Billions of times a year, people turn to Google’s web search box for help figuring out what’s wrong with their skin. Now Google is preparing to launch an app that uses image recognition algorithms to provide more expert and personalized help. A short demo at the company’s developer conference last month showed that the service suggested several possible skin conditions based on uploaded photos.
Machines have rivaled or outperformed expert dermatologists in studies in which algorithms and doctors scrutinize images of past patients. But there’s little evidence of clinical trials deploying such technology, and no AI image analysis tools have been approved for use by dermatologists in the US, said Roxana Daneshjou, a Stanford dermatologist and machine learning and health researcher. “Many don’t make it out in the real world,” she says.
Google’s new app isn’t clinically validated either, but the company’s AI prowess and the recent build-up of its health division make its AI dermatology app remarkable. Still, the skin service will start small — and far from its home base and largest market in the US. The service probably won’t be analyzing American skin blemishes anytime soon.
Speaking at the developer conference, Google’s chief health officer, Karen DeSalvo, said the company aims to launch a dermatology resource in the European Union as soon as possible by the end of this year. A video from the app suggesting that a spot on a person’s arm could be a birthmark had a caption saying it was an approved medical device in the EU. The same comment added a warning: “Not available in the US.”
The company’s America-not-first strategy shows how it can be easier to get approval for medical apps in Europe than in the US. A Google spokesperson said the company would like to offer the service in the US but had no timeline on when it could cross the Atlantic; they declined to comment on whether Google has spoken to the U.S. Food and Drug Administration about the app, but acknowledged the agency’s approval process could take longer.
That detracts from Silicon Valley’s traditional view of Europe as a bureaucracy-strewn landscape hostile to new ideas. Between 2012 and 2018, Facebook did not offer facial recognition suggestions in the EU after an audit by the Irish data regulator forced the company to deactivate the feature and delete its stock of European facial prints. Since 2014, Google has been required to allow EU citizens to have old links about them removed from the company’s search engine under the ‘right to be forgotten’.
Google says its skin app is “CE marked as a Class I medical device in the EU”, meaning it can be sold on the bloc and in other countries that recognize that standard. The company would have encountered relatively few hurdles to get that approval, says Hugh Harvey, director of Hardian Health, a digital health consultancy based in the UK. “You essentially fill out a form and certify yourself,” he says. Google’s conference last month took place a week before the stricter EU rules came into effect. Harvey says that many health apps, probably Google’s too, are needed to show that an app is effective, among other things. Existing apps have until 2025 to comply with the new rules.
Last month’s demo was short and the app’s design isn’t final yet, but US AI health software experts say Google could get a more involved lawsuit from the FDA if it brings its skin app home. takes. An FDA spokesperson declined to comment on Google’s service, but said software purporting to be used to “diagnose, cure, prevent or treat people” could be considered a medical device and require agency approval. . To make that call, the spokesperson said the agency generally needs to review “the intended use of the software and the claims made for the product.” The spokesperson added that the agency has issued guidelines to encourage data collection from different populations.
The design shown in the demo requires a person to take three photos of their stain from different angles and distances. The user can optionally add information such as the affected body part and how long he had the problem. Tapping “Send” will zip the images to Google. The app will then display “Suggested Terms”, with possible terms illustrated by images. Tapping one will bring up a list of important information, such as symptoms, contagiousness, and treatment options. Google says the app is trained on “hundreds of thousands of skin images” and can identify 288 conditions, including skin cancer, which covers about 90 percent of general dermatology searches on the web.
The FDA exempts certain health software it considers to be “lower risk” — such as “wellness” advice such as diabetes management or information about health symptoms — from medical device approvals. It requires approval from others, such as those that provide specific diagnoses, or apps that function as medical devices such as a stethoscope. The line between apps that require permission and apps that don’t is difficult to define because medical software and the rules that govern it are relatively new.
Bradley Thompson, a regulatory attorney at Epstein Becker Green, asks clients a handful of important questions when trying to determine whether they need FDA approval. They include how the software’s output is presented to an individual and whether a company makes specific medical claims.
Google’s app does not flag any potential skin conditions in response to a person’s photos and displays a warning that “the suggested conditions listed here are not a medical diagnosis.” A company spokesperson compared the app to a search engine that displays results for a person to view and draw their own conclusions about.
Still, Google has also emphasized the skin app’s medical issues. DeSalvo, the health chief, said Google developed the app because there aren’t enough skin specialists to help every person with skin conditions. Google’s blog post links the app to peer-reviewed studies comparing the company’s technology to physicians, saying, “Our AI system can achieve an accuracy comparable to that of US board-certified dermatologists.”
That boast attracted Thompson’s attorney. “That really suggests that this is at least comparable to what a human doctor can do,” he says — the kind of claim that could interest the FDA.
This story originally appeared on wired.com.