Liability issues, etc.

From: peterson_at_d...
Date: 2001-06-07 18:08:28


I see that, at least in our immediate reactions, Rob and I really
disagree on the issue of dividing the SW from the HW. I want to
indicate my deep respect for Rob's position because I certainly share
a preference for doing everything in an aboveboard manner. However,
in instances like this I guess my feeling is that the world
(particularly the US)has been twisted very badly askew by the twin
forces of outrageous liability lawsuits and a variety of government
regulation that has more to do with enforcing the monopolistic
practices of some big corporations than with protecting the public--
you know, like the perennial threats of the FDA to regulate,
medicalize or shut down biofeedback because it poses a threat to the
drug industry. In this environment, I am not above engaging in a bit
of (shall we say) "behavioral sophistry" if that is the only way to
avoid wacko lawsuits, comply with wrongheaded regulations, and
accomplish something I view as a great good. Besides which, I really
believe that the hardware with just EEG-reading software capability
would be something of practical use to many people--for example, for
creating and testing entrainment devices, determining individual
interests and attention-inducing activities, etc. I carefully avoid
talking directly about "diagnosing" in the sense of identifying
medical conditions here.

I have raised some of our liability issues with people in the
nonprofit sector, although I haven't talked to any lawyers as yet.
They say it costs about $500 these days to create a private, tax-
exempt nonprofit corporation (which I will refer to as an NPC).
There would be some very good reasons for doing this, such as having
an entity to which US citizens could make tax-exempt contributions,
and having an entity that could apply for a large variety of private
(or possibly even government) grants. However, the mere fact that we
have an NPC would apparently not provide much shelter from potential
lawsuits. All NPCs that see themselves at risk of lawsuits (for
example, those that provide social services to the public) carry
hefty liability insurance policies. Given our situation, I think
that we need to have an NPC if for no other reason than to carry the
insurance.

One more thing--the people I talked to were unanimous in saying that
we should pursue this in a way analogous to the "mind machines" and
avoid the enormous costs and problems associated with medical
instrument certification. This would mean that anybody could buy,
sell and use the machines. Clinicians would not be impeded in any way
by the lack of certification, really. We use all kinds of medically
uncertified gadgets in psychotherapy. I often do temperature
biofeedback in groups with simple little electronic indoor-outdoor
thermometers that are certainly not certified. EMDR practitioners
use a variety of gadgets to provide bilateral stimulation such as
hand vibrators, light bars, little sound boxes with earphones, CD's
and tapes in the clinic, and I don't think that any of these things
are certified. Not to mention all the Hemisync, Holosync, and other
EEG entrainment paraphernalia around. I can go down to my local Best
Buy store and purchase CDs for delta entrainment, theta entrainment,
alpha-theta entrainment alpha entrainment, and God knows what else.
None of this stuff has been anywhere near a certification lab.

As I thought about the incorporation issue, I came up with one more
reason to form an NPC. As a practitioner, I may very well make some
money off the work product of this group. If there is an NPC in
place, I would pledge to donate, say, 10 percent of any profits to
the NPC, and could get an income tax writeoff for this deduction. We
would encourage everyone else who makes money from this work to do
likewise, on an honor system. The "tithing" request, and the
description of what we do with the money, could be sent out with
every machine or kit. This would keep the machine as cheap as
possible for individual users while providing the NPC with an income
stream from those who profit financially from its work.

As to what we would do with the money--in addition to the obvious
purposes, such as paying for the insurance, maintaining the website,
etc., I think we should provide expense reimbursement and some sort
of honoraria or other financial recognition to the engineers and SW
people who really created this wonderful thing.



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