| | | |   | Good morning, Mario here with a story about a big, ambitious effort to improve health care artificial intelligence, plus some updates on Apple, digital therapeutics, and more. | | | Pushing AI to fulfill the hype AI, we’ve been told, is the next big thing in medicine, but many of the promising experiments we read about in academic journals rarely make it to the bedside and when they do, they very often fall short. A newly formed Coalition for Health AI aims to change that. The group of academic hospitals, government agencies, and private companies called for new independent testing bodies and a national registry of clinical algorithms so that experts might better assess and improve technologies.The coalition’s proclamations are nothing more than high-minded talk at this point, but given that its blueprint was written with input from Microsoft, Google, MITRE Corp, Stanford, Duke, and Johns Hopkins, maybe it will turn enough heads — and get enough buy-in — to have an impact. Read Casey’s story on the effort here. | Apple marks important win at patent board Here’s the latest in the ongoing battle between Apple and medical device company AliveCor that I wrote about earlier this week: The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board on Tuesday found that three heart monitoring patents at the core of the dispute between the companies are invalid. AliveCor has alleged for years that Apple copied some of its technologies and sold them to millions of people in the Apple Watch. With the patents now invalidated, AliveCor doesn’t have much legal ground to stand on with its complaints. AliveCor has said it will appeal the decision. More from me on what this means here. | Do digital therapeutics need their own evidence standards? 
Should physicians, payers and others evaluating software-based medical treatments think about them like drugs or medical devices? According to a new report from the Digital Therapeutics Alliance, an industry advocacy organization, the answer is neither. Because these therapeutics for psychiatric and other conditions differ from existing treatments in how they’re developed, how they’re used, what risks they pose to patients, and more, decision makers “should adopt a fit-for-purpose approach” to evaluation, the report argues. The authors stop short of spelling out standard and instead set forth a “foundational set of expectations.”
For example, the table above provides recommendations for thinking about the quality of clinical evidence supporting a product's benefits. While it may not be the final word on evidence that many have been waiting for, it’s a start.
| Unlike external control arms, RCTs with digital twins generate regulatory-suitable evidence While both prognostic digital twins and external control arms leverage external data to reduce trial sizes, only randomized controlled trials with digital twins control for bias and generate regulatory-suitable evidence across different disease indications. Read the article to learn how each approach incorporates external data and yields statistical differences with downstream regulatory implications. | FDA dishes on its virtual reality work In its latest transparency effort, the FDA’s Digital Health Center of Excellence this week published a list of 39 augmented reality and virtual reality devices it has cleared. The list contains a lot of products we’ve covered around here, like AppliedVR’s EaseVRx treatment for chronic lower back pain and Luminopia’s treatment for childhood lazy eye. But what struck me is just how many of the disclosed products I hadn’t heard about. The FDA has cleared eight AR/VR devices so far this year. | Personnel file -
Hims & Hers Health appointed Scott Knoer as chief pharmacy & innovation officer. Previously he was executive vice president and CEO of the American Pharmacists Association and chief pharmacy officer at Cleveland Clinic. -
Surgical training platform Osso VR appointed Stacie Frederick as chief technology officer and Heather Gervais as chief revenue officer. Frederick previously worked at Collective Health, Yahoo, and Amazon. Gervais worked at Everly Health and Athenahealth. - Health care data platform 1upHealth appointed Pieter De Leenheer as CTO. Previously he founded software company Collibra.
| What we're reading -
CMS proposes rule to expand access to health information and improve the prior authorization process, CMS -
Reproducibility of deep learning in digital pathology whole slide image analysis, PLOS Digital Health -
They worked in big tech and lived the American dream. now they might be forced to leave the country, BuzzFeed News - Could Vertex’s cystic fibrosis medicines hold a clue to treating deadly pneumonia?, STAT
| | | Thanks for reading! More next week,  | |
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