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The design shown in the demo requires a person to take three photos of their mistake from different angles and distances. The user can optionally add information such as the affected body part and how long the problem has been present. Clicking “Submit” closes the image to Google. The app then displays the “Suggested Terms” showing the possible terms shown in the images. Clicking on one displays a list of key information such as symptoms, contamination, and treatment options. Google says the app was trained in “hundreds of thousands of skin images” and can identify 288 conditions, including skin cancers, that cover about 90% of searches in regular dermatology networks.
The FDA exempts some so-called “lower risk” health software, such as “wellness” tips, such as diabetes management or information on health symptoms, from medical device approvals. Others need approval, such as those that provide accurate diagnoses or applications that function as medical devices like a stethoscope. It is difficult to define the boundary between applications that require clearance and those that do not, because medical software and the rules that govern it are relatively new.
Bradley Thompson, a regulatory attorney with Epstein Becker Green, asks a number of key questions to help clients determine if they need an FDA session. They indicate how the software output is presented to a person and whether a company makes specific medical claims.
Google’s app doesn’t highlight a single skin condition in response to photos of a person, and a note saying “the conditions listed here are not a medical diagnosis” appears. A company spokesperson compared the application to a search engine that looks at a person’s results and draws their own conclusions.
However, Google has also highlighted the medical chops in the skin app. DeSalvo, the head of health, said Google has developed the app because it doesn’t have enough specialist experts to help all people with skin diseases. Google blog post the app links it to studies studied compared to the company’s medical technology, saying “our AI system can achieve an accuracy comparable to that of a U.S. board-certified dermatologist”.
That pride caught the attention of Thompson’s lawyer. “That’s at least to suggest that it’s equivalent to what a doctor can do,” says the type of claim the FDA may be interested in.
Daneshjou, a Stanford dermatologist and researcher, believes that Google’s app offers medical specialization to consumers and regulators, not just search results. He says the application can be considered a “high-risk” device and requires FDA approval because certain skin conditions, such as melanoma, can be dangerous.
Daneshjou-k a final examination it raises concerns about how the FDA is making AI health software, and says it may be too early to throw open AI dermatology tools at consumers. “If a patient thinks this algorithm works, even a certified dermatologist can have more confidence,” he says. This can lead people to seek unnecessary biopsies or treatment from a doctor or not make a crucial visit.
Daneshjou says Google should let people know how it has tested its technology in different skin tones. So far the company’s AI dermatology studies have involved quite a few people with dark skin.
Google says these publications do not improve the latest data or image recognition models. The spokesperson said that the design and warnings of the dermatology application have been reported by user experience studies; additional research is underway, and it will also investigate how people use the service after the company makes it available in Europe.
Google has faced practical challenges in deploying other promising AI healthcare software outside the lab. In 2018 the company began testing a system capable of detecting eye diseases in people in Thai clinics. In 2020 the company published a study on the expansion of the system it has rejected more than 20 percent due to problems such as variable lighting of patient images and practical limitations of nurses.
Updated, 6-23-21, 11:30 a.m. ET: This article has been updated with FDA comment.
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