Clinical Decision Support & AI Safety — Deployment Gate Checklist

Purpose

This checklist helps teams decide whether a clinical decision support (CDS) or clinical AI tool is ready to move from pilot to broader deployment. Use it to capture required evidence, formalize acceptance criteria, ensure human factors and legal considerations are addressed, and define monitoring and rollback triggers so the system improves care without introducing avoidable risks.

How to use this checklist

Work through each group of items and attach evidence (test reports, meeting notes, screenshots, training records). Where thresholds or metrics are requested, record the measured baseline and the agreed trigger values. Local teams should adapt thresholds and timeframes to clinical context and risk.

Pre-deployment (must be completed before a go/no‑go decision)

1. Clinical validation
   • Independent clinical validation completed and documented (dataset, population, methods, performance metrics).
   • Key performance metrics reported (sensitivity, specificity, PPV/NPV, calibration where appropriate) and compared to clinical acceptance criteria.
   • Known limitations, edge cases, and expected failure modes documented and communicated.
2. Bias, fairness & data provenance review
   • Bias assessment performed and mitigation plan in place for identified risks.
   • Data lineage and training dataset provenance documented.
3. Human factors & workflow review
   • Human factors evaluation completed (usability tests, cognitive load assessment, alert design review).
   • Clinical workflow mapping completed — the CDS action and clinician responsibilities are explicit.
4. Legal, privacy & regulatory review
   • Privacy impact assessment completed and data-sharing agreements in place (if applicable).
   • Regulatory and institutional approvals acquired or a documented plan exists when required.
5. Technical validation & security
   • End-to-end integration tests with EHR and other systems passed (test logs attached).
   • Security review and access control checks completed.
6. Governance & roles
   • Deployment owner, clinical owners, monitoring owners, and incident responders are named with contact info.
   • Decision authority and escalation path documented.

Deployment (pilot and go‑live planning)

1. Pilot scope & objectives
   • Pilot sites/users defined and documented.
   • Sample size, pilot duration, and stopping rules established (e.g., pilot for a minimum of X weeks or Y patient encounters).
2. Training & communications
   • User training completed for participating clinicians; training materials and attendance records attached.
   • Clear clinician-facing guidance on when to trust, verify, or override the CDS output.
3. Acceptance testing
   • End-user acceptance testing completed and documented (sample cases, clinician feedback, observed workflow impacts).
   • Usability issues classified and mitigation actions assigned.
4. Rollout plan & change management
   • Phased rollout plan created (if applicable) with criteria to expand or pause deployment.
   • Communications plan and patient-facing messaging agreed where needed.

Post-deployment monitoring & safety

Monitor continuously and review at predefined intervals. Define what success looks like and what triggers investigation or rollback.

1. Monitoring dashboard configured
   • Dashboards for key metrics are live and accessible to monitoring owners.
2. Key monitoring metrics (examples — adapt locally)
   • Utilization / exposure rate (how often the tool fires).
   • Acceptance vs override rate (clinician accepts recommendation vs overrides).
   • Override rate baseline and threshold for action (example threshold: a sustained increase of override rate > absolute 5 percentage points or >50% relative increase from baseline — tailor to context).
   • Alert fatigue indicators (rising unused alerts, user complaints).
   • Clinical outcome sentinel checks (selected outcome(s) relevant to the CDS — e.g., unexpected adverse events, diagnostic error proxies).
   • Model performance & data drift metrics (statistical shifts in input distributions, performance degradation over time).
   • Incidents and near-miss reports related to the CDS.
3. Alerting & escalation
   • Automated alerts configured for threshold breaches and critical incidents.
   • Escalation procedures and contact list included in the monitoring pack.
4. Clinician feedback loop
   • Mechanism for clinicians to report concerns (in-EHR feedback, quick survey, or hotline) and a cadence for reviewing feedback.
5. Review cadence
   • Initial intensive review frequency defined (e.g., weekly during first month), then less frequent cadence (e.g., monthly) if stable.

Rollback & incident response

Explicit rollback triggers and the stepwise rollback plan reduce delays and unsafe drift.

1. Rollback triggers (examples — adapt locally)
   • Sustained, unexplained increase in override rates beyond threshold.
   • Clinically significant sentinel event plausibly linked to CDS output.
   • Severe EHR integration failures causing workflow or documentation loss.
   • Rapid model performance degradation or detected data drift that cannot be mitigated promptly.
2. Rollback plan
   • Steps to disable the CDS safely (who executes, how to switch off, how to revert configuration).
   • Communication templates to notify clinicians, patients (when appropriate), and regulators if required.
3. Incident response
   • Immediate containment actions, short investigation timeline, and long-term remediation plan with owners and deadlines.
   • Requirement to log all incidents and findings and to run root-cause analysis for serious events.

Sign‑off (required)

• Clinical lead name, role, signature and date
• Deployment/Operations owner name, role, signature and date
• Privacy/Legal/Regulatory approver name, role, signature and date
• Monitoring owner name, role, signature and date
• Final go/no‑go decision: proceed / proceed with conditions / hold / rollback

Included templates & quick reference (attach completed copies)

Teams should attach the following artifacts when they submit this checklist for governance review:

• Clinical validation report and test dataset summary
• Human factors/usability test report
• Integration test logs and EHR test cases
• Pilot plan (scope, duration, sample size, stopping rules)
• Operational monitoring pack (sample structure below)
• Incident response & rollback playbook

Sample Operational Monitoring Pack (minimum)

1. Live dashboard links for utilization, acceptance/override, and sentinel clinical metrics.
2. Weekly monitoring report template (items to report, owners).
3. Contact list and escalation matrix.
4. Recent clinician feedback log with actions taken.

Notes & adaptation guidance

Do not treat this checklist as a one-size-fits-all. High-risk decisions (e.g., autonomous actions, high-mortality conditions) require stricter validation, shorter monitoring cadences, and lower tolerance for unexpected changes. Document any local adaptations and reasons.