Well, it's worth pointing out that there are at least two "standards of
care" here.  (FYI The Joint Commission for the Accreditation of
Hospitals spends the lion's share of its time rooting out separate
standards of care within health institutions: the patients on the first
floor have to be cared for with the same standard of care as the
patients on the second floor).
When the FDA certifies that a drug is safe within its recommended usage,
the tests and studies on which that certification are based are all
public knowledge.  If the public is concerned about the safety of a
drug, it does not have to take the FDA's word for it, it can go directly
to the studies the FDA used to make its determination and make its own
judgement).
If, in fact, the FDA and the DHSS are going to certify software without
revealing their tests, then that's a different standard of care.  The
conceptual difference seems to be between patent and trade secret. 
Drugs are patented meaning that their exact composition is well-known,
and software is trade secret.  It's a problem.
John 

jeff b wrote:
> 
> > Short of exposing the source code, is there any ther way to do that?
> 
> Believe me, if it gets exposed to anyone, it will be to the regulatory
> commission only. These people have many lawyers that earn more in a week
> than I do in a year, who will fight with every once of strength they have
> to protect the spaghetti legacy garbage some of these people have written.
> (disclaimer: not all proprietary code is spaghetti legacy garbage. but then
> again, how would I know?)
>

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