The FDA has said it is developing a plan to regulate medical devices that use generative AI, according to reporting cited in STAT’s Morning Rounds. Rick Abramson, director of the agency’s Digital Health Center of Excellence, told STAT that “the ecosystem is expecting clarity.” He added the agency intends to provide both broad guidance on generative AI and more narrowly tailored guidance on particular generative AI topics of special interest or complexity. The Morning Rounds item links to longer reporting by Mario Aguilar for additional context.
The source did not report specific timelines, draft guidance text, or detailed next steps from the FDA beyond Abramson’s remarks and the agency’s stated intention to develop guidance documents.
STAT noted that less than two weeks after a presidential executive order questioning the childhood immunization schedule, the administration posted a request for information (RFI) seeking public input on a broad range of vaccine-related proposals. The RFI gives the public 30 days to comment and asks whether new categories should be added to the existing vaccines framework, which currently includes universal recommendations, recommendations for certain risk-based groups, and recommendations based on shared clinical decision-making. The newsletter links to additional STAT reporting for readers who want more detail on the HHS request and its implications for vaccine policy.
Morning Rounds summarized a new study finding that soda purchases declined by 12% among Supplemental Nutrition Assistance Program (SNAP) users in 10 states that enacted new restrictions. The source states researchers translated that decline into an average reduction of about 34 fewer 12-ounce cans consumed per person per year. The newsletter also notes there are important caveats, including uncertainty about what products replaced soda in consumers’ purchases, and that experts remain unsure whether such restrictions are the best approach overall. For full study details and analysis, the newsletter points readers to a STAT story by Sarah Todd.
The newsletter highlighted reporting by The Hechinger Report describing a training bottleneck for nurse practitioner (NP) students. To qualify for NP practice, many programs require students to complete at least 500 clinical hours under the supervision of a preceptor. STAT summarized that there are not enough preceptors willing to accept students, leaving some accredited programs doing the minimum and forcing students to seek placements on their own. Preceptors typically are unpaid, and the report notes an increase in students offering payment to obtain clinical hours. The Morning Rounds item links to Colleen Connolly’s reporting on the challenges and consequences of the shortage of clinical mentors for NP trainees.
Morning Rounds featured two First Opinion essays about the everyday practice of medicine. One essay recounts an emergency physician’s decision to shake hands with a patient and family at the start of a shift when a suspected cancer-related emergency presented; the physician wrote that the handshake did not change the diagnosis but helped remind both patient and clinician of the patient’s personhood during a frightening moment. A second essay comes from a retired cardiologist who began volunteering at a community clinic after leaving private practice. In volunteering he found unexpected opportunities for learning and a renewed appreciation of how systemic limitations affect vulnerable patients. The newsletter links to both essays for readers who want the full reflections.
The Morning Rounds roundup curated several external pieces for further reading. Items included a New York Times interactive on vulnerabilities in the bagged-salad supply chain, a Rolling Stone feature about a prominent ketamine advocate, a STAT item about how a Medicaid transgender care rule could set precedent affecting coverage for other drugs, and a Science article on how AI chatbots are becoming skilled at changing people’s minds. The newsletter also includes links to STAT reporting on other prominent stories, such as developments in cancer vaccine research and regulatory actions by the FDA.
Note: all details in this rewrite are drawn from the STAT Morning Rounds item and the linked reporting identified in the source. The source did not provide comprehensive timelines or the full text of any FDA or HHS policy documents; where such specifics were not reported, they are not included here.