Clinical Risk Management File

A clinical risk management file in relation to DCB0129 and DCB0160 NHS safety standards is a comprehensive document that outlines the approach to identifying, assessing, and mitigating clinical risks associated with Digital Health Technologies.

It not only provides the safety documentation as required by the NHS Safety Standards but acts as a repository for all the digital clinical safety resources and outputs.

Here’s a summary of its key components:

  • Clinical Safety Management Plan: This document outlines the overall strategy for managing clinical risks throughout the lifecycle of the Digital Health Technology.
  • Hazard Log: A crucial element that records all identified hazards, their potential clinical impact, mitigations, controls, and final risk assessment.
  • Clinical Safety Case: This is a structured argument supported by evidence that demonstrates the system’s safety for release. It provides a compelling and valid case for the system’s clinical safety.
  • Risk Assessment: A systematic evaluation of potential risks, their likelihood, and severity, using methods such as Functional Failure Analysis (FFA), Hazard Identification (HAZID), or Structured What-IF Technique (SWIFT).
  • Mitigation Strategies: Detailed plans for addressing identified risks, including preventive measures and controls to minimize potential harm.
  • Compliance Documentation: Evidence of adherence to the requirements set out in DCB0129 (for manufacturers) or DCB0160 (for healthcare organizations).
  • Clinical Safety Officer (CSO) Involvement: Documentation of the CSO’s role in overseeing the clinical risk management process, including their qualifications and involvement in risk assessments including clinical safety reviews.
  • Ongoing Monitoring and Review: Plans for continuous assessment of the system’s safety post-deployment, including incident reporting mechanisms and periodic safety reviews. Commonly referred to as post deployment monitoring (DCB0160) or post market surveillance (DCB0129).
  • Training Records: Documentation of staff training on clinical risk management processes and the specific Digital Health Technologies.
  • Change Management: Procedures for reassessing clinical risks when significant changes or updates are made to the system.

This clinical risk management file is mandated under Section 250 of the Health and Social Care Act 2012, emphasizing its critical role in ensuring patient safety in the context of health IT systems. 

The file serves as a living document, continuously updated throughout the system’s lifecycle to reflect ongoing risk management activities and maintain compliance with DCB0129 and DCB0160 standards.

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