open source medical software

[Richard Schilling]

I've been developing health care applications to manage medical 
information since 1996.  That I know of the FDA exemption will still 
apply to your product regardless of how you license it.

Your warranty may or may not limit your liabilities depending on the 
promises you made directly to the people using your software and how the 
warranty is worded.  You do have to be careful.

The folks at opensource.org may take exception to any license that 
limits the use of a piece of software to only physicians.  However if 
you license your product under one of the approved opensource.org 
licenses and then only distribute the application through certain 
channels (e.g. through local physician groups/consortia), it won't 
affect the license itself - that's just a control on how you distribute 
the product.  With an open source license though once another physician 
receives your product they would have the ability to distribute it to 
whomever.  You have to decide if that type of licensing is appropriate 
for your goals.

Having said that, open source licenses like the BSD license generally 
works well for health care applications.

Richard Schilling


Donnal Walter 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
> 
> 
> 
>