Product Economics for HealthTech
Healthcare engineering operates under the tightest regulatory constraints in any industry. HIPAA, FDA, and CMS rules mean that every line of technical debt carries outsized risk.
HIPAA Debt
HIPAA compliance creates technical debt through encryption requirements, access logging, BAA management, and PHI handling. Non-compliance carries $1.5M+ in penalties.
Clinical AI Validation
AI/ML models used in clinical decision support require FDA oversight (SaMD), algorithmic validation, and ongoing performance monitoring.
Interoperability Mandates
HL7 FHIR, TEFCA, and CMS interoperability rules require API standards that add engineering complexity and compliance burden.
Slow Validation Cycles
Clinical validation timelines (months to years) make technical debt uniquely dangerous — you can't iterate fast when deployment requires regulatory clearance.
How I Help HealthTech Companies
- → Quantify HIPAA-driven technical debt and compliance carry costs
- → Audit clinical AI models for regulatory defensibility (FDA SaMD)
- → Calculate the economic impact of interoperability mandates on engineering capacity
- → Design validation-friendly architecture that minimizes rework