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Re: Fwd: paper: Custom software development for use in a clinical laboratory



On Tue, 2014-05-20 at 12:46 -0400, Yaroslav Halchenko wrote:
> very interesting -- thanks for sharing.  
Indeed. 

> I wondered though, if such an
> in-lab software releases under FOSS license could then it be re-used or
> better built-upon in another lab without violating FDA/etc regulations?

Actually, they claim: 

"Thus, there does not appear to be any current requirement to notify the
FDA if you are developing software for use within your own
institution, ..."

(Section: Validation, first paragraph, after the citation [16]). 

In Europe it might be different, but AFAIK non-approved software often
can be used "under research protocol", which may require extra
explanations to the patient, and the signing of some forms about
agreeing to not sue the doctor.

> In-house developments resting on the work of FOSS projects are
> nice but is there a way those could contribute back to the ecosystem?

At the least one would hope that they contribute back by bug reporting
any maybe patches to the FOSS projects they use. 

> What if such are exposed as 'services' and not 'software/devices' --
> could then they be re-used within current legal framework(s)?

I guess that boils down to the used license, cf., e.g.
https://www.fsf.org/blogs/licensing/2007-03-29-gplv3-saas

best regards, 
Gert 


> On Tue, 20 May 2014, Andreas Tille wrote:
> 
> > Hi,
> 
> > I think this paper might also be of interest for readers of Debian Med
> > list ...
> 
> > Kind regards
> 
> >        Andreas.
> 
> > ----- Forwarded message from Ian Malone <ibmalone@gmail.com> -----
> 
> > Date: Tue, 20 May 2014 12:22:21 +0100
> > From: Ian Malone <ibmalone@gmail.com>
> > To: FedoraMedical <medical-sig@lists.fedorahosted.org>
> > Subject: paper: Custom software development for use in a clinical laboratory
> 
> > Hi, been a bit quiet here of late.
> > Anyway, was reading this this morning and thought it might be of
> > interest to some:
> > J Pathol Inform. 2012; 3: 44.
> > Published online Dec 20, 2012. doi:  10.4103/2153-3539.104906
> > PMCID: PMC3551490
> 
> > Custom software development for use in a clinical laboratory
> 
> > John H. Sinard* and Peter Gershkovich
> > http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3551490/
> > (Open Access)
> -- 
> Yaroslav O. Halchenko, Ph.D.
> http://neuro.debian.net http://www.pymvpa.org http://www.fail2ban.org
> Research Scientist,            Psychological and Brain Sciences Dept.
> Dartmouth College, 419 Moore Hall, Hinman Box 6207, Hanover, NH 03755
> Phone: +1 (603) 646-9834                       Fax: +1 (603) 646-1419
> WWW:   http://www.linkedin.com/in/yarik        
> 
> 



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