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Tuesday, April 17, 2012

It Looks Like The Medical Software Industry Association Has Put NEHTA on the Back Foot.

The following page turned up on the NEHTA web site a few days ago.

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.
See here:
It is interesting that this little addition to the e-Health Implementation Section of the web site comes when so little has been updated in the last year and in many cases since 2010!
I reckon all this is a delayed response to the critique of NEHTA at the public hearings at the Senate PCEHR Enquiry in February by the MSIA among some others.
What amazes me is that we still have not seen this amazingly secret PCEHR Clinical Safety Case. Where is it and why is it not public? Blowed if I know other than the most likely reason that is doesn’t yet exist.
Clinical Safety in Health IT is not just a phrase. What it requires is that systems are actually formally tested in very complex ways - on paper through process control and review during development and then by careful evaluation of staged limited implementations of proposed systems before extensive roll out.
Safety in clinical systems is also multifactorial involving user training, system functionality and controls, system and interface design and a whole lot more.
If you want to find coverage of the variety of ways things can go wrong there are two useful resources.
This blog from last year points to an Institute of Medicine Report and some issues that flowed.
See here:
Second is Scot Silverstein’s blog where many of these issues are raised among some other topics.
NEHTA claims it understands but until we see the actual details of the work they have done that is just so much ‘hot air’. This is confirmed when we have their clinical lead suggest a good deal more work and transparency is needed.
I cannot but agree. The treating the health community and public like mushrooms (kept in the dark and fed excrement)  is just obscene and really needs to be condemned.
David.