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Clinical Risk Management for Health IT System Suppliers

DCB0129: Clinical Risk Management

Clinical safety and clinical safety management should be a core practice for your organisation to ensure that you meet your statutory obligations for health IT in the UK – DCB0129 and DCB1060.

Our team has decades of direct experience implementing the rigorous NHS standards and can support you in every aspect the process. We’ll ensure that you meet the mandatory standards related to clinical risk management and its application in the manufacture of health IT systems. The DCB0129 standards are now mandatory under section 250 of the Health and Social Care Act 2012.

The 8fold team will ensure that clinical safety is a core practice for your organisation and that the statutory requirements are met. We’ll work with you to create a compliant clinical risk management process and culture, along with the required documentation (i.e., Clinical Safety Case Report, Hazard Log and Clinical Incident Log) to support your application.

Enlist a named Clinical Safety Officer

A key requirement of the DCB0129 standard is that your organisation has a Clinical Safety Officer (CSO) responsible for the application of the clinical safety process. The CSO must be a suitably qualified and experienced clinician knowledgeable in risk management in clinical domains. We have a team of qualified CSO’s and can offer this expertise if you do not already have a CSO in place.

Ready to get started?

Check out the information above for details of our products, or book your introductory no-obligation call with our experienced team below to understand your responsibilities for the NHS Data Technology Assessment Criteria (DTAC).

You can also read our DCB0129 blog for more details on clinical safety in healthcare IT.

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Frequently Asked Questions

Clinical Risk Management

What is Clinical Risk Management?

Clinical Risk Management is the process of identifying and evaluating risk which can result in clinical harm to a patient or service user.

How can I mitigate clinical risk?

By conducting structured Hazard Assessments, our Clinical Safety Officers can help your team to identify hazards and establish risk control measures as needed. Mitigations can include: design, training and business processes.

What is a Clinical Safety Officer?

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. 

At 8foldGovernance, your named CSO will work closely with your team to carry out hazard assessments and mitigate any risks. Clinical Safety is everyone’s responsibility and a multidisciplinary team process is essential.

What is DCB0129?

DCB0129: Clinical Risk Management: its Application in the Manufacture of Health IT Systems:  

Manufacturers of Health IT systems must comply with DCB0129 to provide evidence that their product has undergone a Clinical Safety Assessment and 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: Clinical Safety Case Report, Clinical Risk Management Plan and Hazard Log. Clinical safety and risk management must be embedded in the software development process by having a named Clinical Safety Officer (CSO) for the lifetime of the product.

What is DCB0160?

DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems.

DCB0160 is the standard which mirrors DCB0129 for deploying organisations who 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.

Is DCB0129 and DCB0160 mandatory?

DCB0129 and DCB0160 are published under section 250 of the Health and Social Care Act 2012 which mandates them under NHS law.

How do I become DCB0129 compliant?

We can help you conduct all required Clinical Risk Management Activities by conducting a thorough review, hazard workshops and a risk assessment to identify risk and recommend control measures. We then produce the DCB0129 documentation and provide ongoing Clinical Safety Officer support for your Health IT product.

What documentation do I need to provide to become DCB0129 compliant?

You will need to evidence the following documentation to become DCB0129 compliant:

  • Clinical Safety Case Report
  • Clinical Risk Management Plan
  • Hazard Log

In addition to these documents, 8foldGovernance also provides supporting documentation to evidence the Clinical Risk Management System is in place.

What are the timelines for becoming DCB0129 compliant?

It is recommended that Risk Management Activities should begin as early as possible in software development process. This helps to ensure that Clinical Safety practices and standards are embedded in the processes from the start. 

Here at 8foldGovernance, we will assess your product and its associated risk management practices, and work with you until you are fully compliant.

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HealthUnlocked

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