A Series B healthcare AI company prepared for regulatory audit and expanded to 3 new EU markets with comprehensive EU AI Act compliance—including 3 autonomous agents.
Company
MedAssist AI
Industry
Healthcare / Clinical AI
Company Size
180 employees
Stage
Series B (€32M raised)
AI Systems
8 (incl. 3 agents)
Risk Classification
6 High-Risk, 2 Limited
Time to Compliance
6 weeks
Markets Entered
Germany, France, Netherlands
MedAssist AI, a Series B healthcare technology company, faced a perfect storm: regulatory authorities announced increased scrutiny of healthcare AI, enterprise hospital systems demanded compliance proof, and the company needed to expand into three new EU markets simultaneously.
With 8 AI systems—including 3 autonomous clinical agents built on CrewAI—MedAssist needed comprehensive EU AI Act compliance that could handle the complexity of multi-agent healthcare AI.
Using Protectron, MedAssist achieved 94% compliance coverage across all systems in 6 weeks, generated over 120 pages of documentation, implemented full audit trails for their AI agents, and successfully entered Germany, France, and the Netherlands with compliant AI products.
MedAssist AI develops AI-powered clinical decision support tools used by 150+ healthcare facilities across Europe, processing 2M+ patient interactions monthly.
| System | Type | Function | Risk Level |
|---|---|---|---|
| Clinical Triage Agent | Autonomous Agent (CrewAI) | Triages patient symptoms, routes to appropriate care | High-Risk |
| Diagnostic Support Agent | Autonomous Agent (CrewAI) | Assists physicians with differential diagnosis | High-Risk |
| Care Coordination Agent | Autonomous Agent (CrewAI) | Coordinates care across multiple providers | High-Risk |
| Medical Coding AI | ML Pipeline | Automates medical coding from clinical notes | High-Risk |
| Appointment Optimization | ML Model | Optimizes scheduling and reduces no-shows | High-Risk |
| Clinical Documentation | LLM Application | Generates clinical notes from consultations | High-Risk |
| Patient Communication Bot | Chatbot | Handles routine patient inquiries | Limited Risk |
| Internal Knowledge Search | RAG System | Helps staff find clinical guidelines | Limited Risk |
In early 2025, MedAssist faced three simultaneous challenges:
The European Commission announced that healthcare AI would be a priority focus for EU AI Act enforcement, with audits beginning Q3 2025.
Three major hospital networks—Charité (Berlin), AP-HP (Paris), and Amsterdam UMC—required comprehensive EU AI Act compliance documentation.
Committed to investors to enter Germany, France, and the Netherlands by Q3 2025. Regulatory compliance was a prerequisite.
"When the Commission announced healthcare AI as a priority, our board asked one question: 'Are we ready for an audit?' The honest answer was no."
— Dr. Elena Vasquez, Chief Medical Officer
Three of their most critical systems were autonomous agents built on CrewAI. Traditional compliance approaches didn't address agent-specific requirements.
Clinical Triage Agent
├── Symptom Analyzer Agent
├── Risk Assessment Agent
├── Routing Decision Agent
└── Human Escalation Handler
Each agent makes autonomous decisions about patient care routing.Patient Interaction Flow:
Patient → Communication Bot → Triage Agent → Diagnostic Agent
↓
Care Coordination Agent
↓
Clinical Documentation AI
↓
Medical Coding AICompliance needed to cover the entire flow, not just individual components.
Cost
€420,000
Timeline
12-18 months
Limitation: No expertise in autonomous AI agents
Cost
€85,000 in legal fees
Timeline
6 weeks (incomplete)
Limitation: Agent systems remained undocumented—too complex
Cost
€150,000-300,000/year
Timeline
6-12 months
Limitation: None had EU AI Act modules or agent logging
"We tried everything. Consultants didn't understand agents. GRC platforms didn't understand EU AI Act. Internal efforts couldn't scale. We were spending money and getting nowhere."
— James Morrison, VP Compliance
MedAssist's CTO discovered Protectron while researching compliance solutions for CrewAI. The Agent Audit Trail feature was the differentiator.
"Every other solution treated AI as a black box. Protectron understood that agents are different—they make decisions, delegate tasks, collaborate. That's exactly what we needed to log."
— Dr. Michael Torres, CTO
| MedAssist Requirement | Protectron Solution |
|---|---|
| 8 AI systems, mixed risk levels | Multi-system dashboard with per-system tracking |
| 3 autonomous agents on CrewAI | CrewAI SDK with per-agent audit trails |
| Healthcare-specific documentation | Document generation with medical AI context |
| Hospital procurement requirements | Audit packages and certification badges |
| Multi-market expansion | Multi-language support (DE, FR, NL) |
| Regulatory audit preparation | Evidence management and compliance reports |
| Speed to compliance | 6-week implementation vs. 12-18 months |
Establish compliance infrastructure and classify all systems
| Activity | Output |
|---|---|
| Platform setup and team training | 8 users onboarded |
| Register all 8 AI systems | Complete system inventory |
| Risk classification for each system | 6 high-risk, 2 limited risk |
| Requirement mapping | 847 total requirements |
| Evidence repository setup | Existing docs uploaded |
Implement audit trails for autonomous agents
| Activity | Output |
|---|---|
| CrewAI SDK integration | 3 agents instrumented |
| Per-agent audit trail setup | Full decision logging |
| Human oversight integration | Approval workflows active |
| PII redaction configuration | HIPAA/GDPR compliant |
Generate all required documentation and compile audit packages
| Activity | Output |
|---|---|
| Technical documentation (8 systems) | 64 pages |
| Risk management system (6 high-risk) | 24 pages |
| Data governance documentation | 12 pages |
| Human oversight procedures (3 agents) | 8 pages |
| Policies and transparency docs | 16 pages |
from crewai import Agent, Task, Crew
from protectron.crewai import ProtectronCallback
# Initialize Protectron callback with healthcare-specific settings
callback = ProtectronCallback(
system_id="clinical-triage-agent",
environment="production",
# Healthcare-specific configuration
log_agent_thoughts=True, # Capture clinical reasoning
log_delegation=True, # Track agent-to-agent handoffs
log_collaboration=True, # Record multi-agent decisions
pii_redaction=True, # HIPAA/GDPR compliance
# Human oversight tracking
human_oversight_required=["routing_decision", "escalation"],
)
triage_crew = Crew(
agents=[symptom_analyzer, risk_assessor, routing_agent],
tasks=[analyze_task, assess_task, route_task],
callbacks=[callback] # Full audit trail
)Triage Session: TRG-2025-001234
├── 09:14:32 - Symptom Analyzer: Received patient input
│ └── Analysis: Identified 3 potential conditions
│ └── Confidence: 87%
│
├── 09:14:35 - Risk Assessor: Evaluated urgency
│ └── Risk Level: MODERATE
│ └── Reasoning: "Symptoms consistent with non-emergency..."
│
├── 09:14:38 - Routing Decision: Determined care pathway
│ └── Decision: Route to telehealth consultation
│ └── Alternatives considered: [ER, Urgent Care, Scheduled]
│
├── 09:14:40 - Human Oversight: Physician review
│ └── Action: APPROVED
│ └── Reviewer: Dr. [REDACTED]
│
└── 09:14:42 - Session Complete
└── Total agents involved: 3
└── Human interventions: 1
└── Audit trail: Complete94%
Overall compliance score
796/847
Requirements completed
124 pages
Documentation generated
89 documents
Evidence items linked
2.4M+
Agent audit events logged
Deployment: Clinical Triage + Diagnostic Support agents
Key Factor: Audit trail demonstration convinced medical informatics team
Deployment: Full platform (6 systems)
Key Factor: French-language documentation and CNIL alignment
Deployment: Care Coordination + Documentation AI
Key Factor: Dutch healthcare authority (IGJ) pre-approval
Germany
8 weeks to first deal
France
10 weeks to first deal
Netherlands
12 weeks to first deal
"We thought agent compliance would be our biggest challenge. It turned out to be our biggest differentiator. Competitors couldn't show what their agents were doing. We could show every decision, every delegation, every human intervention. That's why we won the hospital deals."
Dr. Michael Torres
CTO, MedAssist AI
"In healthcare, explainability isn't optional—it's ethical. The EU AI Act formalized what good medical AI should have been doing all along. Protectron helped us prove we were doing it right."
Dr. Elena Vasquez
Chief Medical Officer, MedAssist AI
"The agent audit trail changed everything. Before, I had to ask engineering 'what does this AI do?' and hope for a good answer. Now I can show anyone—regulators, hospitals, our board—exactly what every agent does, in real-time."
James Morrison
VP Compliance, MedAssist AI
Agent compliance requires agent-aware tools — Generic GRC platforms can't handle multi-agent workflows
Healthcare AI will be scrutinized first — Being prepared is a competitive advantage
Compliance enables market expansion — Three new markets opened because of compliance readiness
Document the journey, not just the destination — Agents make multiple decisions; log them all
Human oversight must be verifiable — Saying you have oversight isn't enough; prove it
MedAssist went from compliance uncertainty to €5.1M in hospital contracts and expansion to 3 new markets. See how Protectron can help your healthcare AI company.
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