Core Clinical safety

As a manufacturer of health IT software, you must implement a clinical risk management process that conforms to DCB0129 standards.

If you are a healthcare organisation looking to deploy and use health IT, you must implement an effective risk management process in accordance with DCB0160 deployment.

Help and tips for completing this section

You must confirm you have appropriately considered, captured, and mitigated against all clinical hazards and these are approved by your responsible clinical safety officer.

For some of our APIs, we provide you with a clinical safety hazard log which you must review and integrate into your own clinical safety hazard log.

You can download the relevant clinical safety hazard log for the specific APIs you're using during this onboarding process.

For details on the requirements for a particular API, read its API specification in our API catalogue.

Q.1

Confirm your organisation type and standard
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Q.1.1

Is your organisation and product compliant with the requirements of DCB0129?
Supporting information

Find out more about the DCB0129 standard for clinical risk management and its application in the manufacture of health IT systems.

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Q.1.1

Is your organisation and product compliant with the requirements of DCB0160?
Supporting information

Find out more about the DCB0160 standard for clinical risk management and its application in the healthcare organisation.

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Q.1.2
Q.1.2
Q.2

Have you undertaken a formal hazard assessment?
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Q.3

Have you undertaken clinical risk analysis?

As part of your clinical risk analysis and evaluation, you must evidence potential:

  • causes (contributory conditions)
  • patient harm outcomes

These must be described to determine severity, likelihood and an overall risk classification.
Q.3.1

Where NHSE have provided a generic clinical safety hazard log, have you reviewed, considered and integrated the risks identified into your own hazard log?
Supporting information

For some of our service or APIs, we provide a clinical safety hazard log template. This is pre-populated with the hazards you must address as part of this clinical safety review. You do not need to use this template, but you must include the hazards listed for the service you are onboarding to. You should also include any additional hazards you have identified.

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Cannot continue

You must complete clinical risk analysis before you can continue.

Q.4

Have you considered appropriate clinical risk controls?

This includes identifying and implementing effective controls for clinical risk.
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Q.5

Has your Clinical Safety Officer approved a clinical safety case report for the version of your product being supported by this declaration?
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