Clinical safety
Last updated 10 July 2026
AyrisIQ holds no patient records and makes no clinical decisions. But it helps draft the policies your staff act on — so we treat clinical safety as applicable, not as a box to argue our way out of.
Our DCB0129 position
We assess AyrisIQ as in scope of DCB0129 (clinical risk management for health IT) on a proportionate basis: the system's hazards are indirect — for example, an AI-drafted policy containing a wrong instruction that is then published — and our controls are built around exactly those pathways:
- mandatory named human review before any AI-drafted content is published;
- a content-preservation check that blocks silent loss or alteration of policy content;
- versioning with rollback, so a bad change is recoverable, and an audit trail showing who approved what.
We maintain a hazard log covering these pathways today, and have a named Clinical Safety Officer. A clinical risk management plan and a clinical safety case report are being put in place and will be complete before AyrisIQ takes paid NHS customers. Status is tracked on the compliance page.
Not a medical device
AyrisIQ has no diagnostic, treatment or prevention purpose and is not a medical device under MHRA regulations. We will reassess this position if the product's scope ever changes.
For your practice's DCB0160 duties
Practices deploying health IT have their own clinical-safety duties under DCB0160. We will provide an adoption pack — intended use, residual hazards from our hazard log, and safe-use instructions (chiefly: the human-review requirement) — so your DCB0160 assessment is an afternoon's work, not a project. Available via the evidence room as it lands.