Clinical Safety activities were undertaken during the development of the CDS API Implementation Guide in accordance with DCB0129 Clinical Risk Management: its Application in the Manufacture of Health IT Systems to ensure safety by design. These activities have informed the development of the implementation guide, the associated usage guidance and the conformance approach.
The purpose of the Clinical Safety Case Report and associated Hazard Log is to identify, assess and manage clinical safety hazards arising from the creation and implementation of the CDS API specified in this Implementation Guide. It demonstrates that associated hazards have been identified and managed, where possible, to ensure they do not give rise to unacceptable risks to patients and delivery of care. Whilst this has informed the development of the Implementation Guide, the development of CDS APIs using this guide and deployment of the resultant APIs are not within the boundaries of this assessment.
The responsibility for managing clinical risk in the implementation of the CDS API guidance lies with the manufacturers of Health IT systems that are developing the API, in accordance with DCB0129 and other in scope standards or regulations e.g. Medical Device Regulations. This report is intended to inform those activities.
The responsibility for managing clinical risk in the deployment and use of the CDS API lies with the deploying Healthcare Organization in accordance with DCB0160 Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems. This report is intended to inform those activities.
The NHS Digital Clinical Safety Group (CSG) has fully endorsed the clinical safety management approach followed by the Urgent and Emergency Care Digital Integration Programme in support of the development and publication of the Clinical Decision Support (CDS) API Implementation Guide Release 2.0. The endorsement does not result in a transfer of risk to the NHS Digital CSG in respect of any part of the Clinical Decision Support (CDS) API Implementation Guide Release 2.0. The element of clinical risk management remains the responsibility of the manufacturer and deploying organisation.
Downloads
You can access the Clinical Safety Case Report and associated Hazard Log below.
