FDA Law

NOVEMBER 18, 2021

PCR) test is considered the gold standard for actual diagnosis. PCR comparators for their clinical studies but refuses to publicly designate which ones are acceptable. We have had more than one client spend considerable time and money conducting a clinical study, only to be told that the comparator is not acceptable.

Screening 98

Screening Manufacturing Healthcare IT 98

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

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

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. How we came about to select these articles or to have interest in this topic is really older adults are unique population that are at risk for both over diagnosis of infections as well as under diagnosis of infections.

Complication 52

Complication Patient-Centered IT Patients 52

FDA Law

NOVEMBER 9, 2021

These cases provide some cautionary insights: The FTC (and DOJ) have been and continue to be very serious about prosecuting claims that a product can prevent, treat, or cure human disease without competent and reliable scientific evidence, including, when appropriate, well-controlled clinical studies substantiating that the claims are true.

Provider 52

Provider Government Diagnosis IT 52

GeriPal

JUNE 19, 2025

Just today (June 17th) as we record this podcast: Ezra Klein released a wonderful interview with Sarah McBride , the first openly transgender member of congress A judge ruled that cuts to NIH grants focused on minority groups, including transgender people, were illegal and ordered the government to restore funding.

Individual 85

Individual Community IT Chronic Condition 85

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

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

GeriPal

APRIL 18, 2024

And you say, “Okay, that’s fine, but can it really … What about a real live clinical situation?” I think we’re getting closer to real live clinical situations, not just answering a test. That is the first clinical use case. I’m connecting. This is GPT-4. “Hi, GPT-4.

IT 139

IT Electronics Patients Healthcare 139

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 think to some extent, the county doesn’t necessarily know what they don’t know about geriatrics, just like I don’t necessarily know what I don’t know about the county and local government and national government and state government. And then, the system responds in turn. Do I have access to good food?

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

APRIL 20, 2023

We would drill down on the tenth differential diagnosis of medium vessel vasculitis, and then we would discharge them back out to the streets. Why was I spending all this time figuring out the detailed differential diagnosis of these obscure diseases when we weren’t actually attending to what people really needed?

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