FDA Law Blog

FEBRUARY 23, 2025

To help in evaluating device changes, manufacturers commonly refer to FDAs guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, which provides FDAs interpretation of the changes it believes could significantly affect the safety or effectiveness of a device. Notably, FDAs public WL database only goes back to 2020.

Manufacturing 64

Manufacturing Provider Consulting IT 64

PEMBlog

OCTOBER 18, 2024

Emergency Care Plans and Advanced Directives Many DMD patients will arrive with comprehensive emergency care plans or letters from their providers. 2020 Jun 5;15(1):141. DMD patients often receive yearly MRIs to monitor their cardiac health, as discrepancies between MRI and echo findings are common. Orphanet J Rare Dis.

Patients 52

Patients Complication Management Consulting 52

GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. And my hypothesis is that’s because it’s no longer the individual managing their own diabetes, it’s the nursing home staff managing their diabetes.

Diabetes 73

Diabetes Management Patient-Centered Families 73

The Clinical Problem Solvers

FEBRUARY 8, 2023

Pearls: In 2020, American Indian and Alaska Native (Indigenous) communities experienced the highest drug overdose mortality rate of any racial or ethnic group, also surpassing rates among the non-Hispanic white population. They can use their training and privilege to advocate for meaningful policy reform.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

JANUARY 30, 2025

In one corner, weighing in at decades of experience, well known for heavy hits of bedside assessments, strong patient-family relationships, and a knockout punch of interdisciplinary collaboration, we have in-person palliative care consults. Consultations versus telehealth. But watch out! That’s what I’m waiting for, Alex.

Telehealth 105

Telehealth Patient-Centered IT Patients 105

GeriPal

JANUARY 25, 2024

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. With their regular providers? The article we discuss today, also published in JAMA , addresses these two gaps. In their communities?

Patient-Centered 122

Patient-Centered IT Illness Patients 122

GeriPal

DECEMBER 8, 2022

So those questions we ask when we’re doing a palliative care consult. And which of those experiences would you like to share with us that we could then write into a story that we’ll share with providers? Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol. Bennett, C.R., Schilling, L.,

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115