open source medical software

[Randall Burns]

Question here:
Could he ship this product under and open source
license-but with a "toy" database-so the software
isn't really a "medical device" until you load the
"real" database. If so, he could ship the software as
open source-and only give the "real" database to
medical professionals. 

RJB
--- Donnal Walter <donnalcwalter at yahoo.com> wrote:

> 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
> 
> 



		
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