Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems
Summary
- Clinical safety
- Information codes of practice
- Community health
- Hospital
- Maternity
- Mental health
- Urgent and Emergency Care
Contact Point
Documentation
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.