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Episode 282: Anti-Racism in Medicine Series – Episode 20 – Medical Racism and Indigenous Peoples

The Clinical Problem Solvers

The dehumanization of individuals of color at the margins of society by the healthcare system is not simply a thing of the past, and is certainly a persistent phenomenon. Cindy Gladue, Brian Sinclair, and Joyce Echaquan are three Indigenous individuals who suffered immense harm at the hands of the healthcare system.

Medical 52
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Approaches for Quelling Stigma related to COVID-19

BMJ

A multilayered view of stigmatizing discourses lays the foundation for eliciting a series of suggestions for quelling stigma, to be implemented at the individual, community, and national levels, as suggested by the WHO. Psychological health during the coronavirus disease 2019 pandemic outbreak. Scholars such as Wen et al.

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Episode 148: Antiracism in Medicine Series Episode 4 – Dismantling Race-Based Medicine Part 2: Clinical Perspectives

The Clinical Problem Solvers

Moreover, center patients not only in discussions about individual decision-making but in constructing and drawing meaning from the research. Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions?

Clinic 52
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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions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 The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).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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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance. Medical information about a patient.

Clinic 52
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Three Entities (and a Part Owner and Pharmacist in Charge) Likely Must Swallow A Bitter PIL for Their Role in the Opioid Crisis; But … For Now, The District Court Denies Government’s Motion for Preliminary Injunction

FDA Law

In addition, the Complaint alleges inappropriate dispensing to numerous individuals, multiple DEA recordkeeping violations, improper alteration of prescriptions, and violations Texas law and federal corresponding responsibility obligations required of pharmacists that dispense opioid prescriptions. 21 U.S.C. §