EU AI Act · BfArM · DiGAV Ready
Clinical Compliance
for Mental Health AI
Real-time validation of AI therapy conversations. Detect suicide risk, bias, and policy violations. Generate BfArM-ready audit reports in one click.
Why Digital Health Teams Choose Us
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Real-Time Risk Detection
AI analyzes every conversation for suicide ideation, manipulation, and bias — before the patient sees the response.
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1-Click Audit Reports
Generate regulator-ready compliance documentation. BfArM, EU AI Act Article 5, DiGAV — all mapped automatically.
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Tamper-Proof Audit Trail
Every validation is cryptographically signed (SHA-256). Local, immutable proof that your safety layer was active.
<20ms
Neural Inference
10K+
Agent Fleet Ready
100%
Crisis Recall
EU AI Act is Here. Are You Ready?
Mental health chatbots are classified as high-risk AI systems. Non-compliance means fines up to €35 million or 7% of global revenue.
Check Your AI Compliance Now