PEMBlog

JUNE 7, 2023

There are protocols in place that assist highly trained Emergency Medical Service providers in assuring that agitated children are safely transported to their destination. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together.

Transportation 122

Transportation Patient-Centered Management Finance 122

Barton Associates

MAY 1, 2025

adults had a mental illness in 2023, and about half (46%) of them did not get any treatment. Nurse practitioners are actually the third-fastest growing occupation in the United States, with a projected 46% growth rate between 2023 and 2033, according to the BLS. Can a mental health nurse practitioner prescribe medication?

Nurse Practitioner 52

Nurse Practitioner Mental Health Behavioral Health Services Provider 52

FDA Law Blog

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

Clinic 59

Clinic Telehealth Provider Electronics 59

FDA Law Blog

NOVEMBER 6, 2024

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. The Court held that it does.

Clinic 111

Clinic IT Patient-Centered Consulting 111

FDA Law Blog

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. analytical, clinical and stability).

Specialization 40

Specialization Clinic Provider IT 40

The Clinical Problem Solvers

MARCH 14, 2025

Dr. Benton mentors clinical and research physicians, fellows, and postdoctoral trainees. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital. Child and Adolescent Psychiatric Clinics of North America.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

FDA Law Blog

JULY 17, 2024

As originally proposed, this new Committee could be convened in conjunction with the existing medical specialty area-focused advisory committees, akin to the Drug Safety and Risk Management Advisory Committee. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

FDA Law Blog

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use.

Specialization 69

Specialization Hospital Physicals Provider 69

PEMBlog

JUNE 14, 2023

This episode is a co-production of the Emergency Medical Services for Children Innovation and Improvement Center whose mission is to minimize morbidity and mortality of acutely ill and injured children across the emergency continuum. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together.

Mental Health 98

Mental Health Management Patient-Centered Illness 98

FDA Law Blog

FEBRUARY 27, 2023

The Ryan Haight Act was enacted to address the legal “grey area” in which prescribers and pharmacies operated via the creation of two new statutory requirements: 1) the at least one “in-person” medical evaluation requirement for prescribing practitioners, 21 U.S.C. § That emergency declaration is set to expire on May 11, 2023.

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

The Clinical Problem Solvers

NOVEMBER 3, 2022

Neurology DDx Schema John Acquaviva @DrJAStrange John Acquaviva is a fourth-year medical student attending Lake Erie College of Osteopathic Medicine in Erie, Pennsylvania. He has a passion for both clinical and academic neurology and will be starting neurology residency in the summer of 2023.

Medical Student 52

Medical Student Internal Medicine Insurance Specialization 52

FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In addition, manufacturers should identify whether the modifications will apply to all devices in the field (referred to as global adaptations) or will be implemented based on a specific clinical site or individual patients” (referred to as local adaptations).

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

Manufacturing 64

Manufacturing Engineering Medical IT 64

FDA Law Blog

OCTOBER 6, 2023

The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. Whether academic medical centers should be treated differently than other laboratories offering LDTs. It does not extend to tests for which FDA has historically not exercised enforcement discretion (e.g.,

Provider 64

Provider Manufacturing IT Medical 64

FDA Law Blog

FEBRUARY 28, 2023

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. By Adrienne R. The guidance describes twenty sections to be included in a Traditional or Abbreviated 510(k).

Provider 52

Provider Electronics IT Complication 52

GeriPal

NOVEMBER 9, 2023

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). AlexSmithMD 1. It’s also a lot what stage of career they are. Beth: Yeah. Greg: Yeah.

Board-Certified 111

Board-Certified IT Primary Care Referral 111

Physician's Weekly

JUNE 19, 2025

Pregnant with her second child, she schleps a backpack instead of a traditional black bag to carry a laptop and essential medical supplies — stethoscope, blood pressure cuff, and pulse oximeter. Their growth has bolstered primary care, and, like doctors, they can specialize in particular branches of medicine.

Nurse Practitioner 52

Nurse Practitioner Families Family Primary Care 52

Medical Xpress

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Other states like Oregon and Colorado have already launched legal clinics using psilocybin, the compound found in mushrooms, The Times reported. Food and Drug Administration (FDA).

Mental Health 52

Mental Health IT Medical Specialization 52

Medical Xpress

JUNE 16, 2025

What is known is that special cells in the eye called intrinsically photosensitive retinal ganglion cells (ipRGCs) detect blue light and send signals to the SCN to reset the clock. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. What are the consequences?

Provider 109

Provider Medical Complication Diabetes 109

ABIM

MAY 30, 2025

Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. One notable trend was a higher representation of international medical graduates and osteopathic physicians in the specialty. Rodriguez, MD , Chair of the Nephrology Board, and John C.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

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. So medication adjustments.

Illness 109

Illness IT Patient-Centered Patients 109

FDA Law Blog

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

PEMBlog

MARCH 27, 2024

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. Updated 2023 Jul 17]. Brad’s not a pediatric medical geneticist. So my special guest host on this episode is a trainee in pediatrics and medical genetics.

Consulting 59

Consulting Individual Families Family 59

PEMBlog

JANUARY 16, 2025

Well dive into the clinical presentations, including acute and chronic symptoms, the dangers of sudden sniffing death, and the specific risks associated with nitrites, hydrocarbons, and nitrous oxide. Clin Toxicol (Phila) 2023; 61:453. Updated February 26, 2024. Accessed January 13, 2025. Intelligencer. Published January 6, 2025.

Complication 52

Complication Patient-Centered Management Patients 52

GeriPal

FEBRUARY 8, 2024

2023 Dec 20:S1524-9042(23)00202-3. ” BJ: Well, I fall back on using physiology in the sort of medical sense. laughter] Eric: And part of that is this idea of, in hospice, sometimes we just try to medicate suffering away. We medicate that away. Pain Manag Nurs. doi: 10.1016/j.pmn.2023.11.004. 2023.11.004.

IT 137

IT Families Family Physicals 137

GeriPal

MARCH 24, 2023

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. Reading Ira’s article, it essentially was the VITAS Medical Director job description.

IT 115

IT Provider Patients Families 115

GeriPal

APRIL 6, 2023

A friend of GeriPal, and prior guest, Guy Micco commented today that we need an RCT for chaplaincy is like the idea that the humanities need to justify their value in medical training: “It’s like being told to measure the taste of orange juice with a ruler.”

IT 99

IT Patient-Centered Families Family 99

GeriPal

AUGUST 15, 2024

We discuss: What is considered a hate incident, how is it tracked, what do we know about changes over time The wider impact of Anti-Asian hate on older Asians, who are afraid to go out, leading to anxiety, social isolation, loneliness, decreased exercise, missed appointments and medications. We do a lot of clinical focused discussions.

Mental Health 118

Mental Health Community Screening IT 118

GeriPal

JULY 13, 2023

Randy died February 26, 2023. It’s really special to be here and to be talking about this paper, which was really important to Randy. And I think that his research was informed by his clinical practice, his clinical practice was informed by his research. Randy Curtis was first author of the JAMA paper. Alex: Yeah.

Patient-Centered 84

Patient-Centered IT Patients Hospital 84

GeriPal

DECEMBER 21, 2023

And that’s where, based on this, I made a decision to leave University of North Carolina to come to Indiana University because my mentor, Chris Callahan, just received the grant from AHRQ to build the first randomized clinical control trial that evaluated the comprehensive dementia care model. ” Diane: Fantastic. Think about CPC+.

Patient-Centered 126

Patient-Centered IT Families Family 126

GeriPal

APRIL 20, 2023

I would talk about this, except I was a clinician, and I’m seeing these folks in the hospital and in clinic. Alex: But the longer title’s Ethno-Geriatrics and Special Populations. The journal section’s requirements are the same as for a clinical investigation. ” It was in my slide deck. Margot: Yeah.

Mental Health 124

Mental Health IT Community Individual 124

GeriPal

SEPTEMBER 14, 2023

That’s focused on older adults who are too frail to get into clinic. In that clinical experience, we saw a lot of older adults who would develop acute illness, often exacerbations of their chronic conditions. We relied on our clinical experience as geriatricians, that home-based primary care experience. Bruce: Sure.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

GeriPal

JULY 20, 2023

See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. Alex: We are delighted to welcome Joe Rotella, who’s the Chief Medical Officer of the American Academy of Hospice and Palliative Medicine. So now that the emergency response has ended, what’s to be done?

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73