Industry Watcher’s Digest

Buzzworthy developments of the past few days. 

• Michelle Tarver, MD, PhD, has her work cut out for her. As the incoming head of the FDA’s Center for Devices and Radiological Devices, she’s taking charge of a division she’s worked in for 15 years. But familiarity doesn’t make inherited fires easy to extinguish. Among the most pressing to-do’s in her inbox: settling nerves over outgoing CDRH head Jeffrey Shuren’s tight ties with industry, dealing with high-profile criticisms from Robert F. Kennedy Jr. about such connections and figuring out what to do with brain-computer interfaces like the one designed by Elon Musk’s Neuralink. The New York Times breaks down Tarver’s challenges in an article posted Nov. 1. The article quotes FDA commissioner Robert Califf, MD. At last month’s HLTH conference, Califf commented on the agency’s lack of capacity to surveil AI-equipped devices once they’re in use. “It’s so bad,” he remarked. “If you said: ‘Well, the FDA has got to keep an eye on 100% of it,’ we would need an FDA two to three times bigger than it currently is.”
   
• Dr. Califf has really been getting around lately. And fielding a lot of questions about healthcare AI. This week he did an interview with NPR. Asked by the host what he would tell folks troubled by the notion of “a computer” helping to make their diagnoses or direct their care, he didn’t hem or haw. “A computer doesn’t get tired, and it’s not distracted by other things in the environment,” Califf said. “In my 40 years of working on computer-human interfaces, the combination is always better as long as the rules of the road are right.” 
   
• The FDA chief also recently said he doesn’t know of a single health system in the U.S. that’s even capable of doing proper AI validation. By this Califf surely means nobody has yet demonstrated the know-how—or maybe the will—to refine their algorithms with local demographic data and then test the updated AI’s performance over time. Reporting on what hospitals are up against in this arena, Axios healthcare editor Tina Reed recounts a quote given her by digital health executive David Newman, MD, of Sanford Health System based in Sioux Falls, S.D. “I looked at my inbox yesterday and I had 22 emails from AI companies,” Newman says. “I don’t know if they’ve been validated or not. I don’t know if they’re solving a problem at all. It’s really hard to wade through that to see what actually is useful for our patients and providers.”
   
• One hospital C-suiter would like to see hospital leaders harness vendor hype and ‘turn it into a commitment.’ He’s Jason Hill, MD, chief innovation officer at New Orleans-based Ochsner Health. If a clinical department purchases AI on the basis of a measurable claim made by a software supplier—and the product fails to hit the target—”we’re going to cancel the contract,” Hill tells MedCity News. Clinical departments, he adds, “need to have some skin in the game for if their thing works.” 
   
• Some parents trust AI chatbots more than their kids’ doctors for pediatric medical advice. Researchers found this out when they asked mothers and fathers to rate text written by either a physician or ChatGPT. Reporting on the study, Fox News Digital sought perspective from a physician with expertise in AI. “AI can provide valuable preliminary information, but it cannot fully grasp a child’s unique medical history, subtle symptoms and nuances from years of specialized training,” says the physician, Harvey Castro, MD. It’s crucial, he adds, to keep not just a human but “the right human” in the loop. 
   
• It’s with an eye on shifting to AI and healthcare that Oracle is downsizing hundreds of jobs from its cloud operation. From a news item posted by Techstory: “As the firm looks to maximize its staff and concentrate resources on high-growth sectors, reports suggest that Oracle is implementing these layoffs as part of its continuous strategy to adapt its operations in response to changing needs in the cloud computing sector.”
   
• Meanwhile Nvidia has plans to land robots in hospitals for taking X-rays, delivering linens and all sorts of tasks. “This physical AI thing is coming where your whole hospital is going to turn into an AI,” Nvidia healthcare VP Kimberly Powell tells Business Insider. “You’re going to have eyes operating on your behalf, robots doing what is otherwise automatable work and smart digital devices. So we’re super excited about that, and we’re doing a lot of investments.”
   
• Recent research in the news:
   
  • University of Wisconsin: Researchers find persistent problems with AI-assisted genomic studies
     
  • Lehigh University: AI for real-time, patient-focused insight 
     
• From AIin.Healthcare’s news partners:
   
  • Cardiovascular Business: ‘A huge win’: CMS significantly increases Medicare payments for cardiac CT