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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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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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

Annals of Family Medicine

NOVEMBER 20, 2024

We utilized AI tools in the qualitative software program Atlas.ti to complete an analysis of qualitative data collected from primary care clinician and staff perspectives on the use of anti-obesity medications. These methods may be useful in reviewing summaries of large data sets and provide additional context for analysis.

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FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. 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510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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Medical Electronics Manufacturing Utilities 64

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. But these early systems often struggled with complex medical terminology and the natural flow of conversation.

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Family Physicians of Greeley

JUNE 16, 2023

Understanding your insurance coverage, managing medical bills, and finding affordable healthcare options are essential for maintaining your health without breaking the bank. In this blog, we will provide you with practical tips to help you navigate insurance and healthcare costs effectively.

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FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

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Medical Clinic Patients IT 111

FDA Law Blog

MARCH 27, 2023

Baumhardt, Senior Medical Device Regulation Expert — The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. So, what is special about September 24, 2023? By Philip Won & Lisa M.

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Specialization Supply Chain Manufacturing Medical 45

FDA Law Blog

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

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Medical Provider IT Manufacturing 59

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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PEMBlog

SEPTEMBER 6, 2023

When should the emergency physician obtain lab tests to medically clear such patients? Also, while evidence for lab evaluation based on history and exam findings was established for adults, children were considered to have a medical etiology (organic psychosis) until proven otherwise. Acute onset psychosis is relatively rare.

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Lab Testing Medical Patients Mental Health 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.,

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Medical Patients Healthcare Electronics 45

The Clinical Problem Solvers

DECEMBER 16, 2020

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. Consensus standards that guide authors on ethical use of race in scientific research exist.

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Clinic Education Clinical Practice Patient-Centered 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. By Adrienne R.

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Consulting Manufacturing Utilities Provider 52

FDA Law Blog

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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Patient-Centered Clinic Medical Utilities 52

FDA Law Blog

NOVEMBER 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information. According to the latest MDUFA performance report , only 25% of 513(g)s in fiscal year 2023 met the 60-day statutory time frame.

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Provider IT Consulting Utilities 69

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

JUNE 27, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Anne K. On June 12, 2023, FDA issued a public notice to solicit comments on the information collection related to the voluntary submission of allegations of regulatory misconduct to CDRH. Any comments to the public notice must be submitted by August 11, 2023.

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Manufacturing Utilities Electronics IT 59

FDA Law Blog

JULY 4, 2023

The CARES Act also provides for an administrative hearing process that may be utilized under certain conditions following the formal dispute resolution process. The draft Monograph FDR Guidance clarifies that FDR is appropriate only when there is a scientific and/or medical dispute related to a final order. By Deborah L.

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Utilities Provider Individual IT 52

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. § a), 1306.06.

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Insurance Patients Utilities Chronic Condition 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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FDA Law Blog

APRIL 23, 2023

Outcomes of interest are more likely to be recorded in clinical records when the events are objective and require immediate medical attention (e.g., If sponsors do not own the data used for the external control arm, they should structure agreements with the data owner to ensure that patient-level data can be provided to FDA.

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Patient-Centered Clinic Patients Provider 49

Annals of Family Medicine

NOVEMBER 20, 2024

Study Design: Secondary data analysis of a retrospective cohort from 2017-2023. Results: Trend lines of opioid MME prescribed by providers at each participating clinic were shared at provider meetings. Setting or Dataset: 4 primary care clinics (PCCs) across Maine, New Hampshire, and Vermont. Concurrent use increased from 6.3

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Patients Patient-Centered Primary Care Electronics 130

Annals of Family Medicine

NOVEMBER 20, 2024

Context: Fetal Infant Mortality Reviews (FIMR) utilize abstracted health service records and family interviews to examine to identify root causes of infant mortality. Compared to cases without family interviews, cases with family interview were associated with a 7 times greater likelihood of identifying one or more medical stressors (CI 1.6-28.9,

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Family Families Utilities Education 130

PEMBlog

MAY 15, 2023

Our role as providers is to identify the patients who have a life-threatening etiology to their syncope. Your history and medication reconciliation will assist in determining acquired vs congenital variants. Acquired long QT can be caused by electrolyte disorders, eating disorders and/or medications. PEMBlog, 8 Feb.

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Utilities Screening Physicals Medical 97

The Motivated MD

SEPTEMBER 19, 2024

A study by Johns Hopkins in 2016 found that medical errors may potentially be the third leading cause of death nationwide. ’ Though it often does not come with the attending salary, medical trainees are getting paid to perform a service, and hospitals provide retirement plans to these individuals.

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FDA Law Blog

JANUARY 4, 2023

Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval. By Dara Katcher Levy — A win for patient access!

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FDA Law Blog

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

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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]. Brad’s not a pediatric medical geneticist. So my special guest host on this episode is a trainee in pediatrics and medical genetics. Inborn Errors of Metabolism.

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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.

Family 52

Family Families 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

FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.)

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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.”

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IT Patient-Centered Families Family 99

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories. Then take a moment to reflect on your unique plate. What similarities do you notice?

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FDA Law Blog

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

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GeriPal

JULY 13, 2023

Randy died February 26, 2023. And if I remember that study correctly, it was priming both patients and providers in the outpatient setting to do goals of care conversations. And we had the date, if it was present in the EHR, to provide that context for the clinician. Randy Curtis was first author of the JAMA paper. Eric: Yeah.

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Patient-Centered IT Hospital Patients 83