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

Review of digital clinical safety standards: DCB0129 and DCB0160

NHS England has started a review of digital clinical standards DCB0129 and DCB0160 to ensure they remain up-to-date, practical and aligned with the latest advancements in healthcare technology and clinical practice.

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.

October 2020: Update: Confirmation from the NHS Digital Clinical Safety Group that this has returned to business as usual activity.

Current release

Release date	07/06/2018
Release number	Amd 24/2018
Release title	2018 Update
Stage	Implementation
Key documents	Change Specification (Amd 24/2018) Specification (Amd 24/2018) [Archive Content] Implementation Guidance (Amd 24/2018) [Archive Content] Information Standards Notice (Amd 24/2018) Guidance - determine the applicability of DCB 0129 and 0160 Compliance Assessment Template (Amd 39/2012)
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
Stage	Maintenance
Key documents	Specification (Amd 39/2012) Implementation Guidance (Amd 39/2012) [Archive Content] Information Standards Notice (Amd 39/2012)
Guidance documents	Agile Development (Amd 39/2012) [Archive Content] Middleware (Amd 39/2012) Telehealth and mobile health solutions (Amd 39/2012) [Archive Content]
Previous releases	Please see the ISB website for information on the previous releases.

Last edited: 15 June 2023 4:07 pm