The guildlines, unless I've missed something, apply to *any* software used in a role which is regulated by the FDA. So, you're concern is "on the money" - even if you create the software yourself. You have to make sure you get FDA approval. Same goes for the U.S. HIPAA regulations.
If the FDA or other governmental agency with jurisdiction happened to walk in (which they can do any time) and have an inspection, the use of your home grown system can earn you some nice fines and in a worst case situation get your entire department to shut down. I'll doublecheck, but I think that's the case.
Richard Schilling
Web Integration Programmer
Affiliated Health Services
Mount, Vernon WA USA
http://www.affiliatedhealth.org
-----Original Message-----
From: Neufeld, Jonathan
To: '[EMAIL PROTECTED]'
Sent: 30/01/02 0:22
Subject: RE: New FDA Software Regulations 1/11/02
Let me clarify my exact concern just a bit. If I write or assemble a
software system to track my patients and my documentation of patient
encounters (which is not and does not intend to be an official "medical
record"), do I need FDA approval for the "system" I create? What if I
store
progress notes in a database? or de-identified patient information
(crutch
notes) in my Palm Pilot?
I'm not a system developer, but I do hold dear my right as a healthcare
provider to develop and use software to help me do my job more
efficiently
and effectively. My question is whether these FDA guidelines have
anything
to do with that.
Jonathan
