[ExI] , question for Max or anyone

[spike at rainier66.com]

...> On Behalf Of BillK via extropy-chat
Sent: Sunday, September 5, 2021 11:28 AM
Subject: Re: [ExI] , question for Max or anyone

On Sun, 5 Sept 2021 at 18:47, spike jones via extropy-chat <extropy-chat at lists.extropy.org> wrote:
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...
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> If Moore’s law drove the price of the watch all the way down to free, we still couldn’t afford one which was med-qualified.
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> spike
> _______________________________________________


That claim sounds odd to me. It is the model that is certified, not every device. If Fitbit are selling 10 million devices each year, the med qualification cost can be covered by only adding a small amount to the cost of each individual device...BillK

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BillK, on the contrary sir.

To have a med-certified device, the suppliers of the components must also be certified by some standard such as ISO9000 for high-reliability devices, a very general class of certification to which FitBit does not conform.  The manufacturing process itself must be controlled, and there are multiple costs involved.

During the impressive rise of FitBit, a patient came in with fibrillation.  The treatment for that differs based on how long the fibrillation has been going on.  He was one who had an app which would take periodic readings from his FitBit and archive it using his phone.  Upon his arrival at the ER, the doctors downloaded his FitBit file and made a decision based on that data, assuming it to be accurate (the patient didn't know or couldn't tell the medics how long the condition had been present.)

Afterwards, a very logical question arose: if a consumer-level device is used by doctors, then it becomes a defacto medical instrument, and as such would require med-certification.  FitBit steadfastly maintains that the device is accurate but its reliability is not sufficient to be used in this manner.  

The watch nor the phone manufacturers may not be sued for practicing medicine without a license, for they are intended as consumer-level devices.  They cannot be sued if they fail.  They are accurate and reliable, but not certified.  Likewise, if people have life-sustaining equipment in their home, the equipment itself is med-certified but the power to drive it is not.  If the power fails and the patient dies, it cannot sue the power company posthumously.

FitBit is a consumer-level manufacturer and will stay that way.

We could create an app to alert the next of kin in a heart emergency, but not to alert anyone likely to be of any real assistance, for that would put the device in a new and unaffordable category.

spike