Clinical safety readiness

Every AI-facing flow states that Healthy AI readiness is not medical advice, diagnosis, treatment guidance, or a safety certification.

Add plain-language limitation copy to onboarding, AI output, summaries, exports, and handoff screens.

The prototype has a documented risk class for wellness, admin, decision support, triage, diagnosis, medication, or emergency-adjacent use.

Classify the workflow, document excluded clinical scenarios, and route higher-risk use cases to qualified clinical and regulatory review.

The prototype identifies urgent symptoms, self-harm, medication, pediatric, pregnancy, and emergency-care boundaries with a non-AI escalation route.

Define escalation triggers, emergency copy, support ownership, and a hard stop for out-of-scope scenarios.

A qualified reviewer is accountable for approving evaluation scope, reviewing edge cases, and blocking unsafe release paths.

Name the reviewer, define their sign-off checklist, and require approval before any external pilot.

The team has a written decision record covering intended users, excluded uses, owners, sign-off roles, and review cadence.

Create a governance record with owners, intended-use boundaries, excluded uses, approval cadence, and change-control rules.

The team has documented PHI/PII boundaries, consent, retention, redaction, access control, and deletion handling.

Document what data is allowed, what is prohibited, how it is stored, who can access it, and when it is deleted.

Claims, prompts, known limitations, test cases, and observed failures are linked to a traceable evidence log.

Create an evidence log that ties claims to sources, test cases, failure examples, and reviewer notes.

Evaluation data covers representative cases, edge cases, demographic slices, language needs, and known failure modes.

Define validation slices, sample minimums, acceptance thresholds, and reviewer notes for failures and borderline cases.

The rollout plan includes monitoring signals, alert thresholds, staged exposure, user feedback review, and rollback criteria.

Define staged rollout gates, production monitors, alert owners, rollback triggers, and post-launch review cadence.

The team has an incident owner, severity levels, response times, rollback criteria, and a feedback-to-fix workflow.

Assign an incident owner, define severity levels, and connect feedback reports to the release-blocking review queue.