Clinical Safety and Clinical Risk Management are about keeping people safe. Nobody wants to use a healthcare device or system that hasn’t been rigorously assessed for its safety. That’s where we come in.
Clinical safety is a core component of the NHS Digital Technology Assessment Criteria (DTAC).
As part of this, you have a statutory obligation to meet and evidence your compliance with the NHS Digital standard for Clinical Safety and Clinical Risk Management known as DCB0129.
Book a free, no-obligation discovery call with one of our clinical safety officers.
Book a free, no-obligation discovery call with one of our clinical safety officers.
With our decades of experience implementing the rigorous NHS clinical safety standards, we’ll support you to meet the DCB0129 standard (mandatory under Section 250 of the Health and Social Care Act 2012).
Our team of experienced, practising CSOs will make clinical safety a core practice for your business. We’ll work with you to create a compliant clinical safety culture and produce all the information you’ll need to evidence your compliance.
Clinical Safety Case Reports
Hazard Logs
Clinical Incident Logs
Clinical Risk Management Plans
Clinical Risk Management System
We’ll also support you to establish and
document any other procedures to support and evidence your clinical risk management.
As digital health technology manufacturer, the DCB0129 standard stipulates that you must identify a named Clinical Safety Officer (CSO) who is responsible for the application of the clinical safety process.
Your CSO must be a clinician with a current UK professional registration and be trained in clinical risk management. Ideally, they should be well practised in risk management in clinical settings.
If hiring a practising registered clinician isn’t an option for your business right now, access our team of CSOs. Choosing an outsourced CSO brings objectivity to a key role and ensures you have the right skill set within your team.
We routinely work in clinical settings and have extensive experience in the application of clinical safety for health IT systems.
When you work with us, your named CSO will complete and maintain your DCB0129 key documents and become a key part of your team.
Clinical Risk Management is the process of identifying, evaluating and mitigating risks which can result in clinical harm to a patient or service user.
By conducting structured Hazard Assessments, our Clinical Safety Officers can help your team identify hazards and establish risk control measures. Mitigations might include design, training and new or revised business processes.
A Clinical Safety Officer (CSO) carries out the initial risk evaluation process, establishes the Clinical Risk Management Plan and oversees the Risk Management System throughout the lifecycle of the product.
DCB0129: Clinical Risk Management: its Application in the Manufacture of Health IT Systems’ is a standard prepared by the NHS Digital Clinical Safety team, designed to help manufacturers of health IT software evidence the clinical safety of their products.
Manufacturers of Health IT systems must comply with DCB0129 to provide evidence that their product has undergone a Clinical Safety Assessment and that the manufacturer has implemented a Clinical Risk Management System.
The standard sets out Clinical Risk Management Activities which must be undertaken in addition to specific documentation including, submitting a Clinical Safety Case Report, Clinical Risk Management Plan and Hazard Log.
Clinical safety and risk management must also be embedded in the software development process and product lifecycle. One of the ways of doing this, is by having a dedicated named Clinical Safety Officer (CSO) for the lifetime of the product. That’s where we can help.
DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems’ is a standard prepared by the NHS Digital Clinical Safety team, designed to help health and care organisations assure the clinical safety of their health IT software.
DCB0160 mirrors DCB0129 for deploying organisations that must conduct their own Clinical Safety Risk Assessment in relation to the deployment of a Health IT product.
Each deploying organisation may have individual risks associated with the use case of the product. Their Clinical Safety Officer will often request a meeting with the Clinical Safety Officer of the manufacturer. We can provide this support as part of our CSO as a service.
We can help you complete all required Clinical Risk Management activities by conducting a thorough review, running hazard workshops and undertaking a thorough risk assessment to identify risks and recommend control measures. We’ll then produce the DCB0129 documentation and host it in your DTAC Portal, and provide ongoing Clinical Safety Officer (CSO) support for your health IT product. That means you can rest assured that you’re in safe hands.
You need to evidence the following documentation to become DCB0129 compliant:
We’ll also provide supporting documentation to evidence that your Clinical Risk Management System is in place. But best of all, we’ll host this in your own DTAC Portal to share with your NHS clients, helping you streamline the compliance and procurement process.
We provide full support in all elements of DTAC including:
We’ll make you DTAC compliant
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Book a free, no-obligation discovery call with one of our clinical safety officers.
Book a free, no-obligation discovery call with one of our clinical safety officers.
