ASYRA and regulatory affairs
Asyra is a biofeedback system that outputs low-power signals and summarises responses measured by galvanic skin measurements in a software interface.
The system is used mainly by health practitioners to gain an insight and clarity about the client’s presenting health picture. Its use is applicable in any human-interaction activity where the intention is to obtain a response that is not influenced and thereby modulated by any processing from the conscious-mind. The system contains a very wide-ranging data set, and it has been observed that testing appears most helpful when there is a synergy between the subject being addressed and the knowledge-base and experience of the practitioner involved. No scientific explanation can be given as to how this improvement occurs. It may simply be the effect of good appropriate interpretation but equally it could be due to some less-understood aspect of what happens in the body-mind system when two people focus together on an intention.
The wide-ranging pre-configured database has been developed mainly by the historic user-base of Asyra and predecessor-systems. It does not reflect any claim by the company on the outer limits of the effectiveness of the testing, which can only be discovered by using it. Application in any, and all areas of the study of living systems is welcomed.
The manufacturers and distributors do not seek licensing of the device in any country as a ‘medical device’. Debates about whether a system is a ‘medical device’ hinge on several subtle areas of legal definition. Some manufacturers of devices with similar aims to the Asyra seek medical device certification to gain credibility with their intended audience of healthcare professionals, and in some cases achieve it by building in a subsidiary function that has a ‘medical claim’ attached to it.
Each user of the Asyra defines their own way of applying the software. If a practitioner makes a claim of the ability to diagnose or treat disease, it is their own claim. Raw response data from the Asyra system does not constitute anything that can be construed as a disease diagnosis. The labelling of conditions or diseases is something that can only be done by a trained person because ‘the label’ is designed for the purpose of selecting medical treatments. With the Asyra, it is certainly intended that a health practitioner will be effective at helping their clients using the insights gained from Asyra, but always these responses apply only within the context of a consultation.
Inevitably the language used in the Asyra database has some crossover with medical language. This cannot be avoided.
REGULATORY BODIES AND ASYRA
Discussions with the MHRA in 2015 concluded with an agreement that it was important for users of the Asyra system to be clear in their language to ensure the system is not seen as a replacement for conventional disease diagnosis, where that is needed. We are committed to support this objective and welcome reports of any claims or marketing that obstruct this goal.
SCEPTICS AND ASYRA
The organised sceptic movement has often chosen Asyra as a target for their attentions, with a stated goal of removing misleading claims from the healthcare marketplace. This is a laudable intention but needs applying according to a rational harm-cost-benefit analysis, as it is very hard to make subjective judgements about what exactly constitutes someone being ‘misled’. So far, no evidence has been presented of negative health outcomes at the individual or population level from the use of Asyra or similar systems by healthcare practitioners.
There appears to have been a concerted effort by a few persons to organise complaints to local and central government organisations with a view to blocking use of the Asyra system, again with no evidence of harm having been done, by omission or commission, to any person. The people who made the most persistent communications with our team had apparently recently retired from running their own consultancies advising pharmaceutical companies.
THERAPIST ORGANISATIONS AND ASYRA
No specific relations are maintained between Asyra and any therapy regulating or subscription bodies.
In June 2018, following an Advertising Standard Authority opinion on the wording of a website created by an Asyra user, the British Association of Nutritional Therapists (BANT) issued a statement that required its members to make clear that Asyra-testing was an activity completely distinct from ‘Nutritional Therapy’, and quoting an erroneous part of the of the ASA statement that said Asyra equipment had not been safety-tested.
It should be noted that appropriate (CE) safety status has always been in place for the manufacture of the device within the normal framework of electrical safety regulations, not to be confused with medical device certification.
The goal of health practitioner, is, of course, to help another person make progress towards feeling happy and healthy. In this work, creating distinctions between one kind of therapy and another may work for some practitioners but not others. In our experience the best practitioners combine many threads of knowledge in building a deep understanding of human nature. They are both scientist and artist, bringing the best of their skill, judgement and intuition to bear on the case as it presents in all its aspects. For this, they will seek to use every tool at their disposal in the most efficient combination. Asyra is an excellent tool to support such a wide-ranging approach.
We support the work done by BANT and all single-therapy organisations to promote high standards in natural health practice. This is a very particular challenge at a time when medicine needs to be able to start to embrace safer alternatives. We recognise the balance BANT need to strike between supporting a holistic approach and giving guidelines that promote the recognition of nutritional therapy.
We would always recommend Asyra practitioners to choose their language carefully in promoting their practices as the technology is easily misinterpreted by the naïve.