Thursday, 4 February 2021
Statements by Members
Therapeutic Goods Administration
Back on 15 June 2020, Apple submitted an application for an irregular rhythm notification feature on their Apple Watch, and I'm glad that a couple of days ago that was finally approved. The irregular rhythm notification feature is used on the Apple Watch and has been a source of consternation for many people wanting to see that facility activated. It's now on the therapeutic goods register, and we understand that entry will occur imminently. I note that the ECG component has not yet been approved, but I hope that that's also expedited by Apple to ensure there are no further delays and that Australia is treated like other nations that have the Apple Watch and those facilities available. It's shown a real health impact anecdotally in a number of cases where the IRN feature has led to people presenting with clinical issues that otherwise would have gone undetected, but of course we have to be assiduous in our assessment of software that is acting as a medical device, in particular when the manufacturer of both the device and the software are the same entity. Where there's a single listing, in some cases the manufacturer of, say, the camera or the device is different to the producer of the software, and that can sometimes necessitate more than one submission to the ARTG. In this case, picking up atrial fibrillation is a net benefit. We know that Europe is still dealing with some new classifications of the app, but, in the interests of avoiding further unnecessary delays, I'm glad that the TGA moved yesterday.