ECG - Apple Watch

Anvisa approves the ECG feature of the Apple Watch in Brazil! [atualizado]

Finally, we have, first hand, good news for Brazilian Apple Watch owners who need / want access to the electrocardiogram (ECG) – and irregular rhythm notifications – on your watches.

But first, let’s do a brief recap of everything.

Expansions

THE ECG was announced alongside the Apple Watch Series 4 in 2018, and a few days later it was officially launched in the United States. In March 2019 (when launching watchOS 5.2), we had its first expansion, encompassing several European countries and Hong Kong; last September, he arrived in India.

In March 2020, Apple launched the feature in Chile, New Zealand and Turkey; and now, in this month of May, he has arrived in Saudi Arabia.

In other words, we are talking about a constant, but very slow expansion.

The resource

To use the ECG, you need to buy an Apple Watch and set it up in one of these countries, as the feature makes use of the user’s location to validate activation.

Recently, Apple started saving information on ECG activation in iCloud (in the cloud); this way, when formatting the watch (due to a problem) or when purchasing a new Apple Watch (including the Brazilian model), just configure it with your Apple ID to use the feature without having to reactivate it.

ECG - Apple Watch

But this, as explained, only works for those who have / had an Apple Watch from any of these countries and activated the feature outside of Brazil at some point in the past.

When activating the ECG, the Apple Watch also starts to notify users when it identifies an irregular heart rhythm that appears to be atrial fibrillation (AFib).

And Brazil?

For the ECG to be set up for the first time on a Brazilian Apple Watch, Apple needs the authorization from the National Health Surveillance Agency.

In April 2019, we communicated first hand that Apple had not yet applied for ECG registration in Brazil; in September 2019, in new contact with Anvisa, we found that the scenario remained the same.

Last December, however, we had news. We informed – also exclusively – that Apple had met with the agency’s technical team to understand the requirements necessary for the regularization of the ECG in the country. As we explained at the time, regularization involves a series of state and / or municipal authorizations before national regularization, and that, once the application is filed, the analysis takes about 60 days.

The time passed, 2020 arrived, and nothing from Apple to request the registration of the ECG – that is, at no time was this whole delay Anvisa’s fault. Now, in May, the situation has finally progressed.

THE MacMagazine found that the request for registration of the ECG at Anvisa was made on May 4 (only three weeks ago, therefore), and that he will be approved today (5/25). The process was much quicker than Anvisa predicted, probably because Apple has already given you very complete documentation based on information obtained at the December meeting.

Thus, with the authorization of the agency in hand, Apple will finally be able to release the activation of the ECG in Brazilian territory – it is, almost two years after the launch of the resource.

When will ECG and irregular heart rate notifications be released?

Normally, the release of ECG and irregular heart rate notifications in new countries happens with the launch of a new version of watchOS. If this is really necessary, Apple could make available a version 6.2.6 with this novelty – and with the traditional bug fixes / general improvements – or, thinking about a more time consuming scenario, who knows just with a future version 6.3 (which should enter in beta soon).

Another possibility is that Apple has already incorporated the feature in watchOS 6.2.5, but in a “hidden” way; with approval, she could release everything remotely, without the need for an update – as apparently happened in India.

Regardless of how the ECG and irregular heart rate notification will be released, the fact is that there is very little left before owners of Apple Watches Series 4 or 5 Brazilians can finally configure and use the features for the first time. Now go!


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Update May 25, 2020 at 13:30

Here is the official statement from Anvisa related to the approval of ECG features and irregular pace of the Apple Watch:

Anvisa Resolution-RE 1,635 was published in the Official Gazette (DOU) this Monday (5/25), which approved two Apple applications for measuring heart rate using the Apple Watch, a watch with several technological resources smart devices, including software (programs) that assist in monitoring data related to user health.

[…] The products were developed by the North American company Apple Inc. and, in Brazil, were registered by Emergo Brazil Import – Importação e Distribuição de Produtos Médicos Hospitalares Ltda. The registration of products with Anvisa corresponds to a kind of simplified registration.

Now Apple just needs to release everything to users!