Clinical safety consultancy helps digital health organisations manage the risk that health IT could cause or contribute to patient harm — so product, deployment and change decisions are evidence-led, proportionate and defensible.
Independent clinical safety consultancy for digital health suppliers, NHS organisations and other health and care providers — from early design through deployment, operation and change.
You are deploying digital technology into care pathways
03
You build software-as-a-medical-device or AI-enabled health technology
04
You are adapting an international product for the NHS and UK market
05
You are preparing for DTAC, procurement, pilot deployment or enterprise adoption
06
You are responding to clinical safety findings, incidents, audit actions or material system change
The service
Why does digital clinical safety matter?
Digital clinical safety assurance is the process through which health IT used by care professionals is assessed and governed so that associated clinical risks are identified, controlled and monitored. Clinical safety failures can arise from more than software defects. Risk may also result from poor workflow design, incomplete data, ambiguous alerts, unsafe configuration, weak integration, inadequate training, supplier dependencies or unmanaged change. Effective assurance must therefore connect technology, clinical practice and organisational governance. Typical stakeholders include Chief Clinical Officers, CMIOs, CCIOs, Clinical Safety Officers, Medical Directors, Product Leaders, General Counsel, DPOs, CISOs, Heads of Compliance, Procurement Leads and Board Sponsors.
Two related services
Which service fits?
Choose Clinical Safety Consultancy when you need help assessing gaps or developing and reviewing clinical safety evidence. Choose Clinical Safety Officer Services when you need a named CSO for an agreed project or ongoing arrangement. Where both are needed, we can scope them together.
The work · You are hereClinical Safety ConsultancyAssessing gaps, establishing or improving clinical risk management, facilitating hazard analysis and developing or reviewing agreed safety evidence.
Applies to organisations manufacturing health IT systems: clinical risk management across development, release, maintenance and change of the product.
DCB0160
Deployment and use responsibilities
Applies to health and care organisations deploying and using those systems: local configuration, workflows, training and operational change.
Supplier evidence does not automatically satisfy a deploying organisation’s obligations. Applicability depends on the product, intended use and deployment context; the current published standards remain the operative requirements while NHS England’s review continues.
What changes for your organisation
Outcomes the service is built to deliver
Clinical safety governance diagnostic
A focused review of the product or deployment context, intended use, clinical pathways, current evidence, responsibilities and material safety risks.
Hazard identification and analysis
Facilitated workshops and evidence review to identify credible clinical hazards, causes, controls, affected users and potential patient outcomes.
Clinical risk management planning
A proportionate plan defining scope, methodology, roles, escalation, evidence requirements, review points and approval responsibilities.
Hazard log development and quality assurance
Creation or review of a controlled hazard log that links hazards to causes, controls, owners, residual risk and verification evidence.
Clinical safety case and report support
Structured evidence explaining why the system or deployment is acceptably safe for its intended use, including assumptions, limitations, unresolved issues and required actions.
Independent challenge and assurance
Senior review of the quality, completeness and traceability of clinical safety evidence before release, procurement, deployment or significant change.
Ongoing governance and change control
Support for safety monitoring, incident learning, periodic review, supplier coordination, decommissioning and material product or deployment changes.
What is the engagement approach?
Five steps to defensible safety evidence
Select a step to see what happens and what it produces.
1
Define the safety context
Confirm the intended purpose, users, patient population, clinical workflows, operating environment, boundaries, dependencies and applicable assurance obligations.
2
Review current evidence
Assess existing plans, hazard logs, safety cases, testing, incident information, supplier evidence and governance records for completeness and consistency.
3
Identify and evaluate hazards
Use structured clinical and technical input to identify hazards, estimate risk and test whether controls are effective and evidenced.
4
Strengthen governance and artefacts
Close priority gaps, clarify ownership, improve traceability and prepare decision-ready safety documentation.
5
Assure and maintain
Provide independent challenge, approval support where within scope, and a sustainable cadence for monitoring, change and continual improvement.
→ Final risk acceptance and formal approvals remain with appropriately authorised individuals in your organisation, including a suitably qualified Clinical Safety Officer where required. Delivered within IG-Smart’s wider Assess → Build → Manage → Assure → Improve approach.
What each stage produces
01
Define the safety context
Agreed safety context and scope.
02
Review current evidence
Evidence review and gap findings.
03
Identify and evaluate hazards
Hazard workshop outputs and decision log.
04
Strengthen governance and artefacts
Hazard log, clinical risk management plan and safety case support.
05
Assure and maintain
Assurance report and governance cadence.
What you receive
What clinical safety evidence can we help produce?
Clinical risk management plan · clinical safety case or report · hazard log and risk acceptance record · hazard workshop outputs and decision log · safety requirements and control traceability matrix · assessment or assurance report · roles, responsibilities and escalation matrix · governance cadence and committee terms of reference · change-impact and release safety assessment · incident, post-market or operational safety review · executive or board assurance summary · prioritised remediation roadmap and action tracker. Examples below are illustrative.
DTAC Readiness Dashboard · Pre-buyer reviewIllustrative data — not client data
Overall positionAmber — closing gaps
DTAC areas evidenced
3 / 5
▲ 1 this period
Open evidence gaps
6
▼ 3 vs last review
Responses challenged
18
▲ 12 resolved
Evidence owners assigned
9 / 10
▲ 2 this period
Evidence gaps by buyer impact
High1
Medium3
Low2
Evidence complete
68%
Overdue actions
2
Documents awaiting sign-off
3
Matters for escalation
1
Illustrative output
DTAC Readiness Dashboard
Readiness at a glance
A single view of readiness across the five DTAC areas, so gaps are closed before an NHS buyer reviews the form.
What it helps you see
Readiness across the five DTAC areas
Open evidence gaps by buyer impact
Readiness challenge progress
Evidence owners and sign-off status
Likely format
Dashboard / reporting view · Supporting registers and evidence records · Executive PDF summary where agreed
Clinical hazard logIllustrative data — not client data
Illustrative Clinical hazard log
Hazard
Control
Owner
Residual risk
Hazard A
Control specified and tested
Clinical lead
Acceptable
Hazard B
Control proposed, not evidenced
Product lead
Under review
Hazard C
Control owned by deploying organisation
Deployment lead
Transferred
Illustrative output
Clinical hazard log
Hazard traceability
Hazards linked to causes, controls, owners, residual risk and verification evidence.
What it helps you see
Each hazard
Cause and control
Owner
Residual risk
Likely format
Control traceability matrixIllustrative data — not client data
Illustrative Control traceability matrix
Requirement
Hazard
Evidence
Status
Requirement A
Hazard A
Test record
Verified
Requirement B
Hazard B
Pending
Open
Requirement C
Hazard C
Supplier evidence
Under review
Illustrative output
Control traceability matrix
Safety requirements
Every safety requirement traced to a hazard and verification evidence.
What it helps you see
Safety requirement
Linked hazard
Verification evidence
Status
Likely format
Change-impact assessmentIllustrative data — not client data
Illustrative Change-impact assessment
Change
Impact
New hazards
Decision
Change A
None
—
Proceed
Change B
Workflow altered
1
Conditions set
Change C
New intended use
2
Safety case update
Illustrative output
Change-impact assessment
Release safety
Whether a release or change alters the clinical risk profile.
What it helps you see
Change
Clinical risk impact
New hazards
Decision
Likely format
Illustrative structure — not a client document. Exact outputs and formats depend on the agreed scope.
Scope boundaries
What is included — and what remains with your organisation
What IG-Smart does
Facilitate clinical risk management
Draft or review clinical safety artefacts
Coordinate stakeholders across product, clinical and technical teams
Provide independent assurance
Not included unless expressly agreed
No guarantee of procurement acceptance, regulatory approval or a harm-free system
Statutory, regulatory, clinical and operational responsibilities (retained by you)
Final risk acceptance and formal approvals (retained by authorised individuals)
Legal advice
Medical-device conformity assessment
Product, penetration or accessibility testing
Your own clinical governance and incident-management responsibilities
Scope, deliverables and assumptions are agreed in writing before work begins.
Relevant evidence
Related NHS & HealthTech evidence
Selected published engagements demonstrating relevant governance, assurance and NHS/HealthTech capability. They are not presented as clinical safety engagements unless the underlying approved case evidence expressly states that.
Named client · Technology / SaaS / RegTech
Clini-Hub
Embedded governance and clinical-safety support since start-up
NHS AI Toolkit, DSPT, DTAC and clinical-safety governance from start-up
Specialist expertise, coordinated around your requirement
Subject-matter expertise is paired with a clear client and programme contact from initial scoping through delivery.
Clinical Safety Officer and health informatics specialist
Himanshu Desai
MSc, MBA, MRPharmS
Specialist expertise in health informatics, prescribing and medication-management systems. Has completed the Digital Clinical Safety – Practitioner course, provided and accredited by NHS England and CPD.
Service lead — clinical safety governance and multidisciplinary assurance
Michael Abtar
LLB (Hons), PG.Dip.Law, Cert. DPO
Leads the service, drawing on his experience as Clinical Safety Officer at Royal Brompton & Harefield and coordinating clinical safety with information governance, privacy, cyber assurance and organisational accountability.
Senior strategic advice through an agreed escalation arrangement, where patient-safety, organisational or public-accountability concerns are significant.
Himanshu Desai has completed the Digital Clinical Safety – Practitioner course, provided and accredited by NHS England and CPD. His certificate of attendance is available on request.
Clinical safety training
Digital Clinical Safety – Practitioner
Provider
NHS England (accredited by NHS England and CPD)
Evidence
Certificate of attendance signed by the Clinical Director for Patient Safety; available upon request
Course completion is training, not a separate professional certification, and does not by itself satisfy every formal CSO appointment requirement or imply NHS endorsement of IG-Smart.
For engagements involving significant patient-safety, organisational or public-accountability concerns, senior strategic advice from Professor Dame Donna Kinnair can be included through an agreed escalation arrangement. Her contribution provides healthcare leadership perspective and challenge alongside the appointed CSO and accountable client leaders.
Advisory involvement is agreed according to the engagement’s scope and availability, and is separate from her Independent Advisory Board role.
Buyer decisions
Questions before you engage
Do all digital health products require DCB0129 or DCB0160?
Not every digital solution requires the same level of formal clinical safety assurance. Applicability depends on the product, intended use, deployment context and potential effect on patient safety. An early applicability and scoping review is the safest starting point.
What qualifications should a Clinical Safety Officer have?
NHS guidance describes a Clinical Safety Officer as a suitably qualified clinician with current professional registration and relevant risk-management experience. The person should also be appropriately trained for the clinical safety role and able to exercise independent professional judgement.
Can you review clinical safety evidence prepared by another supplier or consultancy?
Yes. We can provide an independent quality and traceability review, identify material gaps and recommend proportionate remediation. The review does not transfer ownership of the underlying evidence or risk decisions.
Can you support AI-enabled or software-as-a-medical-device products?
Yes, subject to scope and specialist requirements. Clinical safety should be coordinated with AI governance, data protection, cyber security and medical-device responsibilities rather than treated as a standalone workstream.
When should clinical safety work begin?
At the start of product design, procurement or deployment. Early involvement makes hazards easier to control and reduces the risk of discovering fundamental safety issues immediately before release or go-live.
Are DCB0129 and DCB0160 changing?
NHS England began a national review of both standards in 2026. Organisations should continue working to the current published requirements while monitoring official updates and planning controlled transition when revised standards are issued.
Investment
Defined clinical safety projects from £7,500 + VAT.
Fees depend on clinical risk, system complexity, existing evidence and the support required. Scope, deliverables, responsibilities, available capacity and fees are agreed in writing before work begins. Onboarding, initial safety-case development and substantial remediation are quoted separately where required. Existing evidence is reviewed and reused wherever appropriate. Focused reviews and complex programmes are individually scoped.
What organisations should expect
Clearer clinical safety accountability across product, clinical, technical and executive teams
Earlier identification of hazards before procurement, release or deployment
More complete and traceable safety evidence for DCB0129, DCB0160 and DTAC-related scrutiny
Better informed risk acceptance and go-live decisions
Reduced rework caused by fragmented documentation or late clinical input
A reusable clinical safety capability that supports change, monitoring and incident learning
Greater confidence for boards, buyers, commissioners and clinical governance reviewers
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