EPFX

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How did the subject of legalities regarding the EPFX
begin?
Quantum Biofeedback and the EPFX began gaining
favorable coverage on local news broadcasts, newspapers
and magazines.! People began sharing their amazing
experiences with this modality publicly.! The industry was
growing quickly, as more and more people purchased units
for themselves, or to use professionally in their various
practices.!
Along with that growth came even more attention placed
on the industry, and occasional statements made about
what the device was able to do, or amazing results that
people had achieved which they associated with device
usage.
These comments were communicated in ways that seemed,
to some, as being “outside the scope of it’s original
registration”, which therefore turned those
communications or statements into a legal matter.!
And along with that, came the unfortunate reporting by the
Seattle Times, as well as other news reports that pointed
out isolated “claims” being made.
These reports, unfortunately, characterized the entire
industry unfavorably, and many would argue unfairly and
disproportionately.!
Following that trend, another TV newscast in Texas did a
story on the EPFX that seemed designed to show “both
negative and positive” opinions about the EPFX, possibly
as an attempt at “fair reporting”.!
They attempted to find people who would make negative
statements about the EPFX, and apparently could only
find one person to do so, who had never even been attached
to the device or obtained a session.! !
They found many people, however, who attested to the
positive experiences they had with the device.
The presentation they made, arguably, also presented the
EPFX in a positive light, but they failed to post a follow up
interview with the inventor, Bill Nelson, explaining the
scientific validity behind the device….
Why?
We can’t say for sure, we can only speculate.! Perhaps it’s
the nature of TV programming:! one of the tenants of the
dramatic arts is to examine conflict, competition and “win/
lose” outcomes, such as in competitive sports, which
garners large audiences, who in turn are exposed to
advertising such as for pharmaceuticals.!
Pharmaceutical companies pay TV stations for advertising
time in the United States. This is illegal in some other
countries. !
Perhaps there just weren’t enough people willing to state
anything negative about the device, eliminating the
dramatic conflict, thereby making it “yesterday’s news”.!
However, it may be because it turned out to be a more
complicated story, one that they backed out of when they
realized that there were conflicting stories coming from
within their own industry, and the chance of truly “fair”
reporting was becoming challenging.!
Because these reports seemed contrary to the perceived truth of how
Quantum Biofeedback users experienced it as a modality, many
people suspected hidden agendas operating behind these reports,
based in either personal vendettas or as inspired by other competing
industries.!
However, the scrutiny has resulted in a closer examination of
communication about the device, one that has caused users become
less casual, and more specific in terms of “claims”.!
These reports, and the efforts of one particularly aggressive reporter,
placed legal pressure on the FDA to examine these claims, because
they can, in part, regulate “claims” made about devices.!
The FDA investigated, then cited certain “claims” as inappropriate in
terms of how the device is registered, and therefore took action.!
Their action was to place an “import alert” on the device until they
were satisfied that the limits of the claims being made about the
device fell within the scope of it’s clearance.! !
What is the FDA “import alert” status on the EPFX now,
and is this an FDA “ban” of the device?
An import alert is not a “ban” on the device itself; people
who own and use the EPFX continue to be entitled to do
so; it does not hurt anybody and there is insignificant risk
associated with it.! It poses no danger to the public in and of
itself; however, the FDA considers inappropriate claims as
a different form of danger to the public, and that’s what we
need to remain aware of.!
At the date of this writing, the FDA has not removed the “Import
Alert” from their website, but are nearing what we expect to be final
negotiations with the manufacturer, Eclosion, regarding correcting
claims and adhering to the tenants of EPFX clearance.!
This is called a “CAP”, which stands for “Corrective Action Plan”.!
To date, the corrections have been to stop stating or “claiming” the
following:
!!!“Electro-Dermal Screening” (this should be stated as “Electro-DermalResponse”, which is biofeedback GSR, or Galvanic Skin Response, not
“screening”, which infers diagnosis, which biofeedback does not do.)
!!“Evoked Potential Biofeedback” (“evoked potential” Neurofeedback devices are
different than the EPFX and have a small risk of seizure, therefore this language is
an association that we should avoid for the sake of clarity, but also because there is
insignificant risk associated with the EPFX.)
!!“Reading” the subtle energy fields (“reading” anything beyond biofeedback
reactions infers diagnostic capabilities, and biofeedback reactions are not considered
“diagnostic”.)
!!“Reading” the emotional, physical and mental levels (for the same reasons as
above.)!
Biofeedback measures the strength of reactions.! Therefore, it does
not “read” any of these items; it only detects the client’s reactions,
such as to matrix trivector signatures and other portions of the
program. !
Therefore, these claims have stopped because they were not entirely
accurate.! We should therefore remember not to use these terms
because they have been deemed by the FDA as outside the scope of
the EPFX clearance, and please be sure that they do not remain in
any printed materials.
Why are “claims” a legal issue?
For several reasons, but mainly:
!! Claims can be a “marketing” tool, designed to help a product or
service sell in exchange for money.! Therefore, they are potentially
“advertising” and can also fall under FTC regulations.! The FTC
will follow the advice of the FDA regarding medical equipment.
!! The FDA regulates what a manufacturer (or seller) can say about
the “scope” of devices in advertising.! The EPFX is cleared as
biofeedback for stress reduction, electro dermal response (EDR or
GSR biofeedback), muscle re-education (EMG biofeedback), and
relaxation training.
It also was cleared for trivector calculations, and the original EPFX
matrix of “trivector” signatures contained a mere 2000 items.
References to “virtual” were also in the original clearance.
EEG was removed from the original description, but certain battery
operated devices have since been dropped from the list of devices
requiring registration with the FDA, and are available over the
counter (OTC) because they are safe.
However, the EPFX has a 510 (k) with the FDA, which is
a document which states it’s “substantial equivalence” to
another device, and outlines it’s applications.
Approximately 5 years ago it was decided in a court case
that a product or device with a 510 (k) could “make claims”
outside of it’s clearance and 510 (k) if and only if there was
acceptable peer reviewed research that provided evidence of
those claims.!
An example would be “aspirin”:! it was cleared for “pain relief”, but
then doctors later discovered that it was helpful for some cardiac
issues.! Because the aspirin companies obtained research that
provided evidence of the benefits of aspirin regarding cardiac issues,
they are now able to make this additional claim.! This is why peer
reviewed EPFX research is an important endeavor it’s community of
users can support.
Until that research is in place, the only legally safe claims about the
effects or use of the EPFX should remain as what it was originally
cleared for:! muscle re-education, stress reduction and relaxation
training.! All of the specific programs on the device are regarded and
communicated as such.!
For more information about supporting EPFX research,
please visit the Quantum Biofeedback Advocacy
Association website at www.qbaa.com
The following programs on the device can be referred to in
accordance with the device’s clearance: and are part of the CAP.
These buttons will be renamed on the main test page’s “Programs”
dropdown menu list on the new software version:
"!Allergies Program (becomes “Hyper Reactivity Training”)
"!Spiritual Healing (becomes Spiritual Relaxation Training)
"!ECG (becomes Electro Physiological Oscillation Freq)
"!Pain (Pain Cybernetic Feedback)
"!Timed Therapies (Timed Cybernetic Feedback)
"!Therapy (“Universal Feedback Therapy” but “Training” for
unlicensed biofeedback specialists)
"!Auto Meridian (Biofeedback Meridian Reactivity)
"!Sport Therapy (Muscle Re-education for Sportsmen [I would
suggest “Athletes” verbally to be non gender specific.]) !
#!One of the tenants of the device is for “professional use”.! If you
hold a license in a healthcare field, you may purchase the device
without a prescription.!
#!To obtain it for personal use, if you are unlicensed, you must now
obtain a prescription.!
#!Once you are then certified, you may conduct biofeedback
professionally beyond personal use.!
#!If you are unlicensed, uncertified and conducting biofeedback
professionally, you must now become certified in order to continue
conducting biofeedback legally.!
#!If a prospective purchaser does not intend to practice professionally,
they will declare so on the paperwork that will be obtained by us
AFTER they obtain the prescription to purchase.
#!The FDA will NOT, after August 1, 2008, allow anyone to
purchase the EPFX with the intention of practicing professionally
with it unless they are either a.) licensed or b.) certified.
Are EPFX verbiage recommendations totally driven by the FDA?!
No.! Many people assume that all legalities and verbiage
considerations are primarily driven by the FDA.! This is not true,
they do not regulate the health fields:! there is another component to
the legal picture in healthcare fields that everyone needs to be aware
of, and that’s Licensing Boards.!
Licensing Boards, in the health professions, issue licenses to practice
certain professions in healthcare.! They maintain that only people
holding those licenses can conduct those particular professions or
conduct “therapy” and “treatment” that is designated within the
scope of their profession.
The cosmetology field issues licenses as well, and the “licensed fields”
require that you hold one of their licenses before you practice their
profession.
For example, you cannot professionally and legally insert needles into
someone’s acupuncture points without a license in Acupuncture to
do so.!
!!Licensing boards are regulated at the state level.!
!!Licensing boards have been known to ask the state attorney general
to bring charges against unlicensed professionals that they suspect are
“practicing their profession without a license”.!
Therefore, if you are unlicensed and certified, it is important that you
do not convey your services, regardless of what they are, as services
governed by the licensed fields.!
What is the Difference between “Licensed” and “Certified”?!
The Licensed fields are those where there is a considerable risk of
potential harm involved in the practice of it, and therefore more skill
and education is required for those fields.! Certified Biofeedback
Specialists, if they are unlicensed in other fields, are “certified” only,
however many people hold a License in a certain field, and yet are
also certified in others.!(Such as a licensed Acupuncturist who is also
certified in Biofeedback, or a licensed MD who is also a board
certified surgeon.)
What is the Difference between “Licensed” and “Certified”?!
“Licensed” literally means holding a state license in the field you
practice in:! such as a Licensed Acupuncturist, Licensed MD,
Licensed Chiropractor, Licensed Dentist, Licensed Psychologist,
Licensed Nurse, and in some states: Licensed Massage Therapist, etc.!
(not all states require a license for massage.)
This also applies to Licensed Estheticians in the field of cosmetology.
Holding a certification from a certification board is not the
same as holding an “license” issued by a licensing board.!
“Certified by a board” infers that you have obtained a
certain degree of training, in many cases an extremely
respectable one, and certification means different things in
different fields.
In Biofeedback, certification by a valid certifying board is
enough to be designated as qualifying for “professional
use”.!
The licensed fields are generally those where there is risk involved,
and therefore careful standards are set, and education is more
rigorous:! for example, a doctor could prescribe you a medication at a
level that could harm you, misdiagnose you, or perform surgery
which could harm you, therefore, you need to hold a license to
practice medicine to be able to do these things.!
An esthetician could harm you by using the wrong chemicals on your
head and burn your scalp during a hair coloring, or “miss” with
microdermabrasion and damage your nerves, therefore you must
hold a license to do this.!
An acupuncturist could, if they made a mistake, puncture
an organ with a needle if they inserted it too far.! A
chiropractor could conceivably harm you if they adjusted
your neck or cranium incorrectly, therefore licenses are
required for these fields.!
The licensed fields are those where there is risk of seriously
harming someone in the practice of it, and therefore
considerable more expertise is needed in order to do it
safely.!
Why Does Biofeedback Not Require a License?
Biofeedback does not currently require a license because it poses no
significant risk. It is subtle, safe and does not hurt people. It does not
diagnose, puncture, sever, administer medications, manually adjust
your spine, or apply acids to your skin to peel it, etc..!
However, “professional use” dictates that you need to be trained to a
professional level, use an informed consent form, and understand
what you can and cannot claim with it, and although the risk is
insignificant, you also need to know how to safely conduct a session,
and what the contra-indications are.!
In almost 20 years of device usage, only one “adverse event’ has been
reported to the FDA, which is on their website at :
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?
MDRFOI__ID=886687
Adverse Event Report
ECLOSION KFT EPFX ELECTRO PHYSIOLOGICAL FEEDBACK XRROID
BIOFEEDBACK DEVICE back to search resultsCatalog Number 200001Event Date
05/09/2007Event Type Other Patient Outcome Other;Manufacturer Narrative. This
insignificant risk of skin irritation is due to inappropriate use of the harnesses. This further
prompted us to change the labeling to show a clear warning. The labeling has been changed
to warn users not to place the harness connectors against the skin.Event Description: Health
professional was using the device on herself. She used the device incorrectly in that she
placed the harness lead connectors against her skin. She had an allergic reaction which
caused inflammation that led to skin urticaria.
Many of the words used in biofeedback software, such as “therapy”
and “treatment”, were originally designed to accommodate
terminology used by the licensed medical fields and to accommodate
their insurance billing codes. Biofeedback is deemed a part of these
licensed fields’ other “therapies” and “treatment” programs that they
can administer. (This is a good thing for Biofeedback!) For that
reason, the terms “therapy” and “treatment” are used by them for the
larger scope of services they provide because they can practice either
medicine, acupuncure, chiropractic, etc., treatments in addition to
biofeedback. “Therapy” and “treatment” are therefore referred to on
some program button names.
However, because biofeedback has proven to be safe with little to no
risk of causing harm, licensure is not required to legally practice
biofeedback.!
Separately, the use of the terms “therapy” and “treatment” have been
ruled to infer the practice of medicine. Therefore, if you are
unlicensed and only Certified as a Biofeedback Specialist, you should
avoid the use of those words. It is our responsibility to know what we
can legally language or put in writing describing our services
regardless of button names on biofeedback software. According to
Jim Turner: there are 5 words that should be avoided by unlicensed
but Certified Biofeedback Specialists in references to their services or
diseases or conditions:
1.) Treat
2.) Mitigate
3.) Cure
4.) Diagnose
5.) Prevent
However, many non-licensed, certified practitioners have
enjoyed a successful career in biofeedback, and use the
following verbiage to observe legalities. In general these
terms are what we recommend in place of some of the
“therapy” button names because of issues expressed by
licensing boards in the past:
Ø!!! “Train” instead of “Treat”. (Licensed fields “treat”, biofeedback signals “train”
or “retrain” responses. “Treatment” infers licensure, and if you don’t hold a license,
it’s best to avoid this word.)
!
Ø!!! “Programs” in place of “Therapies”. (Some states interpret “therapy” as
inferring treatment, and those in the “certified” fields avoid the use of this word so
that they are not construed as practicing medicine without a license, unless they
are working under a licensed professional.)
!
Ø!!! “Client” instead of “Patient”. (Only the licensed fields see “patients” and the
use of this word can be construed as your portraying yourself as licensed, unless you
are working under a licensed professional and are seeing their “patients”.)
!
Ø!!! “Educate” instead of “Prescribe”.! Because lifestyle changes are a personal
choice, clients make their own decisions based on education.!
Another reason that the authorities are adamant about
unlicensed professionals not portraying themselves as providing
“therapy” or “treatment” is because unlicensed professionals are
unable to provide emergency medical care.
In a state of emergency, people are under stress. If you have
presented yourself as someone who provides “treatment”, and
cannot provide medical care, they may think to call you instead
of obtaining emergency care in a timely way…this is construed
as potentially causing them harm.
For this reason, in some states, other licensed professionals, such
as Acupuncturists and Chiropractors who are able to provide
some forms of “treatment”, must state on their outgoing
voicemail messages: “If this is a medical emergency, please hang
up and dial 911”.
However, unlicensed Certified Biofeedback Specialists do NOT
need to place this message on their outgoing voicemails, as it
may falsely infer licensure in another field. If you have not
claimed “therapy” or “treatment” in your services and are using
an informed consent form, then you have not falsely portrayed
yourself from the start.
With Jim Turner,
Attorney at Law:!
Email:! [email protected],
Office: 202-462-8800, fax # 202-265-6564
Location: Washington, DC
Frequently Asked Questions and
Responses: !
“One thing that is important about the EPFX is the lack of harm
associated with it.! That is the strongest argument that we have
in being safe from authorities.! There is no evidence of harm that
has come from the device.! The regulatory framework in
America is structured with several different sources that bring
impact on an individual who wants to use the device, either as a
practitioner or as an individual who wants to use it on
themselves.! There is the federal level, which is the FDA, then
the FTC (Federal Trade Commission). Both of them essentially
are regulating claims made by manufacturers at this point.!
Because the EPFX is safe, and has a 510 (k), it can be used as
long as it’s used for the stated purposes cleared by the FDA.!
The way the FDA knows you are using it for it’s designated
purpose is to avoid conveying the notion that you are treating
anyone for a disease or condition. If you can avoid making
that claim, you are in a very strong position with relation to
the FDA. The FTC follows the FDA’s regulation of
advertising, so if you’re compliant with the FDA’s clearance
for the intended use of the device, you will be in sync with the
FTC as well.!
The next level of regulation is at the state level.! There are 2
kinds of regulation at the state level:! one is by the health
boards. If you are licensed practitioner in a state, and you use
biofeedback, your licensing board regulates your use of it.! So
it is wise to check if your board has regulated any issues
surrounding the EPFX.! On a separate note, if your licensing
board finds it necessary, they can raise questions about what
you claim or advertise, or your competence. If you’re certified
in biofeedback and not making health claims, even the license
boards will have difficulty blocking you.!
If you do make health claims, you actually are not regulated
by the boards per se, but the board may refer their complaint
to the state attorney general, asking them to bring a charge
against you for the illegal practice of medicine.! If you make
the claim ”I’m treating somebody for… ” the state medical
board could ask the attorney general to intervene and
discipline you, or they can ask your own board to do so if you
are licensed (in another field).! The closer you look like you
are practicing medicine the more vulnerable you are to
restrictions and actions by the authorities.!
Question: Are licensed professionals who don’t write prescriptions
[for drugs] able to legally write prescriptions [for biofeedback] and do
the laws change from state to state?!
Yes, the laws do change from state to state, but there are no problems
in writing prescriptions for biofeedback.! Anything that you can say
to a client or patient you can write down, and that is what is being
accepted as a prescription.! The prohibition is for writing a
prescription for a drug, which is heavily regulated.! The 2 types of
prescriptions (drugs vs..for a biofeedback device) are completely
different in nature.! There are prohibitions on writing prescriptions
for drugs, and especially narcotic drugs, but there are no prohibitions
on writing recommendations to obtain a biofeedback device.!
.Question: Does California have more lenient standards for
prescription writing? !
Response: They’re even across the country. The way most people
think of prescription writing is with regard to drugs, and then there’s
the DEA and narcotic prescription writing. There is virtually no
regulation in the states to control what these things are about. It is
possible that a [health] board might adopt a rule for it’s profession,
that is your responsibility to check. I would be surprised if there was
legislation that specifically addressed this kind of prescription.! So I
do not believe that California has any more stringent or any more
lenient laws.
Question: Can a licensed spiritual healer write!a!prescription for a
biofeedback device?
Response: No. (Gage): A Licensed Spiritual Healer is a very
advantageous license to have because it gives you the right to address
the spiritual aspects of that person’s life and stress.! This is outside the
scope of many other practices unless you hold a specific credential for
it.! But it is not a license in health care, and that is who the
prescription needs to be written by.!
(Jim): remember that in this instance that there are many licenses
granted by the states:! a marriage license, a driver’s license, a
plumber’s license..! those do not meet the requirements that the FDA
is negotiating with the company:! prescriptions for biofeedback need
to come from a licensed healthcare provider.! A licensed spiritual
healer license is not a healthcare license.
Is there a form that has been created for a licensed practitioner to use for
prescription writing for biofeedback purchase?
Yes, from http://MBACB.com: (Medical Biofeedback Association and
Credentialing Board)
1. Place your name, the name of your business, address information and telephone
number at the top of this form.
2. Place the name of your patient on the blank line in the first sentence.
3. Sign and date the form.
4. Give this form to your patient.
5. For your protection we also suggest you keep a copy in your patient's file.
The prescription can written thus: (next screen):
(from http://MBACB.com continued)
I hereby prescribe biofeedback services for _____________________________ for
the purpose of relaxation to reduce his/her stress and/or pain. This prescription is
valid unless the person named above suffers from a seizure disorder of any kind,
wears a pacemaker or suffers adverse reactions following biofeedback training.
__________________!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! ___________________
date!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! signature
Make no mistake about it, this prescription form is just as valid as the preprinted
pharmaceutical prescription forms. But it does one thing the drug company forms
do not do: it places responsibility for the safety of the client in the hands of the
person who accepts this prescription. When you sell a device to an unlicensed
person the distributorship and the manufacturer is accepting that prescription.
Question: I am assuming that a chiropractor can write a prescription for
biofeedback, is this true?!
Response: Yes, as can Licensed Nurses, Acupuncturists, Psychologists, Dentists,
and Licensed Massage Therapists. The license held must be in the field of health.
Question: What are the criteria for a licensed practitioner to approve a prescription
for biofeedback purchase?!
Response (Gage): That the person has the capacity to operate the device (or has a
family member who has agreed to) and does not wear a pacemaker, and/or
conservatively has no history of siezures, and/or does not have negative reactions to
biofeedback. This is contained in the verbiage suggested for writing the
prescription.
Question: Native Americans can have a status of “Medicine Man or Woman”, can
we write prescriptions, or do we even need to?!
Response: The entire issue of how native Americans are regulated with regard to
health is very murky.! Many of the rules that we are referring to here do not apply
to the Native American community, particularly when they are living on Native
American land.!
Question: Do these legalities apply to Puerto Rico?!
Response: Yes
Question: Could you draft a form for writing a prescription that the prescription
writers are held harmless? !
(Gage): The suggested prescription form places the person receiving it with the
responsibility of disclosing whether or not they wear a pacemaker. That should
absolve you from personal harm. We, The Quantum Alliance, accept the
prescription for their personal use and follow up with the purchasers to determine
whether or not they intend to become certified. The responsibility of
communicating the education process is ours, and you are therefore absolved from
harm of their actions professionally. Your prescription to them is for personal use.
We provide them with scholarships for certification training.
Question: Didn’t the Washington state board of Chiropractic ban the use of the
EPFX, therefore Chiropractors can’t write a prescription?!
Response: You need to be careful about how the boards do things:! they have a
series of statements in chiropractic boards that say “this is experimental” or “this is
not found to be useful”. Technically speaking:! legally the chiropractic board of
Washington state or any state is very limited on what they can actually say about
what you can and can’t do legally.!(response continued on the next panel)
Response continued: However, there are all kinds of internal struggles in the
Chiropractic world, and if a group gets control of a board that doesn’t like
something, they are very likely to issue a statement or regulation against it.
The question becomes “how much of a risk do you want to take and how
much of a problem do you want to have with your board?”! Whether you can
write a prescription or not: the question of writing the prescription has to do
with the manufacturer, they can only sell the device to a qualified person.
From the manufacturer’s point of view, they can sell to a chiropractor in
Washington state, even if the chiropractic board states that they don’t
recognize this biofeedback modality.!
What the Chiropractor in Washington state does with that becomes a
secondary question as far as the company is concerned.! If the board tries to
stop the use of the device, that becomes the choice of the Chiropractor: do
they want to have that issue or battle, or do they want to use it anyway?
Question: How can we say that a board can’t hold a prescription writer liable when
boards, such as the Washington Chiropractic board, banned the use of the device
by it’s members?! !
Response: The issue of the board and it’s regulations we’ve covered, we need to see
what they said and how they said it. There is a belief among boards that they have
a lot more authority than they have.! And they exercise their prerogatives as if they
have a lot more authority than they do.! They get away with it because the average
practitioner is not about to take on their board.! So a board can say, “I don’t want
your shoes to be polished brown, and if you do, we’re going to have a hearing about
it”.! The practitioner says, “okay, I’ll just wear black shoes”.! That does not mean
that brown shoes are banned under the law, just that the politics of the situation
says that “this isn’t worth fighting about”… ( response continued on next slide) :
Response Continued:
That situation exists in all the health boards all across the country, in all kinds of
ways.! It’s a very unfortunate part of our American legal system.! So if you’re a
chiropractor in Washington state and you want to use one of these devices, you
meet the criteria:! the FDA is regulating the manufacturer, who can’t sell to
somebody who is not qualified, and one way you’re qualified is by having a
healthcare license. If you want to turn around and sell it to somebody else, you have
to sell it to someone qualified, and the way that’s organized by the company at this
point is by the prescription process, which the FDA agrees with.! If you want to
determine how to deal with Washington state’s Chiropractic board, then we have to
look at it as a very specific question.! There are many devices that chiropractic
boards in one part of the country, including Canada, will say are completely
unusable and you can’t use them, then in other parts of the country the boards
endorse those same devices… it’s that uneven.!(response continued on the next
panel)
Response cont:
…It’s more in the realms of the politics of Chiropractic rather than the
realm of the law.! Boards have usually responded when they are
presented legal arguments about certain practices and devices being
harmless and legal.! I have no idea what the state board of Chiropractic in
WA would say in the face of being challenged.! Health boards in the U.S.
are extremely arbitrary and very far outside the formal legal structure,
and in fact should probably be reigned in substantially. !You could
petition the board to change what they said about the EPFX, stating
“please remove this from the list of devices that are not appropriate” then
lay the reasons out. They then have to decide if they are going to stand
by what they said or if they are going to engage in a fight. The more
serious you look, the more serious they’re going to have to consider how
they’re going to respond.! They don’t necessarily want to have a fight.
Question: Are people who are currently uncertified in biofeedback, but practicing
professionally, now required to become certified in order to practice professionally?
Response: Yes. Your biggest liability is not being certified.
The FDA regulates the manufacturer of the device.! They say to the manufacturer: !
“you can only sell to qualified professionals.! The agreement is that only certified
practitioners are being sold the device.! If you sell to non professionals, we will
prohibit you altogether.”!
Only people who are certified are to be considered to be qualified.! If someone
challenges your competency in using the device, your best defense is “I am
certified”.! If you are sued the biggest count against you is not being certified. If you
are uncertified, a court will most likely rule that you should not be using the device.!
Question: Is licensed and certified equivalent?!
Response: They are not equivalent, you can practice biofeedback without a license
as long as you are certified. If you have a medical license you do not necessarily
need to be certified, but you are better off in case someone raises questions about
your competence using this device.! Being certified in biofeedback is even more
protection than a medical license when being challenged on whether or not you’re
competent in biofeedback.!
Question: What are the best types of certification and how are they maintained?!!
Response: Certified Biofeedback Specialist is your best certification, and it is
maintained through obtaining CEU’s.
Question: Is there a main group that is providing certification?!
Response: The NTCB and BCIA are the main biofeedback certification boards in
the U.S.!
Question: Does this mean that training will be provided before purchase?!
Response: No, because you receive a prescription for personal use, which you do
not need a certification for.! If you wished to become a professional Certified
Biofeedback Specialist and conduct biofeedback on others for pay, you would then,
if you purchased through The Quantum Alliance, use your scholarship for
Beginners training at The Quantum Academies, where you will be granted (upon
completion and demonstrating competence) a “Temporary Technician” status.
This allows you to legally practice safely and obtain malpractice insurance. (cont to
next slide:)
This then allows you to begin obtaining your required supervised practicum hours
as you complete the remaining scholarships for:
!!The Coaching Skills course,
!!The Anatomy and Physiology course (if you have not taken it prior to obtaining a
biofeedback device), and
!!The Intermediate and Advanced course scholarships.
Most certified fields have a period of “professional internship”, where you are
partially trained enough to practice safely, but not yet complete with all the
advanced training required. This “Temporary Technician” status is equivalent to a
professional internship status because you have had enough training to operate the
device safely, obtain malpractice insurance and use an informed consent form, but
are still not entirely finished with your advanced trainings.
The certification process is clearly outlined at:
www.thequantumacademies.com and www.ntcb.org
Question: I’ve been through beginners training, is it okay to practice on people
before I can get back to Intermedicate and Advanced training?!
Response: Yes, if you have obtained:
1.) Temporary Technician status with the NTCB,
2.) Optionally but highly recommended: malpractice insurance,
3.) Have written and are using an Informed Consent form, saving a signed copy
from each client, and giving all of your clients their own copy to take home.
Question: If I’m in a state that does not regulate biofeedback, what do I do?!
Response: Get certified.!
Question: Will we have to be registered with the FDA as device owners?!
Response: No, they only regulate manufacturers.
Question: Can a massage therapist use the word “therapist” or “therapy”?!
Yes, in reference to massage, but not to any other health issue, disease or condition
outside the scope of massage, and that’s also to distinguish it from recreational
massage.!
Question: Can we still say treat and diagnose stress?!
Response: You should not.!
Question: If we certify through another organization other than NTCB, do we also
have to certify through them?!
Response: Not if the certification is a sound certification, there are criteria for
certifying organizations so check and see if they are valid.!
Question: If you are certified in Canada can you bring the device to America and
use it?
Response: Yes.!
Question: How would this affect a homeopathic certification through White Dove,
and what about homeopathics and herbs?!
Response: This has no bearing on biofeedback certification.! They need to be
certified in biofeedback. You can have more than one certification.
(Gage) With some dosages of Homeopathics, some are considered as requiring a
prescription in some states.! Some in lower dosages are over the counter. Others are
in between for “professional use”.
(Jim) Herbs are not considered to be drugs, unless there’s a disease cure claim is
made for them.! It becomes a drug when claims are made and has to go through the
same process as any other product.! That would also be true for a bottle of water:! if
you say, “this bottle of water cures cancer”, it becomes a drug by virtue of your
saying that about it.! The implications are self evident.! Herbs are dietary
supplements, and they can make certain claims if they have evidence that the FDA
has recognized. As long as you don’t claim that they treat, cure, mitigate, diagnose
and prevent disease, they are not drugs.!
Question: Are there certification regulations on biofeedback in New Mexico, I
haven’t been able to find any?
Response: It should not be difficult to find biofeedback regulations online in a state
if they exist.! If there are none, then they won’t show up in searches. However, If
there are no state regulations on biofeedback, it changes nothing about certification;
that is still necessary.!
Note: we will obtain information on each state’s regulations on biofeedback at a
future date for posting, as we need to time to compile this data.
General Note: The FDA regulates the manufacturer’s use of the words described
above. If practitioners are using inappropriate words, that can reflect negatively
upon the manufacturer, therefore for everyone’s safety, we do not use those words:
treat, mitigate, cure, diagnose or prevent any disease or condition.
Question: Can we tell of our own success stories about our clients of using the
EPFX?!
Response: As long as you do not use or imply any of the 5 words above or concepts
of those words.!
Question: Is it within legal bounds to put client testimonials in literature?!
Response: The law is that it must be edited.! The law is that the words that are
used are attributed to the owner of the website or author of the brochure.! You can’t
say, “It cured my cancer”.! On the other hand there is more flexibility there and I
think that’s an area of law that there’s going to be a lot of controversy over in the
next few years.!
Question: Are you saying we cannot refer to the EEG program even though I am a
licensed Ph.D. psychologist?
Response: Eclosion at this point probably cannot until the implications of the
FDA’s newer OTC EEG regulations are examined further, but you as a Certified
Biofeedback Specialist can conduct EEG biofeedback in general because some
EEG devices are sold and obtained over the counter and are unregulated. General
Note: advertise your Certification as a Biofeedback Specialist as opposed to
advertising the use of any particular device.
Question: Can I say, “If I were you I would take vitamin C” ?
Response: This can easily be adjusted to education on Vitamin C, where the client
can then make their own decision .! For more information, please consider a
“Coaching Skills” course, as this is now required by the NTCB for certification as a
Biofeedback Specialist, and would constitute an excellent choice in obtaining
CEU’s for re-certification. For more information, please visit
www.thequantumacademies.com
Question: Can you mail us a sample brochure?
Response: (Gage) I told you yes, but we cannot place them in the mail. Please refer
to The Quantum Alliance website. There is verbiage used there to describe the
device, and I have also posted a “how to do a demo script” to the lists several times.
You may use the website and script verbiage. Please email
[email protected] if you would like to receive the copy of the “how to
do a demo” script.
Question: Are there professional brochures which can be purchased?
Response: Yes, through www.thequantumcenter.com.
Question: Can we quote research from Stanford that 90% of disease is caused by
stress”
Response: Yes, and place the source in the quotation. Always include the source.
________________________________________________________________
We hope you found this webinar useful. We will conduct another one when more
changes arise.
Stay up to date with world wide Quantum Biofeedback
news by regularly visiting www.thequantumalliance.com.
For education questions and the certification process: visit
www.thequantumacademies.com.
To purchase brochures: visit www.thequantumcenter.com