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Clinical safety Clinical Safety & DCB0129

Clinical Safety, Risk Management & DCB0129

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Clinical safety Clinical Safety & DCB0129
Clinical Safety, Risk Management & DCB0129

Building safety into the heart of your system.

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.

If you manufacture healthcare software which is used in the UK, you’re legally responsible for maintaining your safety practices to the highest standards. You must ensure your software is clinically safe and complies with NHS clinical safety standards, minimising the potential for harm to all users including patients, staff and citizens.
Clinical safety Clinical Safety & DCB0129
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Clinical safety Clinical Safety & DCB0129

Clinical Safety & DTAC

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.

Get DCB0129 support.

Book a free, no-obligation discovery call with one of our clinical safety officers.

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Clinical safety Clinical Safety & DCB0129

Get DCB0129 support.

Book a free, no-obligation discovery call with one of our clinical safety officers.

Book your call now
Clinical safety Clinical Safety & DCB0129

What to expect when you work with us.

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 including:

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  • 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.

Do I need a named Clinical Safety Officer (CSO)?

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 safety Clinical Safety & DCB0129
Clinical safety Clinical Safety & DCB0129

Frequently asked Clinical Safety questions

What is Clinical Risk Management?

Clinical Risk Management is the process of identifying, evaluating and mitigating risks 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 identify hazards and establish risk control measures. Mitigations might include design, training and new or revised 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.

What is DCB0129?

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 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’ 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.

Are 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?

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.

What documentation will I need to become DCB0129 compliant?

You need to evidence the following documentation to become DCB0129 compliant:
  • Clinical Safety Case Report
  • Clinical Risk Management Plan
  • Hazard Log
  • Clinical Risk Management System
We’ll also provide supporting documentation to evidence that your Clinical Risk Management System is in place.
8foldGovernance have been a great partner of patientMpower, assisting us primarily in information governance and clinical safety analysis and planning. Would highly recommend to any digital healthcare company looking to sell into the NHS.
Eamonn Costello
Patient M Power
When we have a problem to solve or a complex issue to untangle around Information Governance, Adam is there to support us through it. Working with the 8fold Governance team has made our lives a lot easier and built capacity within our team.
Marc Singh Jones
Health Unlocked
The team are pleasant, extremely knowledgeable, thorough, prompt in responding to queries and keen to help in any way they could. The work completed on our behalf definitely exceeded expectations.
Michelle Whitham
NHS Thanet CCG

 Support for specific DTAC components

We provide full support in all elements of DTAC including:

Interoperability, Accessibility & Usability

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Full DTAC Support

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Data Security & Protection

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Cyber Security

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Information Governance

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We’ll review your DTAC compliance

FOR FREE!

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Interoperability, Accessibility & Usability

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Full DTAC Support

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Data Security & Protection

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Cyber Security

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Information Governance

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We’ll review your DTAC compliance

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Get DCB0129 support.

Book a free, no-obligation discovery call with one of our clinical safety officers.

Book your call now
Clinical safety Clinical Safety & DCB0129

Get DCB0129 support.

Book a free, no-obligation discovery call with one of our clinical safety officers.

Book your call now
Clinical safety Clinical Safety & DCB0129
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