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Ensuring Safety

Ensuring patient safety is paramount in deploying voice-based clinical AI. Unlike text tools where clinicians review outputs before they reach patients, HANA speaks directly to patients in real-time. To uphold rigorous safety standards, we incorporate advanced methods that reduce errors, mitigate risks, and enhance reliability. Our dual-model architecture and constrained generation collectively improve accuracy, reduce hallucinations, and ensure well-calibrated, trustworthy outputs.

Improved Calibration

Calibrated confidence refers to the alignment between the system’s predicted confidence scores and its actual observed accuracy. A well-calibrated system provides confidence levels that clinicians can reliably interpret as true indicators of prediction correctness. Unlike models prone to overconfidence, especially at higher confidence intervals, a calibrated model avoids falsely reassuring clinical teams with unjustifiably high certainty. Improved calibration directly supports safer and more informed clinical decisions, crucial in high-stakes scenarios where accurate confidence assessment helps prevent potential patient harm due to over-reliance on flawed outputs.

How HANA Achieves Calibration

Pre-Call Reasoning Engine:
  • Generates clinical question sets with associated confidence weights per question
  • Each question tagged with expected information yield score
  • Protocol branching decisions carry explicit confidence thresholds
  • If confidence falls below threshold, system escalates to human review rather than guessing
Real-Time Conversation Engine:
  • Monitors response quality against pre-computed expectations
  • Tracks semantic alignment between patient responses and expected clinical patterns
  • Flags unexpected responses for post-call clinical review
  • Never improvises clinical guidance — falls back to approved protocol language

Confidence Scoring

Scoring Dimensions:
  • Semantic Match (0.0–1.0): Does the patient response match the expected clinical entity?
  • Completeness (0.0–1.0): Did the patient provide all required information?
  • Consistency (0.0–1.0): Does the response contradict prior answers?
Composite Score = weighted_avg(semantic, completeness, consistency)
  • IF composite < 0.7 → Re-ask with clarification
  • IF composite < 0.4 → Flag for human follow-up
  • IF composite < 0.2 → Graceful handoff to staff

Calibration Validation

HANA validates calibration through continuous production monitoring:
  • Binned accuracy analysis: Group predictions by confidence level and measure actual accuracy per bin
  • Expected Calibration Error (ECE): Track weighted average gap between predicted confidence and observed accuracy
  • Per-protocol calibration: Each clinical protocol maintains its own calibration curve, updated with every completed conversation
  • Drift detection: Automated alerts when calibration degrades beyond acceptable thresholds

Reducing Hallucinations

By constraining the conversation engine to pre-approved response templates and grounding all entity references in verified data sources, HANA minimizes individual model biases and substantially reduces hallucinations.

Anti-Hallucination Architecture

Layer 1: Protocol Constraints
  • Only approved questions can be asked
  • Only protocol-defined branches can be taken
  • No freeform clinical advice generation
Layer 2: Entity Grounding
  • All patient references grounded in EHR data
  • Medication names validated against drug database
  • Clinical terms mapped to SNOMED CT / ICD-10 ontologies
Layer 3: Output Validation
  • Real-time semantic check against protocol
  • Post-utterance verification before voice delivery
  • Automated flagging of ungrounded statements
Layer 4: Human Oversight
  • All conversations logged and auditable
  • Flagged conversations reviewed within 24 hours
  • Protocol updates triggered by error patterns

Hallucination Monitoring

Metrics below are measured continuously across production conversations and updated as conversation volume grows. Current figures reflect internal evaluation across pilot deployments.
MetricTargetObserved
Ungrounded clinical entity rate< 0.1%0.03%
Protocol deviation rate< 0.5%0.2%
Patient-reported misinformation00
Automated safety flag rate< 2%1.1%
These metrics are derived from automated evaluation pipelines (LLM-as-judge + rule-based validation) and clinical team review of flagged conversations. Methodology and sample details available upon request.

Observational Safety Agents

Beyond the conversation engine’s built-in safety constraints, HANA deploys independent observational agents that monitor every conversation in parallel. These agents are architecturally separate from the conversation engine — they observe but do not generate responses — providing an independent safety layer.

Why Rule-Based, Not LLM-Based

A critical design decision: HANA’s observational safety agents are rule-based, not LLM-powered. This is intentional:
  • Full traceability: Every risk flag traces back to the exact words, phrases, or patterns that triggered it. No black-box reasoning in safety-critical decisions.
  • Deterministic behavior: Given the same input, the safety agent always produces the same output. No stochastic variation in risk detection.
  • Auditability: Clinicians and compliance teams can inspect exactly why a conversation was flagged, what threshold was triggered, and what protocol was activated.
  • Regulatory defensibility: In clinical safety, you need to explain why a decision was made. Rule-based systems provide this by construction.

Risk Detection Architecture

Direct Signal Detection:
  • Explicit self-harm language, suicidal ideation expressions, and crisis indicators
  • Medication misuse signals (e.g., “I took too many pills”)
  • Acute distress indicators requiring immediate clinical intervention
Associative Signal Detection:
  • Compound signals that individually seem benign but together indicate risk — for example, expressions of hopelessness combined with questions about methods or locations that suggest harmful intent
  • Context-dependent risk patterns developed from clinical literature and clinical team collaboration
  • These associative rules were developed over months of work with behavioral health clinicians across diverse patient populations
Vocal + Content Fusion:
  • When vocal intelligence detects prosodic stress markers and the rule-based agent detects risk-adjacent language, the combined signal is escalated even if neither alone would trigger
  • Text-prosody discrepancy (patient says “I’m fine” with flat affect and vocal tremor) generates a clinical review flag

Escalation Protocols

Each healthcare organization configures escalation protocols during onboarding:
  • 24/7 clinical coverage: If the organization has round-the-clock staff, the agent can initiate a warm transfer to a clinician
  • Emergency services: For organizations without 24/7 coverage, the agent follows a defined protocol — acknowledges its limitations, provides emergency contact information, and notifies the clinical team
  • Clinical team notification: All risk flags generate structured notifications with the triggering signals, conversation context, and patient information
HANA’s safety agents are guardrails, not clinical tools. They detect risk signals and activate clinic-defined protocols. They do not provide clinical assessment, diagnosis, or therapeutic intervention. The clinical response is always the responsibility of the healthcare organization’s care team.

Training Data Safety

To further ensure the safety and compliance of our clinical AI systems, we apply rigorous controls to the data used in training and evaluation.

Data De-identification

  • All real-world clinical data undergoes thorough de-identification, removing or obfuscating PII and PHI in accordance with HIPAA Safe Harbor and Expert Determination standards
  • Re-identification risk assessment performed on each de-identified dataset
  • Every de-identification operation logged with timestamp, method, and verification status

Synthetic Data Generation

  • Expert-designed clinical conversation templates covering common and edge-case scenarios
  • Demographic diversity across age, gender, language, and cultural backgrounds to reduce model bias
  • Complexity gradients from simple appointment confirmations to complex multi-condition medication reviews
  • Adversarial examples with deliberately ambiguous patient responses for robust edge-case handling

Scenario Coverage Without Risk

  • By blending de-identified data with synthetic examples, we ensure high scenario diversity while eliminating risks of privacy breaches or data leakage
  • Training data distributions monitored for demographic, geographic, and clinical condition balance
  • All training data practices audited against HIPAA, GDPR, and SOC 2 Type II requirements