| | | |   | Good morning, health tech readers! We’re starting the day with a reminder that the STAT Summit is two weeks away. We’ll be talking with some of the biggest names in biotech, health care, and tech, including Cerebral’s David Mou. Get your ticket here to join them, and find out more about the agenda at statnews.com/summit. And as always, I appreciate your tips and thoughts! | | | On tap this week: FDA takes up pulse oximeters The nation's medical device regulator plans to examine tools used to measure blood oxygen levels this week following revelations over the past few years of biased measurements in people with darker skin tones. Among questions it'll tackle: Should the devices be regulated differently? What does real-world evidence suggest about the efficacy of pulse oximeters among those populations?
Today, an FDA advisory committee made up of pulmonary experts will convene a nine-hour virtual meeting, with the eventual goal of making recommendations for providers and patients about the devices, my colleague Usha Lee McFarling writes. While Washington has only recently taken up the issue, research as early as 2005 found that the devices often overestimate blood oxygen levels in patients with darker skin. It took much longer for that knowledge to become mainstream.
“I am horrified that these deficiencies in the pulse oximeters have been known for decades,” said Uché Blackstock, a Black physician-advocate and founder of antiracist health care consulting firm Advancing Health Equity. “I would like the FDA to explain how they have allowed deficient pulse oximeters to be used across the country on millions of patients.”
Read the full story from Usha. | The latest on breakthrough devices The FDA has updated its count of authorized "breakthrough devices" — the ones deemed "more effective" for treatment or diagnosis than the standard of care — to 56. And as of the end of September, there are now 729 devices that have earned designation from the program. (As my colleagues Katie Palmer and Mario Aguilar have reported, the designation mostly benefits companies by netting them expedited review and more opportunities to interact with regulators, but there's little evidence to suggest it improves patient outcomes.)
Still, the program appears to be progressing. There were 54 such authorized devices as of August. To keep up with the latest developments with the hundreds of products making their way through the program, check out our Breakthrough Device Tracker.
The agency also published a draft policy on ways the program could shrink health disparities, including potential updates to the breakthrough device guidance that lay out how it could accelerate devices used to treat diseases that disproportionately affect different populations. Comments are due Dec. 20. | Google's stealthy health tech acquisition The search giant confirmed for us this week that it has acquired Sound Life Sciences, a startup building an app to detect respiratory problems, but declined to share more details. The company spun out of the University of Washington and secured FDA clearance for its app last year, according to Geekwire, which first reported the news. | Partnering to advance health equity and diversify the bioinformatics workforce Data show only 7.1% of the employed biomedical and life sciences workforce is Black, Hispanic or Native American. The United Health Foundation is partnering with Harris-Stowe State University, a historically Black college and university in St. Louis, to help change that. Their partnership has created a new bioinformatics training program to increase awareness of the field among high school and college students and further diversify the life sciences workforce. Learn more about our commitment to advancing health equity and diversifying the health tech workforce. | Prepping for the next pandemic The White House's Office of Science and Technology Policy and the federal government's health IT regulator are partnering on an effort to improve the way data is captured for clinical trials — a project that could help the country more quickly identify emerging threats and tools to combat them, the agencies wrote this week. "Currently, researchers must analyze different datasets, developed under different research protocols, stored in different formats, in data repositories that are often not accessible to all participants. This delays the development of evidence," they wrote.
The agencies also put out a request for thoughts on how existing tech could improve clinical research, and what tools still need to be developed. The comment period ends Dec. 27. | Getting data into patients' hands What could giving patients control of their own health data again look like? My colleague Jayne Williamson-Lee reports on some ideas shared at a recent STAT event. - “Every time you get care, the new records would be deposited into your account and you would be the steward of this record of all your care,” said William Yasnoff, president of the Health Record Banking Alliance. “You could decide who to make it available to.”
- Brian Martin, the health and life sciences principal of MITRE, suggested that patients loan health records to clinicians without necessarily allowing them to share the data elsewhere.
- “It has to come from patients acting as consumers and directors of their information because we’re not seeing it through basic regulation,” said Lisa Bari, chief executive officer of Civitas Networks for Health.
| Making hospital websites more accessible "Digital front doors" — entry points for new patients that might include hospital websites — aren't accessible to patients with disabilities, Amanda Krupa, Jill B. Roark and Kirsten Barrett write in an opinion piece for STAT. And an analysis of top hospitals last year found that less than 5% of their websites complied with the World Wide Web Consortium's accessibility guidelines. Among the issues: websites are only navigable by mouse or by keyboard, and patient portals are often complicated and confusing. The authors also offered some tips for hospitals committed to improving their sites, including hiring digital accessibility employees. | What we're reading - Fewer patients are seeking telehealth and ER visits, Fierce Healthcare
- FTC says homework app Chegg may have exposed sensitive data about students’ sexual orientation and religion, New York Times
- States are looking to telehealth as concerns about student mental health rise, Education Week
| | | Thanks for reading! More on Thursday,  | |
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