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The gray area of telehealths weight loss ads

Companies includingRoandCalibratehave capitalized on new weight loss drugs by launching telehealth services dedicated to prescribingWegovyandOzempic. In Ros case, the company has launched with prominent subway ads that feature close-up pictures of people injecting themselves and simple pitches like Wegovy to lose weight.

Experts say that the promotions run into a regulatory gray area of direct-to-consumer drug advertising. There are long-standing boundaries for drugmakers who must list side effects and risks,but less clarity for telehealth companies that have cropped up to prescribe their medicines.TheFDAtoldSTATit may have oversight over prescription drug ads if a telehealth company ships medicines which Ro said it doesnt but in other situations, doesnt have regulatory authority.

Enforcement advertising regulations, FDA, FTC simply have not caught up with this new world, and we think its a wild one,Thomas MooreofJohns Hopkinstold Mohana.Read her full story here.

Boston Scientific is latest to tackle obesity

The obesity treatment landscape has evolved tremendously over the past few years, particularly with the emergence ofweight loss drugs like Wegovy. Device makers want in on the conversation starting withBostonScientific, which yesterday closed on its deal to acquireApolloEndosurgery.

Apollo specializes in minimally invasive surgeries in the GI tract, selling two flagship weight loss devices. Boston Scientifics core focus is also minimally invasive surgery, but Apollo represents its first foray into bariatric surgery. Weve been calling it a measured entry into the bariatric space,Brian Dunkin, who oversees Boston Scientifics endoscopy division,told me.We want to get our experience using a technology that has clinical data to support its use.

I sat down withDunkinto learn more about the acquisition, and whether theres room for device-based treatments in the obesity treatment whirlwind.Read more here.

Biden cracks down on using algorithms to deny care

The Biden administrationis moving forward with proposals that would crack down onMedicare Advantageinsurers that deny care inappropriately including if companies use algorithms to turn down coverage.

A recentSTATinvestigationfoundMedicare Advantagecompanies increasingly have used unregulated algorithms to determine when they can cut off patients care. Many of those people are in nursing homes, rehab facilities, and other post-acute settings, and judges often rule that the algorithms run afoul of Medicare law and should have covered the care.

Starting next year, Medicare Advantage plans cannot reject coverage of procedures, prescription drugs, tests, or supplies that would otherwise be covered if someone were enrolled in traditional Medicare, according tofinal regulationsissued Wednesday. Medicare Advantage, the privatized version of the original Medicare program, coversmore than 31 millionolder adults and people with disabilities in insurance plans. The federal government also specifically called out the use of algorithms being used to reject care.

Snoo, the smart bassinet, gets FDA clearance

TheFood and Drug Administrationhas grantedHappiest Babya clearanceit can use to market its $1,700Snoosmart bassinet more aggressively to parents anxious about sudden infant deaths. It wasted no time taking advantage of the clearance, billboarding the FDA De Novo approval onits website and blasting parents with an email alerttouting the FDAs approval of its ability to keep babies safely sleeping on their backs.

Read closely, the marketing authorization is somewhat unusual. Happiest Baby has pioneered anew FDA device classificationcalled an infant supine sleep system. Babies are locked into the bassinet using a special swaddle that physically prevents them from rolling over. As the FDA notes, babies who sleep on their backs are at lower risk of sudden infant death syndrome or sudden unexpected infant death.

But though the device has shown in asingle-arm observational studyto promote a recommended safe sleep practice, Happiest Babyconcedesin the press release that Snoo has not directly demonstrated a reduction in the incidence of SIDS/SUID. Of 3.6 million births in 2020, there were 3,356 reports of SUID in 2020,according to the CDC. Its likely that the tragic outcome is so rare that a study to detect Snoos impact would need to be prohibitively large.

Alcohol recovery startup Monument leaks patient data

Monument, an online alcohol counseling startup, has been sharing patient data with advertisers for years. In adata breach notification issued last week, the company confirmed it used tracking technology that scooped up personal data and shared it with bigtechcompanies likeGoogleandFacebook. This personal information may have included names, birthdates, and appointment-related information.

Monument is one of dozens of telehealth startups that have shared sensitivehealthdata with bigtechcompanies,STATand The Markup found in December. Monument is also one of the companiescalled out in Februaryby a bipartisan group of senators who citedSTATand The Markups investigation as evidence for Monuments shady data practices. This data is extremely personal, and it can be used to target advertisements for services that may be unnecessary or potentially harmful physically, psychologically, or emotionally, the senators wrote.

Former Magellan execs allegedly sold faulty lead tests

Federal prosecutors have charged three former executives atMagellanDiagnosticswith selling defective lead testing machines that generated inaccurate results for tens of thousands of children nationwide, as well as clients of at least one international relief organization.

Prosecutors said the executives knew the devices including MagellansLeadclear IIproduct, which was used for half of all tests conducted in the United States in 2017 had a manufacturing flaw that generated false negatives, giving parents the mistaken impression their children were safe.We allege that these defendants deceived customers and the FDA about the reliability ofmedicaltests that detected lead levels. By doing so, we assert that they endangered thehealthand lives of incredibly vulnerable victims, Rollins said in a statement. According to the CDC, there is no safe level of lead in the blood.Read more here.

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STAT Health Tech: A crackdown on AI to deny care - STAT

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