This may have been asked already. Do you have links to the UK standards. Europe and the UK in general also tend to be ahead with respect to privacy, I'm told.
Richard Schilling
Web Integration Programmer
Affiliated Health Services
Mount, Vernon WA USA
http://www.affiliatedhealth.org
-----Original Message-----
From: Adrian Midgley
To: [EMAIL PROTECTED]
Sent: 30/01/02 0:01
Subject: Re: New FDA Software Regulations 1/11/02
On Tuesday 29 January 2002 23:10, Schilling, Richard wrote:
> Certainly there are systems that comply, and if this is a new set of
rules
> then the systems that have approval from the FDA are going to be
updated to
> meet the guidelines.
Assertion: The UK, particularly in primary care, is at present ahead in
this
area, and therefore prior art from the UK may be worth looking at.
However, another assertion: the approach of having a remote electronic
notary
stamp teh hash of each record as it is added is better than anything I
know
of currently implemented in commercial software in the UK, for the audit
trailing and assurance of authenticity.
In my view one of the essences of open source development is the ability
to
combine modules from many places, however an all-in-one accreditation or
validation fits this less well than it might. While the assembly needs
to be
validated, there is much to be gained from some process of validation of
modules or components at a lower level, and perhaps even as services
delivered remotely.
I'll try to read the US requirements soon.
--
From one of the Linux desktops of Dr Adrian Midgley
http://www.defoam.net/
