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Using technology to reclaim our time

Today's Hospitalist

Yet this expansion has come with a significant administrative burden, particularly that of clinical documentation. This isn’t about replacing your clinical judgment. Ambient dictation, or ambient clinical documentation, represents a paradigm shift. This isn’t about replacing your clinical judgment.

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Episode 262: Anti-Racism in Medicine Series – Episode 18 – Remedying Health Inequities Driven by the Carceral System

The Clinical Problem Solvers

Our guests remind us to think critically about our role in the carceral system and in imposing systems of control and punishment within clinical settings. Heard-Garris draws parallels between the culture within the carceral system and that within hospitals and clinics.

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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

The eagerly anticipated guidance, Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (i.e., We are heartened to see that this latest guidance reflects many of the advances we observed in practice since 2019.

IT 64
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Improving Patient Communication

CDOCS

Patients depend on our clinical knowledge as well as our recommendations and relationships with our specialist partners.</span></span></p> Educate yourself, teams, and offices you work with so that you are able to communicate the clinical value in an honest, believable way,&rdquo; says Dr. Nelson.</span></span></p>

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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions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 The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

FDA Law

Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes. It is well out of bounds for FDA to regulate them as if they were a determinant of long term clinical outcomes. Gone are the days of tool type indications for this type of device. 21 U.S.C. §

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Critics Suggest FDA Approving Aduhelm Will Erode the “Public Trust”: What About Patients’ Trust?

FDA Law

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.