FDA Law Blog

MARCH 16, 2023

The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when tested at least twice over three days with at least 48 hours between tests. The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g.,

Healthcare Professional 40

Healthcare Professional Specialization Diagnosis Transportation 40

Annals of Family Medicine

NOVEMBER 20, 2024

About 90% were either currently or formerly undocumented, 2/3 spoke Spanish, 2/3 made <$50,000 annually, and 1/3 reported inadequate transportation. Cancer Screening: Challenges with making appointments and getting PAP Smears due to time, employment, transportation, and lack of established primary care provider.

Diagnosis 130

Diagnosis Screening Transportation Diagnose 130

FDA Law Blog

JUNE 22, 2023

To obtain clearance of an OTC home IVD, a sponsor must provide the usual suite of analytical and clinical validation that would be required for any IVD, demonstrating adequate repeatability, stability, sensitivity, specificity, and so on. HbA1c, diagnosis of a particular virus, etc.). dried blood, in viral transport media).

Manufacturing 59

Manufacturing Clinic IT Medical 59

Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. When to use telehealth for a sore throat Telehealth offers a convenient way to treat a sore throat and also provides guidance when you’re unsure if you need in-person care. This requires emergency treatment.

ER 52

ER Telehealth Primary Care Doctor Appointment 52

GeriPal

JULY 21, 2022

Often when there’s a cognitive concern, it’s a family member that is calling saying, “I just want to make sure my mom should still be driving after this happened, or after this diagnosis.” So we’re trying to help replace the transportation option.

Families 102

Families IT Family Diagnosis 102

GeriPal

JANUARY 30, 2025

But in reality, given workforce shortages and just the challenges and the resources necessary to be able to provide early integrated palliative care from the time of diagnosis of advanced cancer, the model simply is not implementable, at least not in our current state with our available infrastructure and resources. Eric 10:25 Great.

Telehealth 106

Telehealth Patient-Centered IT Patients 106

PEMBlog

MARCH 27, 2024

She is a member of the Clinical Genome Resource Inborn Errors of Metabolism (IEM) Clinical Domain Working Group, where as a biocurator she assesses the pathogenicity of variants in IEM-associated genes to facilitate expedited genetic diagnosis for IEMs. Inborn errors of metabolism in infancy: a guide to diagnosis. Pediatr Rev.

Consulting 59

Consulting Individual Families Family 59

GeriPal

JANUARY 18, 2024

Our field really lacks specificity in the terms that we use, and I think we really don’t know how chronic cancer pain, let’s say, a few years out from that initial diagnosis differs from, let’s say, chronic low back pain. And Katie, as an advanced practice provider, is much better than I am at explaining how this works.

Illness 137

Illness Patient-Centered Screening Clinic 137

GeriPal

OCTOBER 17, 2024

Eric 12:05 Any pearls on the diagnosis of HFpEF. So I would agree, just in terms of not trying to dismiss a lot of these patients in terms of deconditioning and really trying to sometimes hone in on the diagnosis despite a Bnp level that is not necessarily very high. Nicole 12:14 No, HFpEF is cool, and it’s fine. What is GDMT?

Primary Care 114

Primary Care Patient-Centered IT Patients 114

GeriPal

JULY 6, 2023

It was designed to really balance what Medicaid at the time was to provide nursing homes and Medicare is obviously health insurance. The long-term care is being actually provided in the community at a much higher rate than what the formal system provides. But, what you need is a community-based game there.

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Eric: Okay.

Patient-Centered 126

Patient-Centered IT Families Family 126

GeriPal

SEPTEMBER 14, 2023

And we would provide ongoing longitudinal care to them in the home, much like the Mount Sinai Visiting Doctors programs, and other programs like that. And the treatments are different than what hospice might provide in the home setting. I trained at Hopkins. We had, since the late seventies, a home-based primary care program.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115