AI developers battle with FDA, what’s next with Amazon and One Medical, & protecting wearables data

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Industry fumes as FDA increases AI tool regulation

Health tech companies are in a tizzy. After years of letting companies roll out software tools to guide patient care with little oversight, the Food and Drug Administration is taking a tougher stance.


In September, the FDA announced its intentions to regulate many of these AI-powered clinical decision support tools as devices — which regulators say has always been their plan and within their purview. But the industry says it was blindsided by the move. Earlier this month, the Clinical Decision Support Coalition filed a petition asking the FDA to withdraw its final CDS guidance, arguing regulators are overstepping their bounds. “Truthfully, the result is that more products are regulated,” said Bethany Hills, a partner at DLA Piper who advises FDA-regulated device companies. “That’s hard for folks to digest.”

I’ve got the full details on the battle here.


Stroke risk tools may not work well for Black patients

Stroke risk prediction tools don’t work as well for Black patients, according to a new study led by researchers at the Duke University School of Medicine. Doctors use these algorithms to suss out whether patients are in danger of suffering from strokes, with newer models relying on machine learning. The research team found these newer algorithms weren’t much better at predicting stroke risk than simpler algorithms — and were worse at detecting risk for Black patients compared to white patients.

“We got the shocking result — to me, shocking — that the measure of discrimination, the ability to rank them, was much better… for white participants than Black participants,” Michael Pencina, director of Duke AI Health and a lead researcher on the study, told Ambar Castillo. Read more.

Amazon closes $3.9B buyout of One Medical

Amazon has officially closed its $3.9 billion deal to acquire primary care company One Medical, which it first announced in July. New U.S. customers will be able to buy an annual membership at the discounted price of $144 (the service is typically $199 a year).

The deal has bolstered Amazon’s growing health care portfolio, which include its Amazon Pharmacy prescription business and the telehealth platform Amazon Clinic. The One Medical deal rounds out Amazon’s ambitions to streamline primary care and health care delivery. The acquisition rang alarm bells for antimonopoly groups and the Federal Trade Commission, which began a review of the deal in September but hasn’t blocked it. “The FTC’s investigation of Amazon’s acquisition of One Medical continues,” FTC spokesperson Peter Kaplan said in a statement. Read more here.

De-identifying wearable device data isn’t enough

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Wearable devices typically de-identify user data before sharing it with third parties, like researchers, to protect privacy. But is this practice effective, or is wearable device data so extensive and personalized that it’s possible to re-identify individuals? In a paper published last week by The Lancet, researchers from Duke University analyzed 72 studies that examined whether individuals were able to be reidentified based on data from wearable devices. Most studies used electrical heart signals, electrical brain activity, and body movement to identify participants.

Eight studies were able to identify individuals based on heart signals, 17 studies based on brain activity, and 13 based on an individual’s walking gait. The researchers concluded that sharing deidentified data may not be sufficient to protect patient privacy. “These findings call for concerted efforts to rethink methods for data sharing to promote advances in research innovation while preventing the loss of individual privacy,” they wrote.

Industry news

    • On Thursday, Ambience Healthcare announced the launch of its AutoScribe technology, which summarizes patient-doctor visits through artificial intelligence. The startup has raised $30 million in funding from investors such as Andreessen Horowitz and the OpenAI Startup Fund.
    • Digital health company Eko is launching a new cardiac disease detection platform called Sensora, which works to identify heart murmurs.
    • Philips executives are waiving their bonuses — aside from former CEO Frans van Houten, who netted about $222,000 in his bonus — after a disastrous year due to its ventilator recalls.
    • The FDA has approved a new patient monitor from pain management company Medasense through the de novo pathway. The monitor uses physiological signals to measure pain in anesthetized patients.
    • Axena Health, a medical device company focusing on women’s pelvic health, secured $25 million in a Series A funding round.
Source: STAT