Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in the Washington Post, in “Apple Now Says Its Smartwatch Tech to Detect Atrial Fibrillation Is Not for Those with Atrial Fibrillation,” by Christopher Rowland.
Following is an excerpt:
The fine print on Apple’s latest foray into health care carries a seemingly strange caveat: its new Apple Watch technology to detect atrial fibrillation is not intended for people who have atrial fibrillation.
The contradiction sums up the deeper questions raised by the introduction of a mass-market monitoring tool for the heart. Apple’s products are designed to inspire, with clean designs and seamless operation. But health care is messy and unpredictable.
The latest gadget worn on the wrist is simply not accurate enough to handle the task of assessing serious medical conditions, according to health officials. It’s mostly a gateway for conversations with your doctor, and Apple’s detailed setup screens for the new watch are loaded with warnings and explanations, including one that informs people with atrial fibrillation that the Apple Watch app is not for them. …
But for skeptics, the fast approval for the Apple heart apps was an unsettling indication that the agency is not sufficiently scrutinizing consumer tech that does not perform as well other devices on the market.
“There are a lot of tech companies that are focused on the consumer-grade medical device,” said Bradley Merrill Thompson, a Washington lawyer at Epstein Becker Green who represents clients before the FDA.
He said the Apple apps are not designed for sick people but rather for the “worried well” who want to monitor their biological signals.
“There’s probably a big market for it. I don’t doubt the economics of it,” Thompson said. “I’m just not sure of the public health imperative behind it.”
