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There is no central clearinghouse for regulating algorithms used in healthcare. Certain commercial applications, such as the heart rate monitor in the Apple Watch, are authorized by the Food and Drug Administration. However, algorithms developed by electronic health records companies, like Epic or Oracle Cerner, fall under the Office of the National Coordinator for Health IT, or ONC.
“We are not regulating the AI-enabled tools themselves,” ONC director Micky Tripathi told Forbes about the new rules his agency recently finalized that go into effect on March 11, 2024. Rather, he compares the approach to a “nutrition label” found on food packaging – electronic health records companies will be required to document 33 different data elements that give their hospital and doctor customers information about what data the model is trained on and how it works. In technical parlance, these labels are often called model cards. “We’re not getting deep into ‘is this a good product, is this a bad product,” said Tripathi. “We’re just saying information should be provided to the customer, so that they themselves can make the decision. But it applies to a much broader array of products than FDA regulations do.”
While the rules only apply to tools the electronic health records companies develop, Tripathi hopes that other app developers or health systems building tools in house will also fill out the nutrition labels. “We actually think blank fields are informative,” he said, meaning if a developer declined to provide information around topics like health equity or safety or performance bias then a customer should be judicious about using the tool. “We’re not trying to dictate how they do this, but we’re saying you should have a formal thoughtful process for how you incorporate algorithms into your product.”
This $674 Million Deal Aims To Turn Your Body’s Garbage Disposal Into A Disease Fighter
VantAI just announced a deal with Bristol Myers Squibb potentially worth up to $674 million. The goal? To use generative AI to design what are called “molecular glues.” These glues bind to pathogens in the body, like cancer cells, connecting them to the protein degraders your cell uses to break down stuff it doesn’t need anymore.
Why AI? Because your body doesn’t naturally use this process to fight disease, VantAI CEO Zach Carpenter explained to Forbes. “You can’t just discover glues through trial and error.” You have to design the molecules that do it, a Herculean task without the last decade’s advances in machine learning.
Read more here.
Pipeline & Deal Updates
Liver Disease: Gilead is acquiring CymaBay, which is developing a potential treatment for the liver disease primary biliary cholangitis, in a transaction worth about $4.3 billion.
Non-Opioid Pain: Biotech startup Latigo Biotherapeutics emerged from stealth with a $135 million series A round led by Westlake Village BioPartners. The company aims to develop non-opioid treatments for pain.
Digestive System: The FDA has approved Takeda’s drug Eohilia, an oral treatment for eosinophilic esophagitis. The condition, caused by inflammation of the esophagus, can cause choking and other issues with swallowing.
Metabolic Diseases: BioAge, which is developing treatments aimed at tackling obesity and metabolic diseases, announced that it has raised a $170 million series D round led by Sofinnova Investment.
Frostbite: The FDA has approved iloprost, marketed by Eicos Science as Aurlumyn, for the treatment of severe frostbite. It’s the first such approval and in clinical trials its application helped prevent the need for amputation of toes and fingers in patients.
Meet The Bryan Johnson-Approved AI Full Body MRI Startup That Just Raised $21 Million
Bryan Johnson is the self-proclaimed “most measured person in human history.” He’s the new poster boy for an old Silicon Valley obsession: “biohacking” your body to extend your lifespan. His “gold standard” body measurement tool? The the full-body MRI scan. Johnson told Forbes he plans to get six this month alone.
One of his go-to providers is New York-based startup Ezra, which uses artificial intelligence to speed up the process. With $21 million in fresh funding, Ezra cofounder and CEO Emi Gal, a biohacker and longevity enthusiast himself, wants to take these MRIs mainstream. But medical experts are concerned that full-body MRI scans could do more harm than good for the majority of patients — setting up people who have no specific risk of cancer or another illness for overtreatment and overdiagnosis.
Read more here.
Other Healthcare News
The European Union on Tuesday approved Casgevy, the world’s first medicine based on CRISPR gene-editing technology to treat two blood disorders, following the U.S. and U.K.
CVS Health CEO Karen Lynch said the healthcare giant is sticking with plans to open 50 to 60 medical clinics for seniors next year even as rival Walgreens pulls back on clinic expansion.
The CDC is planning to drop its five-day isolation guidance for Covid.
Defense Secretary Lloyd Austin was hospitalized for a second time this year and transferred duties to his deputy.
Patients in rural areas face worse EMS care and more sirens than those in urban and suburban areas, according to a new study.
Across Forbes
California Dreaming: How 90-Acres Of Huntington Beach Oceanfront Could Finance America’s Greenest Petroleum
AI Found Him A Date. ChatGPT Told Him To Propose. Now They’re Getting Married.
The 50 Hottest Fintech Startups
What Else We are Reading
A year in, the U.S. is still not taking advantage of lower-cost biosimilars for Humira (Stat)
The future of precision cancer therapy might be to try everything (Nature)
Will slow uptake of Leqembi pose a risk to Biogen’s recovery? (Endpoints)
