Healthcare. Audit-ready software supply chain assurance, without slowing the ward.
Hospital networks, device manufacturers, and digital-health platforms operate under HIPAA, FDA SaMD, and a patching calendar dictated by clinical operations. Safeguard cuts the patch window with reachability, ships FDA-ready SBOMs per release, and runs air-gapped where egress is not an option.
Patient safety is a supply chain problem.
Regulator, manufacturer, and clinical-operations pressures all land on the same evidence requirement.
HIPAA + HITECH
Every dependency in the stack must be audited, and customer data must not enter inference. Vendor breaches that leak PHI carry both regulatory penalties and patient-trust damage that compounds for years.
FDA / SaMD
Connected medical-device software has stringent SBOM and vulnerability-disclosure requirements under FDA premarket guidance. The bar is no longer best-effort — it is binary, and submissions are rejected without it.
Slow patching windows
Clinical systems cannot be rebooted casually. You need to know precisely what is reachable in a running deployment before scheduling change windows that may take weeks to negotiate with clinical operations.
Vendor breach blast radius
One breached vendor can affect millions of patients across hospital networks. Shared transitive dependencies in the EHR, imaging, and lab-integration stack make blast-radius modelling a board-level requirement.
Platform capability mapped to clinical reality.
Reachability-first triage cuts the patch window
Focus on the small percentage of CVEs that actually reach a vulnerable code path in your deployment. Clinical change windows become tractable when the worklist is ranked by exploitability, not by severity alone.
Per-release signed SBOMs and provenance
Attestations satisfy FDA SaMD premarket SBOM requirements out of the box. Every build produces a CycloneDX SBOM, a signed provenance statement, and a VEX document that maps to the submission template.
TPRM with HIPAA-aligned questionnaires
Continuous third-party risk scoring with HIPAA-aligned questionnaire automation. The annual vendor review becomes a live dashboard with evidence pinned to the latest scan, not a stale PDF in a shared drive.
Air-gapped deployment for hospital networks
For hospital networks where internet egress is not an option. The entire stack — engine, models, signing infrastructure, vulnerability feed — runs inside the clinical perimeter, with offline update bundles.
Frameworks the platform is mapped to.
Pre-mapped control narratives and evidence in the formats your auditor, regulator, and FDA reviewer already accept.
A typical deployment inside a hospital network.
Dedicated cluster, optional on-prem GPU for sensitive environments, signed SBOMs published per release, and continuous TPRM streamed into the hospital SIEM.
Dedicated cluster
Single-tenant control plane and inference cluster for the hospital network. No cross-tenant traffic, deterministic latency, SHA-pinned weight attestation.
On-prem GPU optional
For the most sensitive environments — radiology, lab, EHR — GPU lives inside the clinical perimeter. No internet egress required for inference.
Signed SBOMs per release
CycloneDX SBOMs and signed provenance statements published with every release, ready to attach to FDA SaMD submissions and customer security reviews.
Continuous TPRM + SIEM integration
Continuous third-party risk scoring across the vendor stack, with every action emitting a signed event to the hospital's SIEM for retention and search.
Four surfaces where patient safety and software risk meet.
Connected medical devices
Every device with a network stack is now subject to FDA SaMD SBOM requirements. Pumps, monitors, imaging endpoints — each is a release artefact that needs signed provenance and a VEX statement on every submission.
HIPAA-protected data residency
Customer data must not enter inference. PHI stays on-device or in-tenant; model calls run inside the clinical perimeter. There is no acceptable workflow that ships PHI to a third-party cloud for processing.
Slow patching windows
Clinical systems cannot reboot casually — change windows are negotiated with clinical ops in weeks, not hours. Reachability analysis tells you what is actually exposed so the window is spent on real risk.
Vendor blast radius
One breached vendor can cascade to millions of patients across hospital networks. Recent payer-scale events were the warning. Continuous TPRM at the component level is no longer optional.
What is hitting hospitals and device makers right now.
- FDA premarket SBOM scrutinyEvery release ships with signed CycloneDX or SPDX provenance attached to the submission.We address this through Signed SBOM + attestation
- HIPAA / HITECH cross-border + access loggingAuditable trail of every access to PHI, with residency-aware controls and break-glass evidence.We address this through Compliance evidence pipeline
- Ransomware targeting hospital chainsCascading clinical-system failures when one shared dependency or one upstream tool is compromised.We address this through Eagle reachability + KEV prioritisation
- Third-party EHR / billing / insurance compromiseContinuous TPRM scoring across every vendor with access to clinical data.We address this through TPRM with concentration heatmap
- Coordinated disclosure on connected-device CVEsField-patch windows of weeks; reachability decides what actually needs the emergency window.We address this through Reachability-first triage
Quantified benefits for healthcare.
What changes for hospital security teams and device manufacturers in the first quarter of production use.
| Metric | Before Safeguard | With Safeguard (typical) |
|---|---|---|
| FDA premarket SBOM prep / release | ~2 weeks | ~30 min |
| Patch window via reachability | ~21 days | ~4 days |
| HIPAA evidence audit prep | ~6 weeks | ~2 days |
| Critical-vendor monitoring | Monthly review | Continuous |
| Tool consolidation | 5 vendors | 1 |
| Alert volume per service / month | ~2,100 | ~210 |
| MTTI on a vulnerable connected device | Weeks | Hours |
Audit-ready evidence. Trust you can prove.
Talk to the team about FDA SaMD submission packages, HIPAA-aligned TPRM, and air-gapped deployments inside hospital networks.