Category: STAT+

  • STAT+: Utah plows ahead with more health AI pilots for prescriptions, women’s health

    STAT+: Utah plows ahead with more health AI pilots for prescriptions, women’s health

    Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.

    Utah regulators on Monday announced a plan to allow an artificial intelligence product to evaluate patients for acne treatment and write new drug prescriptions without prior human review. 

    A startup called Nolla Health will launch an AI-powered service in the state that will assess a patient for mild-to-moderate acne treatment using a structured intake and by analyzing photos of their skin. The product may determine whether one of a list of low-risk drugs is appropriate. In the first stages of the pilot, the decisions of the AI will be reviewed by a licensed clinician who will sign off on prescriptions, but Nolla may eventually be allowed to prescribe drugs without this review. The company last year announced it raised $4.5 million from investors including General Catalyst, and Nolla aspires to direct treatment for a host of conditions using AI.

    The new pilot is part of a significant expansion of a closely watched “AI sandbox” program that allows Utah’s Office of Artificial Intelligence Policy, or OAIP, to waive regulations, including around the practice of medicine, for companies that want to test AI products under state supervision. 

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  • STAT+: NIH awarded all its grant funding, but delayed and opaque decisions stymied researchers

    STAT+: NIH awarded all its grant funding, but delayed and opaque decisions stymied researchers

    A STAT analysis of National Institutes of Health spending shows that in the 2026 fiscal year, which ended Wednesday, the agency continued reducing grant awards involving health disparities, race, and ethnicity but made little progress toward other Trump administration priorities, including disbursing funds more evenly across the country and expanding support for early-career scientists.

    While the agency, like last year, spent its entire external grants budget of roughly $34 billion after a slow start, the manner in which it did so is sowing deep uncertainty among researchers. In a survey and interviews, they said delays in the grant review process are slowing down the pace of their work, and making it difficult for them to propose and conduct the sort of innovative, impactful science that the NIH exists to support.

    Overall, the agency funded around 58,000 projects, a slight drop from the 61,000 awarded during the 2025 fiscal year and well below the roughly 63,700 grants awarded annually in the years before the second Trump administration. Though this number may increase somewhat in the coming weeks because of reporting lags in the NIH grants database, the smaller number of grants potentially resulted from the White House’s push to fully fund more multiyear grants in advance, which meant that there was less funding on hand to issue new awards. 

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  • STAT+: A major insurer on how it may replicate Medicare’s chronic-care experiment

    STAT+: A major insurer on how it may replicate Medicare’s chronic-care experiment

    You’re reading the web edition of STAT’s Health Tech newsletter

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    Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.

    You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday.

    Blue Shield of California is one of 17 major health plans that has committed to adopting payment models inspired by the Medicare Innovation Center’s ACCESS Model.

    The insurer’s chief medical officer Ravi Kavasery told me that it’s still figuring out details of what this will look like, including whether it will adopt CMS payment amounts and what organizations it will work with. He said Blue Shield of California, which serves 6 million members, expect to launch similar models in commercial plans in 2027. 

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    1. Health Tech Correspondent

      Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.

  • STAT+: HHS announces new efforts to speed up, expand clinical trials with AI

    STAT+: HHS announces new efforts to speed up, expand clinical trials with AI

    WASHINGTON — The Department of Health and Human Services announced a set of new initiatives aimed at speeding up clinical trials by incorporating more artificial intelligence and computational models and moving away from sharply delineated trial phases. 

    The centerpiece five-year program, dubbed SURPASS — “Simulation-augmented, Real-time Platform Adaptive Seamless Trials” — will kick off later this fall by accepting “ground-breaking ideas from cross-disciplinary teams in statistics, AI, and clinical trial design, operations, and regulation,” reads a website about the program. 

    HHS is launching the program through the Advanced Research Projects Agency for Health. The initial announcement did not note how much funding was designated for the new initiatives, nor did it provide details on whether participants would be offered more flexibility or resources.  

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  • STAT+: What health tech leaders are talking about in Washington policy circles

    STAT+: What health tech leaders are talking about in Washington policy circles

    You’re reading the web edition of STAT’s AI Prognosis newsletter

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    Brittany Trang, Ph.D., covers AI in health and medicine: Does it actually work? Who benefits, or might be harmed? She writes the weekly AI Prognosis newsletter. Follow her on Threads, Mastodon, and Bluesky. You can reach Brittany on Signal at btrang.01.

    This is the web edition of STAT’s AI Prognosis newsletter, our guide to artificial intelligence in health care and medicine. Sign up to get it delivered in your inbox every Wednesday. 

    It never crossed my mind that there would be a Cookie Monster AI satire piece in the New Yorker, but it does exist and I love it so much. h/t to my colleague Sarah Todd for sharing “Cookie Monster Tries to Meet His A.I. Mandate.”

    News I missed, story tips, comments: [email protected]

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    1. Brittany Trang, Ph.D., covers AI in health and medicine: Does it actually work? Who benefits, or might be harmed? She writes the weekly AI Prognosis newsletter. Follow her on Threads, Mastodon, and Bluesky. You can reach Brittany on Signal at btrang.01.

  • STAT+: Anthropic joins ARPA-H clinical AI moonshot, will hold closed-door health care event

    STAT+: Anthropic joins ARPA-H clinical AI moonshot, will hold closed-door health care event

    You’re reading the web edition of STAT’s health tech newsletter

    Nicolas TUCAT / AFP via Getty Images

    Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.

    You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday.

    Good morning health tech readers!

    Anthropic has been loudly warning that AI might one day lead to catastrophe. And yet, the company is moving aggressively into health care, even as AI regulation is in a state of flux.

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    1. Health Tech Correspondent

      Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.

  • Why MAHA wants to make health data much more accessible

    Why MAHA wants to make health data much more accessible

    WASHINGTON — The Make America Healthy Again movement wants your health data.

    The MAHA Institute, a think tank formed by allies of Robert F. Kennedy Jr. after his appointment as health secretary, held an event on Monday that emphasized the benefits of opening up health data sharing in the United States. In particular, the event highlighted how sharing patients’ health records with federal researchers could benefit the study of the origins of chronic diseases.

    In a speech at the event, Kennedy said that user agreements restrict access to data, giving “institutions that control important health data the power to decide who can study it and what questions they’re allowed to ask, and that creates protectionism in science and it leads to the politicization of science.”

    “A qualified researcher with legitimate hypotheses should not need permission from a gatekeeper to test it, particularly from an industry gatekeeper,” he said in his remarks, which began and ended with a standing ovation.

    The idea of using data from health information exchanges for research is controversial because of privacy concerns.

    Speakers throughout the day brought up the state of Nebraska’s partnership with the federal government. As reported earlier this year by KFF Health News, Nebraska’s health information exchange network, called CyncHealth, is sharing patient data with the federal government to enable studies on vaccines and autism. 

    Kennedy said Monday he wants to aggregate “immunization records, clinical data, laboratory results, pharmacy information, and claims to create a more complete picture of a patient’s health over a long period of time.” That data would come from state health information exchanges, EHRs, laboratories, Medicare, Medicaid, and commercial health data platforms like HealthVerity. 

    “We’re already using all these data to answer some of our most important questions. Too much remains fragmented, vulcanized, difficult to link, and inaccessible to researchers,” he said, citing a desire to aggregate the data and make it available to all researchers.

    While KFF reported Nebraska’s partnership was with the Centers for Disease Control and Prevention and focused on vaccines and autism, MAHA Institute President Mark Gorton said a partnership between Nebraska and the National Institutes of Health “has successfully produced data for the study of chronic disease and serves as a proof of concept for the state-federal hybrid model.” Neither partnership seems to have been publicly announced, though the NIH has already stood up an effort to build Medicare and Medicaid databases within the NIH in an effort to better understand autism.

    Nebraska’s CyncHealth was, until the end of last year, led by Jamie Bland, who became chief data strategist of the MAHA Institute in April.

    At the time of KFF’s reporting, leaders of other state health information exchanges decided not to share information with the government. Using such data for research could run into patient privacy, ethics, and legal issues.

    For example, Jonathan Ketcham, who was chief health care economist at the White House until earlier this year, when he moved back to his economics professorship at Arizona State University, said on Monday that Arizona’s health information exchange data “cannot be used, even de-identified, for researcher grants without individual consent” from providers.

    “The issue is not a technical limitation,” Andrew Kress, CEO and founder of data company HealthVerity, told STAT last year. “It’s really been more around data governance, data ownership, data privacy. Those are the reasons that these things have not worked, more so than you can’t find the right data to do it.” Hospitals, for example, sometimes sell their patients’ de-identified data, or carefully grant access under data use agreements that spell out what purpose the data can be used for. Patients also normally have to consent to their information being used for research.

    Gorton said that the partnership with Nebraska has only worked “because of the investments that Nebraska has made in data governance.” “If this model is going to expand, we will need to see other states make similar investments in the mundane yet crucial function of data governance,” he said.

    The administration has sought to give patients more control over their own data through initiatives like the CMS Health Tech Ecosystem. “Liberate patient records,” said top HHS official Chris Klomp at a STAT event in March. “Let us be very clear on CMS’ official position on this: The record belongs to the patient. It goes everywhere the patient needs to go. We’re serious about this.” 

    But the improved health data infrastructure from these and other Trump administration efforts would help standardize health data, making it ripe for helping answer research questions.

    “We’ve had a lot of public controversy about vaccine safety,” said Donald Rucker, chief strategy officer at 1upHealth and national coordinator for health IT during the first Trump administration. “Many of the [health information exchanges] could answer these questions right now if the immunization registries weren’t actually unlinked to the HIEs,” he said.

    Gorton said at the event that the partnership with Nebraska is a model for state-federal cooperation on health data, and that all 50 states will try different approaches to “growing America’s health data infrastructure.”

    “With these successes, residents will experience health data record portability and a better healthcare experience. Once citizens experience what is possible in one state, other states will rush to follow,” said Gorton. “This pilot is just one small step on a long journey, and we are excited to be part of this adventure.”

  • STAT+: The last ‘breakthrough’ devices to get special treatment from Medicare

    STAT+: The last ‘breakthrough’ devices to get special treatment from Medicare

    Katie covers the impact of health technology on patients, clinicians, and businesses. Her stories explore the price tag of clinical AI, digital health at the FDA, and the boom in direct-to-consumer telehealth. Confidential tips can be sent on Signal at palmer.01.

    In the last month, manufacturers have announced “breakthrough” status from the Food and Drug Administration for a menagerie of devices: triage algorithms for abdominal CT scans, diagnostic panels for urinary tract infections, and thrombectomy robots, to name a few.

    They’re coming in just under the wire: As of October, new breakthrough-designated devices will no longer be eligible for special treatment when it comes to qualifying for extra Medicare payments. These devices, and more than a dozen others, are included in the latest update of STAT’s Breakthrough Device Tracker, which since 2022 has captured nearly 800 devices reported to have FDA breakthrough status. 

    In August, the Centers for Medicare and Medicaid Services finalized the removal of pathways that have made it easier for breakthrough devices to qualify for supplementary Medicare payments for both inpatient and outpatient use. Since 2020, devices that received the designation from the FDA have been able to qualify for new technology add-on payments and transitional pass-through payments without proving they provide a substantial clinical improvement over alternatives, or that they are new. 

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  • STAT+: The rise of the AI-native radiology practice

    STAT+: The rise of the AI-native radiology practice

    Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.

    Good morning health tech readers!

    It’s gonna be a great day. 

    Reach me: [email protected]

    The Medicare RPM backlash

    Medicare’s plan to rein in spending on remote patient monitoring has prompted surprising pushback from insurers. Under these billing codes, Medicare pays health care providers to track and manage the health of their patients using connected devices like blood pressure cuffs.

    As I report in a new story, UnitedHealth Group, CVS Health, and Kaiser Permanente all wrote letters opposing a medicare proposal that such remote-monitoring services be rendered directly by employees of the provider billing for it. Currently much of RPM is delivered by vendors working under the supervision of the billing providers.

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