review

    Architecture and dependency posture.

  3. 3

    SBOM construction

    Software Bill of Materials, with vendor evidence requests.

  4. 4

    Vulnerability monitoring

    Ongoing CVE feed against your SBOM.

  5. 5

    Regulatory alignment

    FDA premarket cybersecurity, NIST SP 800-218, MDS2.

Frequently Asked Questions

FDA premarket cybersecurity guidance?

Yes, the 2023 final guidance and ongoing updates.

What about MDS2?

Generated and maintained as a deliverable.

Generative AI components?

Treated with elevated scrutiny: supply chain risk, model risk, and prompt injection.

How does this interface with our SOC?

Integrated with your existing SOC or stood up alongside it.

Build security in from the start.

Send us your current architecture and dependencies. We will return a posture report within four weeks.

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