Clinical safety — DCB 0129 (manufacturer) and DCB 0160 (deploying organisation).

Our position, in detail

Clinical Safety Officer

A named Clinical Safety Officer (CSO) with a clinical background is responsible for the Halo clinical safety programme. The CSO reviews every new feature that could affect clinical outcomes before release.

Hazard log

Living hazard log covering every identified clinical hazard — false-negative alert, delayed alert, incorrect resident association, stale baseline, integration failure, and dozens more. Each hazard has: initial risk score, mitigation applied, residual risk score, verification method.

Clinical Safety Case Report

The Clinical Safety Case Report (CSCR) is refreshed at every material release and made available to deploying organisations to support their DCB 0160 obligations. Latest CSCR available on request.

Deployment risk management

For each customer deployment, we support the deploying organisation’s DCB 0160 process — providing the CSCR, participating in local hazard identification workshops, and adjusting the hazard log for customer-specific context.

Post-market surveillance

Every alert type is monitored per-tenant for suspicious drift in performance (rising false-positive rate, delayed acknowledgement pattern, dropped-alert rate). Detected drift triggers CSO review and, where needed, notification to affected customers.

Incident reporting

Any patient-safety-relevant incident is reported to the deploying organisation and, where required, to the MHRA under the Yellow Card Scheme. Incident learning is fed back into the hazard log.