September 30, 2023

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Trade fumes as FDA will increase AI instrument regulation

Well being tech firms are in a tizzy. After years of letting firms roll out software program instruments to information affected person care with little oversight, the Meals and Drug Administration is taking a harder stance.


In September, the FDA announced its intentions to regulate many of those AI-powered scientific determination help instruments as units — which regulators say has at all times been their plan and inside their purview. However the trade says it was blindsided by the transfer. Earlier this month, the Medical Choice Help Coalition filed a petition asking the FDA to withdraw its closing CDS steering, arguing regulators are overstepping their bounds. “In truth, the result’s that extra merchandise are regulated,” mentioned Bethany Hills, a accomplice at DLA Piper who advises FDA-regulated system firms. “That’s arduous for folk to digest.”

I’ve acquired the complete particulars on the battle here.


Stroke danger instruments might not work effectively for Black sufferers

Stroke danger prediction instruments don’t work as effectively for Black sufferers, in keeping with a brand new examine led by researchers on the Duke College Faculty of Medication. Medical doctors use these algorithms to suss out whether or not sufferers are at risk of affected by strokes, with newer fashions counting on machine studying. The analysis group discovered these newer algorithms weren’t significantly better at predicting stroke danger than easier algorithms — and had been worse at detecting danger for Black sufferers in comparison with white sufferers.

“We acquired the surprising end result — to me, surprising — that the measure of discrimination, the power to rank them, was significantly better… for white members than Black members,” Michael Pencina, director of Duke AI Well being and a lead researcher on the examine, advised Ambar Castillo. Read more.

Amazon closes $3.9B buyout of One Medical

Amazon has formally closed its $3.9 billion deal to amass main care firm One Medical, which it first announced in July. New U.S. prospects will have the ability to purchase an annual membership on the discounted worth of $144 (the service is often $199 a 12 months).

The deal has bolstered Amazon’s rising well being care portfolio, which embrace 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 well being care supply. The acquisition rang alarm bells for antimonopoly teams and the Federal Commerce Fee, which started a evaluation of the deal in September however hasn’t blocked it. “The FTC’s investigation of Amazon’s acquisition of One Medical continues,” FTC spokesperson Peter Kaplan mentioned in a press release. Read more here.

De-identifying wearable system knowledge isn’t sufficient

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Wearable units usually de-identify consumer knowledge earlier than sharing it with third events, like researchers, to guard privateness. However is that this apply efficient, or is wearable system knowledge so in depth and personalised that it’s doable to re-identify people? In a paper published last week by The Lancet, researchers from Duke College analyzed 72 research that examined whether or not people had been capable of be reidentified based mostly on knowledge from wearable units. Most research used electrical coronary heart indicators, electrical mind exercise, and physique motion to determine members.

Eight research had been capable of determine people based mostly on coronary heart indicators, 17 research based mostly on mind exercise, and 13 based mostly on a person’s strolling gait. The researchers concluded that sharing deidentified knowledge will not be adequate to guard affected person privateness. “These findings name for concerted efforts to rethink strategies for knowledge sharing to advertise advances in analysis innovation whereas stopping the lack of particular person privateness,” they wrote.

Trade information

    • On Thursday, Atmosphere Healthcare introduced the launch of its AutoScribe expertise, which summarizes patient-doctor visits by synthetic intelligence. The startup has raised $30 million in funding from traders akin to Andreessen Horowitz and the OpenAI Startup Fund.
    • Digital well being firm Eko is launching a brand new cardiac illness detection platform referred to as Sensora, which works to determine coronary heart murmurs.
    • Philips executives are waiving their bonuses — other than former CEO Frans van Houten, who netted about $222,000 in his bonus — after a disastrous 12 months as a consequence of its ventilator remembers.
    • The FDA has permitted a brand new affected person monitor from ache administration firm Medasense by the de novo pathway. The monitor makes use of physiological indicators to measure ache in anesthetized sufferers.
    • Axena Well being, a medical system firm specializing in girls’s pelvic well being, secured $25 million in a Collection A funding spherical.