Google is preparing to launch a medical application - to aid in the diagnosis of skin diseases. Users upload three photos of their blemished skin areas, and the app will give an analysis that tells the user what kind of skin disease this could be. Google says the app can recognize 288 skin conditions, including skin cancer, covering about 90% of common skin conditions.
Currently, the application has been approved by the European Union, but to be marketed in the United States, it will need to pass strict scrutiny by the FDA (U.S. Food and Drug Administration). Stanford dermatologist Dr. Daneshjou believes it may be too early to disclose the AI dermatology tool to consumers.
Using image-recognition detection to cover 288 skin diseases
When you're not feeling well, you go online and search for what might be wrong, and that's what a lot of people do. Although many people know that "Google doctor" is not reliable, but still can not help but open the search engine.
Google is about to launch a self-proclaimed "reliable" medical app for skin disease diagnosis. At the Google I/O developer conference last month, Karen DeSalvo, Google's chief health officer, said that Google would launch a dermatology aid in the European Union as soon as the end of this year.
Live from the Google I/O developer conference in 2021
He showed exactly what the app would be used for. Users need to take three photos of their skin blemishes from different angles and distances, with text messages such as how they feel and when the symptoms appeared, and then click "submit" to upload the images. The app then automatically analyzes the images and gives "suggested results" that tell the user what kinds of skin conditions they might have, and for each possible result, lists the symptoms, contagiousness, and treatment options for that condition.
However, the app warns users that "the suggested results listed here are not medical diagnoses" when displaying the results.
Google said the app was trained on "hundreds of thousands of skin images" to recognize 288 skin diseases, including skin cancer, which covers about 90% of common dermatology web searches.
According to statistics, users search Google for skin problems billions of times a year. Google claims to have developed the app because there aren't enough skin specialists to help everyone with a skin condition. Google's blog post refers to a comparative study that says "our AI system can achieve accuracy comparable to that of a U.S. board-certified dermatologist."
But Roxana Daneshjou, a dermatologist at Stanford University, is skeptical. She said the technology has little evidence from clinical trials, and no AI image analysis tools have been approved for use by dermatologists in the US.
Markets in Europe, not the US, as FDA scrutinizes health software
It's worth noting that Google didn't choose its home market in the US to promote the dermatology diagnostic software, instead choosing to make its first stop in Europe.
Google says its skin app has been approved by the EU - " CE marks it as a Class I medical device" (note: CE is the European Union's mark of conformity for safety in the marketplace, a mandatory certification mark), which means it can be used in the EU and in other countries or regions that recognize the standard.
This came as a surprise to many, given the EU's reputation for strict regulation of AI applications. Harvey, managing director of Hardian Health, a UK-based digital health consultancy, said that last month, the EU introduced stricter AI regulation, with new rules requiring that health-related apps demonstrate that the app is effective. Previously existing apps have until 2025 to comply with the new rules.
And Google showed off the app at the Google Developers Conference a week before the new EU regulations came into effect.
In the US, the app may have a long road to market, pending approval by the FDA, the US Food and Drug Administration, which is the highest law enforcement agency authorized by the federal government to specialize in food and drug regulation. A spokesman for the FDA declined to comment on the product, but said that software claiming to be used to "diagnose, cure, prevent, or treat human beings" could be considered a medical device and would need to be reviewed for approval.
The FDA is known to take a tiered approach to approving health software. For software that only provides health advice or health information, the FDA considers it "low risk" and does not require medical device approval. Software that provides a specific diagnosis or is used as a medical device is subject to more rigorous review and approval. But as medical software continues to evolve, this line is sometimes difficult to define.
However, Google's dermatology aid should now be considered "subject to approval," and an FDA spokesperson said it has issued guidance on the software that encourages data collection from a variety of populations.
Dermatologist Daneshjou agreed that Google should have disclosed more information about how the software was tested on people of different skin colors. There is evidence that Google's AI dermatology studies have looked less at people with darker skin tones.
In fact, the use of image recognition in search engines is well established. For example, when people see an unfamiliar plant on the road, they take a picture and upload it to a search engine, and immediately get information about the plant.
However, using image recognition for skin disease diagnosis is clearly different from using it for general object recognition. Some skin diseases are very dangerous, such as melanoma, and can be fatal. If the software makes an error in judgment, there will be serious consequences.
"It may be too early to expose AI dermatology tools to consumers." Daneshjou said.