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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions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

In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.

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

FDA Law Blog

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature).

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

GeriPal

A 2020 RCT of coaching for primary care physicians shows that coaching improves burnout well-being during the intervention and has a sustained duration at 6 months of follow up. We’re doing a lot of interactive relationship building. This is the first RCT that was available for coaching in physicians. [link] 5. Greg: Yeah.

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Episode 275: Anti-Racism in Medicine Series – Episode 19 – Reframing the Opioid Epidemic: Anti-Racist Praxis, Racial Health Inequities, and Harm Reduction

The Clinical Problem Solvers

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. The foundational literature in this area has furthered stigma and bias, especially towards Black birthing persons.

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The Nature of Suffering: BJ Miller and Naomi Saks

GeriPal

Panelists BJ Miller and Naomi Saks have no relationships to disclose. ” So there’s this element too, of what’s suffering in relationship to others, and can we compare? It’s the relationships to the world. It really depends on the person, their relationship, what’s going on.”

IT 137
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RCT of Palliative Care for Heart Failure and Lung Disease: David Bekelman and Lyndsay DeGroot

GeriPal

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. Panelists David Bekelman, Lyndsay DeGroot, and Diah Martina have no relationships to disclose. Or telephone calls, I should say.

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Storytelling in Medicine: A Podcast with Liz Salmi, Anne Kelly, and Preeti Malani

GeriPal

So my piece is really reflections around caring for my mom who died toward the beginning of the pandemic in 2020, and the influence of my work in hospice and palliative care and the perspective that I brought to my care for her in that time. It feels special to me. This was in May of 2020. But it’s May 2020.

IT 96