FDA Law

MARCH 15, 2023

See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006). A reader may miss a cancerous lesion if the image quality is poor, resulting in a false negative diagnosis, which could delay treatment and result in an avoidable death.

Healthcare 59

Healthcare Diagnosis Provider Individual 59

FDA Law

OCTOBER 17, 2023

This implies that if device technologies and features can produce a clinically meaningful impact for the treatment or diagnosis of a condition in certain populations, such data could support the case that the device satisfies the first designation criterion. Other Updates With respect to the first part of the first criterion (i.e.,

Medical 53

Medical Diagnosis Healthcare Clinic 53

GeriPal

OCTOBER 20, 2022

For the policy buffs and policy newbies out there, we hope this podcast is an essential primer to government in action. And so there was a report in 2009 by the Institute of Medicine saying that we need to equip all of these individuals in caring for older person in an evidence based manner. We talk about: . So you’re right.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

JANUARY 11, 2024

Alex: We’re delighted to welcome Leonie Herx, who’s a palliative care physician and clinical professor at the University of Calgary. Sonu: Prior to that it was illegal and actually in the criminal code, so not only illegal, it’s actually a prohibition in the clinical code. Bill, welcome back to GeriPal. Eric: Yeah.

Illness 144

Illness IT Medical Provider 144

FDA Law

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. This limitation is virtually unenforceable because prescriptions and Medicaid claims for drugs do not identify the patient’s diagnosis or condition.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

GeriPal

JUNE 26, 2025

But from our clinical work, many of us are familiar with people with dementia who experience sudden shocks to their health, think hip fracture, think hospitalization for pneumonia. And the government can do something about that?!? Wait, so one key message is that social health is linked to physical and cognitive health?!?

Illness 93

Illness Hospital IT Patient-Centered 93

GeriPal

JULY 6, 2023

I have 24,500 veterans on our caseload, 14,000 individuals with diagnosed mental health issue, 8,500 with an alcohol and substance abuse. Eric: Which is, so let’s say I am a provider, a healthcare provider taking, let’s say a nurse practitioner working in an older, a clinic that’s mainly caring for older adults.

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

APRIL 20, 2023

What are the structural factors and individual factors that contribute to homelessness? We would drill down on the tenth differential diagnosis of medium vessel vasculitis, and then we would discharge them back out to the streets. The journal section’s requirements are the same as for a clinical investigation.

Mental Health 123

Mental Health IT Community Individual 123

GeriPal

DECEMBER 21, 2023

But what happened when we finally… When he did get the diagnosis, it all fell into place. So IU, we have been able to convert our paper, Chris Callahan paper that was published in 2006, the first clinical trial that was positive. So what that means is I take care of you just in my clinic, just in my hospital. Diane: Yeah.

Patient-Centered 125

Patient-Centered IT Family Families 125