Oracle-L: RE: HIPAA

From: Vergara, Michael (TEM) <mvergara_at_guidant.com>
Date: Thu, 22 Aug 2002 13:01:11 -0800
Message-ID: <F001.004BD821.20020822130111@fatcity.com>

All:

It's not just the pharmaceutical industry, it's any medical product manufacturer that keeps electronic records of the manufacturing process.

We make devices for cardiac intervention and prevention, and we have a project team just to deal with what HIPAA means to us. I think the governing regulations are in 21 CFR Part 11.

I am not a part of our team, but I and the systems I manage may be affected by what the team decides.

Cheers,
Mike

-----Original Message-----
Sent: Thursday, August 22, 2002 1:27 PM
To: Multiple recipients of list ORACLE-L

All:

Are you asking about the auditing requirements?

Essentially, you will have to keep an unchangeable record of any data manipulation in your system. This is especially the case in the pharmaceutical industry.

i.e. What type of change was it (insert, update or delete)? Who changed it? What was it changed from? What was it changed to? When did the change occur?

I have a little bit of information on HIPAA, but not sure what you are looking for...

Andy.
--

Andrew Sit
Systems Engineer
DataMirror Corporation
+ 1 905 415 0310 (O)
+ 1 416 839 9908 (M)

-----Original Message-----
Sent: Thursday, August 22, 2002 4:04 PM
To: Multiple recipients of list ORACLE-L

relates to anyone's role as any worker bee with insurance

HIPAA says that if you have had continuous health care coverage then if you change jobs you cannot go into a "pre-existing condition" state where they delay covering you until the next open enrollment period.

Or is there some other set of HIPAA rules I an unaware of?

--

Please see the official ORACLE-L FAQ: http://www.orafaq.com
--

Author: Vergara, Michael (TEM)
INET: mvergara_at_guidant.com

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