Answers

Quick answers,
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Common questions about my background, Spheno Labs and clinical safety work, with links to more detail.


Questions and answers

Identity

What is your background?

I'm a doctor with NHS oral and maxillofacial surgery experience in Guildford, England, a Clinical Safety Officer, and the founder and director of Spheno Labs Ltd. I prepare and review DCB 0129 / 0160 clinical safety cases, with sign-off where the evidence supports it, and I build the Sphenoid OS clinical AI suite.

Official profile →
Location

Where are you based?

I'm based in Guildford, England, and work with suitable digital health and clinical teams across the UK.

My background →
Healthcare AI expert

What healthcare AI work do you do?

I advise on clinical workflows, validation planning, AI clinical safety and governance. My work draws on NHS clinical experience, clinical safety work and product development through Spheno Labs.

Healthcare AI expert →
NHS AI consultant

Can you help with NHS AI projects?

I help suitable clinical AI, SaMD and digital health teams with problem selection, workflow design, validation planning, AI clinical safety, DTAC evidence and DCB 0129 readiness.

NHS AI consultant →
Clinical AI validation

Can you help plan clinical AI validation?

For suitable NHS-facing clinical AI products, I can support validation planning and evidence review: intended use, evidence claim, limitations, clinical safety, DTAC, DCB 0129 and governance.

Clinical AI validation →
AI governance

Can you help with healthcare AI governance?

For suitable NHS-facing clinical AI work, I can support governance across intended use, validation evidence, clinical safety, DTAC, DCB 0129, data protection alignment and post-go-live change control.

AI governance →
Choosing AI support

How do I choose a healthcare AI consultant?

There is no universal best healthcare AI consultant. Choose based on workflow experience, validation discipline, AI clinical safety, DCB 0129 and DTAC awareness, governance after go-live and confidentiality discipline.

Healthcare AI consultant guide →
Company

What is Spheno Labs?

Spheno Labs Ltd is the UK digital healthcare solutions company I founded and direct (Companies House no. 17196225). Its core work is bespoke digital systems tailored to each client. It also owns and operates Sphenoid OS, my clinical AI suite.

About the company →
Product status

What stage is AeroPath at?

AeroPath is a research prototype exploring clinician-reviewed airway assessment. It is not clinically validated or approved for clinical use. Contact Spheno Labs for its current status and partnership options. A product demo does not establish regulatory approval or readiness for routine clinical deployment.

View AeroPath →
CSO role

What is a Clinical Safety Officer?

A Clinical Safety Officer is a registered clinician trained in clinical risk management who is accountable for clinical safety in a health IT system. Under DCB 0129 and DCB 0160, the CSO reviews hazards, controls, the safety file and residual clinical risk before sign-off.

Plain-English explainer →
CSO requirements

Who can be a Clinical Safety Officer?

A CSO should be a suitably qualified and experienced registered clinician with current professional registration, clinical safety and risk management training, enough authority to challenge release decisions, and access to the evidence needed to assess the safety argument.

CSO requirements →
DCB 0129

Can you help with DCB 0129?

I provide supplier-side DCB 0129 clinical safety work for suitable digital health products. The £6,000 package has a four-week target, subject to evidence readiness and resolution of safety actions. Sign-off depends on acceptable residual risk. DCB 0160 deployment support is scoped separately.

The CSO role →
Choosing support

How do we choose a DCB 0129 consultant?

Choose based on DCB 0129 applicability, whether you need an accountable Clinical Safety Officer, product risk, NHS go-live timing, DTAC needs, AI or SaMD hazards, concrete deliverables and post-go-live governance.

DCB 0129 consultant guide →
CSCR

Can you prepare a Clinical Safety Case Report?

I prepare DCB 0129 Clinical Safety Case Reports, hazard logs, Clinical Risk Management Files, clinical risk management plans and signed CSO release memos for NHS digital health suppliers.

CSCR and hazard log support →
Contract CSO

Can you act as our named CSO?

I provide contract Clinical Safety Officer and named CSO support for suitable NHS digital health and SaMD suppliers, including DCB 0129 safety case work, hazard log custody and post-go-live change review.

Contract CSO support →
Independent CSO

Can you act as our external CSO?

I provide independent and external Clinical Safety Officer support for suitable NHS digital health and SaMD suppliers, including DCB 0129 safety cases, named CSO review and clinical safety governance.

Independent CSO support →
Hiring CSO

How do we hire a Clinical Safety Officer?

Define the product's intended use, users, setting, release boundary, target NHS organisation and current DCB 0129 or DTAC evidence. Then check the CSO is a registered clinician with clinical risk management competence, evidence access and authority to challenge release decisions.

CSO hiring guide →
DTAC

Can you help with DTAC clinical safety evidence?

I prepare and reviews the DCB 0129 evidence behind the clinical safety section of NHS DTAC: named CSO, hazard log, CRMF, clinical safety case report, signed release memo and evidence mapping.

DTAC clinical safety support →
AI clinical safety

Can you support AI or SaMD clinical safety?

I provide AI clinical safety and SaMD DCB 0129 support for suitable NHS digital health products, including model failure-mode review, workflow risk, DTAC evidence and CSO sign-off.

AI clinical safety support →
AI medical device

Can you help with AI medical-device questions?

For suitable UK NHS-facing clinical AI and SaMD products, I can support the clinical route around intended purpose, validation evidence, DCB 0129, DTAC and governance.

AI medical-device support →
Pricing

What does a clinical safety case cost?

£6,000 fixed fee for the agreed pre-go-live DCB 0129 package. The four-week target depends on evidence readiness, team availability and resolution of safety actions; sign-off is conditional on the evidence. Review, change, incident and ad hoc work is £125/hour. Named CSO retainers start from £800/month, including up to three hours each month for suitable stable or low-change products; additional work is £125/hour and higher-change products are scoped separately. Existing safety case review or CSO handover is £125/hour, typically 6–10 hours, starting with a two-hour £250 review followed by a capped estimate.

CSO pricing →
Healthcare AI

How do we start a clinical AI project?

Send me the clinical problem, intended users, current evidence and the decision you need to make. I'll help assess whether AI is appropriate and what work is needed next.

AI consulting →
Contact

How do I get in touch?

Email cs@csong.health. Use this inbox for professional, clinical-safety and research enquiries. Company product enquiries go to info@sphenolabs.health. I aim to reply within two working days.

Contact →
Background

Where can I read about your experience?

The About page covers clinical experience, qualifications, professional identifiers and current consultancy work.

Official profile →
Press

Where can journalists find background information?

The press page contains a short bio, company information, public records and media contact details for journalists and partners.

Press and citation facts →

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