Clinical risk management standards

Information standards underpin national healthcare initiatives from the Department of Health, NHS England, the Care Quality Commission and other national health organisations. They provide the mechanism for introducing requirements to which the NHS, those with whom it commissions services and its IT system suppliers, must conform.

The following two standards, relating to clinical safety, are accepted for publication under section 250 of the Health and Social Care Act 2012 by the Data Coordination Board (DCB). In line with current DCB practice, each standard comprises:

• a specification, which defines the requirements and conformance criteria to be met by the user of the standard - how these requirements are met is the responsibility of the user
• implementation guidance, which provides an interpretation of the requirements and, where appropriate, defines possible approaches to achieving them

Compliance with DCB0129 and DCB0160 is mandatory under the Health and Social care Act 2012.

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.

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.