Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems
Prepared by the NHS Digital Clinical Safety team, this standard is designed to help health and care organisations assure the clinical safety of their health IT systems.
About this standard
- Publisher
- NHS England
- Reference code
- DCB0160 Amd 25/2018
- Publication date
- 07/06/2018
- Status
- Active
Show definitions of statuses
Active. Active standards are stable, maintained and have been approved, assured or endorsed for use by qualified bodies.
Deprecated Deprecated standards are available for use and are maintained, but are being phased out, so new functionality will not be added.
Retired standards Retired standards are not being maintained or supported and should not be used.
- Standard type
- Information standards
Show definitions of standard types
Collections. A Collection is a systematic gathering of a specified selection of data or information for a particular stated purpose from existing records held within health and care systems and electronic devices.
Extractions. An extraction is a type of collection that is pulled from an operational system by the data controller and transmitted to the receiver without additional processing or transcription by the sender.
Information standards. Information standards are agreed ways of doing something, written down as a set of precise criteria so they can be used as rules, guidelines, or definitions.
Technical Standards and specifications. Technical standards and specifications specify how to make information available technically including how the data is structured and transported.
- Contact point
Link to standard
- Documentation
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- Applies to
- Health organisations responsible for ensuring clinical safety in the deployment, use, maintenance or decommissioning of IT systems
- Associated medias
- Digital Clinical Safety Informatics team The Digital Clinical Safety Informatics team provides a clinical safety assurance service across the whole of NHS England's work and to the wider health and social care service in England.
- Digital Clinical Safety Informatics team
- Effective from
- 01/07/2018
Topics and care settings
- Topic
- Clinical safety
- Information codes of practice
- Care setting
- Community health
- Hospital
- Maternity
- Mental health
- Urgent and Emergency Care
Dependencies and related standards
- Dependencies
No known dependencies.
- Related standards
Review Information
- Scope
- Health Services, NHS Services, Adult Social Care
- Sponsor
Manpreet Pujara, Clinical Director for Patient Safety, NHS Digital
- Senior Responsible Officer
Stuart Harrison, Head of Safety Engineering, NHS Digital
- Business Lead
- Sean White, Principal Practitioner Solution Assurance, NHS Digital
- Approval date
- 29/05/2018
- Post Implementation review Date
- 31/12/2018
Legal basis and endorsements
- Legal authority
Section 250 of the Health and Social Care Act 2012
This information standard is published under section 250 of the Health and Social Care Act 2012
More information
This information standard provides a set of requirements suitably structured to promote and ensure the effective application of clinical risk management by health and care organisations deploying and using Health IT Systems. The standard forms part of the NHS Digital Clinical Safety Standards; it is accompanied by the related standard for the application of clinical risk management in the manufacture of Health IT Systems (DCB0129).
About this change
Following the publication of the Medical Devices Regulation (EU 2017/745) in May 2017 and evidence of the need for clinical risk assessment of medical devices using software, a decision has been made to extend the scope of the standard to now include medical devices. Previously medical devices have been excluded from the scope of the Clinical Safety Standards.
Page last updated: 04 May 2024