Re: LEGAL/FDA

From: peterson_at_d...
Date: 2001-07-01 15:19:53


--- In buildcheapeeg_at_yahoogroups.com, "frans" <f.smith_at_c...> wrote:
>
> Hi Peterson,
>
> I think whe (you and i) have a little comunication
> problem. I think (as a ducht man) i cannot express
> my-self clearly in englisch).
>
Let us simply be thankful that we don't have to rely on my
nonexistent knowledge of Dutch for communication.

> * i am not angry, why should I ????

I apparently misunderstood the tone of what you wrote, and apologize.

> * Whe don't steal if whe would use Toms Paper.
> The things he wrote can be found everywhere on
> the net.

> * I wrote: eventual whe can make a reverent to Tom
> collura.
> So whe would not steal from Tom. I think you don't
> understand me.

Why rewrite something that has already been done so well? We can at
least link to it, and probably get permission to use it as is if we
provide a link to Tom's BM sites.

> * I did not steal anything.

Of course not--but using it on our site without crediting it would be
stealing. I just didn't want us to ever "take the low road" on the
project.

> *check-out: weird science, alternatieve science,
> keely-net, tesla, w. reich, orgone therapy, ruth
> brown (radionica), magnetic wave oscillator, etc..
> you will find a real battle of freedom there...you will
> find lots of cases about fda.

Thanks--I've had some fun with these sites.

I do not hate or attack BM. Why ????
> I only pointing out that Tom has his own project.
> Working with us could only replace the old BM.
> *If i am rigth, then the BM starded the same way as the
> rs232.
> *I respect Tom for what he has been doing all those
> years. Why do you think i cannot see that ?
> *whe are not concurent for at the moment. But if rs232
> would come to the marked, then BM would be to ex-
> pencive. People would by rs232.
> *I wrote about the time and money Tom invested.
> In fact, to point out that it is only fear to make
> some money !!!!!.(for him)
> * the BM project is nice, i like the project.
> In fact, i once asked if i still could have the
> technical details. they send me back my mail.
> with no detail or no answer nothing..
> * Peterson, i have the bleu print of the BM, in fact its
> a simple machine (old technology). So i know that the
> BM would be no match for rs232.
> Thats why i try to make it clear that if Tom would
> join us, whe could work toward a new EEG. Whe
> then could name it BM-2 or so. The reason for that
> is that a cheap (modern) machine with al lot of people
> working on it would damage the BM project.
> Tom would benefit from our group. If you read again
> you can see that i pointed out the benefits for both of
> us. I am not saying he need to...only that is would
> be in-logic to wait until a better machine comes.
> * You can also read that i wrote: whe could talk to Tom...
> * Even if there would be two project, why should i care.
> I did not attack Tom, only pointed out that all his work
> would be in danger because of a large group working
> for free, and building cheap machines.
> * I don't know if the group would like to build a EEG
> for professionals.
> * Today i found a site from an ex-FDA member who
> now offering help to people. (speed up fda)
> I wrote him al letter to find out more. If you don't make
> medical claims then how will you sell the system to
> Health-professionals ?. I will send his mail to the group.
>
I certainly have no objection in principle to getting FDA
certification, but really don't think it is necessary. The
professional market is tiny in comparison to the potential home-user
market. I don't know how many EEG-certified therapists there are in
the U.S., but bet that the number is not over 2,000. At this point in
our development, I would not want to see us putting a huge amount of
energy into getting FDA cert rather than releasing something for home
use as an educational device. And I will say thatI woiuld see no
particular problem in using an undertified machine in the clinic, as
long as it is a physically safe device. One can always say it is
being used as a psychoeducational tool. I train temperature all the
time with simple little thermometers & thermocouple devices that have
never been near an FDA certification process.

> *to avoid mis-interpretations in he future, i will
> not interfere with organisation, lega stuff anymore.

Frans, I value your contributions very much. I really did not mean to
inhibit you in this way or to make you feel bad. I hope you will
continue to offer your thoughts.
> please forgive me if my englisch is not correct.
>
> Regards, Frans
>
>
>
> .
>
> From: peterson_at_d...
> To: buildcheapeeg_at_yahoogroups.com
> Sent: Saturday, June 30, 2001 8:42 PM
> Subject: [buildcheapeeg] Re: LEGAL/FDA
>
>
> --- In buildcheapeeg_at_yahoogroups.com, "frans" <f.smith_at_c...> wrote:
> > Hi Moritz,
> >
> > I found the paper in files from canadian hackers !!!!
> > All the files had tho do with hacking and freaking, but
> > there where some files about electronics. I found two
> > files about biofeedback. The files where written by
> > Tom collura. (brainmaster). Whe from buildcheapeeg
> > are not bound to ask Tom for permission. In fact whe
> > could just re-write the paper, and eventual make a re-
> > verent to Tom Collura.
>
> Frans--You are generally a wonderful and idealistic fellow, but I
> believe you are wrong here. Why are you angry? Tom has put an
> immense amount of work into the BM project, made his design
available
> to others for years, did not steal anything from anybody, and
> eventually developed his device into what is arguably the best
low-
> cost EEG training device on the market. He continues to improve
it,
> as witness the new version that handles coherence. If he makes a
few
> $$ to offset the tremendous work he has done, good for him. I
don't
> really see us as in competition with him; we are filling a
different
> niche. I also don't want to see us use other people's property
> without permission. Let's find that article on the BM website if
> it's still there, and link to it; or otherwise, publish it
ourselves
> only with Tom's permission and with a link to the BM home page.
I
> have followed developments in the BM world for years, and have
always
> been impressed by Tom's character and generosity. And at some
point
> in the next year, I expect that I will buy a BM, even though I
have
> every hope for the success of our OpenEEG. There really need not
be
> a conflict between the two camps.
>
> > I don't think Tom would like to to help us. Not because
> > he don't want to, but the brainmaster is an other project.
> > It is still running (software). So our group will at the end
> > re-place the expencive and old brainmaster.
>
> Tom has no obligation to help us. Nevertheless, he is (or was; I
> haven't checked lately) a member of this group, and has
corresponded
> with Yaniv.
>
> > As a matter of fact, ideal would have been when Tom again
starded a
> new project for a new device. But he did
> > not do so. They (BM) starded software projects.
> > So when his project was running they had no reason to
> > develop a newer system. Then came others who
> > starded a new project (buildcheapeeg). You understand
> > that this could be the end of BM. Suppose if Tom had
> > contacted our group, then ther would be no problem, for
> > the rs232 could replace BM in time, lets say up-grade BM. In
fact
> when Tom would be a member, whe would
> > have already a channel for marketing. RS232 would then
> > be the test-name, and BM could then promote the new
> > machine. So all BM users and new users could by a much
> > cheaper device. The software project from BM could then be
> compatible with rs232. Its a fact that an new
> > device is only so for some years, like a computer.
> > Tom did not joined the group, he could have done so.
> > I don't know if he likes the project, but he could know
> > that just as his old 486-pc would had to go because of
> > pentium, the BM would have to make place for rs232.
> >
> > The succes of rs232 together with modern computers
> > (and lower cost for pc's), and better software could make
> > BM a second choice. for the machine uses old technolgy,
> > while rs232 is modern, at the same time the price is
> > about 800.00 US dollar !!!. No normal thinking man
> > would by a BM.
> >
> > It seems that in the past the BM was patented. So some-
> > one (Tom) had to pay for the patend. Also for FDA
> > approvement, production, marketing etc..So a lot of in-
> > vestment. Is only fair then that Tom would have to ask
> > a price so as to earn back all the time and money.
> > Therefore a compleet new device, much cheaper would be but an
evil
> concurent. (afther all, those man starded
> > BFB/NFB al long time ago).
> >
> > If Tom would think logic, he would participate in the
> > project. None of us would be against it. In fact, afther
> > all the basics (fda approvement, patent etc) Tom could
> > try to sell the system as the new BM. None of us need
> > to make a living out of it. In fact, whe would support Tom
> > where ever whe could. Make the sytem 100% compatible
> > with the BM-open sourche project etc.
> >
> > Perhaps whe should talk with Tom about this, in time.
> > For me it is not logic to wait until some engineers finally
> > succeed in building an selling an new device.
> >
> > Information about FDA can also be found at there web-
> > site. Or whe could write to BFB organisations etc.
> > however, a FDA approvement could take a long time and
> > money. This is where the project could end up dead.
>
> I have argued before, and will continue to argue, that we don't
need
> FDA approval to develop and put forward our device, provided we
don't
> make medical claims for it. That's what the disclaimers you and
I
> worked on are all about.
>
> > for now its the members like me who build those machines for
> personal use, and to fool arround..
> > If however the project must end up...in the market then
> > whe need more members (not technologist) to bring in
> > some use-full stuf.
> > I don't know if i have posted a message about FDA,
> > but i did investigate something like ECG at there site.
> > I look if i can find it and post it again.
> >
> > regards. Frans.
> >
> >
> > ----- Original Message -----
> > From: Moritz v. Buttlar
> > To: buildcheapeeg_at_yahoogroups.com
> > Sent: Friday, June 29, 2001 9:52 PM
> > Subject: Re: [buildcheapeeg] LEGAL/FDA
> >
> >
> >
> > Hi frans !
> >
> > Great text you posted there ! Where did you pick it up ?
Maybe we
> could ask the
> > author if we could post in on our website ?
> >
> > Moritz
> >
> >
> > --
> > --------------------------------------------------------------

----
> --------
> > Baltic Microsolutions / Flash Microcontroller Custom-
> Development 
> > http://www.baltic-microsolutions.de 
> > 
> > < open-source neurofeedback project at 
http://www.openeeg.org !>
> > 
> > 
> > 
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> > 
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