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

Prepared by the NHS Digital Clinical Safety team, this standard is designed to help manufacturers of health IT software evidence the clinical safety of their products

About this information standard

This standard provides a set of requirements suitably structured to promote and ensure the effective application of clinical risk management by those organisations that are responsible for the development and maintenance of Health IT Systems for use within the health and care environment.

The standard includes implementation guidance and is supported by the related standard for the application of clinical risk management in the deployment and use of Health IT Systems - DCB0160.

This information standard is published under section 250 of the Health and Social Care Act 2012. An Information Standards Notice (see below) provides an overview of scope and implementation timescales, and the other documents provide further detail for those who have to implement the information standard.

April 2020: Update: In the current circumstances of the COVID-19 pandemic, organisations may defer full compliance with DCB0129. It is expected that the fundamental principles of the standard will be adhered to during this period and that organisations will work towards demonstrable compliance within 3-6 months of commencement of the pandemic (11 March 2020).  It is recommended that organisations  continue to follow and evidence Clinical Risk Management principles and that the Compliance Assessment Template is used to manage and track compliance.

This derogation does not apply to those organisations engaged in assurance activities with NHS Digital; specific arrangements will be in place to support such activities.

Current release

Release date


Release number

Amd 24/2018

Release title

2018 Update



Key documents

Further information

Please see the  NHS Digital website  for further information about the Clinical Safety team.

Previous release

Release date

15/02/2013 (updated 05/05/2016)

Release number

Amd 39/2012

Release title

Version 4



Key documents

Guidance documents

Previous releases

Please see the ISB website  for information on the previous releases.

Last edited: 21 April 2020 3:01 pm