Subject: open source medical software
From: Donnal Walter <donnalcwalter@yahoo.com>
Date: Thu, 27 Jan 2005 10:02:43 -0800 (PST)

Warning: this posting is about open source software, but the
specific issues I want to bring up are somewhat off topic.

At Arkansas Children's Hospital we have been developing a set of
custom applications for use in patient care. This software is never
connected directly to the patient, nor is there an indirect link
through a "medical device," either diagnostic or therapeutic. From
that point of view the software does not not fall under the FDA's
review of medical devices.

The applications are, however, used by healthcare professionals to
keep track of patient information and to calculate parameters used
in medical decision making, drug dosing and so on. The FDA might
consider this software to be a medical device in a broader sense
and thus take an interest in it. Until now we have not worried
about this possibility because there is a clear exemption for
"licensed practitioners, including physicians, dentists, and
optometrists, who manufacture or otherwise alter devices soley for
use in their own practice." [Code of Federal Regulations 21 CFR
807.65(d)]

But now we want to make our software available to other licensed
practitioners under an open source license (including the usual
disclaimer about warrantees). What we want is for this software to
be "peer reviewed" and peer improved. Does anyone on this list know
of medical software that is licensed in this way? Does the
warrantee disavowal count for anything in terms of limiting
liability? Would a license that requires a user to be a licensed
practitioner (1) still be considered open source, and (2) make any
difference regarding whether or not the above exemption applies?
Apologies if these questions are too off topic.

Thank you,
Donnal Walter, M.D.
Arkansas Children's Hospital