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TGA Irregular Heart Rhythm Notification Apple Watch Approval

Australian Government Approves Apple Watch Irregular Rhythm Notifications

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Irregular Rhythm Notifications, a significant capability of the Apple Watch, may soon be available in Australia. The Australian Government has recently given Apple medical approval for the feature to be enabled in Australia. Paving the way for one of the most requested features to be enabled – ECG.

Irregular Rhythm Notifications is a feature of the Apple Watch which alerts the user of any identified episodes of irregular heart rhythms. By analysing the pulse rate data on the go. Any irregular heart rhythms is a potential sign of atrial fibrillation (AFib), an abnormal heart condition.

Feature shown on Apple Watch

Apple Watch has had the capability to perform Irregular Rhythm Notifications since Series 3 (3 years ago). But it has never been enabled in Australia because it required medical approval from the government – until now.

Approval by TGA

At the begining of Feburary, 2021, the Australian Government through the Department of Therapeutic Goods Administration (TGA) approved the feature. The public summary can be viewed on their website.

It is now up to Apple to enable the feature, which they will likely do in the next available software update. But what about ECG? At this stage TGA has not yet given approval for that feature. But this highlights that Apple is atleast making submnissions to the TGA.

The TGA has made the following points regarding the Irregular Rhythm Notification feature:

  • is a software-only mobile medical application that is intended to be used with the Apple Watch.
  • analyses pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user.
  • intended for over-the-counter (OTC) use.
  • not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis.
  • data is only captured when the user is still. Along with the user’s risk factors, the feature can be used to supplement the decision for AFib screening.
  • is not intended to replace traditional methods of diagnosis or treatment.
  • the feature has not been tested for and is not intended for use in people under 22 years of age.
  • is also not intended for use in individuals previously diagnosed with AFib.

The newest software releast for Apple Watch (watchOS) is currently being tested among public BETA testers and developers. And should be released within the next month. It is unclear if Apple will enable the feature with its release, but its our best bet yet.

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