- The Clinical Safety Unit comprises clinicians with specialist training and experience in eHealth and risk management as well as system safety.
- The Clinical Safety Working Group works with the clinical and programme leadership for the PCEHR and for products and solutions constituting the component infrastructure of the PCEHR. Their work is to validate the evidence that forms the ‘Clinical Safety Case’ for the PCEHR. This includes identifying risks, recommending the controls to address the potential risks and evidencing these in operation.
- The Clinical Governance Review Board has an advisory role to support existing NEHTA product development and implementation and provides expert and systemic clinical and safety advice.
1.3 Overall Risk Assessment
NEHTA has made an assessment that there are no clinical hazards identified in relation to the Consumer Release – 1 July 2012 that are classified as a High or Medium Clinical Risk, which leaves a Justifiable Residual Risk Classification as per Appendix A, Table 4.
NEHTA therefore considers that there are no Unacceptable Residual Risks present in Consumer Release – 1 July 2012.
NEHTA Clinical Safety Unit has determined one generic hazard, defined according to the NEHTA Clinical Safety Management System, as important to the analysis of clinical safety residual risk, specifically the Consumer Release - 1 July 2012. This generic hazard is listed below and summary analysis, including an outline of pertinent mitigating controls, is provided in Section 1.8:
- Clinical information is presented inappropriately or in a manner that its context is misleading or cannot be ascertained
1.8 Summary analysis of priority Clinical Hazards & Mitigating Controls
- A note is displayed to consumers, indicating that Providers will not have access to Personal Health Notes, on the page that consumers enter the note.
- Consumers are to be educated that a provider cannot access health information in the Personal Health Notes and that any information that is related to their care in the notes should be discussed as per usual methods e.g. General Practitioner or Specialist appointment
- Guidelines are to contain information on the functional limits and constraints of the PCEHR, including roles and responsibilities