On Wed, May 25, 2016 at 12:42:21PM +0200, Steffen Möller wrote:
> I think to have gathered enough reason in my initial email for a judge to
> decide that the intent to package OpenAPS is good and genuine and not
> intending to persuade anyone to actually use the software on a patient.
I am with you on that. Debian will also want to make this
abundantly clear in writing in an IN-YOUR-FACE way.
> The former mentioned technical reasons aside I would like to add support
> for the political statement that this technology is available and should
> become clinical practice.
What should or should not become "clinical practice" is
something that time (and RCTs and SMRs) will tell, so, no.
You are, of course, entitled to _your_ opinion. Which I
happen to largely agree with, BTW.
> It may all be a bit too early for Debian. Do we have someone at the FDA or
> BfArM to consult?
The OpenAPS docs clearly state what the FDA things. As far
as BfArM is concerned it's all here:
http://www.bfarm.de/DE/Medizinprodukte/Abgrenzung/medical_apps/_artikel.html
Karsten
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