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Clinical Safety Officer (CSO)
The Clinical Safety Officer (CSO) is one of the cornerstones of NHS clinical safety compliance. Filling this role is one of the most complex items undertaken by technology vendors, as there are very specific requirements for the person who handles the role.
What is a clinical safety officer?
A Clinical Safety Officer (CSO) is a registered healthcare professional responsible for ensuring the safety and compliance of technologies within NHS healthcare settings by creating and managing a clinical risk management strategy that the whole company can undertake. They assess potential hazards, implement clinical risk analysis, evaluation and control, and collaborate with product teams to maintain ongoing compliance with clinical safety standards.
Clinical Safety Officer Responsibilities
The DCB0129 clinical risk management standard defines a set of responsibilities Clinical Safety Officers have to meet. These are:
The Clinical Safety Officer must be a suitably qualified and experienced clinician
Clinical risk management requires a qualified and experienced clinician to maintain compliance (e.g. doctors, nurses, paramedics, physiotherapists). The clinician should be as relevant as possible to the product in question either in role or experience (e.g. having a psychiatrist or psychologist for a mental health application). At The AbedGraham Group, all our Clinical Safety Officers have a wealth of experience across all aspects of primary, secondary and community and mental healthcare. This allows us to optimally match our team to your product specifically, giving the best results.
A Clinical Safety Officer must hold a current registration with an appropriate professional body relevant to their training and experience
This requirement builds on the first one in that the clinician in question must have an up-to-date professional registration relevant to their background (e.g. a General Medical Council (GMC) number for a doctor). It is optimal if the clinician in question has a UK background so that the nuances and specifics of the NHS can be incorporated into the clinical risk management process.
A Clinical Safety Officer must be knowledgeable in risk management and its application to clinical domains
It is impossible to conduct risk assessments on technology in healthcare without any prior experience. Navigating the complexities of clinical risk management and building clinical safety into all aspects of the product’s software development life cycle is a time-consuming and difficult process to navigate. Again, having a granular base knowledge and understanding of the clinical environment that the product is going into is critical. The NHS Digital course is the easiest and most common course evidenced here – all our CSOs have been through the nationally approved course and refresh their knowledge on an ongoing basis.
A Clinical Safety Officer must make sure that the processes defined by the clinical risk management process are followed
Any applicable vendor product must have a defined and robust clinical risk management process. The CSO is the driving force behind ensuring that each part of the company’s processes has clinical safety built into them. Although final liability resides with top management and the company itself, the CSO has to be involved with all relevant aspects of the team and needs to ensure that all safety documentation is signed off, approve hazard logs, decide if the product is safe to release and raise any unacceptable risks internally.
Do I need a clinical safety officer?
If your product qualifies as applicable under the NHS applicability flowchart, then yes you will need to complete DCB0129 clinical risk management and fulfil the Digital Technology Assessment Criteria (DTAC), which will require a Clinical Safety Officer. We can assist you in defining whether your product is applicable or not.
Broadly speaking, however, any digital technology that is implemented within the NHS that can affect the real-time or near real-time care of patients will qualify, as well as a significant subset of medical devices placed on the market. Ensuring you understand your compliance requirements is a critical first step before engaging in any procurement pathways.
You can only use someone internal in the company if they fulfil the criteria laid out in the standard as described above. They must hold a valid clinical registration and have experience in risk management in healthcare. If they cannot provide a clinical registration number, they will not be eligible to handle the CSO role.
Why choose The AbedGraham Group for your Clinical Safety Officer?
Outsourcing the CSO role to a third party is common practice, and at The AbedGraham Group, we have extensive experience in creating the base documentation, managing ongoing compliance, acting as the named Clinical Safety Officer and covering all other aspects of compliance from communications with regulators, partners and deploying organisations to sales and marketing content generation. The benefits of using The AbedGraham Group as your trusted compliance provider include:
Track Record
We have managed clinical safety for hundreds of products and taken vendors through all aspects of the Digital Technology Assessment Criteria (DTAC), national and regional frameworks and direct bids. Our experience in this area and the granularity of our documents are unsurpassed in the marketplace.
Diverse Experience
As outlined above, risk assessment is optimal when you have a CSO who has at least some experience in the clinical area the product is going into. Having covered over a hundred products now across all types of healthcare and with a team that has decades of frontline experience across all areas, we are well-placed to manage risk for any product coming to market.
Peace of Mind
Navigating clinical safety in product development requires reliability, evidence-based information, and trustworthiness when engaging with deploying organisations and regulators. With extensive experience, we've encountered various requests and challenges. Many companies pay mere lip service to clinical risk management, leading to complications during document reviews. Avoiding these issues expedites procurement, streamlines budget discussions, and eliminates compliance hurdles in deal closures.
Other Value-Adding Services
Compliance with clinical risk management standards is just the starting point for a wider discussion on compliance, strategic, and marketing best practices. Whether it is assistance with the Data Security and Protection Toolkit (DSPT), or strategic or marketing services, we can help you navigate all parts of NHS procurement to help expedite returns.
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If you need help with your DCB0129 compliance, or any other healthcare legislation, partnering with The AbedGraham Group will ensure your applications run smoothly and that you are able to operate in the healthcare sector.
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FAQs
Is DCB0129 mandatory?
DCB0129 is mandatory if your product is considered applicable, as part of the Health and Social Care Act 2012. You must show evidence of a suitable risk assessment and appoint a Clinical Safety Officer to manage DCB0129 compliance on an ongoing basis. If you are unsure as to whether your product is applicable, then contact us for a free consultation.
What is clinical risk in the NHS?
Clinical risk management in the NHS is centred around the deployment of two standards: DCB0129 (applying to vendors) and DCB0160 (applying to healthcare organisations). Vendors must ensure they have covered all parts of the standard to ensure compliance that they can show to healthcare organisations, regulators and partners.
What is digital clinical safety?
Digital clinical safety is about ensuring that technologies deployed in the NHS are safe to use, but also that those technologies then help to improve patient safety. The Digital Clinical Safety Strategy published in 2021 outlines the nationwide strategy and the stakeholders involved in maintaining this.