AI is rapidly becoming a standard part of the healthcare industry, from ambient scribes that help healthcare workers chart patient data to algorithms that can predict disease.

Yet the regulatory environment surrounding health AI is still the Wild West.

“The vast majority of medical AI is never reviewed by a federal regulator—and probably no state regulator,” I. Glenn Cohen, a law professor and faculty director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard University, told the Harvard Gazette in January.

Regulating health AI is particularly challenging because the technology evolves much faster than the healthcare industry is used to developing regulations, experts told Healthcare Brew. However, 83% of 277 polled healthcare workers say AI needs more regulation, according to a 2025 Morning Brew Inc. survey.

States and health agencies are piecemealing guidelines.—MA

The FDA is putting its foot down on compounded GLP-1 drugs—well, kind of.

The agency has sent “thousands” of letters warning telehealth and pharmaceutical companies about misleading advertising since September, per a March 3 release.

This “crackdown” includes two rounds of warning letters to telehealth firms that sell compounded GLP-1s. The letters warn that advertisements can’t compare a compounded drug to an FDA-approved drug or say a compound has the same active ingredient as an FDA-approved drug. Telehealth companies also can’t imply they are the ones compounding the drug when they’re buying it from another compounder.

More than misleading advertising, though, there’s a potentially bigger concern at hand: Some online sellers might not be legal compounders at all but counterfeit producers using manufacturers that aren’t making them in a sterile manner.

This threatens the reputation of compounding that is done safely and by the book, Todd Harrison, partner and co-chair of the FDA Group at law firm Venable, told us.

Here’s why compounds have drawn criticism lately.—CC

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Trust in health insurers is sinking and healthcare costs are soaring. Amid this turmoil, startups are trying to provide alternative models.

These companies’ offerings range from plans without provider networks to models built around individual coverage health reimbursement arrangements (ICHRAs) where employers give employees cash to buy their own individual insurance plans.

Then you have Austin, Texas-based health services startup Curative.

Curative originally rose to fame as a Covid-19 testing provider but pivoted in fall 2022 to provide health insurance for self-funded employers. Its pitch? No copays, deductibles, or coinsurance for in-network visits as long as members get a baseline preventative care visit within 120 days, which 98% do, CEO Fred Turner told Healthcare Brew.

The provider raised $150 million in December, bringing its valuation to nearly $1.3 billion. Turner talked to Healthcare Brew about how the plan works for its 165,000+ members.

See the full conversation here.—CC