LONDON — A U.K. commission on Thursday unveiled its recommendations for how the country should regulate artificial intelligence in medicine, as health authorities globally try to determine how to continuously review ever-changing products after they have been authorized instead of simply clearing them once for the market. 

In its report, the commission sought to strike a balance between ensuring that the U.K. takes advantage of AI’s potential in medicine — the ability to review the millions of scans that are generated each year to track the eye health of patients with diabetes, for example — while prioritizing safety, tracking device performance over time, and treating patients equitably.

The 44 recommendations include some that would allow for the staged authorization of new AI models and others that would build a system for providers to report how tools are performing in their clinics — including when they malfunction or potentially inhibit patient care — as the models learn and adapt and perform differently depending on the setting.  

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NEW YORK — The two measles-related deaths in Pennsylvania last month involved infants, and the virus itself caused one of the deaths, a Pennsylvania coroner confirmed Wednesday.

Lancaster County’s coroner, Dr. Stephen Diamantoni, said he told the Centers for Disease Control and Prevention of his conclusions. CDC officials, however, have not said whether they will count either death as measles-associated, and the agency’s website still carries a disclaimer about them.

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ARPA-H, the government agency that funds cutting-edge health research, plans to commit $62.7 million to develop artificial intelligence bots that direct treatment of heart failure. Among the goals of the program, called ADVOCATE, is to produce partially autonomous AI devices authorized by the Food and Drug Administration to help treat patients, including assessing symptom severity, prescribing drugs, and ordering lab tests. 

ARPA-H on Wednesday announced the first batch of awards to health tech companies Atman Health, UpDoc, Tempus AI, and teams from Stanford University, Duke University, and the Kaiser Permanente health system. ARPA-H may still fund additional teams. The amount committed for the first year is $33.7 million, and the remainder may be renegotiated up or down. 

Many of the 6.7 million Americans with heart failure don’t get optimal treatment because of difficulty accessing specialists, and the hope is that AI agents developed with ARPA-H funding can help address the gap, especially in rural and other underserved settings.

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It’s hard to resist the world’s obsession with productivity and efficiency and to force yourself to be present in a quiet space. I’ve been enjoying the wandering_cassettes Instagram account, which posts videos of Fisher Price cassette players playing songs in different settings. This one is particularly calming, but they’re all timeline cleansers.

The newsletter will be off next week as I work on a big new story, but I’ll be back in your inboxes Sept. 23.

AI scribes only fix a tiny slice of the problem

Today’s AI Prognosis — and my new story — are brought to you by “The Pitt.” Not in any financial way — I just mean that I finally started watching “The Pitt.” (No spoilers! I’m only halfway through season two.)

Everyone is right — it is extremely compelling television. But what struck me the most was how “The Pitt” feels exactly like the ambulance ride-alongs and emergency department shadowing visits I’ve done: Dropping in on the worst day of someone’s life, but doing it over and over every 40 minutes, for eight to 12 hours, without enough resources.

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First came the new teaser for Nathan Fielder’s documentary on Elizabeth Holmes. Now come the memes. Bring it on.

FDA names permanent heads of drug and biologics centers

For the past few months, key centers at the FDA have been led by acting officials. The agency said yesterday it will now make them permanent. Michael Davis will be director of the Center for Drug Evaluation and Research, and Karim Mikhail will be director of the Center for Biologics Evaluation and Research.

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Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a needed cuppa stimulation. Our choice today is ginseng peach, a favorite from our pantry. Meanwhile, here is the latest menu of tidbits to help you on your way. We hope you conquer the world and have a wonderful day. And as always, please do stay in touch. We appreciate feedback, tips and criticism. …

In a pair of late-stage trials, an AstraZeneca drug reduced the dangerous flare-ups that worsen COPD, positioning it as a potential new option for the vast number of patients with the debilitating lung condition, STAT explains. According to data released Tuesday, the results also amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months, most dramatically with a heart disease drug. Analysts and the company have projected that the injectable drug could reap billions in annual sales if approved, both in COPD and in other conditions including asthma. 

The Trump administration permanently filled four key leadership roles at the U.S. Food and Drug Administration on Tuesday, after nominating Heidi Overton to lead the agency late last month, STAT says. Three of the officials are serving in an acting capacity, and will take the same roles permanently. They are Michael Davis, a psychiatrist who will be director of the Center for Drug Evaluation and Research; former Merck official Karim Mikhail, who will be director of the Center for Biologics Evaluation and Research; and Bret Koplow, an attorney who has been at the FDA since 2011 and will serve as director of the Center for Tobacco Products. 

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Good morning. I didn’t have space to mention it yesterday, but can you believe Nathan Fielder made an Elizabeth Holmes documentary? Variety called it shameless and fascinating. I may need to see for myself. 

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SAN DIEGO — When Kura Oncology decided to take aim at a protein involved in cell division and signaling, researchers reported a bonus finding: Targeting the protein, menin, didn’t just control the growth of leukemia cells, it also helped control blood sugar levels in animal studies. The biotech on Wednesday announced that it is turning that insight into a new company.

The new firm, Caspian Therapeutics, is launching with $50 million in financing to develop menin inhibitors for diabetes and other cardiometabolic diseases. The initial funding, led by BVF Partners and joined by Eli Lilly and members of Kura’s leadership team, among others, is meant to advance Caspian’s lead small molecule drug through an early-phase clinical trial in diabetes and support the development of a second candidate.

Kura will retain around 50% ownership of Caspian, and Kura CEO Troy Wilson will serve as executive chair of the new biotech’s board. Robert Spencer, who was most recently CEO of Neurommune Therapeutics and has previously led drug discovery programs at Merck, was named Caspian’s head.

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