FDA Law

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. This comparison is misplaced. If finalized, the PR may also be subject to broader challenges.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 220(e)(2).

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

FDA Law

FEBRUARY 27, 2024

FDA also approved two NDAs on the same first day for micafungin (MYCAMINE)—NDA 021506 for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, and NDA 021754 for the treatment of esophageal candidiasis. In that case, the NDA sponsor applied for two PTEs based on these approvals—one for either U.S.

Patients 59

Patients IT Provider Individual 59

FDA Law

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 220(e)(2).

Lab Testing 40

Lab Testing Referral Individual Patient-Centered 40

GeriPal

NOVEMBER 9, 2023

The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life. ” Eric: It strikes me that there also seems to be a difference between coaching a team, like many of us are familiar with, and this individual coaching, although there may be group coaching as well. Beth: Yeah.

Board-Certified 110

Board-Certified IT Primary Care Referral 110

Annals of Family Medicine

NOVEMBER 20, 2024

Using linked administrative databases, we identified all instances of PIP-AP according to the STOPP-START criteria, which have previously been shown to predict adverse clinical events such as ED visits and hospitalizations. Residents were followed for 1 year or to date of death, whichever occurred first.

Patients 130

Patients Provider Individual Hospital 130

The Clinical Problem Solvers

APRIL 5, 2022

Dr. Margot Kushel is a Professor of Medicine and Division Chief at the Division of Vulnerable Populations at Zuckerberg San Francisco General Hospital and Trauma Center and Director of the UCSF Center for Vulnerable Populations and UCSF Benioff Homelessness and Housing Initiative. Can you refer your patient there? 3.

Community 52

Community Patient-Centered Emergency Room Medical 52

GeriPal

FEBRUARY 27, 2025

We address: Why is caring for patients with this overlap so hard? Sach Kale set up an outpatient clinic focused on substance use disorder for patients with cancer. Who follows the patient once the cancer goes into remission? I see this in the hospital when I’m doing addiction medicine consults.

Patients 72

Patients Clinic Patient-Centered Illness 72

Medical Xpress

DECEMBER 20, 2022

Since December 2019, more than 60 million people have been diagnosed with coronavirus disease 2019 (COVID-19) worldwide, while approximately six million individuals have died as a result of the disease. Hospital treatment was required in about 10%–20% of COVID-19 patients, with this proportion decreasing over time.

Diagnose 74

Diagnose Individual Hospital Patients 74

The Clinical Problem Solvers

MAY 30, 2022

We all must recognize the codification of racism within our institutions and work to unlearn these hierarchies in order to better care for Black and Indigenous patients. She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. Published January 16, 2019. link] Katy B.

Community 52

Community Patient-Centered Families Family 52

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. AFP 2019 Gabapentin for chronic neuropathic pain in adults. Happy to be here.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

MAY 18, 2023

Mike: 2019. Eric: 2019. There are some older adults in whom these are the correct drugs, either because of their particular clinical circumstances or because shared decision making and patient values and preferences. So we want to alert clinicians as well as patients and policy makers to the presence of these drugs.

Medical 97

Medical IT Patients Clinic 97

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. Im b leary eyed.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

MARCH 24, 2023

I think some individuals thought there was cherry-picking of stories that made it seem like hospice is this bad thing, that it’s taking advantage of vulnerable individuals and it didn’t talk enough about the good things that hospice does. And that’s an ADC of two to three patients a day. Eric: Great.

IT 113

IT Provider Patients Families 113

GeriPal

AUGUST 25, 2022

Second, Hospice was originally designed for patients with advanced cancer, but the fastest growing admitting diagnosis is dementia. Krista Harrison found , to her surprise, that caregivers of people with dementia who died rated hospice as well as similar patients without dementia who died on hospice. AlexSmithMD. Transcript.

Families 106

Families Family IT Patients 106

GeriPal

APRIL 13, 2023

But, should we as clinicians care about the social lives of our patients? Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? Has kept me interested, the patient experience and the older adults in the community, their experience.

IT 99

IT Community Patient-Centered Medical 99

GeriPal

NOVEMBER 2, 2023

I was very close with my grandparents growing up, and then I actually was exposed to geriatrics as a pre-med student at Yale New Haven Hospital as one of the volunteers and Dr. Sharon Inouye’s initial help trial and had a fabulous role model Dr. Verano, who I wanted to be. Ryan: Actually, a very similar story as to Jerry.

Board-Certified 91

Board-Certified IT Community Medical Student 91

BMJ

MAY 10, 2022

Family physicians and family health workers, considered reliable sources of vaccine information, have a unique position where individuals in rural and urban areas can access frequently, uninterruptedly, cheaply, and easily [2]. Individuals over 65 years of age at home Yes 23 (65.7) Immunization, 2019. 150 (54.3) 126 (45.7)

Vaccination 40

Vaccination Healthcare Professional Healthcare Primary Care 40

Medical Xpress

JUNE 8, 2025

As is the case internationally, sucrose is used widely in New Zealand, but there is considerable variation in protocols of use across hospitals. However, we do not guarantee individual replies due to the high volume of messages. No national guidelines for best practice exist. Whats more, pain isnt always managed.

IT 59

IT Management Vaccination Medical 59

The Clinical Problem Solvers

MAY 2, 2023

A lot of compounding trauma occurs at the border that has potential downstream mental health implications for individuals and their families. She also mentioned Dr. Mark Kuczewski’s sanctuary doctrine toolkit that focuses more on the individual level. Refer to Good Sanctuary Doctoring for Undocumented Patients for more information.

Healthcare 52

Healthcare Provider Clinical Practice Clinic 52

PEMBlog

APRIL 4, 2025

The episode emphasizes thoughtful, individualized care in the context of rising vaccine hesitancy and declining immunization rates. of their patients were fully vaccinated, five and a half percent were under vaccinated, and 3% were unvaccinated. For most patients, this should be ceftriaxone 50 milligram per kilogram intramuscular.

Vaccination 66

Vaccination Illness IT Clinic 66

GeriPal

APRIL 17, 2025

Summary Transcript CME Summary I read Farah Stockmans article in the NYT on why attacks on DEI will cost us all , and thought, Yes, and everyone includes harm to our healthcare workforce, our patients, and their families. I’m asking you, have you ever walked in and talked to a black, older black patient and used their first name?

IT 70

IT Community Government Management 70

FDA Law

SEPTEMBER 13, 2021

A May 2019 CMS final rule that would have required drug TV advertisements to disclose the WAC of the drug was challenged by a group of pharmaceutical companies and vacated on statutory grounds by the D.C. Controlling Medicare Part D Patient Out-of-Pocket Costs and Total Drug Costs.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98