Version: 1.0.1 | Published: 1 Dec 2025 | Updated: 45 days ago
Clinical Risk Management: its Application in the Manufacture of Health IT Systems
Dataset
Summary
Reference Code:
DCB0129 Amd 24/2018
Type:
Information standards
Effective From:
01 July 2018
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.
Topics:
- Access to records
- Continuity of care
- Dispensing
- Information codes of practice
- Information governance
- Key care information
- Messaging
- Patient communication
- Pharmacy, Medicines and Prescribing
- Reference data
Care Settings:
- Community health
- Dentistry
- Hospital
- Maternity
- Mental health
- Pharmacy
- Social care
- Urgent and Emergency Care
Publication Date:
07 June 2018
Contact Point
Contact Point:
Documentation
Description:
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.
Relations:
This standard relates to:
Name:Clinical Risk Management: its Application in the Deployment and Use of Health IT
Systems
Explanation:DCB0160
Review & Status
Sponsor:
Manpreet Pujara, Clinical Director for Patient Safety, NHS Digital
Approval Date:
29 May 2018
Business Lead:
Sean White, Principal Practitioner Solution Assurance, NHS Digital
Post Implementation Review Date:
31 December 2018
Scope:
Health Services, NHS Services, Adult Social Care
SRO:
Stuart Harrison, Head of Safety Engineering, NHS Digital
Technical Committee:
Data Co-ordination Board (DCB)
Dataset Identifier:
463ad94b-1b07-4abe-92d0-bd0a612d9ce1
Mandated:
Yes
Status:
active
Legal Authority 1
Legal Authority:
Section 250 of the Health and Social Care Act 2012
Legal Authority Description:
This information standard is published under section 250 of the Health and
Social Care Act 2012
Origin
Name:
NHSE-SD Data Catalogue