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.

Healthcare 130

Healthcare Utilities Patient-Centered Illness 130

Medical Xpress

MARCH 17, 2023

The AADOCR/CADR Annual Meeting & Exhibition took place at the Oregon Convention Center in Portland on March 15-18, 2023.

Utilities 87

Utilities IT 87

Annals of Family Medicine

NOVEMBER 20, 2024

Study Design: We analyzed eleven interviews with primary care providers recruited from ABFM diplomates who completed a recertification exam in 2023. Instrument: Interviews were semi-structured and conducted in Summer 2023. Participants were asked about the meaning, value, and components of professionalism.

Family Physician 130

Family Physician Family Families Patient-Centered 130

FDA Law

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510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.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.

Medical 64

Medical Electronics Manufacturing Utilities 64

Annals of Family Medicine

NOVEMBER 20, 2024

Setting: Alberta, Canada from May 2022 to October 2023. We utilized theoretical constructs of salutogenesis – manageability, meaningfulness, and coherence; and resilience. Study Design and Analysis: We used a mixed-method complexity-informed methodology.

Healthcare 130

Healthcare Referral Provider Utilities 130

FDA Law

SEPTEMBER 16, 2024

This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.

Manufacturing 59

Manufacturing IT Supply Chain Provider 59

Myriad Genetics

MARCH 13, 2024

The NORD report notes: “Genetic testing…is being increasingly utilized to help diagnose rare diseases, the majority of which are genetic in origin. Knowing link] Accessed February 2023. Which one of those 17 doctors ultimately was able to pull together the pieces of Alex’s health picture and suggest a diagnosis? None of them.

Diagnose 52

Diagnose Screening Diagnosis Family 52

Today's Hospitalist

MAY 9, 2025

At its core, the technology utilizes sophisticated speech recognition to transcribe a conversation in the exam room or at the bedside. These systems also provide a consistent note structure, which can improve the overall readability and utility of patient records. This isn’t about replacing your clinical judgment.

Patient-Centered 52

Patient-Centered Telemedicine Clinic Electronics 52

Barton Associates

JUNE 19, 2025

Recent data shows that about half of physicians (45.2%) reported symptoms of burnout in 2023 —and according to a 2023 study published in the “Journal of the American Medical Association,” one-third of surveyed doctors considered leaving medicine behind.

Healthcare 52

Healthcare Healthcare Professional Provider Community 52

FDA Law

MARCH 27, 2023

So, what is special about September 24, 2023? For the stakeholders who use UPC as their device identifier, UDI alternatives UDI-A160001 and UDI-A16002 will expire on September 24, 2023. Devices that are manufactured and/or labeled on or after September 24, 2023, cannot use this alternative.” Emphasis added.) It is not far off!

Specialization 45

Specialization Supply Chain Manufacturing Medical 45

FDA Law

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.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

MAY 13, 2024

In December 2023, FDA issued a new draft guidance on RWE, which updates and clarifies how FDA evaluates RWD to determine if it is sufficient to be used in regulatory decision-making for devices and provides updated recommendations for sponsors collecting RWD. Congress has recognized the challenges with FDA’s acceptance of RWD and RWE.

Medical 111

Medical Clinic Patients IT 111

PEMBlog

OCTOBER 26, 2023

This nuclear medicine scan utilizes a radioactive tracer that is taken up by the gastric mucosa in Meckel’s diverticulum, thereby helping to identify its presence. Reference article, Radiopaedia.org (Accessed on 26 Oct 2023) [link] Sagar J, Kumar V, Shah DK. Updated 2023 Jan 30]. ” An et. J R Soc Med. An J, Zabbo CP.

Diagnosis 64

Diagnosis Complication Consulting Management 64

FDA Law

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. We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed.

IT 69

IT Medical Patient-Centered Provider 69

FDA Law

JUNE 27, 2023

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. FDA does not define, however, when information submitted is deemed to be “complete.”

Manufacturing 59

Manufacturing Utilities Electronics IT 59

The Clinical Problem Solvers

DECEMBER 16, 2020

Fields Time Stamps 00:00 Mission, vision, and introductions of hosts 01:30 Background on three-episode series 02:26 Introductions of guests 04:16 How Dr. Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions?

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law

NOVEMBER 7, 2024

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. By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N.

Provider 69

Provider IT Consulting Utilities 69

Family Physicians of Greeley

JUNE 16, 2023

Utilizing in-network providers ensures that you receive the maximum coverage and reduces your out-of-pocket expenses. This knowledge will help you make informed decisions when seeking medical care and avoid unexpected out-of-pocket expenses.

Insurance 40

Insurance Healthcare Patients Provider 40

FDA Law

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.

Patient-Centered 52

Patient-Centered Clinic Medical Utilities 52

FDA Law

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. Fiscal Year 2023 showed similar performance.

Consulting 52

Consulting Manufacturing Utilities Provider 52

FDA Law

JULY 17, 2022

Currently, a health care provider identifies any discarded quantity from such a vial in the claim using a JW modifier, and Medicare Part B pays for both the utilized and the discarded amount. On July 8, as part of its annual physician fee schedule update for 2023, CMS issued a proposed regulation to implement the new refund.

Manufacturing 52

Manufacturing Utilities Government Provider 52

FDA Law

FEBRUARY 2, 2023

Alternative methods will require significant research investment to demonstrate their utility for a particular context of use and inform regulatory decision-making. The pre-existing statutory language did not require animal testing. In our experience, FDA is inherently an empirically driven body of scientists, physicians, and policy-makers.

Clinic 64

Clinic IT Utilities Government 64

FDA Law

NOVEMBER 15, 2022

The small business fees for FY 2023 can be found here. If you would like to request for FY 2023 status, you can submit an application through September 30, 2023. However, it is most likely your submission will be logged in on the next business day (Monday, October 3, 2022) during the new fiscal year 2023. Not eligible.

Medical 59

Medical Provider IT Manufacturing 59

FDA Law

MAY 15, 2023

AAFCO is requesting stakeholders, such as veterinarians, animal nutritionists, consumer groups, and the public, to provide feedback on the initial CFI by June 2, 2023. Manufacturers are responsible for determining that the common food is safe and has utility for its intended use prior to commercial distribution as animal food.

Manufacturing 45

Manufacturing Utilities Provider IT 45

FDA Law

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. It may be a while before anyone seeks to utilize the processes covered by the draft guidance, but it is another commitment under OTC monograph reform checked off FDA’s to-do list.

Utilities 52

Utilities Provider Individual IT 52

FDA Law

JUNE 21, 2023

We also note this CDRH’s effort aligns with the FDA-wide effort to utilize digital health technologies that are discussed in recent draft guidance documents as follows: Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices. By Philip Won & McKenzie E. We previously blogged on the draft guidance here.

Medical 45

Medical Patients Healthcare Electronics 45

FDA Law

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. By Larry K. 823(g)(1).

Insurance 52

Insurance Patients Utilities Chronic Condition 52

FDA Law

APRIL 23, 2023

However, as the Draft Guidance explicitly does not apply to the use of summary-level estimates in an external control arm, it is unclear how sponsors of NDAs seeking to utilize summary-level information available may best make use of such information and still comply with this regulation. Tobolowsky & David B.

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

PEMBlog

SEPTEMBER 6, 2023

Clinical utility of screening laboratory tests in pediatric psychiatric patients presenting to the emergency department for medical clearance. Hosp Pediatr (2023) 13 (1): 66–71 When should the emergency physician obtain lab tests to medically clear such patients? Decades ago, psychiatric complaints in the pediatric ED were infrequent.

Lab Testing 52

Lab Testing Medical Patients Mental Health 52

Physician's Weekly

JUNE 22, 2025

A greater social risk burden was linked to increased odds of unplanned healthcare utilization (severe vs none: OR, 3.5 [1.2-10.2]) High social risk burden in adults with IBD drives emergency care use and medication gaps—spotlighting the urgent need for social screening in clinical practice.

Healthcare 52

Healthcare Transportation IT Insurance 52

PEMBlog

MAY 15, 2023

Pre-Publication Peer Review This post underwent pre-publication peer review on Thursday May 11, 2023. Syncope is described as a brief loss of consciousness and postural tone caused by transient global cerebral hypoperfusion. It is followed by a complete recovery. It is also known as pre-excitation. Red Flags in Children with Syncope.”

Utilities 97

Utilities Screening Physicals Medical 97

The Motivated MD

SEPTEMBER 19, 2024

Saving $23,000 when the national average unweighted resident salary in 2023, according to AAMC data , was $63,800. Before we discuss each individual savings account, let us first highlight exactly what it means to ‘automate’ your savings. So yes, humans make mistakes. This is the same for personal finances. Fight this temptation.

Finance 52

Finance Individual Education Healthcare Professional 52

FDA Law

SEPTEMBER 5, 2023

Bloomberg News reports that the National Institute on Drug Abuse agreed with the recommendation. Riley Griffin, et al., US Health Officials Urge Moving Pot to Lower-Risk Tier, Bloomberg News (Aug. HHS’ recommendation that DEA move cannabis to schedule III falls short of recommending total decontrol as many pro-cannabis advocates had hoped.

Medical 111

Medical IT Manufacturing Utilities 111

FDA Law

JANUARY 4, 2023

2617, the “ Consolidated Appropriations Act, 2023 ,” was signed into law by President Biden on December 29. The PIE Act, otherwise known as section 3630, “Facilitating Exchange of Product Information Prior to Approval” of H.R. Industry has grappled with interpreting this regulation – what is promotion? what is commercialization?

Patients 64

Patients Provider IT Utilities 64

PEMBlog

MAY 24, 2023

This entails utilizing the least invasive non-pharmacologic means of assisting them, before moving to physical or chemical restraints. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about age-appropriate non pharmacologic management strategies for agitated children.

Management 54

Management Patient-Centered Physicals Finance 54

FDA Law

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.

Manufacturing 59

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]. This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. References Jeanmonod R, Asuka E, Jeanmonod D.

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