Re: Aw: Re: OpenAPS as in Artificial Pancreas System
On 24/05/16 19:53, Karsten Hilbert wrote:
>> Well, if we try to create a package than we are doing this since we are
>> the experts in doing installations and we can do this usually better
>> than a random user. We are trying our best to let things perform
>> correctly. Imagine we install gpg that way and tell the user that we
>> are not sure whether encryption will work correctly and thus he is doing
>> on its on responsibility by confirming a debconf question. This does
>> not sensible in this case neither does it for OpenAPS.
> It doesn't matter much what we think. In this case we will have to
> make the user do something very distinctly manually in order to be
> able to use the package. Or else this will be a "Medical Device"
> and BfArM and FDA etc will shut it down for lack of certification.
> However, if I understand things correctly, this openAPS offers _tools_
> but not a ready-made solution to run your blood-glucose. So, no
> matter how well we install the package, the user WILL have to
> write their own monitoring/dispensing loop.
I am not sure if they write their own loop. But they will certainly
have to plug and play things together. And Raspian is basically working
out of the box, too. We thus became part of a medical device that
laymen who cannot evaluate any Python could start using. And knowing
about how sleep deprived parents of Type-1 diabetes kids are, the
barriers to try things are low. I am with Karsten that we need to make
sure that someone with no coding skills who cannot unfasten the
break is not in the position to make an informed decision at this
stage of the software development.
>> What we should probably do is asking a lawyer
> That is useless for several reasons at several levels.
We are have the exact discussion that I hoped to spawn and why I thought
that a decision to package OpenAPS is beyond my own.
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.
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.
Question: Can you imagine Ubuntu redistributing this package? In the US?
It may all be a bit too early for Debian. Do we have someone at the FDA or
BfArM to consult?