Independent clinical safety assurance
Clinician-led DCB0129 and DCB0160 assurance for suppliers and NHS organisations, from the first hazard log to monitoring after go-live. Built for digital health and clinical AI, where the risk keeps moving after sign-off.
Intended use, setting, users and the standards that apply.
Structured hazard workshops with your clinicians and engineers.
Mitigations tested, residual risk justified, gaps named honestly.
Clear accountability at sign-off, then a living record after go-live.
01 · WHO WE WORK WITH
You need a clinical risk management file an NHS CSO will accept, not one that triggers six weeks of questions.
The supplier's safety case does not cover your workflows, your staff or your patients. That part is yours.
02 · SERVICES
Most clients begin with a fixed-scope readiness review and decide what they need from there.
A focused look at where you stand against DCB0129 or DCB0160, with a prioritised gap list you can act on.
Fixed scope · ~2 days
Clinical risk management plan, hazard log and safety case report, developed with your team and ready for sign-off.
DCB0129 · DCB0160
Safety signals, incident review and hazard log updates for live AI, so the safety case stays true after go-live.
Ongoing · quarterly review
Clinical safety evidence and governance structures aligned to DTAC, so procurement does not stall on paperwork.
Evidence pack · review
03 · WHERE AI DEPLOYMENTS GO WRONG
What we look for first, and what we do about it.
| WHAT WE SEE | WHAT WE DO |
|---|---|
| Safety case written after go-live, to satisfy procurement | Build the hazard log alongside design decisions, so risk shapes the product rather than documenting it |
| Deployer assumes the supplier's DCB0129 covers them | Map local workflows, staff and patient groups to a DCB0160 case the organisation owns |
| Model updates ship without a safety review | Set change triggers that reopen the hazard log before release, not after an incident |
| No one is watching once it is live | Define safety signals, review cadence and a named owner for each residual risk |
04 · WHO YOU WORK WITH
Registered mental health nurse and accredited Clinical Safety Officer. Sarah has spent more than two decades in the NHS, including as a Chief Nursing Information Officer, leading electronic record migrations and regional mental health programmes.
She has authorised or reviewed clinical safety cases for more than 20 AI and digital health products, from ambient voice technology to virtual wards and mental health apps. Every engagement is led by a clinician who has carried the accountability.
ALSO FROM TRUSTPOINT
One living record of assessment, hazards, evidence and post-launch monitoring for organisations deploying digital health and clinical AI, under DCB0129 and DCB0160. A free three-month pilot is open now.
Vikela is a separate product. Clients are never required to use it, and we don't review safety cases produced with it.
05 · INSIGHTS
We take on a limited number of engagements each quarter so every client gets senior clinical attention. We reply within 5 working days.
Prefer email? hello@trustpointdigitalhealth.com