Version: 1.0.1 | Published: 1 Dec 2025 | Updated: 3 days ago
Clinical Risk Management: its Application in the Manufacture of Health IT Systems
Dataset
Summary
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
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:
[object Object]
Origin
Name:
NHSE-SD Data Catalogue