System Operator The participant with responsibility for establishing and operating the My Health Record system. As of 1 July 2016, the System Operator is the Australian Digital Health Agency. Appendix A Clinical safety review risk rating matrix Review findings have been assigned one of five risk ratings critical, major, moderate, – minor and minimum, consistent with the clinical safety review risk rating matrix. These categories have been confirmed by the Commission’s Clinical Safety Oversight Committee and the My Health Record System Operator during the review process. Risk Reputation and public Clinical safety Control rating confidence of My Health harm Record / quality of service Critical Profound influence on the My A clinical incident supervisory and/or Health Record system’s resulting in patient monitoring controls are reputation, resulting in a inadequate and require profound loss of public and urgent management healthcare provider attention participation A critical patient safety Profound sustained incident has occurred degradation of service value and quality Significant influence on the A clinical incident Basic, supervisory and/or My Health Record system’s resulting in major monitoring controls are reputation, resulting in permanent loss of inadequate and require significant loss of public and function prompt management healthcare provider attention participation A major clinical safety Decline in service value and incident has occurred quality is recognised by a majority of patients or health service providers Moderate Loss of reputation affecting A clinical incident Basic, supervisory and/or participation in the My Health resulting in monitoring controls are Record system permanent partly inadequate and reduction in require management Decline in service and function attention quality is recognised by a moderate number of patients High potential for a clinical and health service providers safety incident
System Operator The participant with responsibility for establishing and operating the My Health Record system. As of 1 July 2016, the System Operator is the Australian Digital Health Agency. Appendix A Clinical safety review risk rating matrix Review findings have been assigned one of five risk ratings – critical, major, moderate, minor and minimum, consistent with the clinical safety review risk rating matrix. These categories have been confirmed by the Commission’s Clinical Safety Oversight Committee and the My Health Record System Operator during the review process. Risk rating Reputation and public confidence of My Health Record / quality of service Clinical safety harm Control Critical Profound influence on the My Health Record system’s reputation, resulting in a profound loss of public and healthcare provider participation Profound sustained degradation of service value and quality A clinical incident resulting in patient supervisory and/or monitoring controls are inadequate and require urgent management attention A critical patient safety incident has occurred Significant influence on the My Health Record system’s reputation, resulting in significant loss of public and healthcare provider participation Decline in service value and quality is recognised by a majority of patients or health service providers A clinical incident resulting in major permanent loss of function Basic, supervisory and/or monitoring controls are inadequate and require prompt management attention A major clinical safety incident has occurred Moderate Loss of reputation affecting participation in the My Health Record system Decline in service and quality is recognised by a moderate number of patients and health service providers A clinical incident resulting in permanent reduction in function Basic, supervisory and/or monitoring controls are partly inadequate and require management attention High potential for a clinical safety incident
My-Health-Record-Clinical-Safety-Review-10-Summary-Report-Feb-2018.docx