Could Apple’s new FDA-approved watch spark litigation?

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Apple’s unveil of its FDA-approved Series 4 smartwatch that can perform an electrocardiogram and alert medical professionals of an emergency, may expose the tech giant to personal injury lawsuits, some attorneys warn.

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Apple executives plus the head of the American Heart Association hailed the new watch Wednesday as both an advanced health-tracker and a life-saving gadget for its ability to spot irregular heart problems in users “anytime, anywhere.”

But one attorney says the advancement could put the tech giant in legal crossfire because of the Health Insurance Portability and Accountability Act (HIPAA) if all warnings aren’t detailed to users in advance.

“[They] need to be telling customers about what data it is storing about them and who is being sent to and what to do if the watch get lost,” Bryan Rotella, attorney and founder and CEO of GenCo Legal, tells FOX Business.

However, Mark Lanier, founder of The Lainer Law Firm, adds that Apple will no doubt have all the warnings associated with the device placed into user agreements before a user will be able to access the feature, which will keep the tech giant from having legal exposure “should the function fail at a critical moment.”

Still, Rotella says he can definitely foresee two bad scenarios playing out for the company by adding this electrocardiogram functionality.

“First, thousands of users rushing to stretched and understaffed ERs because their Apple Watch is falsely saying they have an irregular heartbeat,” says Rotella. “Second, users having real symptoms but Apple Watch says ‘OK’ and [they] end up having a major cardiac event,” he says, adding that both scenarios could potentially lead to multiple consumer fraud and malpractice suits for the company.

However, not all lawyers see such a great potential for personal injury and privacy lawsuits.

“The fact that the technology is approved by the FDA, without more, doesn’t necessarily change Apple’s obligations under laws like HIPAA,” Erica Holzer, litigation attorney at Maslon in Minneapolis, tells FOX Business.

“What matters is how and to whom protected health information is transmitted. Apple is a sophisticated company that understands how to treat protected health information. My bigger concern would be smaller app developers looking to break into this space, but who may not have laws like HIPAA on their radar.”

Apple representatives did not immediately respond to FOX Business’ request for comment on the potential liability concerns around its new watch.

Source : https://www.foxbusiness.com/features/could-apples-new-fda-approved-watch-spark-litigation