Summary : If somebody tells you his device is certified as a Medical Device ask him for which Diseases it is certified – understand that it is illegal to use the device to treat other symptom medically – medical devices are never certified for general functions like “biofeedback” but for specific diseases only
We have long waited to go for certification because the benefits are doubtful for you the users, however very lucrative for us the producer, however expensive first to get it.
Why ?
A medical device is such always only for a very narrow group of diseases. If you use a medical device for any disease outside this group you are making yourself liable if you give the impression to your client that you are using a medical therapy on him while he is coming to you with a disease for which this device might be effective but where it has not yet proven this effectiveness in appropriate trials.
From our holistic approach it is very doubtful to classify a persons symptoms into a narrow disease name but exactly this is what you have to do if you do clinical trials and if you want to make sure you are not using a device outside the limited frame for which it was certified.
However we had to find that most doctors are ignorant of this fact but on the opposite completely under the spell of the magical CE sign. This goes so far that they would not even put a device in their office that does not have this sign.
BUT they are so naive to use a Biofeedback device that has a CE sign on any disease that someone comes with, believing that once the device it approved as a medical device it is up to them to decide what they want to us it for. NO, devices are not approved for a general use of a function, if you do you risk your license.
This tendency is reinforced by the majority of companies that got a CE sign for very limited fields of application but give the impression to their customers that this sign protects them from any liability. Nothing could be further from the truth as the opposite is the case. Using a device that is certified as a medical device need much more of your informed consent to be used than one that is not.
A system like the LIFE for example is approved as a medical device for some form of arthritis of the leg, that is so exotic that I already have forgotten its medical name. None of their users even has heard about this disease for which it was approved but naively use it in their practice for any disease that is listed in the software.
Especially if you are in USA you open the door wide to any of the many people who makes a living on suing other people or in Germany those who run “Abmahnvereine”. So if you would need to make some extra money you could go to a LIFE practitioner and have you treat for any fictitious disease and then you would sue him that he used his device outside the ONE disease for which its effectiveness was proven .
Others like the SCIO users are even less in touch with legal reality. When you read about SCIO or its predecessor QXCI you will always hear the name EPFX as well, which is added to any sentence where these are mentioned. This is being done because the EPFX the grandfather of it all, 20 years ago, got a FDA approval by misrepresenting it as biofeedback device. Of course the biofeedback approval was also based on only one or two diseases. Even the EPFX, today, could not be used on any disease in its biofeedback function because
it is not in the first line “how you use a device” but “what for you use it” that makes it legally a medical device or puts you outside the realm for which it is approved as such.
The QXCI community is so naïve that they think to change the name is the remedy for any bad press that they receive while they keep the benefits that their grand or great-grand-father received. If you do not know the QXCI is not the SCIO anymore, now it is the INDIGO.
As you probably know Kiran has a bad press among its competition because he does not play these games that only are greed based. I want you to be save in what you are doing and I want to help a lot of people with a technology that is kept outside the main-stream by forces that want to make money in another way.
How to present your work in a way that is legally acceptable ?
We could have saved ten thousands of dollars if we would have only attempted to get a certification for only one exotic disease but the Health Navigator is certified on the basis of over 20 studies for the following very wide 3 indications :
- Pain therapy
- Wound healing
- Depression
We were lucky to get 3 so very common indications certified BUT what if someone comes to you with one of the other 9997 diseases of the IDC (International disease classification catalog) ? If you treat him giving him the impression that you do a medical therapy he can sue you even although he certainly will not have any worsening of his symptoms resulting from your treatment, but simply for the fact that you mis-represented your work and your tools.
Therefore PLEASE PLEASE listen to the following: Despite the fact that you have now a medically approved device, if someone comes to you with a disease other than one of the above 3 you have the following 3 options.
- Send him home and tell him you can do nothing for him
- You tell him that you have him hold these electrodes but the tingling he will feel is only for educational or entertainment and certainly you agree with the majority of the “scientific community” that currents of such minute voltage and amperage cannot have any physiological effects neither for the better or the worse, so certainly you do not diagnose, cure or prevent disease with it… but it might be entertaining or educating.
- You tell the person that in your believe system all pain wants to remind you about a spiritual message that you have forgotten and that you are doing a spiritual ritual when you connect the electrodes and to tingle the message out of the subconscious that is important for him to be aware of.
To me the 3rd option was and is the best and most elegant way to represent our work as holistic healers that is most close to the truth while at the same time not getting into legal conflict with a very corrupt and dysfunctional legal medical system.
But even within this scenario using the CoRe system as a spiritual device don’t go so far to say that you are practicing “spiritual healing” because any healing/ curing/ remedying is under the monopoly of the medical establishment.
What you are doing is giving spiritual impulses and if you client gets any improvements after a visit with you and a use of the Health Navigator don’t be so naïve to confirm that this is a result of your intervention that a grateful client might want you to confirm. NO what he and many others before or after him experience is a coincidental improvement that has no causal relationship with what you have done.
Many people will see through the absurdity of this argument, particularly if you spell it out as plainly as that.
However again here on a deeper level this forced re-adjustment of reasoning is pointing us all in the right direction as John of God says “It is not me who heals it is only God” and he does not say this because he is afraid of the FDA…..so why you don’t you do it the same…. And this argument, will make you an even better healer.
