| |   | | | Jury convicts Holmes of fraud After a monthslong trial and seven days of deliberation, a federal jury convicted Theranos CEO Elizabeth Holmes yesterday of defrauding investors, capping the stunning downfall of a company and founder that promised to revolutionize medicine. The jury convicted Holmes on four counts of lying to investors while fundraising for the blood-testing startup, but cleared her on four counts of defrauding patients. The jurors didn't unanimously agree on three counts of defrauding individual investors, which opens the possibility of Holmes being tried again for those charges. The court hasn't sentenced a scheduled a sentencing hearing yet for Holmes, but each of the four wire fraud charges carries a maximum prison sentence of 20 years, which likely would be served concurrently. Our colleague Damian Garde has more. | The implications of 'information loss' for medics Emergency medics are being cut out of health care’s vast information loop. Often the first responders to medical crises, they seldom get timely access to electronic health records that may inform their treatment decisions and help save lives. The information black out is not only bad for patients, but also leaves paramedics and emergency medical technicians with no way of knowing how their patients fare, rendering them unable to gain closure on cases that may deeply affect them. STAT contributor Marion Renault has the full story. | FDA directs use of digital tools in clinical trials The FDA has published a new guidance on the use of digital health tools to gather data for clinical trials. The document sets forth recommendations for validating the performance of digital products and their suitability for a given trial, as well as what information should be disclosed to trial participants. Importantly, the guidance zeroes in on the need to clearly outline how data collected from participants will be analyzed and used, and to make sure participants understand the privacy risks. It also lays out details that should be addressed in obtaining informed consent, such as an explanation of who will have access to data collected during and after the trial. | STAT@JPM: Will 2022 bring biotech renewal? Come explore what’s happening in biotech, virtually, with STAT’s Adam Feuerstein. On Jan. 11, he’ll convene experts and reporters to discuss the need-to-know news from biotech’s biggest confab, and ask what it all means for the year ahead. | What's next for digital therapeutics in 2022? Digital therapeutics companies had a banner year in 2021, with public listings, hundreds of millions in new funding, and notable clearances from the FDA. But the software solutions remain on the fringes of care, even as other forms of virtual care have surged during the pandemic. What will it take for that to change? In many cases, digital therapeutics have yet to prove that they provide meaningful benefit in real-world settings — which will require systems to get the tools into the right patients’ hands, and developers to come up with smart approaches to keep users engaged. And prescription digital therapeutics have a ways to go to lock down reliable reimbursement. Mario has the full story. | Going viral at the great tech event in the desert The Consumer Technology Association is plowing ahead with CES in Las Vegas this week, despite concerns about the rapidly spreading Omicron variant. Some companies and media organizations, including STAT, canceled their plans to attend in person. The annual showcase of the latest gadgets and gizmos will require attendees to show proof of vaccination, will provide free rapid tests from keynote presenter Abbott, and will close the show a day early. (Getting sick at CES is an annual tradition even without Covid-19.) Digital health is one of the key themes on the bill, with roughly a dozen official events onon digital therapeutics, bias in medical artificial intelligence, and more. On the show floor and in suites and meeting rooms up and down the strip, expect to hear about lots of devices designed to track cardiovascular and metabolic health as companies seek to seize slices of the growing market for personal health monitoring. As always, we’ll be watching for evidence that the tech can actually help people achieve better health outcomes. | Aetion acquires an AI pioneer -
The real-world evidence company Aetion has acquired Replica Analytics, a company whose technology uses AI to generate synthetic, privacy protected copies of patient data. The deal is designed to help expand and strengthen Aetion’s offerings, giving potential customers greater assurances that patient privacy will not be compromised. - Scientists at the University of Cincinnati are building drones to support telehealth visits and deliver supplies. The drones are designed to maneuver through rooms while carrying a smartphone or tablet and medical kits. The product is still in testing.
- Curi Bio, which uses AI to support drug development, raised $10 million in a Series A round that included investments from Dynmak Capital and DS Asset Management. The company plans to use the money to develop a platform to generate and analyze 3D engineered human muscle tissues.
| Does race belong in cardiovascular risk calculators? In recent years, several clinical algorithms that have been challenged over their use of race — a social construct, not a biological one — and some calculators, like one to determine the risk of a C-section and a widely-used kidney test, have been updated to remove racial variables. A new analysis published in the Lancet Digital Health shows that another race-adjusted risk calculator, for atherosclerotic cardiovascular disease, produces significantly different, “biologically implausible” results for Black and white patients with otherwise identical risk profiles. Despite the fact that the cardiovascular calculator doesn’t explicitly disadvantage a historically marginalized group — Black patients received higher risk scores, potentially enabling easier access to therapies such as statins — the authors argue that “race should be replaced with the causal factors that it represents,” which would ultimately lead to more meaningful tools. | Blind spots for blitzscaling mental health startups With mental health tech startups pulling in more than $3 billion in investment in 2021, many companies are now faced with the difficult task of meeting venture capitalists’ expectations for returns. But as Tarun Galagali and Leonard Schlesinger, a student and professor at Harvard Business School, argue in STAT, fast-growing companies in behavioral health face a trifecta of blind spots that make their jobs much harder. As demand for licensed mental health providers increases, startups are facing an ongoing shortage of therapists — and even if they can employ them, the margins expected by many investors mean companies can’t always afford to pay them competitively. Read more in their First Opinion. | | | Thanks for reading! More Thursday,  | | | | Have a news tip or comment? Email Us | |
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