ECG Feature on Apple Watch Could Take Years to Be Approved in the United Kingdom

[sakabaro]

Hum, my series 4 offered hearth stats for the hours it was resting on a table this morning.

Not sure if that's very accurate already.

 

[kevingaffney]

Atrial Fibrillation is believed to be greatly under-diagnosed given its sporadic in nature, especially during early to middle age. Even in older people, like myself, it's very hard to capture and diagnose given the occurrence rate is too low to be reliably picked up by routine ECG tests. People experiencing mild atrial fibrillation often are unaware of it.

Yet this disorder has a high correlation to strokes later in life. Your first indication of a problem could be a disabling stroke.

The beauty of the Watch Series 4 (when the software arrives) is that it potentially can monitor you 24x7, and as a result will eventually detect when AF occurs, even if it's very sporadic or related to certain activities. (Assume for the moment that sex is what trigger's your AF... kind of hard to capture that moment in the doctor's office. Or only when you're hiking up a steep hill. Or having a strong emotional reaction to something.)

The challenge then is to get your cardiologist on board. The problem is exponentially worse if you don't already have a cardiologist that you see. I'm not aware of a standard stress test that can be used to reliably reveal the problem.

Some docs will embrace the opportunity for 24x7 monitoring, and others will be less receptive. That might depend on how they get paid (in the US anyway).

For my part, as soon as the software is available, I'm going to be talking to my cardiologist about how to get him plugged in. Assuming he's not already welcoming this feature.

The difference in the US versus the UK is that docs in the US have significantly more freedom in how they respond to new technology, given that healthcare in the US is mostly a private business and docs can set their own rules (within reason).

That said, it will be interesting to see how private insurance handles compensation for doctor visits triggered by the Watch. Preventing a stroke by detecting AF and treating it early (with meds) is a LOT cheaper than treating the patient after a stroke, so likely they'll view this as a good investment. Insurance in a free market environment is always looking at the lowest total cost of treatment.

Excellent post. Only someone who suffers from heart problems can appreciate the benefits from what the Apple Watch 4 can provide. Unfortunately living outside the US means likely years before we ever get our hands on the feature. I am curious though if it’ll be possible to cheat the location in settings to still get the ecg facility

 

[simonmet]

I don't really understand why a watch needs an ECG. I mean, if you're worried about heart health or have any symptoms shouldn't you go see a doctor?

 

[kevingaffney]

I don't really understand why a watch needs an ECG. I mean, if you're worried about heart health or have any symptoms shouldn't you go see a doctor?

As I do every six months. Big difference in having it performed several times a day in varying situations. Also, had this been around a few years ago, I would like have had my aFib diagnosed earlier and treatments started earlier. I’m lucky though, many strokes can be avoided using this technology

 

[iFan83]

Although I don’t have much need for ECG at this point in my life, I do like that they added it and where it will go moving forward.

 

[cmaier]

I don't really understand why a watch needs an ECG. I mean, if you're worried about heart health or have any symptoms shouldn't you go see a doctor?

Convenience. And one visit to get an ECG here can cost more than the watch.

 

[TheCardiologist]

Surly a company with billions and billions of dollars, the life-saving stories that will appear when the feature is available elsewhere, and a large outcry from the UK citizens will speed up the approval process.

Fortunately for all of us it takes more than a company with a few billions turning up and saying 'hey we have this thing that saves lives' in order to get approval for a diagnostic test, device or treatment...
[doublepost=1538076968][/doublepost]For all the arm chair cardiologists out there (claiming harm no harm etc) consider the following

The benefit of the device, is most likely to be in the detection of atrial fibrillation. This could be useful but inaccuracy has significant ramifications positive and negative. Consider...

1. Atrial fibrillation (AF) is a significant finding at any age
2. At the very least a detection of atrial fibrillation by the watch would require reproduction using some other method (more tests)
3. There would be other tests to look for underlying causes of AF (more tests)
4. Someone has to pay for all these tests (either you in the US or the tax payer in the UK)
4. A confirmed diagnosis could lead to the need for therapy that has risks as well as benefits (anti arrhythmic drugs/ anticoagulants)
5. A spurious diagnosis could lead to inappropriate use of these and avoidable risk
6. The threshold of how much AF you need to have before the benefits of these treatments kicks in remains contentious
7. An incorrect diagnosis of AF would affect you in other ways (think insurance etc)

So the argument that we should just do this and move on is not quite so simple.

Most people don't worry about these things until afterwards...

Oh, and this is in no way the first device onside to the public for the self recording of a single lead ECG. This thing has been around for some years and is a lot cheaper than an Apple Watch

https://www.alivecor.com

(Conflict of interest: None)

 

[alangrehan]

It is amazing that the UK government has to treat its citizens like babies who can't be trusted to make decisions for themselves. How about giving people the freedom to decide they want to use it or not? Sure, if they need to have a ton of disclaimers, go ahead.

It isn't as if this is a defibrillator that is going to try and shock your heart back into rhythm, it is another tool that could potentially save someone's life by recording an ECG/EKG to show to their doctor later. It isn't perfect no doubt since it is an early version, but give people the freedom to choose for themselves whether to use it. I know plenty of people who are competent enough to understand the limitations.

Talk about heavy-handed, paternalistic interference in people's lives.

Well as a UK tax payer... I couldn't have rolled my eyes more when I saw this feature announced.

In the US if you receive a notification saying there may be a problem you can ring up a doctor and arrange to be seen within a few days and you are paying for that service. Apple will almost certainly err on the side of 'better be safe than sorry' and it won't really matter as people are paying for their own treatment.

The NHS is publicly funded and cardiology clinics are already at maximum capacity. The last thing we need here is a queue of 'the worried well' people adding to an already huge waiting list.

Nobody's palms are being greased. The MHRA is a government body which regulates all healthcare devices to ensure they are safe and accurate (and in this case to make sure that tax payers money is not wasted treating people who don't need to be treated).

 

[Seoras]

I wonder if it's geo ring fenced like Apple Pay is with cards (you can only add your credit cards to your Apple device while located in card's country of origin).
I'm not holding my breath for ever getting it in the techno back water that is New Zealand.
Still waiting on visual voice mail (11 years on!) and no GSM support for Apple watch S3/4.
Enjoyed using Apple pay -everywhere- when I was back in the UK last week. Not so in NZ...

 

[petercooper]

The Series 4 is the first ECG product being offered over the counter directly to consumers.
​

Certainly not true in the UK. You can get one from Qardio - I bought one. I've also seen numerous cheaper devices on Amazon though they might all be stuff from China.

 

[triton100]

Maybe, but it's not "free" is it, and this is the future. just the first steps.

The NHS should appreciate the fact that rather than explaining symptoms that may come and go but aren't present during your 10 mins with your GP you can now show them some data. Currently if you have intermittent symptoms you can be given a device from the NHS to do this work anyway.

The FDA are an incredibly hard regulatory body to please, I work with medical systems for a living. Some of this work should be valid for use here.

It's this backwards & slow, archaic thinking that holds us back these days, even when the tech is there. Same with autonomous cars. We need to embrace the future not be scared of it. The NHS needs all the modernisation it possibly can in my opinion, it's like stepping back into the 1990's in places.

Amen
[doublepost=1538081842][/doublepost]

As I do every six months. Big difference in having it performed several times a day in varying situations. Also, had this been around a few years ago, I would like have had my aFib diagnosed earlier and treatments started earlier. I’m lucky though, many strokes can be avoided using this technology

But shouldn’t people just be changing to a healthier diet with more exercise rather than hoping a watch can do an early catch of any resulting problems from not following this ?

 

[KPOM]

It makes sense. This is a very serious feature that needs to be thoroughly tested.

No one is suggesting that this replaces a medical exam. Technology like this should get expedited approval.

 

[ani4ani]

Your approach to this is hyperbolic. You and others are acting as if the FDA gave some type of hand-wavy approval of this product. Apple is not going to release the feature without FDA approval.

FDA approval
FDA approval
FDA approval

Not Apple magic, fairy dust approval. FDA approval.

You do not work for the FDA. You are not one of the doctors who worked on the testing for Apple. You are not privy to all of the data that was analyzed, nor are you qualified to analyze it.

You are playing armchair doctor/analyst based on the very limited public information that is available about this.

We, on the other hand, are putting our trust in the same agency that is responsible for approving the 10 and 12-lead devices that you seem to have no problem with.

They didn’t get FDA approval....they got FDA clearance. Totally different matter altogether.

 

[andreiru]

What an appalling set of news. UK, ffs, we can do better than that! I only just recovered from having lost my pulse wave velocity with the nokia scales...

 

[purplehaze0]

Medicines and Healthcare products Regulatory Agency just want their palms greased. Europe is famous for waisting time via regulations. Nothing like log jamming a digital watch feature.

How is the UK regulatory system
Making money from this? It’s a quality assurance measure that I think is very wise.
[doublepost=1538085100][/doublepost]

The Series 4 is the first ECG product being offered over the counter directly to consumers.
​

Certainly not true in the UK. You can get one from Qardio - I bought one. I've also seen numerous cheaper devices on Amazon though they might all be stuff from China.

All of our lovely apple products are “stuff from China”

 

[jpn]

hi

sorry if i have missed it, but i have a question that a few other posters have raised about how these models with and without ECG functionality is differentiated.

how is apple actually preventing this ECG functionality from being used on apple watch series 4 models sold outside of the USA?

it is not by actually changing the actual model number of units w/ w/out this function: apple watch models are differentiated by LTE band frequency. there are basically 2 sets of models right now. one set based on LTE frequencies used in the USA and one set based on most commonly used LTE frequencies outside of the USA.

so is the functionality entirely just software based? meaning that this function is enabled or not enabled depending on where you download your apple watch software from?

so, is it tied to the country of where one's iPhone contract is based, and therefore by extension to where you get yr watchOS software from?

this would have implications for anyone thinking that they can simply purchase the watch in the USA but ties it to an iPhone with a contract outside of the USA carriers.

 

[mazz0]

I wonder if part of their trial could be open for public users to volunteer to take part in. Rather like a beta test.

Maybe Apple will cut the price in the UK as a gesture of goodwill to us missing out on this feature....

Haha, yeah, cos we always get a discount for features that don’t work outside the US! :’D

 

[wbeasley]

surely the potential benefits far outweigh the concerns. many times over.

i would never take my pulse rate when walking. i don't log my sleep patterns.

but i let my Watch do it and i have checked their reports occasionally out of interest. i don't "live and die" by the numbers.

for some reason people are scared of information. treat it as extra anecdotal indicator tools. simple. done. it might even save lives.

having a partner who has had a heart attack, i bought him a FitBit. the HR feature actually got him interested. and now after a Garmin he would like a Watch when the ECG feature is enabled. it's all about providing everyday data collection that doctors dont and cant capture. it wont replace proper medical tests. but if it can collect something then it's got to be a good thing.

i also worked in aged care for 4 years. the Falls Detection is another similar potential life saving feature. so many people fall out of bed. would be great if they added in notifications if people wandered during certain time periods. night staff don't have enough workers. these two features could ensure elderly people in danger get assistance in a timely manner before issues became big problems.

 

[Futurix]

US and European regulators test medical devices very differently - in US they are basically allowed unless they are obviously harmful, while in Europe they are only allowed if they are proven to be safe.

 

[sk2sep2304]

When it’s works in the UK, I’ll upgrade from my Nike Series 2.

Same for me except I’m in the US and I have series 0 lol

I’m returning the series 4 as I don’t use it very much. Long live watch series 0! Lol I can’t even update to 5.0 software.

 

[mypins]

Maybe being dim here - but could they not just have massive disclaimers saying the readings aren't regulated/approved and are advisory only? See a doctor etc.

Regulations in the UK prevent simple disclaimers for being used. Essentially, Apple will have to register this as a medical device.

 

[cylack]

Guess Brits are going to be buying their Series 4 Apple watches when they visit the US.

 

[jeremiah256]

Also have to consider sensor strength. ER sensors pull from 120VAC, and can easily detect 10mV signals. A 1.12 watt-hour battery on the other hand has reduced capabilities. Hence my gimmick stance, and confusion as to why its considered a medical device.

It's not a gimmick, it's about classification.

The United States has several classes (based on risk) for medical devices. A tongue depressor is a Class I medical device. As is dental floss. The Apple Watch Series 4 will be a Class 2 medical device, in the same category as condoms and pregnancy testing kits. Both condoms and testing kits have good levels of reliability, but no one expects them to be 100% effective, or take the place of more complicated technology or procedures. Same with the Apple Watch Series 4.

 

[usarioclave]

This is a great example of bureaucracy being behind the curve. Really, the question should be: how accurate is it compared to the other single-lead ECG devices out there? Do the errors fall into the accepted range? If so, then that's fine. Then publish the data so that the readings can be interpreted correctly.

An in-office ECG may not be very useful because the condition may not be visible at the time of the office visit.

Fearmongering about hypochondriacs ignores the fact that the hypos are already bothering their doctors about every ache and pain they have. A quick ECG will allow the doctor to assuage the patient's concern...or possibly discover that indeed the hypochondriac is correct.

Apple isn't claiming a health benefit. That's like saying a scale claims a health benefit. A scale is just a reading; the question in the ECG case is a question of accuracy.

 

[oober_freak]

By all accounts, China and India should have the ECG feature by Series 20!

The regulatory process here in Asia is a mess. Medical boards and councils are *really* conservative on standards, however no name, generic manufacturers still get away with not following standards to the tee.