NEWS - eHealthNews.nz editor Rebecca McBeth
This is a companion discussion topic for the original eHealth News article:
This is a companion discussion topic for the original eHealth News article:
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I note that the Therapeutic products bill has now been passed by parliament.
Does anybody have insight into what the implications to this bill will actually be, and what role clinicians will have in assessing whether an IT product is? Rebecca’s excellent article from last year highlighted real concerns about what products might be included, and what the unintended consequences might be… but I am unaware if the bill has been refined to meet any of these very cogent concerns.
While there is a bit of a lag time before this bites, there are likely real changes, which probably warrants some thinking about. From a simpleton’s perspective, this means that software will now be assessed by a “Pharmac equivalent” and that purchasing of medical software will centrally approved and or purchased centrally.
This could either be great - all those IT tools which frankly hinder patient care, waste time or cause re-work could be replaced with better tools. It could also open a door to national IT platforms, removing some of the barriers created by the siloing of information.
Or it could be a disaster. Centralised procurements haven’t exactly shone as a high spot of IT brilliance thusfar. Tools such as medchart, the philips PACS/RIS in the central region and Orion’s Clinical portal are probably not the first things which spring to mind when people think of stellar IT success… they have utility, but are also a bugbear for many… Similarly, it could make upgrade and improvement clunky and painful.
Anybody got more to say?
Hi Mat,
I was one of some folk who provided feedback via the DHA submission. There were a lot of concerns around the originally drafted bill.
Fortunately, some significant changes came during
select committee which alleviated the majority of these.
Rebecca summarised this in her recent update
Essentially there will be more detailed guidelines around which types of software will need regulation and there has been a differentiation between Software as a Medical Device and Software in a Medical Device. The Australian guidelines will hopefully provide a starting point.
Re central procurement, that’s really a different thing I think. The onus of response to regulation is on the vendors, not the customers.
Thanks Alastair! Thanks also for clarifying that a “Pharmac-like” approach to to procurement of software is actually not part of this bill… I had it in my head that this was where this bill was headed. That seems not to be the case, however it seems to still be part of the broader Pharmac plan. (at least according to their website). While it’s not central procurement, it’s more along the lines of “only software and devices on this list can be purchased by a hospital in NZ”… That could be interesting!
Approved software solution lists are common in other jurisdictions so I wouldn’t be surprised to see that happen here too. The big question will be the process to to put solutions on (or take them off) said lists….