health tech
FDA relaxes oversight of wearables
ANDREW CABALLERO-REYNOLDS/AFP via Getty Images
The FDA will ease regulation of digital health products, the agency announced yesterday, as part of the Trump administration's business-friendly AI strategy. The softened approach applies to both clinical decision support software and consumer devices that the agency calls "low risk products that promote a healthy lifestyle." One of the agency's priorities is to foster an environment that's good for investors, Commissioner Marty Makary said, so regulation needs to move "at Silicon Valley speed."
The FDA announced the changes without giving the public a chance to comment, but there's been intense negotiation and debate internally, a STAT team reports. Three agency officials, who were not authorized to speak publicly, said that leaders in Makary's office have been pushing for rapid, broad digital health deregulation. Medical device center employees have been trying to temper those impulses. Read my colleagues' analysis of the news.
public health
Latest data on annual pediatric flu toll
Nine children have suffered flu-related deaths so far this season, according to the latest FluView data from the CDC, which is reported weekly. It's hard to say how that compares to last year, as reports continue to come in, but pediatric flu hospitalizations are surpassing last year's numbers, per the report. In Boston, two children under two have died after having the flu this year, marking the first reported pediatric flu deaths in the city since 2013.
The data, released Monday, also included one late report of a pediatric death from last season, bringing the total to 289 deaths. That's the highest number since the CDC started recording pediatric flu deaths in the 2004-2005 season, STAT's Helen Branswell told me. It's even higher (by one) than the 2009 H1N1 pandemic.
For the latest information on this year's flu, I'll once again point you to Helen's story from yesterday.
chronic disease
Young adults with IBD struggle for coverage
Young adults with inflammatory bowel disease particularly struggle to access health care and to get their IBD care covered by insurance compared to other age groups, according to a survey of more than 1,700 people with the condition and caregivers for kids who have it. The data, published yesterday by the Crohn's & Colitis Foundation, likely reflects the problems that young adults with a variety of chronic conditions face when transitioning from pediatric to adult care.
People between 18 and 25 years old were significantly more likely to be subjected to step therapy mandates — meaning they were required to try a lower-cost medication before their insurance would cover a more expensive treatment. And more than a third of young adults expressed low confidence in knowing what to ask insurers when they experience coverage issues, compared to 25% of caregivers. Almost one-fifth of young adults reported taking on extra work to cover health care or insurance costs for IBD, a significantly higher rate than the 11% of both adults and caregivers who reported the same.
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