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Digital clinical safety governance

Clinical Safety Officer Services

Appoint a named CSO or strengthen your existing clinical safety capability. Clinical safety leadership, evidence and ongoing support for HealthTech and NHS teams, under an agreed mandate.

Named clinical safety leadership, coordinated with governance and programme delivery.

View relevant evidence — View Relevant Evidence

Selected client experience

Related client engagements

View all case studies

When this service fits

When this service fits

  • You need to appoint a named Clinical Safety Officer for a product or deployment

  • Your existing CSO needs specialist capacity for evidence, reviews or change

  • Your HealthTech business is preparing clinical safety evidence for NHS market entry

  • Your NHS or care organisation needs DCB0160 deployment and local workflow assurance

  • Releases, AI-enabled functionality or integrations are changing the clinical risk profile

  • You need a defined-scope DCB0129/DCB0160 review or evidence-development engagement

The service

Appoint a CSO or strengthen the one you have

A CSO role needs active clinical involvement, not just a signature at the end. IG-Smart offers a named appointment within agreed clinical risk management arrangements, or specialist support alongside an existing CSO. Defined-scope assessment and evidence-development engagements are available through Clinical Safety Consultancy. The manufacturer or deploying organisation remains accountable for its systems and use; appointment and clinical review responsibilities are distinct from organisational risk acceptance and deployment authority.

Appointment and decision rights

An agreed clinical mandate. Clear organisational decision rights.

Formal CSO appointment
IG-Smart can provide the named practitioner; your organisation confirms the appointment, mandate and governance arrangements.
Clinical review and approval
The appointed CSO performs the clinical review and approvals required by the applicable standard and documented appointment. In support-only engagements, your existing CSO retains those duties.
Residual-risk acceptance
Authorised individuals in your organisation accept residual clinical risk and release decisions.
Organisational accountability
Accountability for clinical safety stays with the manufacturer or deploying organisation.

Two related services

Which service fits?

Choose Clinical Safety Officer Services for a named appointment or ongoing support for an existing CSO. Choose Clinical Safety Consultancy for defined-scope assessment, evidence development or implementation support. Appointment provision can form part of an engagement where expressly agreed.

The workClinical Safety ConsultancyAssessing gaps, establishing or improving clinical risk management, facilitating hazard analysis and developing or reviewing agreed safety evidence.Explore this service
Appointment or ongoing support · You are hereClinical Safety Officer ServicesA named CSO within an agreed mandate, or additional specialist capacity alongside your existing CSO. Client accountability and decision rights remain explicit.

DCB0129

Manufacturer responsibilities

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.

Already have an appointed CSO?

This service supports their clinical-risk-management processes, safety evidence, change reviews and governance reporting. Your appointed CSO retains clinical review and approval responsibilities.

Need a formally appointed CSO?

IG-Smart can provide a named senior clinical safety professional for an agreed CSO appointment. Suitability, current eligibility, availability, scope and responsibilities are checked before appointment. Your organisation retains accountability and authorised risk-acceptance and deployment decisions.

Why IG-Smart

Clinical safety connected to the rest of your assurance

Clinical safety rarely fails in isolation. Our wider governance, risk and assurance work means clinical risk evidence stays consistent with privacy, security, supplier and board reporting. These are the connections we draw on; each engagement’s scope is agreed separately, and not every capability below is included in CSO support.

  • Governance and accountability

    Clear decision rights, escalation routes and RACI, so clinical safety sits inside organisational governance rather than beside it.

    HealthTech governance

  • Supplier and manufacturer evidence

    Testing whether supplier safety evidence is sufficient before a deploying organisation relies on it.

    Supplier assessments

  • DCB0129 and DCB0160 responsibilities

    Keeping manufacturer and deployer evidence aligned, including transferred risks and handover.

  • Deployment, change and incidents

    Linking change control and incident learning back to the hazard log and safety case.

  • Board and procurement assurance

    Turning clinical risk evidence into decision papers and DTAC-ready evidence buyers can scrutinise.

    DTAC readiness

Service lead Michael Abtar’s experience includes serving as Clinical Safety Officer for Royal Brompton & Harefield NHS Foundation Trust. Read the RBHT case study

Official requirements: NHS DCB0129 — manufacture · NHS DCB0160 — deployment and use. For broader evidence development, see Clinical Safety Consultancy. Clinical safety sits alongside your organisation's data security obligations; see NHS DSPT readiness and audit preparation.

What changes for your organisation

Outcomes the service is built to deliver

  • Named CSO provision

    An appropriately qualified senior professional to fulfil the expressly agreed appointment and clinical risk management role.

  • Clinical safety governance

    Clear responsibilities, decision rights, escalation and reporting across clinical, product, technical and executive teams.

  • DCB0129/DCB0160 activities

    Clinical risk management and evidence work appropriate to manufacture or deployment and use; the two responsibilities remain distinct.

  • Safety evidence development

    Gap analysis, hazard assessment and development or review of the agreed safety case, hazard log and clinical risk management records.

  • NHS assurance coordination

    Clinical safety evidence connected to relevant DTAC and wider governance workstreams where commissioned.

  • Release and continuing assurance

    Advice, evidence updates and review of changes or incidents within the agreed scope and cadence.

How the engagement runs

From an agreed mandate to ongoing assurance

The engagement model determines who performs clinical review, what is delivered and how continuing support is organised.

  1. Assess

    Review intended use, applicable responsibilities, existing evidence and whether you need an appointed CSO, support or defined-scope consultancy.

  2. Build

    Agree the named practitioner where required, check suitability and eligibility, document decision rights and develop the agreed clinical safety evidence.

  3. Manage

    Provide clinical safety leadership or support under the agreed mandate, coordinating product, clinical and programme stakeholders.

  4. Assure

    Review hazards, controls and safety evidence against the applicable standard and documented appointment; escalate unresolved issues to authorised decision-makers.

  5. Improve

    Use release reviews, incident learning and periodic reassessment to update evidence and working arrangements where commissioned.

Clinical review and approvals follow the applicable standard and documented appointment. Unresolved issues follow the agreed escalation routes; organisational decisions remain with authorised decision-makers. Every engagement follows IG-Smart’s structured delivery approach: Assess → Build → Manage → Assure → Improve. Explore how we work

What each stage produces

  1. Assess

    Agreed scope, appointment model and evidence gaps.

  2. Build

    Appointment and responsibility records; agreed safety documentation.

  3. Manage

    Maintained evidence, action tracking and change-review records.

  4. Assure

    Clinical review, assurance findings and decision-support evidence.

  5. Improve

    Updated evidence and prioritised improvement actions.

Engagement options

Appointed CSO services or support for your existing CSO

Appointed Clinical Safety Officer Services

  • A named senior professional for an agreed CSO role
  • Suitability, current eligibility and availability checked before appointment
  • Mandate, clinical responsibilities, approval authority and escalation documented

Clinical Safety Officer Support

  • Governance, risk management, evidence-development and assurance capacity
  • Ongoing support or a focused requirement
  • Your existing CSO continues the agreed clinical review role

For defined-scope assessment, evidence development or implementation support, see Clinical Safety Consultancy through the service selector above. Consultancy is separately scoped and quoted; it does not automatically create a CSO appointment.

What you receive

What evidence will be produced?

Outputs are agreed for the product, deployment and lifecycle stage. The example below is not a live assessment, completed safety case, clinical approval or guarantee of compliance.

Appointment and accountability recordIllustrative structure
Appointment and accountability recordIllustrative data — not client data
Illustrative Appointment and accountability record
ActivityAppointed-CSO modelExisting-CSO supportClient responsibility
CSO mandateNamed IG-Smart practitioner; terms agreedExisting appointed CSOConfirm appointment and governance arrangements
Clinical reviewApplicable standard and documented appointmentExisting CSO; IG-Smart supports evidenceProvide information and authorised escalation routes
Risk acceptance / deploymentClinical advice and review within mandateEvidence and decision supportAuthorised organisational decision-makers

Illustrative output

Appointment and accountability record

Responsibility map

Distinguishes an IG-Smart appointment from support for an existing CSO, showing the clinical duties and organisational decision routes to document.

What it helps you see

  • Mandate
  • Clinical review
  • Decision authority

Likely format

Role and decision-rights record

Illustrative structure — not a client document. Exact outputs and formats depend on the agreed scope.

Scope boundaries

Clinical leadership with explicit accountability

Agreed IG-Smart responsibilities

  • Named CSO provision where expressly agreed
  • Clinical safety governance and risk assessment
  • Clinical Safety Case Report, Hazard Log and Clinical Risk Management File where scoped
  • Change review and ongoing advice where commissioned

Responsibilities and limits

  • Your organisational, operational and regulatory accountability
  • Authorised residual-risk acceptance, release and deployment decisions
  • No guarantee of NHS procurement acceptance, regulatory approval or a harm-free system
  • Appointment eligibility, capacity, scope and fees must be confirmed; no automatic appointment from an enquiry

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 Officer engagements unless the underlying approved case evidence expressly states that.

  • Named client · Healthcare / NHS

    Royal Brompton & Harefield NHS Foundation Trust

    Three-year managed service: Information Governance, data quality, Payment by Results, trust-wide information security and clinical systems safety, reporting to the board-level SIRO

    Three-year managed IG, data quality, security & clinical systems safety service · reporting to the board-level SIRO

    The approved Royal Brompton & Harefield engagement documents a managed NHS governance and clinical systems safety service. Michael Abtar's practitioner experience is attributed separately; the case is not used to infer another practitioner's registration or current availability.

    View the evidence: Royal Brompton & Harefield NHS Foundation Trust

  • 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

    The approved Clini-Hub case describes clinical safety case reports and DCB0129/DCB0160 support alongside NHS and AI governance. The client's compliance statement is client-reported, not an independent certification.

    View the evidence: Clini-Hub

  • Named client · Technology / SaaS / RegTech

    accurx

    Retained DPO and NHS IG support

    Retained DPO services · privacy and NHS information-governance support during growth

    Relevant retained privacy and NHS information-governance support; not presented as evidence of a formal CSO appointment under this service.

    View the evidence: accurx

  • Named client · Higher Education / Research

    UCL

    IG audit, improvement plan, training and physical-security audit

    Helped shape and focus the final DSPT submission

    Relevant NHS/HealthTech governance and assurance context; no clinical safety appointment or clinical approval is inferred from this engagement.

    View the evidence: UCL

Explore all case studies →Request Clinical Safety Evidence →

Your IG-Smart team

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 attended NHS England’s Digital Clinical Safety – Practitioner course; his certificate of attendance is available on request.

    View profile

  • 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.

    View profile

  • Client & programme contact

    Julia Andrade

    BA

    Coordinates scope, practitioners, delivery and stakeholder communication.

    View profile

Practitioner credentials

Himanshu Desai MSc, MBA, MRPharmS

Himanshu Desai attended NHS England’s Digital Clinical Safety – Practitioner course. His certificate of attendance is available on request.

Clinical safety training
Digital Clinical Safety – Practitioner
Provider
NHS England
Evidence
Certificate of attendance signed by the Clinical Director for Patient Safety; available upon request

Course attendance is training, not a separate professional certification. Professional membership and postnominals do not establish current statutory registration or appointment eligibility; training does not imply NHS endorsement of IG-Smart.

Request Clinical Safety Training Evidence

Buyer decisions

Questions before you engage

Do DCB0129 and DCB0160 require a Clinical Safety Officer?

Yes. NHS guidance states that both standards require the organisation to nominate a Clinical Safety Officer. The CSO should be a senior clinician with current professional registration and sufficient training in clinical safety and clinical risk management.

Does IG-Smart provide an appointed Clinical Safety Officer?

Yes. IG-Smart provides appropriately qualified, named senior clinical safety professionals who can be appointed to fulfil an agreed CSO role within the client's clinical risk management arrangements. We also support organisations with an existing CSO. The named practitioner's suitability, current eligibility, availability, responsibilities and appointment terms are checked and agreed before the engagement. Appointment does not transfer the client's organisational accountability or all risk-acceptance, release and deployment decisions to IG-Smart.

Is the CSO responsible only for signing the safety case?

No. The role should provide active clinical safety leadership across hazard identification, risk evaluation, control review, evidence quality, change assurance, incident learning and governance reporting. A signature without adequate involvement does not create credible assurance.

How do DCB0129 and DCB0160 differ?

DCB0129 applies to manufacturers responsible for developing and maintaining health IT systems. DCB0160 applies to health organisations responsible for deployment and use. Many implementations require the supplier and deploying organisation to coordinate evidence and transferred risks.

Are the standards changing?

NHS England is reviewing DCB0129 and DCB0160. Its published standards pages currently list the 2018 releases. We check the applicable requirements when scoping an engagement.

Can CSO support help with DTAC?

Yes. Clinical safety is one of the core DTAC areas. IG-Smart can help ensure the hazard log, clinical safety case and supporting governance are coherent, current and ready for buyer scrutiny.

What does the £3,000 + VAT monthly starting investment cover?

The retained service is scoped for ongoing governance, reviews, release assurance, board reporting and incident support alongside your appointed CSO. The agreed scope, deliverables, responsibilities, available capacity and fee are confirmed in writing before work starts. The published starting investment is not a fixed number of hours, systems or releases. Onboarding, initial safety-case development and substantial remediation are quoted separately where required.

Who leads the work, and who approves clinical safety decisions?

Michael Abtar leads clinical safety governance and multidisciplinary assurance; Himanshu Desai brings health informatics and clinical safety expertise. Practitioner allocation and capacity are agreed during scoping. The appointed CSO performs the clinical review and approvals required by the applicable standard and documented appointment; in support-only engagements, your existing CSO retains those duties. Authorised organisational decision-makers retain risk-acceptance, release and deployment authority. Experience, membership and training do not establish current professional registration or appointment eligibility.

What happens when our product or deployment changes?

Releases, configuration, integrations, workflows or new intended uses may alter the clinical risk profile. Within the agreed scope, we assess change impacts, review affected hazards and controls, and update the hazard log, safety case and decision records. Unresolved issues are escalated through the documented clinical review and organisational decision routes.

Investment

Starting investment: £3,000 + VAT per month

This published starting investment applies only to retained support alongside your existing CSO. Appointed-CSO engagements are individually scoped and quoted; no appointment price is published. Capacity, responsibilities and fees are confirmed in writing. Onboarding, initial safety-case development and substantial remediation are quoted separately where required. Defined-scope consultancy is separately scoped.

Choose the right commercial model

  • Appointed CSO — named role, mandate and fee agreed individually
  • Existing-CSO support — retained support or focused additional capacity
  • Defined-scope consultancy — assessment, evidence or implementation requirement
  • Peer review — conflicts and independence assessed for the proposed reviewer and scope

Procurement or supplier-assurance review?

Visit our Trust Centre

Ready to move forward?

Clinical safety expertise for the role and decisions you need to support.

Not sure which service applies? Find the Right Service

  • Still defining your requirement?

    Talk to a Senior Practitioner

    Discuss the requirement, risk, scope and the right engagement model with an experienced practitioner.

    Talk to a Senior Practitioner

  • Have a defined scope, tender or RFP?

    Submit a Requirement

    Share a defined requirement, RFP, tender, statement of work or existing scope for senior review.

    Submit a Requirement

  • Procurement or supplier assurance

    Prepare for Procurement Review

    Access company, security and assurance information for supplier review, with controlled evidence available on request.

    Open Trust Centre