Jason Brooke, Politico
Apple is touting its new health software with an aggressive public relations strategy that worries many cardiologists, who feel the company is exaggerating the significance of the Apple Watch readings of a heart condition called atrial fibrillation.
Critics are also concerned that the FDA’s unusual celebration of Apple’s new tech — which is central to the company’s move into health care — represents boosterism that distorts the agency’s role of assuring the safety and efficacy of medical devices.
The concerns center on an algorithm accessible through the Apple Watch that detects atrial fibrillation, an irregular heart rhythm that can elevate some individuals’ risk of stroke. In many cases, the watch has given users warnings that led them to get necessary and even life-saving medical help.
When FDA gave a so-called de novo clearance to the watch’s atrial fibrillation program last fall, Commissioner Scott Gottlieb enthused about what he called a “significant step forward in FDA policy because we decoupled review of the app from review of the watch itself.”
Gottlieb described Apple as an example of a new type of healthcare company — a welcome influx into an industry insufficiently welcoming to disruptive technologies. Joe Grogan, then with the Office of Management and Budget and now director of the Domestic Policy Council, said medical device regulation was an “old system that’s barbaric,” and endangered America’s predominance in innovation.
But the administration’s rosy assessment worried some regulatory observers. Grogan’s comments, said Jason Brooke, a medical device regulatory expert with Navigant, suggest that “FDA at the highest level took extra efforts to accommodate one company.”
“The FDA is responsible for regulating the industry, not fostering its growth,” Brooke wrote in an email. “Their mission is to promote and protect the public health.” The agency eroded its standards in its rationale for approving the device, creating a worrying precedent, he said.
The atrial fibrillation function on the watch relies on two distinct technologies: a physical sensor, which picks up data off the human body; and software, which interprets the sensor data. The agency approved the software, but not the physical device. That’s a flawed approach, Brooke argued, because it means the agency is overseeing only half the product. If the product’s machinery changes, it could change how well the software works, he said.