Do not confuse a working application with a commissioned clinical tool.

The code can be deployed for internal evaluation. Clinical use requires the following evidence, governance, privacy, security, and operations gates to be completed and documented.

Open

Evidence commissioning

Complete licensed database searches
Document dual screening and extraction
Finish formal RoB, GRADE, and AGREE II
Reconcile exact current labels and access dates
Obtain five named external specialist sign-offs
Freeze a commissioned release and change log

Open

Clinical validation

Write representative gold-standard cases
Blind-review retrieval relevance and output fidelity
Test rare, conflicting, and insufficient-evidence cases
Validate red-flag bypass and failure states
Define acceptance thresholds and rollback rules
Approve clinician onboarding and competency checks

Open

Privacy & security

Validate that raw quick-case text never leaves browser memory
Red-team quick-case parsing, ambiguity, and identifier rejection
Verify OpenAI Zero Data Retention project controls
Complete vendor, BAA/DPA, legal, and privacy review
Place the site behind Cloudflare Access
Verify no body logging across every layer
Run threat model, penetration test, and secret review
Approve incident-response and breach procedures

Open

Regulatory & quality

Complete FDA CDS/device classification assessment
Complete state professional-practice review
Establish a quality management and change-control owner
Define complaint, correction, and recall workflows
Approve labeling, intended use, and limitations
Validate accessibility against WCAG 2.2 AA

Open

Living evidence

Assign surveillance owners and cadence
Automate source discovery without auto-publishing
Require human evidence appraisal and approval
Publish cutoff, version, amendments, and corrections
Trigger urgent review for regulator safety actions
Test rollback to the previous evidence release

Open

Operations

Set rate, spend, timeout, and concurrency limits
Define downtime and API refusal behavior
Monitor service health without collecting case bodies
Provide a staffed clinician feedback channel
Audit access and offboarding
Schedule prompt, model, and evidence regression tests

Launch rule

If a required control cannot be verified, fail closed or keep the affected function in internal demonstration mode. No disclaimer substitutes for a missing safety control.