From: richard boswell (richardboswellhotmail.com)
Date: Wed Apr 09 2003 - 13:26:09 CDT

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Since the topic of HIPAA and 21 CFR Part 11 has come up, does anyone know of
a good reference with respect to security for both topics? I have looked in
some places, maybe the incorrect ones, but I haven't discerned anything that
seems applicable to my particular company (which is Healthcare, so you would
think that I would have to find something somewhere). Any help is
appreciated.

Richard Boswell
Corporare Network Manager
Symbion Healthcare

>From: "Brian W. Spolarich" <bspolarichnephrostherapeutics.com>
>To: "Evan Mann" <emannpinnaclefinancial.com>,<focus-mssecurityfocus.com>
>Subject: RE: SUS server
>Date: Tue, 8 Apr 2003 11:14:12 -0400
>
>Evan Mann wrote:
> > I've read the 21 CFR Part 11 spec and no where in the documents I've
> > read does it make indications as to what controls you need on your
> > systems in terms of updates to your OS and OS related files. 21CFR
> > Part 11 is all about document control and/or electronic signatures on
> > resources related to your medical business, not what can or cannot be
> > done to the operating system itself.
>
> Typically the issue arises in controlled and regulated environment where
>systems and applications that fall under regulatory scope (21 CFR Part 11
>and GxP in particular) need to be validated for their intended use. This
>typically requires a qualification process for the systems that the
>applications are deployed on (Installation Qualification, Operational
>Qualification, and Performance Qualification [IQ/OQ/PQ]), both server and
>client depending on the architecture, and a detailed and documented
>validation of the applications themselves.
>
> If you apply OS patches in an uncontrolled manner, you wind up with
>validation exposures. e.g. "How do you KNOW the application continues to
>behave as expected after you applied the patch? Did you test it?" So in
>these environments patches tend to be applied less often an usually en
>masse. I suspect many folks use the Service Pack releases as the
>opportunity to do that, and only deploy critical interim patches when
>absolutely necessary.
>
> In those environments, the very incremental approach that SUS takes is
>probably not a Good Thing.
>
> -bws
>
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