Clinical Risk Management: its Application in the Manufacture of Health IT Systems
Designed to help manufacturers of health IT software evidence the clinical safety of their products.
About this standard
- Publisher
- NHS England
- Reference code
- DCB0129 Amd 24/2018
- 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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- Impacts on
- This Notice is addressed to Manufacturer personnel who are responsible for ensuring clinical safety in the development and modification of Health IT Systems through the application of clinical risk management.
- Effective from
- 01/07/2018
Topics and care settings
- Topic
- Access to records
- Continuity of care
- Dispensing
- Information codes of practice
- Information governance
- Key care information
- Messaging
- Patient communication
- Prescribing
- Reference data
- Care setting
- Community health
- Dentistry
- Hospital
- Maternity
- Mental health
- Pharmacy
- Social care
- Urgent and Emergency Care
Dependencies and related standards
- Related standards
This standard relates to:
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
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: 19 June 2024