Why We Are Building Vikela, and Why TrustPoint Will Not Review Safety Cases Made With It

Every NHS organisation that deploys health IT, including AI, has to apply DCB0160. That means a named Clinical Safety Officer, a hazard log, risk assessments and a safety case that is kept up to date. It is not optional. DCB0160 is a legal requirement under section 250 of the Health and Social Care Act 2012, and it applies to the organisations that deploy technology, not only to the companies that make it.

In practice, most of this work still lives in spreadsheets, Word templates and email threads.

What goes wrong when the safety case is a folder

The problem is not that the people doing the work are careless. It is that the tools were never designed for it.

• Evidence scatters. The hazard log is in one file, the test evidence in another, the sign-off in someone's inbox.
• Versions drift. By the time a board asks to see the safety case, nobody is certain which copy is current.
• The record stops at go-live. A safety case written for procurement is a snapshot. AI keeps changing after sign-off, through model updates, new workflows and new users, and the snapshot quietly goes out of date.
• AI hazards do not fit the old templates. Automation bias, model drift, opacity and hallucination were never in the generic templates most organisations inherited.
• Capacity is thin. Accredited Clinical Safety Officers are in short supply, so governance becomes the bottleneck between an organisation's AI ambitions and a safe go-live.

All of this lands at exactly the moment boards are being asked to approve AI at pace. When a board or a regulator asks "how do you know this is safe?", a folder of documents is not a good enough answer.

What Vikela is

Vikela is an isiZulu word meaning to protect, to shield, to defend. It is a clinical safety platform that holds assessment, hazards, evidence and post-launch monitoring for digital health and clinical AI in one living record, under DCB0129 and DCB0160.

It follows the work a Clinical Safety Officer already does:

1. Capture. A guided workspace for each deployment: scope, clinical context, and a hazard log seeded with AI-specific hazard libraries.
2. Assess. Consistent risk scoring, mitigations and residual-risk decisions, with Clinical Safety Officer review and sign-off built into the flow.
3. Evidence. A Clinical Safety Case Report generated from the live record, so boards, auditors and regulators all see one source of truth.
4. Monitor. Post-deployment surveillance and incident linkage, so the safety case stays true after go-live.

Every decision is versioned, attributable and exportable. Evidence for a board, a CQC conversation or an audit becomes a by-product of doing the work, not a separate project.

Vikela does not replace the Clinical Safety Officer. The judgement, and the accountability, stay with a named person. The platform's job is to make that judgement visible, consistent and easy to evidence.

Why we started with the organisations that deploy

Most clinical safety tools are built for manufacturers and DCB0129. That makes sense commercially, but it leaves a gap. A supplier's safety case does not cover your workflows, your staff or your patients. That part belongs to the deploying organisation, and it is where accountability actually sits.

So Vikela is built first for NHS trusts, integrated care boards, primary care and other organisations that deploy technology. Suppliers can use it for DCB0129 too, but the deploying side of the standard is where we started.

Keeping our assurance work independent

TrustPoint Digital Health sells independent clinical safety assurance. Vikela is a TrustPoint Digital Health product. Those two facts could pull against each other, so I want to be clear about how we keep them apart.

Vikela is a separate product. Clients are never required to use it, and we don't review safety cases produced with it.

In practice, that means:

• You never need Vikela to work with TrustPoint. A Readiness Review, a safety case or a CSO retainer can be delivered in whatever tools your organisation already uses.
• We will not mark our own homework. If your safety case lives in Vikela, TrustPoint is not the right independent reviewer for it, and we will tell you so.
• Our advice does not depend on the tool. If your existing approach is working, we will say that, whether or not it involves Vikela.

Independence is the reason anyone should trust an assurance opinion. It would be a poor trade to weaken it in order to sell software.

Join the pilot

A free three-month pilot is open now for organisations deploying digital health or clinical AI. You can watch an 11-minute tour of Vikela working end to end, using fictional data, and join the pilot at vikela.app.

If you would rather talk it through first, book a 20-minute call.