Concept of Operations: Relating to the introduction of a Personally Controlled Electronic Health Record System

7.4.2 Clinical safety

The governing body (or bodies) responsible for the PCEHR System will be responsible for ensuring that any identified clinical safety risks associated with the appropriate use of the PCEHR System have been mitigated. To help support this requirement the PCEHR System Operator will need to implement a clinical safety management system that:
  • Considers clinical safety risks from a range of perspectives, including patient and healthcare provider perspectives.
  • Follows best practice principles adopted in the safety critical software industry and is compliant with international standards relating to the management of clinical risk, such as ISO/IEC 80001 [IEC80001].
  • Provides policy, procedures and document templates for managing patient safety for a software release and documenting the clinical safety case.
  • Involves the participation of representatives of relevant colleges and other organisations in the process of assessment and recommendations for mitigation.
  • Has a process for continuous improvement that will over time refine the approach to clinical safety.

The clinical safety management system is a logical extension to the operator’s and governing bodies’ risk management system(s) and its application will highlight:
  • Potential clinical safety risks in the development lifecycle processes.
  • Product quality and design flaws around clinical safety

It will be possible to:
  • Identify the scale and scope of the risks and issues faced.
  • Manage clinical safety risks.
  • Identify and prioritise recommendations for improvement.

From time to time, the governing body (or bodies) will request an independent audit of the clinical safety aspects of the PCEHR System.

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Page last updated 26 August, 2011