Tuesday, July 31, 2012

NEHRS Clinical Safety Is Apparently Assured. But How Are We To Know?

NEHTA has deigned to provide an update on the clinical safety of the NEHRS. For context here is the page on which the report is found - with links.

Clinical Safety

The national eHealth system will improve clinical outcomes, and to do that it needs clinically safe and efficient foundations. That’s why the clinical safety and integrity of NEHTA’s products guides everything NEHTA does as an organisation.
There are three key clinical quality and safety processes in NEHTA, the Clinical Safety Unit; the Clinical Safety Working Group and the Clinical Governance Review Board, each ensuring safety.
  • 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.
NEHTA works with organisations such as the Australian Commission on Safety and Quality in Health Care (ACSQHC) and the University of New South Wales Centre for Health Informatics to ensure the clinical safety and governance of the PCEHR and eHealth products.
The page is found here:
Cutting right to the chase - here is the conclusion from page 4 of the comprehensive 8 page document.

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

What this means is found here:

1.8 Summary analysis of priority Clinical Hazards & Mitigating Controls

Clinical Information is Presented Inappropriately or in a Manner that its Context is Misleading or Cannot be Ascertained
There is the ability for consumers to enter their own health information in the PCEHR through Personal Health Notes, which will never be visible to providers, and the Personal Health Summary, which will be visible to providers. There may be an assumption on behalf of consumers that providers will regularly refer to, read and act upon information in the Personal Health Notes and or Personal Health Summary. This assumption may lead to incorrect, delayed or no care being provided. This potential risk will be reviewed when provider access is enabled in a subsequent release of PCEHR.
While consumer generated health information is currently exchanged between consumers and providers and is variable in quality, the PCEHR Personal Health Summary (designed for sharing with providers) presents a potential amplification of any disconnect between consumers¡¦ expectations of providers using this health information.
In the context of the Consumer Release - July 1 2012, no consumer generated data will be available to providers.
The control for this risk is:
  •           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.
Additional recommended controls include:
  • 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

1.9 The Way Forward

The CSU will continue to work closely with the NEHTA PCEHR team as the staged delivery of provider and consumer functionality is made available. A fundamental aspect of this work is to seek specific evidence as to the effectiveness of mitigating controls, both system specific and those relating to non-functional end user, process and policy elements of the PCEHR in operation that impact safety. Verification of these mitigations in operation will allow elaboration of the PCEHR Clinical Safety Case Report and act as evidence of the continuous clinical safety management and assurance.
---- End Extract from Page 6.
What this seems to be saying is that, confusingly there are both Personal Health Notes and a Personal Health Summary for former of which a healthcare provider won’t be able to see the latter the provider will always be able to see.
With all this said what is unsaid is way more than what is said. There is no discussion of the methodology beyond giving it a name and the approach to risk identification, prior to the assessment of each of the risks. Again we seem to have another one of these ‘trust us’ documents and are provided with essentially no reason to do so.
Not being provided with the range of risks that have been assessed leaves us all in the dark as to how seriously NEHTA’s claims as to safety. I note we are not told what actions have been taken to remedy the issues identified in the earlier case report (linked above).
NEHTA need to do a good deal better than this.