Subject: RE: open source medical software
From: "Lawrence Rosen" <lrosen@rosenlaw.com>
Date: Thu, 27 Jan 2005 11:30:10 -0800

Software distributors must obey the law regardless of what an open source
license says. So if you must obtain FDA approval before you can distribute
certain software intended for patient care, the license doesn't override
that requirement. You may be required by law to perform certain tests or
peer review before distributing the software; a mere license won't let you
avoid that. 

However, the open source license you use cannot *require* licensees to
obtain FDA approval or get peer review. The only thing you can do is remind
licensees of *their* duty to obey the law as they understand the law.

This is similar to the issue of export regulations. As a distributor of
software in the United States, you are required by law to obey US export
regulations. But you can't impose that requirement on your customers who
live and work in other countries. It is up to them to obey the law as they
understand that law. So OSI has never accepted a license that expressly
requires licensees to obey specific US export law.

Your open source license cannot impose specific restrictions on how to copy,
modify or redistribute the work, or restrict such activities to certain
professionals.

As for whether you must include a warranty, that too is often a subject of
legal regulation. A disclaimer of warranty or limitation of liability in an
open source license may not be enforceable in some jurisdictions and for
some forms of injury. 

In these cases, you and your customers should probably consult an attorney
specializing in the requirements of the FDA and other government agencies. 

/Larry Rosen

Lawrence Rosen
Rosenlaw & Einschlag, technology law offices (www.rosenlaw.com)
3001 King Ranch Road, Ukiah, CA 95482
707-485-1242  ●  fax: 707-485-1243
Author of “Open Source Licensing: Software Freedom 
               and Intellectual Property Law” (Prentice Hall 2004)
 

> -----Original Message-----
> From: Donnal Walter [mailto:donnalcwalter@yahoo.com]
> Sent: Thursday, January 27, 2005 10:03 AM
> To: license-discuss@opensource.org
> Subject: open source medical software
> 
> 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