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Film Representation and Stigma of Individuals with Intellectual Disabilities [Social determinants and vulnerable populations]

Annals of Family Medicine

Context: Media representation of individuals with disabilities shapes public perception and understanding of disability. Individuals with intellectual disability (ID) often experience negative stigma from society. Results: Analyzed 16 films produced between 1939 and 2019. Sixteen films appeared on both lists.

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Association between obstructive sleep apnea and quality of life in Korean middle-aged people: a cross-sectional study.

Physician's Weekly

The aim of this study was to investigate the relationship between OSA risk and quality of life among middle-aged and older adults in South Korea. This study utilized data from the 8th Korea National Health and Nutrition Examination Survey for 2019 and 2021 to investigate the relationship between OSA and health-related quality of life (HRQoL).

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Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

FDA Law

However, the two previous FDA guidance documents, released in May 1998 ( Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products , available here ) and December 2019 ( Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products , available here ), differ from the new guidance.

IT 64
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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law

See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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District Court Interprets EKRA

FDA Law

A “health care benefit program” is defined as “any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.”

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

GeriPal

The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life. Summary Transcript Summary Coaching is in. When I was a junior faculty, coaching wasn’t a thing. We address: What is coaching? How does it differ from therapy? link] Transcript Eric: Welcome to the GeriPal podcast. Indeed, matey.

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District Court Interprets EKRA

FDA Law

A “health care benefit program” is defined as “any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.”