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AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law Blog

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

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Agitation Podcast Series Episode 1: Differentiating organic versus psychiatric causes of agitation and altered mental status

PEMBlog

Most children who present to Pediatric Emergency Departments these days with mental health concerns – including agitation – have a known psychiatric problem or diagnosis. Furthermore, the connection between physical and functional symptoms is inextricably linked in many patients.

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Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law Blog

The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

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Should you have a coach? Greg Pawlson, Beth Griffiths, & Vicky Tang

GeriPal

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). We make a diagnosis. AlexSmithMD 1. It’s so different from therapy. Beth: Yeah.

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Guiding an Improved Dementia Experience (GUIDE) Model: A Podcast with Malaz Boustani and Diane Ty

GeriPal

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Care Ecosystem.

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Hospital-at-Home: Bruce Leff and Tacara Soones

GeriPal

We talk with Bruce Leff and Tacara Soones about the hospital-at-home movement, which has been shown to reduce costs, improve outcomes and improve the patient experience. JAGS Hospital-at-Home Interventions vs In-Hospital Stay for Patients With Chronic Disease Who Present to the Emergency Department: A Systematic Review and Meta-analysis.

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