Introduction

Clinical safety remains the responsibility of the system supplier and end user organisation, as laid out in the NHS e-RS Integration API compliance approach.

Resources

DCB0129 - Clinical Risk Management: its Application in the Manufacture of Health IT Systems.

This standard sets clinical risk management requirements for Manufacturers of health IT systems.

DCB0160 - Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems.

This standard requires a health organisation to establish a framework within which the clinical risks associated with the deployment and implementation of a new or modified health IT system are properly managed.

Compliance with DCB0129 and DCB0160 is mandatory under the Health and Social care Act 2012.
Click here to read more about clinical risk management standards.

Training

Clinical risk management training is designed to provide health and social care organisations and manufacturers of health IT products with training in the principles of safety, risk management and risk mitigation, all within the context of health IT by implementing the safety standards, DCB0129 and DCB0160.

Click here for more information about training.

Additional Guidance

Download the NHS Digital Clinical Safety Guidance document.

Further document templates can be downloaded from the NHS Digital Clinical Safety website.

Note: The information contained within these pages is intended solely as a guide, assuring the clinical safety of any system remains the responsibility of the commissioning party._