FDA Law

NOVEMBER 9, 2021

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. By Adrienne R. It does not appear that any changes to the eSTAR template are proposed at this time.

Electronics 40

Electronics Physicals Provider Utilities 40

FDA Law

FEBRUARY 28, 2023

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. By Adrienne R. The guidance describes twenty sections to be included in a Traditional or Abbreviated 510(k). Learnings on how eSTAR works Starting Too Early.

Provider 52

Provider Electronics IT Complication 52

GeriPal

NOVEMBER 2, 2023

Alex: Today we’re delighted to welcome Jerry Gurwitz, who is a geriatrician and professor of medicine at the UMass Chan Medical School. I’ve seen this question come up a lot since finishing fellowship nearly two decades ago. Eric: And Alex, who do we have with us today? Jerry, welcome to GeriPal. Jerry: Great to be here.

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Board-Certified IT Community Medical Student 91

GeriPal

NOVEMBER 17, 2022

We additionally firmly establish that the song How to Save a Life by the Fray was a product of the aughts (2005, to be exact), not the 90’s ): Enjoy! AlexSmithMD (still on Twitter at present). Transcript. Eric: Welcome to the GeriPal podcast. This is Eric Widera. Alex: This is Alex Smith. And which journal again? Eric: JAMA Network Open.

Community 97

Community IT Mental Health Medical 97

FDA Law

NOVEMBER 22, 2021

Over the past 16 years, there have been numerous advances in healthcare technology, particularly with respect to the use of software in and as a medical device. Summaries of the impact of the 21st Century Cures Acts on software and the definition of a medical device are available here, here, here, and here. corrections and removals).

Management 52

Management Medical Provider IT 52

The Clinical Problem Solvers

OCTOBER 11, 2021

London: Routledge; 2005. Structural competency: theorizing a new medical engagement with stigma and inequality. Episode Takeaways: 1. We tend to think of health inequities as big, monolithic, deeply entrenched patterns, and they are, but their variability is really important. It gives us a sense of how different things can be.”-Professor

Government 52

Government Community Education Individual 52

The Clinical Problem Solvers

DECEMBER 20, 2021

provision in only English +/- Spanish), limitations of medical technology (i.e., [link] CPSolvers: Anti-Racism in Medicine Series Episode 13: Centering Asian Americans: Racism, Violence, and Health Show Notes by Naomi F. Insufficient language services (i.e., Remember that more deeply understanding your patients can provide meaning!

Community 52

Community Patient-Centered Relationship Healthcare 52

GeriPal

SEPTEMBER 12, 2024

She’s a geriatrician and palliative care doc and is associate chair for professional development in the department of Psychosocial Oncology and Palliative Care at the Dana Farber Cancer Institute and Harvard Medical School. Well-being committees are popping up at every level of an organization. Jane, welcome to the GeriPal podcast.

IT 112

IT Healthcare Healthcare Professional Patient-Centered 112

GeriPal

DECEMBER 29, 2022

Dealing with conflict in caring for the seriously ill: “it was just out of the question” JAMA 2005. So many times, family caregivers have to argue with their loved ones about getting more help in the home or moving them to a place that has safety, has close proximity to medical care. Journal of Patient Experience.

Families 96

Families Family IT Patient-Centered 96

Physician's Weekly

JUNE 12, 2025

It led to revocation of the elder Geier’s medical license and disciplinary action for David Geier for practicing medicine without a license. In a 2005 article for Rolling Stone that was later retracted, Kennedy claimed government officials had buried data showing a link between vaccines and autism, The Wall Street Journal said.

Vaccination 52

Vaccination Patient-Centered Government Diagnosis 52

Pamela Wible MD

JUNE 19, 2025

Published 2/5/19, updated 6/19/25) Rowdiest audience ever (at a medical conference at least). It’s now so common that more than half of all doctors report symptoms, with medical students , residents , and even senior clinicians feeling pushed to the brink. Among medical trainees suicide is the number one cause of death today.

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Clinic Nurse Practitioner IT Medical 246

Physician's Weekly

JUNE 25, 2025

When Sturdevant first tested positive for HIV in 2005, he didn’t seek treatment. — Cedric Sturdevant woke up with “a bit of depression” but made it to church, as he does every Sunday. In a few days, he would drive from Mississippi to Washington, D.C., About 40% of adults with HIV rely on it for their lifesaving treatments.

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Government Community Families Family 52