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DCB0129 with Naq

Show the NHS your product is clinically safe.

NHS customers ask for your safety case and hazard log before they use your product. Naq sets up the work for you and keeps your hazard log under review.

DCB0129 with Naq walkthrough video

DCB0129 with Naq, a three-minute walkthrough of the product · Narrated, with captions

What is DCB0129?

DCB0129 is the NHS clinical safety standard for companies that make health software. There is no certificate: you show your safety case and hazard log.

Mandatory

For every company whose health software is used in the NHS in England.

A clinician

Your Clinical Safety Officer must be a registered clinician, and approves your safety case and hazard log.

After release

You keep monitoring safety once your product is in use, not only before it.

Six steps to meet the standard, most of them done for you.

This is everything DCB0129 asks of you. For each step, here is what you do and what Naq does.

Step
1

Define the product it covers

You

Create a DCB0129 instance on your product's scope.

Naq

Maps it for you: 24 requirements, linked to 11 ready-made controls.

No mapping from scratch
Step
2

Appoint a Clinical Safety Officer

You

In People, give the Clinical Safety Officer role to a registered clinician.

Naq

Links the role to the controls that ask for it.

Responsibility on record
Step
3

Plan how you will manage clinical risk

You

Fill in your details, then approve the plan.

Naq

Gives you 13 ready-written templates, such as your Clinical Risk Management Plan and Clinical Safety Case Report.

No blank pages
Step
4

Log and assess every hazard

You

Log each hazard to patients, such as a booking made for the wrong patient, and link the controls that reduce it.

Naq

Keeps the risk rating before and after your controls, for every hazard, in one hazard log.

One hazard log
Step
5

Have your Clinical Safety Officer approve it

You

Your Clinical Safety Officer approves each version of the hazard log.

Naq

Checks it every night, and flags it for review if a hazard changes after approval.

Changes flagged for review
Step
6

Keep monitoring safety after release

You

Log each clinical safety incident, resolve it, and write down what you learned.

Naq

Keeps the type, severity and owner of every incident, with the lessons learned.

A full safety record
Then, prove it

Checked every night, not once a year.

Naq links your hazard log to the right controls and checks it every night. A hazard that changes after approval is flagged for your Clinical Safety Officer.

Hazard Log and Clinical Risk Estimation
Needs review
DCB0129 · 3.3, 4.3, 4.4, 5.1

Hazard log

Register · linked by Naq

  • Hazard log has an approved version
  • The hazard log has changed since it was approved 30 days to fix
  • Every hazard has a residual risk rating
Last checked today, 02:00

Real checks from a DCB0129 control in Naq. The results shown are illustrative.

Trust Centre

Show customers, before they ask.

Publish your clinical safety controls and documents on your own Trust Centre. NHS customers answer their own questions before they ask you.

1
Customers filter your controls to DCB0129

They see your clinical safety controls.

2
They request a restricted document

For example your Clinical Safety Case Report, with their name and the reason they need it.

3
You approve the request

Naq emails them a link straight away.

24 requirements, in 6 sections

  • Clinical risk management process 6
  • Clinical risk management documentation 6
  • Clinical risk analysis 4
  • Clinical risk evaluation 1
  • Clinical risk control 4
  • Delivery and post-deployment monitoring 3

Mapped to DCB0129, version 5.0.

11 ready-made controls

  • Clinical Risk Management Process and Plan
  • Clinical Safety Case and Reports
  • Clinical Risk Control and Benefit Analysis
  • Hazard Log and Clinical Risk Estimation
  • Clinical Safety Officer Appointment and Competence
  • Safety Incident Management Log
  • Third-Party Product Clinical Safety Assessment
  • Product Definition and Value Proposition
  • Role-Based Security Training

And 2 more.

13 ready-written templates

  • Clinical Risk Management Plan
  • Clinical Safety Case Report
  • Clinical Risk Management System
  • Clinical Safety Incident Management Policy
  • Safety Change and Configuration Management Policy
  • Risk Management Policy
  • Change Management Policy
  • Secure Software Development Policy
  • Event and Incident Management Policy

And 4 more.

Every document you link as evidence is also checked automatically: its current version must be approved, staff acknowledgements must be complete, and its review date must not have passed.

Built from the Naq control library for DCB0129.

Get ready for DCB0129with Naq.

See the six steps in your own workspace, with your own product.