[AccessD] Slightly OT:Electronic Medical Record

Dan Waters dwaters at usinternet.com
Tue Apr 8 14:52:42 CDT 2003


Jim,

http://www.fda.gov/ora/compliance_ref/part11/

This is the web site from the FDA that has all the official information.
It's a lot to wade through, and the requirements seem strict.

Your company should have a Regulatory Manager who is or should be
familiar with these requirements.  

AFAIK, Access alone does not meet the security requirements, but an
Access FE with a SQL BE will.  The difficult requirement is that the
user must re-enter the user name and a password (not necessarily the
same as the network log-in password) immediately prior to making an
electronic 'signature'.

There may also be a requirement for an audit trail of all the changes
made in a record.

Also, the strictness of the rules can vary depending on the product or
service.

Good Luck!

Dan Waters


-----Original Message-----
From: accessd-bounces at databaseadvisors.com
[mailto:accessd-bounces at databaseadvisors.com] On Behalf Of Jim DeMarco
Sent: Tuesday, April 08, 2003 12:20 PM
To: accessd at databaseadvisors.com
Subject: [AccessD] Slightly OT:Electronic Medical Record


Does anyone on this list (in the health care industry) have any
familiarity with these or use them?

Thanks,

Jim DeMarco
Director of Product Development
HealthSource/Hudson Health Plan


-----Original Message-----
From: Mwp.Reid at Queens-Belfast.AC.UK
[mailto:Mwp.Reid at Queens-Belfast.AC.UK]
Sent: Tuesday, April 08, 2003 1:54 PM
To: accessd at databaseadvisors.com
Subject: [AccessD] OT Smart Tags


Anyone know of any security issues surrounding the use of Smart Tags
with particular reference to thier use in Access.

Martin
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