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.
Regulator, manufacturer, and clinical-operations pressures all land on the same evidence requirement.
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.
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.
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.
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.
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.
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.
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.
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.
Pre-mapped control narratives and evidence in the formats your auditor, regulator, and FDA reviewer already accept.
Dedicated cluster, optional on-prem GPU for sensitive environments, signed SBOMs published per release, and continuous TPRM streamed into the hospital SIEM.
Single-tenant control plane and inference cluster for the hospital network. No cross-tenant traffic, deterministic latency, SHA-pinned weight attestation.
For the most sensitive environments — radiology, lab, EHR — GPU lives inside the clinical perimeter. No internet egress required for inference.
CycloneDX SBOMs and signed provenance statements published with every release, ready to attach to FDA SaMD submissions and customer security reviews.
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.
Talk to the team about FDA SaMD submission packages, HIPAA-aligned TPRM, and air-gapped deployments inside hospital networks.