Risk Management

Risk Mitigation

Eight material risk clusters have been mapped with concrete mitigation actions to protect valuation and ensure resilience.

High Risk

Regulatory & Quality

Core Threat

Algorithm updates trigger new submissions; cyber-security of PHI.

Mitigation Strategy

Internal RA/QA council; secure SDLC; ISO-27001 certification.

High Risk

Clinical Evidence

Core Threat

Interim sensitivity, high-usage subgroup powering.

Mitigation Strategy

RCT misses endpoint; augment with VA pilot data.

Medium Risk

Reimbursement

Core Threat

Delays at DoD/VA; CMS coding parallel.

Mitigation Strategy

Dedicated payer relations lead; CMS DME application.

Medium Risk

Data Privacy

Core Threat

HIPAA/GDPR violations; ransomware on cloud portal.

Mitigation Strategy

SOC-2 Type II; zero-trust architecture; annual penetration testing.

Early-Warning Triggers

Device SAEs
> 0.5%
FDA 15-day alert
Adherence
< 60%
Patient-advocate blitz
Net-Debt / EBITDA
> 3x
Freeze hiring
Cloud Breach
> Threshold
SIRT Activation

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