FDA Law Blog

OCTOBER 16, 2023

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Javitt & Steven J. Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products.

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Medical Patient-Centered Healthcare Specialization 119

PEMBlog

JUNE 7, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. NASEMSO: Clinical care and restraint of agitated or combative patients by emergency medical service practitioners. These articles will take another look at the content included in this episode.

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Transportation Patient-Centered Management Finance 122

Barton Associates

JUNE 19, 2025

There’s a lot that goes into running a healthcare facility , from managing patient care to ensuring adequate coverage around the clock. This means if you’re a rural hospital or clinic struggling to retain permanent staff, locum tenens providers are a critical resource to maintaining the quality of patient care.

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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Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices.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.

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Clinic Telehealth Provider Electronics 59

FDA Law Blog

MAY 19, 2023

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). The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion.

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Specialization Clinic Provider IT 40

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. clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

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PEMBlog

OCTOBER 18, 2024

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Below are key considerations based on current best practices.

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Patients Complication Management Consulting 52

FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

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FDA Law Blog

FEBRUARY 22, 2023

The generation of HF data is a detailed and fairly burdensome process, although certainly short of a full-blown clinical study. And HF‑related AI requests are especially nerve‑racking to manage, because of the ever‑present threat that the study must be repeated to adequately respond. In one way, this is good news.

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Manufacturing Engineering Medical IT 64

Physician's Weekly

JUNE 19, 2025

“It’s also often the family member or the person helping to manage them.” The number of nurse practitioners specializing in geriatrics has more than tripled since 2010, increasing the availability of care to the current population of seniors, a recent study in JAMA Network Open found.

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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).

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Mental Health IT Medical Specialization 52

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. Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients. Intelligencer.

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Complication Patient-Centered Management Patients 52

PEMBlog

MARCH 27, 2024

This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. 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]. Inborn Errors of Metabolism.

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Consulting Individual Families Family 59

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. James 00:32 Good afternoon.

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Illness IT Patient-Centered Patients 107

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.

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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. How many patients is my hospice nurse case manager responsible for on any given day?

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GeriPal

FEBRUARY 8, 2024

Hospital Chaplains, Spirituality, and Pain Management: A Qualitative Study. Pain Manag Nurs. 2023 Dec 20:S1524-9042(23)00202-3. Naomi: Well, I have a special place of not being a doctor within this great group of people. doi: 10.1016/j.pmn.2023.11.004. 2023.11.004. Epub ahead of print. PMID: 38129210. Kleinman, A.

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GeriPal

APRIL 6, 2023

Alex Practice-PC Program Information: UCSF’s Practice-PC program is now accepting applications for the 2023-2024 year. We welcome all professions, including but not limited to physicians, chaplains, social workers, nurses, nurse practitioners, case managers, administrators, and pharmacists. This is Eric Widera.

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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.

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Mental Health IT Community Individual 123

GeriPal

DECEMBER 21, 2023

This model will give participating programs a per-member-per-month payment to offer care management, care coordination, and other services such as caregiver training, disease education, and respite. I didn’t know how to manage it. He created fee for service, special fee for depression. And I was terrified.

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Patient-Centered IT Families Family 125

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.

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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. They couldn’t get a case manager to refer them in palliative care. It may have come to a care manager. Start with a story as Carly did in her Op Ed. Stories trump data. Write to your congressperson.

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