Wednesday, August 01, 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.


B said...

The following statement suggests to me that whoever is writing this stuff doesn't know what they are doing:

The national eHealth system will improve clinical outcomes, and to do that it needs clinically safe and efficient foundations.

"Improving clinical outcomes" is a desired outcome it is not a guaranteed characteristic.

To say that "The national eHealth system will improve clinical outcomes" and then state a dependency and to do that it needs.... is just spin.

A better statement would have been The national eHealth system will assist in achieving improved clinical outcomes.

But that is nowhere near the level of hubris that seems to have infected Health and NEHTA.

There is so much about this eHealth initiative that could be better. Much, much better.

Or maybe I should say, could have been better. It's too late now.

IMHO, the trust that is needed to get full community buy-in for eHealth cannot now be gained.

Anonymous said...

In all the bumf expounded by NEHTA and DOHA there appears to be a total lack of understanding of what clinical outcomes means and no real direct link to improving safety except for motherhood statements.

In fact, the use of their system in its current state would probably lead to a clinical disaster.

The really sad part in all this is that to unwind all this and to actually focus on a 'complete' system that may be useful to practitioners at the myriad of patient interfaces is going to take a long time.

It is really hard to see a way forward...........

Anonymous said...

alright, what do you anonymous experts think that clinical outcomes means?

Pat D said...

Clinical outcomes at the simplist is that the patient got better; or the patient didnt get better. All this (PCEHR) recording, reporting and observations are the written history of the clinicasl event (better, no change or worse). reading the balony above should make even the most supportive advocate question "how will ordiinary patients/people ever cope with all the malarky and rules"?

B said...


"alright, what do you anonymous experts think that clinical outcomes means?

I'm afraid you just don't get it.

The point I am making is that the statement The national eHealth system will improve clinical outcomes is a logical inconsistency.

In this context, what clinical outcomes means does not matter. NEHTA should not be making such statements. It is like saying "I'm going out to buy a lottery ticket and win $10million dollars". You can go out and have a reasonable expectation of buying a ticket, but not of winning $10million dollars.

NEHTA can implement an eHealth system (by some definition) but there is no guarantee it will improve clinical outcomes - whatever they are.

Dr David More MB PhD FACHI said...

Just so we are all clear 'clinical outcomes' are what you get from an intervention in the health service delivery system. They may be positive (longer life, feel better, improved national health statistics) or the reverse.

The final outcome, after full implementation, is what NEHTA hopes will be positive - but they have not a shred of evidence that will be the case. The NEHRS is a one off approach and so no-one knows.


Cris Kerr said...

A clinical outcome is usually reported from the doctor's professional perspective, notes and tests.

But the patient... the person at the centre of all the activity... is the person most familiar with the clinical outcome.

I have long advocated for patients to be given capacity to self-report their health outcomes in structured ways.

The starting point for that, logically, is to populate the patient's personal section of their PCEHR with prescribed medications, rather than forcing patients to enter their own medications (with associated typos).

A drop down list could then facilitate (time relevant) effectiveness ratings for each medication.

From my perspective, this should always have been a part of what was planned:

Submission to Strategic Review of Health and Medical Research:

Anonymous said...

This thread is really about whether or not there is a direct correlation between spending considerable money on Health IT and a specific type of IT based initiative and end outcomes or benefits from a patient, clinical and health system perspective. Broadly, there is consensus that ehealth has the potential to make an improvement but in reality perhaps we have to be more critical about who is claiming the benefits and why. IE a technology supplier and systems integrator will clearly say what they do has benefits. But then they would say that. The questioning of the possible new errors or dis-incentives that introducing new technology is not anti health but prudent common sense.

Anonymous said...

PCEHR -> NEHRS -> eHealth Record System -> National eHealth System

What next?