What is a Clinical Safety Officer?

A Clinical Safety Officer (CSO) is a senior clinician responsible for assessing and managing the risks that digital health systems may pose to patients. The role exists because digital tools in healthcare carry potential hazards, and someone qualified must oversee whether those risks are being properly controlled.

The CSO is not just a job title to fill a compliance checkbox. They are the person with the authority to say "yes, this system is safe to deploy" or "no, we need to pause and address these risks first."

In practice, the role might be better described as a Digital Clinical Safety Officer, because the focus is specifically on the safety of digital health technology, not clinical practice generally.

Why the CSO Role Exists

When a GP practice, Primary Care Network (PCN), or other health organisation deploys a digital tool, that organisation is responsible for ensuring the tool is safe in their specific environment. This is the core requirement of DCB0160.

But how can an organisation assess whether a digital tool is clinically safe? Who has the authority to make that judgement?

The answer is the Clinical Safety Officer. They are the person qualified to:

Identify what could go wrong when using a digital tool
Assess whether the risks are acceptable
Determine what controls are needed to reduce risks
Decide whether the system can go live, or whether it must be paused or stopped

Without a CSO, an organisation has no qualified individual overseeing clinical risk. That leaves the organisation exposed, both to patient harm and to regulatory non-compliance.

Legal Requirements Under DCB0160

DCB0160 is the NHS standard for managing clinical risk when deploying and using health IT systems. It is mandated by the Health and Social Care Act 2012, which means compliance is a legal obligation for NHS-funded organisations in England.

Under DCB0160, every organisation deploying a digital health system must appoint a Clinical Safety Officer. This is not optional. The standard requires that:

The CSO must have demonstrable oversight of the clinical risk management process
The CSO must be actively involved throughout the system's lifecycle—from initial deployment through to updates, changes, and eventual decommissioning
The CSO must approve key safety documentation, including the Clinical Risk Management Plan, Hazard Log, and Clinical Safety Case Report
The CSO must be given the authority to pause or stop deployment if safety concerns arise

If an organisation cannot demonstrate that a suitably qualified CSO is in place and actively fulfilling these duties, it is not compliant with DCB0160.

Qualifications and Registration Requirements

Not just anyone can be a Clinical Safety Officer. DCB0160 sets clear requirements:

1. The CSO Must Be a Registered Healthcare Professional

The CSO must hold current registration with an appropriate professional body. This typically means:

A doctor registered with the General Medical Council (GMC)
A nurse registered with the Nursing and Midwifery Council (NMC)
A pharmacist registered with the General Pharmaceutical Council (GPhC)
Another registered healthcare professional (such as an allied health professional) with relevant clinical experience

The requirement for professional registration ensures that the CSO has a clinical background and is subject to professional accountability.

2. The CSO Must Be Suitably Qualified and Experienced

In addition to professional registration, the CSO must be:

Experienced in clinical practice, typically with at least five years of clinical work
Knowledgeable in risk management and its application to clinical domains
Trained specifically in clinical risk management under the DCB0129 and DCB0160 standards

This means that a newly qualified clinician, or a clinician with no background in risk management, cannot simply be appointed as CSO without further training.

3. The CSO Must Complete Accredited Training

To fulfil the role, the CSO must undergo formal training in clinical risk management. Accredited courses are available from organisations including:

NHS England (two-day Clinical Safety Training course)
The Professional Record Standards Body (PRSB)
Other accredited providers such as Ethos

This training covers:

The principles of hazard identification
Risk assessment methodologies
Development of Clinical Safety Case Reports
How to maintain Hazard Logs
The legal and regulatory context of DCB0129 and DCB0160

Without this training, a clinician lacks the specific skills needed to assess digital health risks.

Core Responsibilities of the CSO

The CSO's role spans the entire lifecycle of a digital health system, from initial procurement through to decommissioning.

Risk Management: The CSO oversees identifying, assessing, and controlling clinical risks. They review the supplier's hazard log, identify additional hazards specific to your deployment environment, assess their likelihood and severity, and determine what controls are needed. The CSO does not necessarily do all this work themselves, but they are responsible for ensuring it is done properly and deciding whether residual risks are acceptable.

Change Governance: Digital systems are constantly updated, reconfigured, and integrated with other tools. The CSO reviews proposed changes, assesses whether they introduce new hazards or affect existing controls, and approves or rejects changes on clinical safety grounds. If a supplier issues a software update, the CSO must assess whether that update is safe to deploy in your environment.

Incident Oversight: When something goes wrong—whether a near miss or actual incident—the CSO investigates what happened, identifies whether existing controls failed, updates the hazard log if needed, and implements corrective actions. Serious incidents must be reported to NHS England or the Care Quality Commission. The CSO leads the learning loop: incidents are analysed to improve safety, not just logged and forgotten.

Supplier Assurance: When procuring a digital health product, the CSO reviews the supplier's DCB0129 documentation, assesses whether risks have been adequately identified and controlled, identifies gaps that your organisation must address, and decides whether the product is safe enough to proceed with procurement.

Documentation: The CSO maintains comprehensive records including the Clinical Risk Management Plan, Hazard Log, Clinical Safety Case Report, and incident investigation findings. These documents provide the evidence base for regulatory compliance and audit readiness.

Authority and Decision-Making Power

The CSO is not a ceremonial role. They must be given real authority to make decisions about the deployment and use of digital systems.

Specifically, the CSO has the authority to:

Approve or reject the deployment of a digital health system
Pause deployment if safety concerns emerge during rollout
Stop the use of a system if uncontrolled risks are identified
Require additional controls before a system can go live
Escalate safety concerns to senior leadership or external regulators

This authority is critical. If the CSO identifies a risk that could cause patient harm, they must have the power to act without needing permission from non-clinical managers or being overruled on commercial or operational grounds.

In practice, this means:

The CSO must report to a senior level in the organisation (typically the accountable officer or governing body)
The CSO must not be pressured to approve a system for non-clinical reasons (such as budget constraints or contractual deadlines)
The CSO's decisions on clinical safety must be final

If an organisation undermines the CSO's authority, it is not compliant with DCB0160.

Training Requirements

Before taking on the CSO role, a clinician must complete accredited training. The most widely recognised course is the NHS England Clinical Safety Officer training, which covers:

The legal and regulatory framework (Health and Social Care Act 2012, DCB0129, DCB0160)
Hazard identification and risk assessment techniques
How to write a Clinical Safety Case Report
How to maintain a Hazard Log
Incident investigation and root cause analysis
Supplier assurance and DCB0129 compliance

The training typically takes two days and includes practical exercises. Upon completion, the clinician is equipped to fulfil the CSO role.

Ongoing professional development is also expected. As digital health technology evolves, the CSO must stay current with emerging risks, new regulatory requirements, and best practices in clinical risk management.

Next Steps: Setting Up a CSO in Your Organisation

Now you understand what a Clinical Safety Officer is, their legal obligations, qualifications, and responsibilities, you are ready to establish the role in your practice, PCN, or federation.

Practical guidance on how to set up a CSO role—including shared CSO models across multiple practices, time commitments, and how to integrate the CSO into existing governance structures—is available in: Setting Up a Clinical Safety Officer Role Without Extra Headcount.

Resources to Bookmark

Key Takeaways

The Clinical Safety Officer is the person responsible for ensuring that digital health systems are safe to deploy and use. They must be a registered clinician with specific training in clinical risk management, and they must be given real authority to approve, pause, or stop deployments based on clinical safety grounds.

The CSO is required under DCB0160, which means appointing a suitably qualified individual is a legal obligation, not a discretionary choice.

Understanding the CSO role is essential if your organisation is deploying digital health technology. Without a CSO, you cannot comply with DCB0160, and you have no qualified oversight of clinical risk.