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

FDA Law

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products.

Medical 119
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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. Why then do we persist with the “is it medical/organic or psych” question? Government.

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Telemedicine and the Prescribing of Controlled Substances After the End of The Covid-19 Pandemic Emergency: DEA Announces Two Significant Proposed Rules: Read the Summary Below, But Learn All the Details and More at HPM’s Webinar on March 23, 2023 (Details Forthcoming….)

FDA Law

The Ryan Haight Act was enacted to address the legal “grey area” in which prescribers and pharmacies operated via the creation of two new statutory requirements: 1) the at least one “in-person” medical evaluation requirement for prescribing practitioners, 21 U.S.C. § That emergency declaration is set to expire on May 11, 2023.

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Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law

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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Sweet! A Metabolic Disorders focused podcast episode

PEMBlog

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. Updated 2023 Jul 17]. Inborn errors of metabolism in infancy: a guide to diagnosis. Brad’s not a pediatric medical geneticist. References Jeanmonod R, Asuka E, Jeanmonod D.

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What are the signs of an eating disorder?

Vida Family Medicine

This week, February 27-March 5, 2023, marks National Eating Disorder Awareness Week. 30% of people who seek medical care for weight loss show signs of binge eating disorder. If you or someone you love is suffering, I hope that this information will help you find the resources you need to find recovery.