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Introduction to Clinical Safety

Clinical Safety Introduction

Introduction

The overall NHS Digital assurance approach to new product compliance has a Clinical Safety Management System embedded at its core, ensuring that all NHS IT systems support clinicians provide better and safer patient care. This approach is centred upon the adoption of two Clinical Safety standards, DCB0129 and DCB0160, which are mandatory under the Health and Social Care Act 2012 and delivered by appropriately skilled Safety Engineers and Clinical Safety Officers. The Target Operating Model (TOM) for API assurance methodology referenced within this section promotes this safety approach and ensures that effective clinical risk management is carried out by organisations that are responsible for deploying, developing and modifying health IT systems.

The newly released suites of NHS e-Referral Service (NHS e-RS) APIs allow third-party system suppliers to integrate and achieve compliance with NHS e-RS functionality. Compliant clinical software may use some or all of the available APIs to carry out some or all of the NHS e-RS workflows within their overall deployed solutions. For each use of APIs by a third-party system supplier the TOM document will need to be completed, assuring that both the third-party company’s use of the e-RS APIs and the end user organisation’s use of the software is complaint with the two required standards.

Through use of the TOM document, the system supplier and end user organisation can assess and record the clinical safety case for the use of the NHS e-RS APIs with varying support and involvement from the NHS e-RS Programme Team and central NHS Digital Clinical Safety Group (CSG) dependent on the level of risk pose by the scope of the functionality built into the new product solution.

This section seeks to provide new system suppliers and end user organisations alike with a useful introduction into how such methodologies to clinical safety and risk management can be effectively integrated into NHS e-RS API adoption projects.

Roles and responsibilities

Roles and Responsibilities Diagram

Further Information:

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.


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