| | | |   | Happy Holidays everyone! Casey Ross here, filling in for Mohana, who is half-way around the world visiting with family this week. It’s a week to hunker down and take stock. But we also want to flag several newsy items we’ll be following into the new year, including some deep-dive reporting into equity issues surrounding pulse oximeters, FDA approvals of AI tools, and how Medicare is responding to a ransomware attack that exposed beneficiaries’ personal data. | | | FDA continues to green light AI tools, but are hospitals ready to use them? The FDA is approving medical AI tools at a rapid clip. The latest count puts the total number of cleared devices to 521, a 65 % increase over the past two years, according to one recent analysis. About three-quarters of those products are designed for use in radiology, including to expedite treatment of strokes and flag lesions suspicious for cancer. But how many hospitals are actually using these products? How long did it take to validate them locally? And are they improving outcomes for patients? Those are the harder questions STAT will be trying to answer in 2023 as part of an ongoing series on the use of AI in medicine. Last week we caught up with Curt Langlotz, director of the Center for Artificial Intelligence and Imaging at Stanford University, to get the lay of the land. Langlotz said he’s noticed that several developers of AI tools in radiology are beginning to provide tools to help hospitals validate them on their own populations, an acknowledgement that such support is necessary to gain adoptions. He said Stanford is developing a multi-step protocol for testing and implementing AI tools in clinical practice. “But I worry that there are many health care organizations that don’t have the resources to put in place that kind of rigorous process,” Langlotz said. | Why suicide risk tools struggle in the clinic Predictive models to flag patients with an increased suicide risk often hit performance targets in the lab. But implementing them in live care settings is another story. A new study at Kaiser Permanente in Washington found that putting a flag in the electronic health record to identify at-risk patients failed to prompt additional evaluation as intended. Subsequent interviews with patients and clinicians surfaced a number of concerns, including doubts about the accuracy of the flag, the lack of a clear plan for follow-up care, and worries that patients would be coerced into getting additional services, regardless of true needs. The authors emphasized the need to clarify for front-line caregivers that the flag is meant to augment, not replace, clinical judgments. | Inside the lab trying to fix pulse oximeters The FDA has turned to a small lab in San Francisco to sort out concerns that commonly-used pulse oximeters do not work as well for people with darker skin. STAT’s Usha McFarling recently spent a day monitoring testing activities in the Hypoxia Lab at the University of California, San Francisco, where researchers are carrying on the work of John Severinghaus, a physicist turned anesthesiologist who was among the first to raise concerns about the accuracy of the devices in darker-skinned patients. Her story is a close-up look at the process to get to clear answers and to point the way toward solutions for a troubled, $2 billion industry. Read her full story here. | When hard data points to soft answers: Drawing a new roadmap toward health equity Advocating for greater health equity has become the work of every self-respecting healthcare institution. Now, asks one scientist and health equity leader: What exactly is that work? What steps can we take toward meaningful change? The answers, she writes, is in the data. Her team is mining healthcare data in smart ways to pinpoint specific, actionable gaps – and, she suggests, the entire medtech industry is positioned to help. Read more. | A data breach in your stocking The Centers for Medicare and Medicaid Services is sending cards to beneficiaries this week, but this is one holiday mailing list you don’t want to be on. The agency is scrambling to respond to a ransomware attack at a government subcontractor — Healthcare Management Solutions — that exposed personal information on about 254,000 beneficiaries, including social security numbers, phone numbers, and bank account information. While it is still assessing the extent of the breach, CMS is sending letters to affected parties as well as replacement Medicare cards with new identification numbers. The agency said it is not aware of any fraud or improper use of the information resulting from the breach, but the incident serves as another reminder of the continued vulnerability of health data networks heading into the new year. | Industry news & notes - Headspace Health has laid off about 50 employees, about 4% of its workforce, Bloomberg reported.The company said the reduction is meant to keep it sustainable during uncertain economic waters. Those waters have been tough on digital mental health companies lately, with job cuts hitting several companies. Last year Headspace merged with the digital mental health provider Ginger in a $3 billion deal that tripled its head count.
- Fujifilm Corp. is acquiring Inspirata, a Florida-based digital pathology business. The deal is meant to bolster Fuji’s Synapse imaging product to combine images and patient data in electronic health records to improve services for oncology patients. The advancing digitization of pathology slides is supporting an array of new data products and services, including artificial intelligence tools to support diagnosis and decision-making.
- Synchron, a company working on a brain computer interface to help paralyzed patients, raised $75 million in a funding round led by ARCH Venture Partners. Elon Musk’s Neuralink tends to attract a lot of press, but Synchron has attracted big name backers, including Jeff Bezos and Bill Gates. Synchron plans to use the funds to start a pivotal clinical trial.
| Personnel file - LeanTaas, a company using AI to improve infusion center operations, hired Mark Fidow to serve as its chief technology officer. Fidow previously worked at Change Healthcare.
- The managed care organization AmeriHealth Caritas has tapped Neil Gomes to be its chief digital officer. Gomes has served in similar roles at providers such as CommonSpirit and Jefferson Health.
| What we're reading - The failed promise of online mental health treatment, Wall Street Journal
- Want to email your doctor? You may be charged for that, Associated Press
- We finally have new drugs for sickle cell disease. Why are so few patients taking them?, STAT
| | | Thanks for reading! More on Thursday,  | |
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