ECG or SpO2 disclaimer

[Guy_]

Is there a reason why there is an incessant disclaimer for using the Stress Management score [each time you logon] but never a disclaimer to be agreed to for using the ECG and SpO2 functions, especially in countries where it's not currently available?

If there was a disclaimer for each function then everything could be released in all countries and it would be up to the user to accept responsibility for the use of the results, and not be dependent on where he lives.

[SunsetRunner]

Hi @Guy_ 

As far as I know, national health authorities just do not allow any instrument claiming to produce ECGs without them testing it first and then approving it. ECG is an established medical designation whose use is strictly regulated worldwide by health authorities. Its misuse can cause serious health damages, even death. Disclaimers will not be enough. Just like many medicines.

Maybe that is the reason why Sense's ECG is maybe its one function that works best. I only heard very positive opinions by two different doctors, after showing them ECG records I got with my Sense.

I imagine the same may happen with SpO2.

[Guy_]

Hi @SunsetRunner , Thanks.

Though probably country approval is only for medical equipment, as used in hospitals or by doctors, and wouldn't need to apply to private equipment use, used non medically.

If for example, you take a Fitbit report to a doctor or hospital, the first thing they would do anyway would be to use their own equipment to make measurements, so it's a non issue requiring private equipment to conform to country approvals, and a disclaimer could easily make that clear.

What people are looking for is signs of a problem or anomalies or merely an indication.

The equipment measures temperature without any requirement to conform. If It detected a violent change, it could be a faulty measure or equipment or signs of an illness. 

The only way to know for sure would be to consult a doctor, why not the same for ECG and SpO2?

Given the faults and inaccuracies of the Sense watches, it would be foolish to consider anything it produces as more than an indication.

Presumably the original country approvals were done with the original firmware and Fitbit App at that time.

Given the number of changes and issues introduced in the firmware and software since, it is probable that the original approval is no longer valid.

This would be the same as changing chemicals or proportions of an approved medication. It would need reapproval.

Hence a disclaimer would avoid that.

[SunsetRunner]

I'm not gonna argue with that, @Guy_.  Maybe you have a point there.

I read a few things about that more than a year before buying the Sense. By then, Apple was the only watch with FDA approved ECG. But I never was an Apple guy and didn't intend to change that.

FDA, the American national health authority, is probably the strictest of all, in the world, concerning these kind of approvals of new medicines or medical equipments. As I read then, it is common that FDA takes a lot of time to approve something new (many months, years sometimes). But once FDA approves, most of the other countries health authorities usually quickly follow, though many perform their own studies.

By the end of Summer 2019, Samsung released their Active 2 watch, packed with new features, one of them "prepared for ECG", which would be made available "as soon as FDA issued their approval", which "was expected soon". It was a big flop for Samsung and its customers (mainly those with heart issues) who rushed to buy an Active 2 then. I was one of those who were very much interested, but decided to wait, constantly checking whether FDA or the european health authority had already approved. FDA and its european equivalent issued their approvals about one year later, around the same time they approved Sense's ECG.

So, FDA approval mostly, but also other countries health authorities', must have huge commercial impact.