“If you’re in the UK and were wondering how long it might take before Apple is allowed to enable the ECG feature on the Apple Watch Series 4, the news doesn’t look good,” Ben Lovejoy reports for 9to5Mac.
“Apple obtained FDA clearance to use the feature in the US just one day before the launch of the Watch, though Apple has not yet enabled it,” Lovejoy reports. “But despite a study suggesting an accuracy rate of 98% in detecting AFib, Apple may face a much tougher battle in gaining similar clearance in the UK.”
“I asked the Medicines and Healthcare products Regulatory Agency (MHRA) what would be involved, and how long the process would typically take,” Lovejoy reports. “The good news is that the process itself isn’t that complicated… However, Apple may also be asked to carry out a ‘clinical investigation’ – or medical study – designed to test the effectiveness of the AFib detection.”
Read more in the full article here.
MacDailyNews Take: Hopefully, Apple has already done the advance work and it won’t take” “years” to get Apple Watch ECG to the UK.
Has to be done once in the EU. No need to do in every country separately. If Brexit then another story.
Even with Brexit it does not have to be a new certification process if the UK will sign a deal with the EU about recognition of such certifications.
There is already a body of data from the Stanford Study. That study was pretty aggressive with immediate follow-up using a week long continuous and then Stanford contacting the customer’s doctor. That may have influence in the UK, especially if the UK develops protocols for addressing AFibs that are identified. It is also gong to be clear in short order that consumers want that feature on their Watch and it is a challenge to deny them that feature – especially if some Watch owners actually die when their heart problem could been identified with the software.
How does “medical study or clinical investigation” automatically turn into years? Why not just months if most of the groundwork has already been laid out? Is there some great biological difference between people living in the U.S. and people living in the U.K.? Or is it that tests are just a lot more stringent in the U.K.?
It seems there’s always some Apple product there are doubts about or Apple’s always running into some regulatory problem. That will be quite a shame if the citizens of the U.K. can’t get approval of that feature on AppleWatch.
I think it’s more likely that Apple just has to present their and other qualified research in a format that the UK authorities can accept. Well backed exhaustive research is readily accepted if it has relevance and has asked the same questions as the approval would require. It’s not just moniteering accuracy but data security and compatibility issues.
Probably a year at the most given it took a similar time for clinical use of iPads in hospitals to gain approval.