Annals of Family Medicine

NOVEMBER 20, 2024

Context: The COVID pandemic disrupted global healthcare, impacting academic medical centers (AMCs) in the United States, necessitating a comprehensive understanding of its effects on healthcare delivery and utilization. Study Design: This retrospective case series analysis utilizes Vizient’s clinical database data.

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Utilities Healthcare Patient-Centered Illness 130

Annals of Family Medicine

NOVEMBER 20, 2024

Objectives: We explored how to design a system to provide near real-time feedback on context and impacts to inform health system innovations; and how to operationalize data collection across diverse patient populations and providers. Setting: Alberta, Canada from May 2022 to October 2023.

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Referral Healthcare Provider Utilities 130

Barton Associates

JUNE 19, 2025

In fact, hospitals, clinics, and other facilities are already reeling from a shortage of providers and it’s hurting patients— according to the United States Department of Health and Human Services (HHS) , tens of millions of Americans live in areas with shortages of primary care, dental, and mental health professionals.

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Healthcare Healthcare Professional Provider Community 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice. Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality.

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Clinic Education Clinical Practice Patient-Centered 52

Today's Hospitalist

MAY 9, 2025

Since the mid-1990s, our capacity for innovation has never stopped as hospitalists navigate a complex landscape of acute illnesses, interprofessional collaborations and the imperative to provide efficient, high-quality care. Yet this expansion has come with a significant administrative burden, particularly that of clinical documentation.

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Patient-Centered Telemedicine Clinic Electronics 52

Barton Associates

MAY 8, 2025

In this blog, we’re going to outline four key ways temporary medical staff such as locum tenens providers can help healthcare facilities maintain continuity of high-quality patient care in the face of growing shortages. Enter temporary medical staff, such as locum tenens providers. Many healthcare facilities in the U.S.

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Medical Staff Medical Patients Healthcare 52

FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

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Medical Electronics Manufacturing Utilities 64

FDA Law Blog

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.” percent of examples.

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Medical Clinic Patients IT 111

FDA Law Blog

SEPTEMBER 20, 2021

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. By the end of Q2 FY 2023, FDA will establish a committee including members from CDER and CBER to support implementation of the commitments in this section.

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Patient-Centered Clinic Medical Utilities 52

FDA Law Blog

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. FDA), and to generate data in a format that would streamline FDAs review.

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Consulting Manufacturing Utilities Provider 52

FDA Law Blog

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g.,

Medical 45

Medical Patients Healthcare Electronics 45

FDA Law Blog

DECEMBER 11, 2023

In fact, as of November 2023, the CMS’s Standards and Certification’s (S&C’s) Quality, Certification and Oversight Reports (QCOR) CLIA Laboratory Lookup Database shows 17,206 CLIA-certified laboratories. Thus, it is wholly unrealistic for the Third-Party Review Program to provide any meaningful reduction in Agency workload.

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IT Medical Patient-Centered Provider 69

FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). 42 U.S.C. §

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Clinic IT Utilities Government 64

FDA Law Blog

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. Outcomes of interest are more likely to be recorded in clinical records when the events are objective and require immediate medical attention (e.g., stroke).

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

PEMBlog

SEPTEMBER 6, 2023

They carry existing diagnoses and are followed by outpatient mental health providers. Attention to any toxidromes, any abnormal vital signs or mental status, eye findings, and neurologic examination provide the greatest help in narrowing the differential diagnosis. Hosp Pediatr (2023) 13 (1): 66–71 Health Aff (Millwood).

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Lab Testing Medical Patients Mental Health 52

Annals of Family Medicine

NOVEMBER 20, 2024

Historically, palliative care has been predominantly provided in the inpatient setting, but there is a growing awareness that patients may also benefit from outpatient care. Objective Describe the population of patients referred to a palliative care clinic and observe their healthcare utilization patterns.

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Patients Diagnosis Patient-Centered Utilities 130

FDA Law Blog

JUNE 27, 2024

After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. 21 U.S.C. §

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Insurance Patients Utilities Chronic Condition 52

Annals of Family Medicine

NOVEMBER 20, 2024

Study Design: Secondary data analysis of a retrospective cohort from 2017-2023. Setting or Dataset: 4 primary care clinics (PCCs) across Maine, New Hampshire, and Vermont. Results: Trend lines of opioid MME prescribed by providers at each participating clinic were shared at provider meetings. delta +1.4 [95%CI

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Patients Patient-Centered Primary Care Electronics 130

FDA Law Blog

JANUARY 4, 2023

2617, the “ Consolidated Appropriations Act, 2023 ,” was signed into law by President Biden on December 29. The provision amends the Federal Food, Drug, and Cosmetic Act section 502 to provide explicit protection for conveying certain information about products in development to payors, including unapproved uses of approved products.

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Patients Provider IT Utilities 64

FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

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Clinic Provider Individual IT 59

FDA Law Blog

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price. Kirschenbaum & Sophia R.

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Manufacturing Utilities Provider IT 59

PEMBlog

MARCH 27, 2024

She did her MD/PhD at Columbia University, where she investigated the diagnostic utility of exome sequencing for kidney disease. Updated 2023 Jul 17]. Therefore understanding these diseases, their presentations and their evaluation is critical for emergency medicine providers. On clinical presentation.

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Consulting Individual Families Family 59

PEMBlog

APRIL 26, 2023

Listen Gun Violence and Safety (2023) – Brad Sobolewski, MD, MEd – featuring Kit Carney, MD & Kristen Humphrey, MD – PEM Currents: The Pediatric Emergency Medicine Podcast [link] Subscribe Advocacy and education resources Be SMART Campaign Be SMART emphasizes the importance of responsible gun ownership and secure gun storage.

Families 52

Families Family Mental Health Healthcare 52

FDA Law Blog

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

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Manufacturing Vaccination Government Diagnosis 59

GeriPal

APRIL 6, 2023

To provide context, we are joined by Karen Steinhauser, a social scientist at Duke who has been studying spirituality for years (and published one of the most cited papers in palliative care on factors considered important at the end of life , as well as one of my favorite qualitative papers to give to research trainees ).

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IT Patient-Centered Families Family 99

GeriPal

JULY 13, 2023

Randy died February 26, 2023. And I think that his research was informed by his clinical practice, his clinical practice was informed by his research. And if I remember that study correctly, it was priming both patients and providers in the outpatient setting to do goals of care conversations. Erin: Mm-hmm. Eric: Yeah.

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Patient-Centered IT Hospital Patients 84

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.”

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Patient-Centered IT Families Family 125

FDA Law Blog

JUNE 1, 2025

Senator Durbins letter references a January 2023 study from the Journal of the American Medical Association, which found that more than two-thirds of drugs advertised on television were considered to have low therapeutic value. Maximizing patient clinical outcomes and quality of life may ultimately minimize healthcare resource utilization.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

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. What was life for you as a provider pre-pandemic? We were the highest utilizers of telemedicine in the whole UCSF health system at that time which we’re very proud of. Stories trump data.

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Telemedicine Telehealth Patient-Centered Board-Certified 73