Online vision test apps focus debate over doctor replacement
Friday, September 3, 2021
Source: POLITICO
The hip eyeglasses retailer Warby Parker may be an unlikely candidate to revamp health care. But its push into at-home vision testing could be a harbinger of a more digital post-pandemic medical system.
The company, worth an estimated $3 billion, revealed in a recent regulatory filing that it’s branching out into virtual vision testing, joining a crowded field with at least three dozen rivals, as part of an effort to expand its reach beyond its chic glasses stores. It’s part of a boom in digital health products fueled by the pandemic restrictions and loosened FDA regulations that could over time reduce the demand for optometrists and other health professionals.
Products such as the Apple Watch, at-home genetic or Covid-19 tests and teeth straighteners all offer the promise of delivering care outside traditional settings as the virus continues to spread, said University of Pennsylvania medical ethicist Anna Wexler. “We're just seeing this happen all across the board,” she continued.
Some companies behind the gadgets — such as AliveCor, the manufacturer of devices tracking heart rhythms — used pandemic easing to introduce new products, including measuring Covid patients’ risks of developing heart conditions. But brick-and-mortar health practices warn some of the new tools can’t substitute for in-person care and, in some cases, jeopardize patient safety.
The push for remote testing adds more complexities to the digital health push, by testing the ability of regulators to police myriad gadgets that haven’t been fully evaluated. At the beginning of the pandemic, FDA loosened restrictions on a series of devices — from digital therapeutics treating psychiatric disorders to remote ophthalmic assessment — by announcing the risks of allowing such devices on the market outweighed the risks of catching Covid-19. For the duration of the public health emergency, the agency said it would scale back enforcement.
The makers of these devices accordingly rushed into the market, supercharging a previous conflict over such devices: whether or not the convenience and low prices of these products is simply a cover for safety risks.
The vision testing market is the perfect example. Online tests such as Warby Parker’s run patients about $15; patients simply download an app, wear their glasses or contacts, and read an eye chart on their phone. That allows patients to renew — not strengthen or weaken — a previous prescription. Such tests are “very convenient for the consumer,” said Bob Kocher, a venture capitalist at Venrock.
But there have been safety concerns. Visibly’s online refraction vision test was recalled in 2019 after the FDA said the Chicago-based startup hadn’t received authorization to sell it to consumers. The company did so — only for the pandemic to allow the product back on the market.
Prospects improved, with patients flocking to a product that could keep them out of a doctor’s office. Visibly CEO Brent Rasmussen said his app was downloaded "hundreds of thousands" of times over the year-and-a-half it's been on the market. With increasing tech adoption, and the pandemic habituating patients and regulators to telemedicine, "the concept is no longer novel," he said.
Many of the products operating without formal approval will need to either come off the market or get approved once the public health emergency ends. In the case of Warby Parker and Visibly, the FDA could expand the range of online tests that can be offered, now limited to existing patients renewing prescriptions, and let the companies write new prescriptions for different strength lenses, Rasmussen said.
Warby Parker’s plans aren’t as clear. The company declined to comment for this story, owing to its preparations for an initial public offering on the stock market, which constricts what it can say to the public. Still, the company’s documentation with the Securities and Exchange Commission reveals its plans to submit a so-called 510(k) application to get clearance to offer its online vision test to the market.
But the American Optometric Association already is warning that a Wild West market could result, and urging strict regulation.
“Whenever you are putting a regulated medical device, such as a contact lens, on the surface of your eye, care must be taken,” said AOA president Robert Layman.
The association in April wrote to the FDA requesting it pull back on its regulatory forbearance on the products. Agency policy is “now being used to allow a device that was voluntarily recalled just months ago to reenter the market,” argued the association. “This action could create patient safety concerns and confusion in the public.”
Visibly’s Rasmussen says it’s a responsible provider of tests: It hasn’t received any complaints; and it tries to direct high-risk patients — such as those with glaucoma — to a doctor. “This vision test is for healthy people,” he said.
The FDA declined to comment for this story, but longtime observers wonder whether it’ll rethink its position on digital tests.
“The Covid-19 pandemic gives regulators an opportunity to learn where there's room for flexibility,” said Patricia Zettler, a Ohio State University law professor and former agency lawyer. The agency might keep tabs on whether the influx of digital tests and products have worked well or not, and adjust regulations accordingly, she said.
“Each of the direct-to-consumer tests is like a remake of a movie” in terms of the concerns being raised, said the University of Pennsylvania’s Wexler. But “once a profession realizes these products are here to stay, the positions change,” she said.
Not everyone agrees. Kocher doesn’t think there will be any wholesale replacement of doctors. While there are a number of products that show promise, it’s harder to find a business model. Google and other tech companies, he noted, developed interesting artificial intelligence to scan the back of a retina or other image analysis.
But Google is pulling back from its health work. “They did lots of R&D, they told the world, we have a thing, that's as good as a doctor — and no one wanted to buy it,” Kocher said. The economics mostly work for direct-to-consumer products; other systems need to work through insurers and health systems, which don’t have an interest in scaling back on doctor use. “There's not much pressure today” to use this technology, he said.