As GP practices across the UK embrace more digital tools to enhance patient care and streamline operations, a crucial safety standard often comes into play: DCB0160. If you’ve heard this term but aren't quite sure what it means for you, you’re not alone.
In simple terms, DCB0160 is the NHS standard for clinical risk management when deploying any health IT system. It’s a legal requirement in England under the Health and Social Care Act 2012, designed to ensure that any technology you introduce into your practice is safe for patient care.
Think of it as a safety check. Before you start using a new digital tool, DCB0160 requires you to pause and think: "What could go wrong here, and how can we prevent it from harming a patient?". This isn't just about the technology itself; it's about how it's used by your staff, with your patients, in your specific practice environment.
This guide will walk you through what DCB0160 means in practice, what’s expected of you, and how you can manage compliance effectively.
What is actually required of a GP practice?
Complying with DCB0160 isn't just a box-ticking exercise; it's an ongoing process to safeguard your patients. The Care Quality Commission (CQC) expects to see evidence that you have assessed the risks of your digital tools.
Here are the core responsibilities for your practice.
Appoint a trained Clinical Safety Officer (CSO)
Every practice must appoint a Clinical Safety Officer (CSO) to lead and sign off on all clinical risk management activities. This is a critical role with specific requirements:
Who can be a CSO? The CSO must be a registered and suitably qualified clinician, such as a GP, nurse, or pharmacist. In a GP practice, this is often a GP partner or another senior clinician.
Mandatory Training: The appointed CSO must be properly trained in clinical risk management. NHS England provides free eLearning modules, and other accredited courses are available from professional bodies. This training ensures the CSO understands the formal process of hazard identification and safety case development.
Ongoing Commitment: This isn't a one-off course. The CSO needs to keep their knowledge up to date, especially as digital health technology and the standards themselves evolve.
If your practice doesn't have a clinician with the capacity or training for this role, you should seek support from your Primary Care Network (PCN) or Integrated Care Board (ICB), who may have a shared CSO service.
Create and maintain key safety documents
The CSO is responsible for producing and maintaining a Clinical Risk Management File for each health IT system you implement. This file serves as your evidence of compliance and typically includes three key documents:
Clinical Risk Management Plan: This document outlines how you will manage risk for a specific project, defining the scope, responsibilities, and activities involved.
Hazard Log: This is a live record of all potential hazards you've identified. For each hazard, it details the potential harm, the likelihood and severity, the actions taken to mitigate the risk, and the remaining (residual) risk.
Clinical Safety Case Report: This is the final summary document. It brings together all the evidence to make a clear argument that the system is safe to use in your practice. The CSO must formally sign this report before the system goes live, confirming that all risks are at an acceptable level.
Which systems does this apply to? It's more than you think
A common question is, "Which of our systems fall under DCB0160?" The rule of thumb is that if a digital tool could affect patient care in real-time or near-real-time, you must assume DCB0160 applies.
This includes a wide range of systems, from the obvious to the less apparent.
Obvious clinical systems
These are the core tools you use daily that directly impact patient care and data. Compliance is mandatory.
Electronic Health Record (EHR) systems (like EMIS or SystmOne)
Online consultation and triage tools
ePrescribing systems
AI-powered diagnostic aids or decision support tools
Less obvious (but still in-scope) systems
The scope of DCB0160 extends beyond these core systems to any software that handles patient data or influences clinical decisions, even indirectly. This could include:
Patient communication platforms
Digital record transfer services
A simple webform on your practice website that collects patient health information for "open access" requirements. If this form feeds into your clinical workflow, it needs a risk assessment. What happens if a request is lost or delayed? That’s a clinical risk.
A note of caution: Avoid becoming an accidental developer
Some practices create their own clever solutions using macros in spreadsheets or simple scripts to automate tasks. Be very careful.
If you develop your own software—even a complex macro—that influences clinical care, you could inadvertently take on the responsibilities of a manufacturer. This would mean you also need to comply with DCB0129, the sister standard for health IT developers. This is a significant undertaking. Unless you have the expertise and resources, it is best to avoid in-house development of clinical tools and instead procure solutions from vendors who can provide you with their DCB0129 safety case.
Putting it all together: A continuous cycle of safety
Achieving DCB0160 compliance might seem like a lot of work, but it’s a vital part of ensuring patient safety in an increasingly digital world. By appointing a trained CSO, thoroughly assessing your systems, and documenting your findings, you create a robust framework to protect your patients and your practice.
Remember, this is not a one-time task. Clinical risk management is an ongoing commitment. You should review your safety documentation regularly, especially when a system is updated, and encourage a culture where staff feel comfortable reporting any issues or near-misses with digital tools. By doing so, you can confidently embrace innovation, knowing you have put safety first.
Disclaimer: This article is for informational purposes only and reflects understanding as of August 2025. It does not constitute legal, financial, or medical advice. Practices should consult with relevant professional bodies or legal counsel for specific circumstances and always refer to the latest official NHS England (and other relevant bodies) guidance and contractual documents.