Millions of people visit Google’s web every year search to find out what’s wrong with their skin. Now, Google prepares the launch of an app that uses image recognition Algorithms to provide more competent and individual help. A short demo at the company’s developer conference Last month showed the service, which suggested several possible skin conditions based on uploaded photos.
Have machines Voted or exceeded experienced dermatologists in studies where algorithms and doctors scrutinize images of previous patients. But there’s little evidence from clinical trials using such technology, and no AI image analysis tools for dermatologists are legal in the US, says Roxana Daneshjou, a dermatologist and researcher at Stanford machine learning and health. “A lot of people don’t get along in the real world,” she says.
Google’s new app has not yet been clinically validated either, but the company’s AI capabilities and recent build up of its health department make its AI dermatology app noteworthy. Still, the skin service will start small – and a long way from its home market and the largest market in the US. The service is unlikely to be analyzing American blemishes for the foreseeable future.
At the developer conference, Karen DeSalvo, Google’s Chief Health Officer, said the company plans to launch a so-called dermatology aid tool in the European Union by the end of this year. A video from the app suggesting that a mark on a person’s arm might be a mole included a caption stating that it was an EU approved medical device. The same note added a caveat: “Not available in the US.”
The company’s America-not-First strategy shows how it can be easier to get medical apps approved in Europe than the US. A Google spokesman said the company would like to offer the service in the US but has no schedule for when it could cross the Atlantic. They declined to comment on whether Google spoke to the U.S. Food and Drug Administration about the app, but acknowledged the agency’s approval process may take longer.
This changes Silicon Valley’s traditional view of Europe as a bureaucracy-strewn landscape that is hostile to new ideas. Between 2012 and 2018, Facebook did not offer facial recognition proposals in the EU after an investigation by the Irish Data Inspectorate forced the company to disable the feature and delete its inventory of European facial prints. Since 2014, Google has been obliged to allow EU citizens to request that old links to them be removed from the company’s search engine under the keyword “Right to be forgotten. “
According to Google, its skin app with the CE mark has been approved as a Class I medical device in the EU, which means it can be sold in the block and in other countries that recognize this standard. The company would have had relatively few hurdles to get this clearance, says Hugh Harvey, managing director at Hardian Health, a digital health consultancy in the UK. “You essentially fill out a form and certify yourself,” he says. Last month’s Google conference was held a week before stricter EU rules came into force, which Harvey says many require health apps, probably Google’s as well, to show, among other things, that an app is effective. 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, but U.S. AI health software experts say Google could face a more burdensome process from the FDA when it brings its skin app home. An FDA spokesman declined to comment on Google’s service, but said software that claims to be used to “diagnose, cure, prevent, or treat people” can be considered a medical device and requires approval from the agency requires. To make that call, the spokesman said the agency generally “needs to review the intended use of the software and the claims made about the product.” The spokesman added that the agency has issued guidelines encouraging the collection of data from different population groups.
The design shown in the demo requires a person to take three photos of their flaw from different angles and distances. The user can optionally add information such as the affected body part and the duration of the problem. If you tap “Send”, the images will be zipped to Google. The app then displays “Suggested Conditions”, which illustrates possible conditions through images. Tapping one will bring up a list of important information such as symptoms, contagion, and treatment options. According to Google, the app has been trained on “hundreds of thousands of skin types” and can identify 288 diseases, including skin cancer, which covers about 90 percent of popular dermatology web searches.
The FDA excludes some health software it deems to be “lower risk,” such as “wellness” advice such as diabetes management or information about health symptoms, from the approval of medical devices. For others, it is subject to approval, for example those that offer certain diagnoses or apps that act as medical devices such as a stethoscope. The line between apps that need approval and those that don’t is hard to see 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 key questions as he tries to determine if they need FDA clearance. This includes how the output of the software is presented to a person and whether a company makes certain medical claims.
Google’s app does not highlight a single possible skin condition 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 read and draw their own conclusions.
However, Google has also highlighted the skin app’s medical capabilities. DeSalvo, the health chief, said Google developed the app because there weren’t enough skin specialists to help everyone with skin conditions. Googles blog entry links the app to peer-reviewed studies comparing the company’s technology with doctors and says, “Our AI system can achieve an accuracy comparable to that of US dermatologists.”
This boast caught Thompson’s legal interest. “That really suggests that this is at least comparable to what a human doctor can do,” he says – the kind of claim the FDA might be interested in.
This story originally appeared on wired.com.