Apple Watch ECG App approved in Australia by Therapeutic Goods Administration (TGA) — 2021
On 2nd March 2021, the Therapeutic Goods Administration (TGA) in Australia approved Apple to use an electrocardiagram (also called an ECG or EKG) app in the Apple Watch.
There’s some important considerations, and a release date is not yet confirmed, however this is good news for Apple Watch users.
Many people have also delayed buying an Apple Watch, specifically for the release of these new health apps.
The ECG app has been available in many countries worldwide on most Apple Watch versions, since the release of Apple Watch 4 in September 2018.
The ECG app can record your heartbeat and rhythm using the electrical heart sensor on Apple Watch Series 4, Series 5, or Series 6* and then check the recording for atrial fibrillation (AFib), a form of irregular rhythm.
*The ECG app is not supported on Apple Watch SE.
However, it has only just received regulatory approval in Australia.
Should I buy a watch now?
If you have been waiting to buy an Apple Watch, you might notice that the Series 4 and Series 5 is no longer featured on the Apple website.
- The Series 6 could be quite expensive for entry-level buyers
- The Series 5 is still promising, and will support the ECG app
- The Series 4 is running out of stock, and supports the ECG app
- The Apple Watch SE does not support ECG app
- The Apple Watch 3 does not support ECG app
There is some good news for those who want a cheaper entry-level alternative with the ECG features still available.
The cheaper Apple Watch Series 4 and Series 5 are still available on the Australian Amazon store but it seems these are facing limited supply.
It seems news has got out — the Apple Watch 4 appears to be running out of supply since the recent announcement.
What exactly did the TGA approve?
The TGA has approved ARTG 355992 to use Cardiac electrophysiology application software effective 2nd March 2021 — specifically:
The ECG app is a software-only mobile medical application that is intended to be used with the Apple Watch to create, record, store, transfer and display a single-channel electrocardiagram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AF) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrythmias.
The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation with a qualified health professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AF from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment.
The ECG app is not intended for use in people under 22 years old.
When will it be available?
As at 5th April 2021, Apple has not yet updated its Feature Availability list, so it’s not yet clear when Apple will release this feature to the Australian market.
However, now that the TGA has approved the functionality in wearables, it’s likely that this release will happen very soon.
It’s likely that the release will happen alongside WatchOS 7.5 and iOS 14.5 which is speculated to occur in April 2021.
Why did it take so long?
The TGA held some strong concerns around the accuracy of ECG data.
An analysis of medical device recalls by the TGA in the five years to April 2020 showed that software defects were one of the most common reasons for hospital or retail level medical device recalls.
Over 20 % of all device recalls in that period were due to software faults — for example, this equated to 50 recalls in the six month period from 1 October 2019 to 1 April 2020.
While the recall reports are largely from software problems when the software is integrated with a medical device they illustrate the significant and negative health impacts from faults that have required recalls.
Software faults required recalls in a number of devices that perform critical diagnostic and in patient functions. Some examples reported to the TGA include:
Electrocardiographs: Either loss of data or improper signal analysis, incorrect patient assignment affecting clinical assessment of ECG arrhythmias.
One thing is for sure, Apple is here to expand further into the Health & Wearables market, so this announcement will certainly pave the way for more exciting technology to be made available to Australian residents.