AI-powered compliance solution enabling healthcare providers to automate audit processes, detect algorithmic biases, and maintain real-time regulatory adherence across medical AI systems. Reduces compliance risks by 65% through automated report generation and pre-certification templates.
HealthAI Auditor addresses critical compliance challenges for healthcare institutions deploying AI diagnostic tools. This AI-driven platform offers real-time monitoring of algorithmic decision-making, automated audit trail generation, and bias detection across 18+ medical use cases. Designed for 500+ bed hospitals and telemedicine providers, it integrates directly with Epic/Cerner systems while ensuring GDPR/HIPAA/EU AI Act compliance through dynamic regulatory updates.
Core Functionality
- Automated regulatory checks for GDPR/HIPAA/Algorithmic Accountability Act
- Bias detection models monitoring diagnostic accuracy disparities
- Blockchain-secured audit trail generation
- Real-time dashboard with compliance scoring
- API integrations with major healthcare AI platforms
Target User and Segment
Primary: Compliance officers at 500+ bed hospitals implementing predictive diagnostics. Secondary: Healthtech startups requiring FDA/EU MDR pre-certification support. Serves 23 high-risk medical AI use cases including sepsis prediction and radiology analysis.
Recommended Tech Stack
- Frontend: React + TypeScript RBAC dashboard
- Backend: Python/Django API with Celery queue
- AI Core: PyTorch/TensorFlow models + Hugging Face NLP
- Compliance DB: Neo4j knowledge graph updated via regulatory APIs
Estimated MVP Hours and Costs
€65k-€85k development budget (650-850 hours @ €100/h):
- AI Audit Engine: 300h
- Regulatory DB: 200h
- Reporting Suite: 150h
- Platform Integrations: 100h
SWOT Analysis
- Strengths: First-mover in EU AI Act compliance tooling
- Weaknesses: Dependency on regulatory API access
- Opportunities: Expansion to fintech via PSD3 regulations
- Threats: Open-source alternatives from academia
First 1000 Customers Strategy
Acquisition via:
- Epic/Cerner consultant partnerships (40%)
- LinkedIn ABM campaigns targeting compliance officers (30%)
- HIMSS/RSNA co-branded webinars (30%)
€300 CAC with 7% webinar-to-trial conversion
Monetization
- Model: Tiered SaaS (€1,500/mo + €0.25 per inference)
- Break-even: 82 subscribers (€123k MRR)
- Team: 5 FTEs (Regulatory Lead, MLOps Engineer, Healthcare Architect, 2 Developers)
Market Positioning
€420M TAM in EU/US healthcare compliance tech. Differentiated through pre-certified templates for medical AI. Co-sell via compliance consultancies (20% rev share). Outperforms Holistic AI in medical specificity.
