Medical safety is not a feature.
It's our foundation.
Homy's clinical intelligence system is built with safety-first architecture, human oversight protocols, and transparent decision-making at every layer.
Safety-First Architecture
Five core principles guide every decision in our system
Human-in-Loop Design
AI proposes, humans decide. No automated clinical conclusions without oversight.
Audit-Ready Decision Trails
Every decision logged and traceable from patient input to recommendation.
Medical Ontology Foundation
Reasoning grounded in validated medical frameworks like ICD-10 and SNOMED CT.
Continuous Validation Loops
Ongoing accuracy monitoring, clinical feedback, and model retraining.
Fail-Safe Protocols
Red-flag escalation, uncertainty thresholds, and override capabilities at all levels.
Regulatory Alignment
Designed with EU AI Act, GDPR, and medical safety requirements at the foundation.
"Every clinical decision point requires human review. No automated clinical conclusions without oversight."
Human-in-Loop Protocols
Detailed implementation of human oversight at every critical point
AI Proposes, Humans Decide
The AI system structures data and highlights clinical signals, but all final decisions require human review and approval.
Red-Flag Escalation to Clinicians
High-risk symptoms automatically trigger immediate clinician notification and review protocols.
Uncertainty Thresholds Trigger Review
When confidence levels fall below established thresholds, cases are automatically flagged for expert review.
Override Capabilities at All Levels
Clinicians can override any AI suggestion at any point, with full documentation of the override rationale.
Audit Logs for All Interactions
Complete audit trail maintained for every patient interaction, AI recommendation, and clinical decision.
Medical Ontology & Reasoning
Homy doesn't guess. It reasons using validated medical frameworks.
Symptom Extraction
Natural language narratives transformed into structured clinical symptoms.
Medical Ontology Mapping
Symptoms mapped to validated medical ontologies including ICD-10, SNOMED CT, and clinical guidelines.
Differential Pattern Generation
Multiple possible clinical pathways identified based on symptom patterns.
Risk Scoring
Clinical risk assessed with confidence intervals and uncertainty quantification.
Clinical Pathway Selection
Evidence-based care pathways recommended for clinician review and decision.
Validated Frameworks
- ICD-10 Clinical Classifications
- SNOMED CT Terminology
- Evidence-Based Guidelines
Validation & Testing
Systematic validation approach with continuous monitoring
Benchmark Dataset Selection
- Real-world clinical scenarios from primary care and urgent settings
- Expert-labeled ground truth by board-certified physicians
- Diverse patient demographics and clinical presentations
Clinical Expert Review
- Medical advisory panel with multi-specialty expertise
- Blind assessment protocols to prevent bias
- Inter-rater reliability checks for consistency
Continuous Monitoring
- Live accuracy tracking across all clinical domains
- Drift detection systems to identify performance changes
- Regular revalidation cycles with updated datasets
Regulatory Alignment
Designed with regulatory requirements at the foundation, not as afterthoughts
EU AI Act
Homy is classified as a high-risk AI system and meets all EU AI Act requirements:
- Risk Management SystemContinuous identification, assessment, and mitigation of risks
- Transparency ObligationsClear disclosure of AI system capabilities and limitations
- Human Oversight RequirementsHuman-in-loop design with override capabilities at all levels
- Technical DocumentationComprehensive documentation of system design and validation
GDPR Compliance
Full compliance with EU data protection regulations:
- Data MinimizationOnly essential health data collected and processed
- Purpose LimitationData used only for specified clinical care purposes
- User Consent ManagementExplicit consent obtained and managed throughout patient journey
- Right to ExplanationClear explanations of AI-driven recommendations provided
Medical Safety Standards
Adherence to medical device and healthcare software standards:
- Clinical Safety ClassificationMedical device pathway evaluation in progress
- Clinical EvaluationSystematic validation against clinical benchmarks
- Post-Market SurveillanceContinuous monitoring and improvement protocols
Audit Trails & Accountability
Full audit trail from patient input to clinical recommendation
Triage Decision Logging
Every triage decision fully logged with timestamp, input data, reasoning process, and final recommendation.
Input Data Versioning
Patient narratives and clinical data versioned to enable exact reconstruction of decision context.
Model Version Tracking
AI model versions tracked for every decision, enabling retrospective analysis and improvement.
Clinical Review Records
All human review actions documented with reviewer identity, timestamp, and decision rationale.
Override Documentation
Clinician overrides fully documented with original AI recommendation, override reason, and alternative decision.
Regulatory Audit Readiness
Complete audit trail maintains chain of custody for regulatory inspection and quality assurance.
Limitations & Boundaries
Transparency about what Homy does and does not do
What Homy Does NOT Do
What Homy DOES Do
Continuous Improvement
Safety is not a milestone. It's a continuous commitment.
Regular Accuracy Audits
Systematic review of system accuracy across all clinical domains on a continuous basis.
Clinical Feedback Loops
Direct feedback from clinicians integrated into model improvement cycles.
Model Retraining Protocols
Regular model updates with new clinical data and emerging best practices.
Safety Incident Reporting
Structured process for reporting, investigating, and learning from safety events.
External Review Processes
Independent expert review of system performance and safety protocols.
Regulatory Alignment Updates
Continuous monitoring and adaptation to evolving regulatory requirements.
"Safety is not a milestone. It's a continuous commitment."
Questions About Our Clinical Safety Approach?
We're committed to transparency. Reach out to learn more about our safety architecture, validation methodology, or regulatory compliance.