Making sense of Apple's hypertension alert data

Apple's new smartwatch hypertension alert missed over half of cases in a clinical study of 2,200 people. On the other hand, 7% of people who do not have the condition were notified. All screening tools come with this tradeoff between catching disease in people who have it and not scaring the bejeezus out of people who don't. Apple has over the years consistently erred on the side of minimizing the latter.

In a new story, I take a closer look at the data and how the tradeoff might play out in the case of hypertension, a stubborn and widespread chronic condition affecting 120 million people, many of whom don't know it. I also talk to several cardiologists who believe the feature will still help, even if it's not perfect.

research

AI industry payments to providers lack transparency

If a rep for a traditional medical device company takes your cardiologist out to lunch to fill them in on the benefits of their latest implantable gizmo, the $17.99 turkey club would be disclosed in OpenPayments, a database maintained by the government. It's a critical tool for tracking the influence of industry handouts on health care.

The practice has not caught up to the growing world of artificial intelligence-powered devices, Katie Palmer reports. An analysis of data found that of 850 AI/ML devices authorized by the Food and Drug Administration, fewer than 10% had disclosed data. Some of this is attributable to the nature of AI as a new technology, Katie explains, but experts feel more transparency is warranted.

Read more here

regulation

FDA takes a shot at compounding

A closer look at the Food and Drug Administration's crackdown on pharmaceutical promotions reveals a surprising stat: Most of the letters weren't targeted at drugmakers at all. More than half of the heavily publicized letters were directed at providers and companies offering compounded drugs, Katie reports.

There has been broad concern about telehealth companies marketing compounded versions of popular GLP-1s obesity medications, many of which fail to disclose risks of the drugs. The letters from FDA focus mostly on claims suggesting that compounded drugs are FDA approved when they are not. Is this the sign of a broader crackdown coming?

Health tech news roundup

The Department of Veterans Affairs is launching an ambient documentation pilot with two vendors, deputy undersecretary Carolyn Clancy revealed during a Digital Medicine Society event in Washington D.C. on Monday. Contracts suggest the vendors are Abridge and Knowtex. Though I don't have any intel on this, it's completely astounding to me that the VA did not pick Oracle, which is in the middle of refreshing the department's EHR at a cost that may balloon to $50 billion.
T.Rx Capital raised $77.5 million for its first fund. The firm was launched by former Pear Therapeutics CEO Corey McCann and Michael Langer, the son of biotech veteran Robert Langer. As I reported a few weeks ago, the firm quietly invested in Swing Therapeutics and also backs telehealth company PursueCare, which now markets Pear's the digital addiction treatments.
Capital Rx announced $400 million in funding, including $252 Series F round with the remaining coming from "additional investments into the company's securities." The round was led by Wellington Management and General Catalyst. The company is a rebranding as Judi Health and operates a pharmacy benefit manager solution and a health benefits administrator, and sells enterprise software that can be used by health plans.

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What we're reading

The age of diagnosis: How the over-medicalization of everything makes us sick, anxious, and lost, Derek Thompson
If A.I. Can Diagnose Patients, What Are Doctors For?, The New Yorker