Sound Physicians

APRIL 28, 2025

Still, we know that sometimes the final decision comes down to a single factor: cost. While we’ve earned our reputation over the decades for our clinical excellence in hospital medicine , we’ve also earned — somewhat unfairly — a reputation for being more expensive than our competitors. Physician compensation is tied to quality of care.

IT 52

IT Hospital Telemedicine Clinic 52

FDA Law Blog

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Clinic Provider IT Utilities 105

Minnesota Academy of Family Physicians

FEBRUARY 20, 2025

How Family Physicians Can Help Address Food Insecurity Family physicians are often the first point of contact for patients, uniquely positioning them to identify food insecurity and connect individuals to vital resources. Community Partnerships: Mayo Clinic collaborates with local food banks to offer mobile food distributions.

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Family Physician Community Family Families 52

Common Sense Family Doctor

MARCH 15, 2025

A 2022 article in the Harvard Business Review introduced the term sludge to describe “these types of situations in which the design of a specific process consistently impedes individuals from completing their intended action.”

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Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices.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

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Clinic Telehealth Provider Electronics 59

FDA Law Blog

OCTOBER 14, 2024

The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. Stem Cell Clinic, LLC , 998 F.3d Regenerative Sciences, LLC , 741 F.3d

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Clinic Patient-Centered Asthma Patients 59

East Cary Family Physicians

OCTOBER 20, 2023

In this blog, we’ll explore the importance of Breast Cancer Awareness Month, focusing on early detection, prevention, and the vital role of regular screenings in women’s healthcare. Genetic counseling and testing can help individuals understand their risk. At East Cary Family Physicians, we believe that knowledge is power.

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Family Physician Family Families Screening 40

The Motivated MD

NOVEMBER 19, 2024

For many who follow the blog regularly, you likely have noticed that I haven’t published a blog post in quite some time (a month or two). True we have a fulltime nanny, but we still both work full-time clinically and still wish to have a steady hand in our children’s lives. Keeping a personal finance blog is a tricky thing.

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Finance Education Family Families 52

The Motivated MD

OCTOBER 10, 2024

So, with this chapter, I hope to briefly touch on the basics of market investing and describe why simple diversification and index fund investing are the most effective ways for busy clinical physicians and healthcare providers to invest with the expectation of long-term gains. Most clinical physicians are busy. We simply cannot.

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Finance Individual Management IT 52

FDA Law Blog

JULY 17, 2024

This individual will play a key role in overseeing the new integrated Hub model and helping to develop and implement its strategic agenda action plan. clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

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Patient-Centered Community Medical Specialty Clinic 105

The Clinical Problem Solvers

JANUARY 18, 2021

Understand that collective action and a focus on community, rather than individualism, are most effective in combating racism and achieving health equity. One of the biggest barriers to health equity is the narrow focus on the individual and a failure to see health as a widespread community issue. The Clinical Problem Solvers Podcast.

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Community Medical Individual IT 52

FDA Law Blog

NOVEMBER 29, 2023

See our prior blog post on the topic here. Risk-based This guiding principle ensures risk management principles are used to evaluate the individual and cumulative changes over the life of the device. If the change does not meet specified performance criteria, it will not be implemented under the PCCP.

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Management Manufacturing Medical IT 115

FDA Law Blog

AUGUST 23, 2022

The 80% sensitivity requirement for antigen tests has yet to be explained either scientifically or clinically by the Agency. The study represents the most robust attempt at understanding the performance of serial use of rapid antigen tests for SARS-CoV-2 detection among asymptomatic individuals in the U.S.

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Individual Clinic Healthcare Provider 97

Imperial Center Family Medicine

APRIL 21, 2025

This blog will help you understand basic terms, concepts, and expectations related to cholesterol screenings. This blood test provides a complete cholesterol breakdown by measuring individual lipid components. Cholesterol tests are among the most important practices for your heart health. What Is a Lipid Panel?

Screening 52

Screening DO Family Medicine Family 52

FDA Law Blog

JUNE 21, 2021

Sasinowski — On June 17, 2021, FDA gave notice of an upcoming public workshop focused on clinical trial designs for progressive multifocal leukoencephalopathy (PML). PML is a rare disease that occurs when the JC virus (JCV), generally thought to lie dormant in the adult population, takes advantage of immunocompromised individuals.

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Clinic Individual Provider Healthcare 40

FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here.

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Clinic Medical Provider Patients 52

Vascular Physician

OCTOBER 26, 2021

Transparent walls allow the clinical staff to monitor the patient closely and minimize discomfort for those with claustrophobia. Increased oxygen supply can also help individuals suffering from air embolism, decompression sickness, burns, cerebral edema, diabetic wounds, gas gangrene, stroke, and many others.

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Patient-Centered Diabetes Treatment Plan Insurance 52

FDA Law Blog

FEBRUARY 28, 2022

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. What would be the potential benefits if companies prospectively design medical device clinical studies with input from diverse patient advisors?

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Patients Clinic Medical Patient-Centered 52

FDA Law Blog

JUNE 3, 2025

Houck We appreciate receiving feedback on our blog posts. The assertion that prescribing immediate-release opioids longer than two or three months is a red flag may have originated with the Center for Disease Control and Prevention (CDC) 2022 Clinical Practice Guideline for Prescribing Opioids for Pain. By Larry K. Recommendation 1.

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Clinical Practice Patient-Centered Patients Clinic 59

FDA Law Blog

DECEMBER 7, 2022

In simple terms from a non-scientist, these gene therapies add functional versions of genes to patients that do not have them, and thus the idea is to have these genes function in the same way as they do in individuals without these disorders.

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GeriPal

MARCH 14, 2024

We also talk about the importance of a proactive approach to involving speech-language pathologists in the care of individuals early on with neurodegenerative diseases like dementia and ALS. So as you mentioned, dementia, there’s some research that show about 86% or 93% of those individuals will get that. Raele: I do. I have one.

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IT Patient-Centered Hospital Individual 124

FDA Law Blog

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development.

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Clinic Patient-Centered Medical IT 59

ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. Johnson, MD, FACP, FIDSA , Senior Vice President for Academic Affairs, added that ABIM provides program directors with aggregate performance data in their programs and, with permission, individual graduate data so that program directors can make adjustments to the programs as needed.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

GeriPal

MAY 19, 2022

It depends on the clinical situation. As I’ve been blogging about this for a couple months now, I’m really trying to find anyone who loves these things. But we still, regardless of how you do this calculation have to temper it with clinical judgment. Drew: I’ve published a draft version of it on the blog.

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IT Patients Individual Relationship 139

FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. §

Lab Testing 52

Lab Testing Individual Referral Patient-Centered 52

Aspiring Minority Doctor

JUNE 1, 2022

It will be a healthy mix of clinic days with operating days, and a good transition into my second year of residency. She just finished the school year and is now a 10th grader, has been working on her driving skills, staying involved with band and color guard, and is just an all-around awesome individual. So proud of my daughter!

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Hospital IT Medical Student ER 52

FDA Law Blog

AUGUST 4, 2022

The approval process, pre-approval concerns, product labeling, clinical trials, adverse events reports, patent concerns, and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. MASTER the basics of the application and approval processes for drugs and biologics.

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Government Clinic Individual Provider 40

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. What medical technologies could be ideal to transition to use in non-clinical settings?

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Medical Patients Healthcare Electronics 45

FDA Law Blog

OCTOBER 11, 2022

For the past two years, CDER’s Guidance Agenda has included a spot for this eagerly anticipated guidance, tentatively titled ‘Meeting the Substantial Evidence Standard Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence’. Some may confuse this requirement for two studies as a need for replication.

Clinic 61

Clinic Provider IT Patient-Centered 61

FDA Law Blog

JANUARY 5, 2025

We described the 2022 proposed rule and the ten-plus year history leading up to its issuance in our blog post here. FDAs policy has prohibited the simultaneous prescription and OTC marketing of the same drug product under the same conditions of use unless there is a clinically meaningful difference between them. 105288 (Dec.

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Provider Healthcare Individual IT 59

FDA Law Blog

DECEMBER 12, 2023

In fact, clinical studies estimate that as many as 23% of cats suffer from urolithiasis. To allow for some spread in individual RSS values while still providing an acceptable margin of safety against urolith formation, CVM’s recommended mean RSS and 95% CI limits are: Struvite: Mean RSS ≤ 1.8; Upper bound of 95% CI ≤ 2.5

Utilities 59

Utilities Manufacturing Provider Individual 59

FDA Law Blog

MARCH 8, 2023

Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. eMDR submissions can be submitted in one of two ways: Health Level 7 Individual Case Safety Reports (HL7 ICSR) via AS2 (for high volume reporting) or by using FDA’s eSubmitter software (for low volume reporting).

Electronics 59

Electronics Manufacturing Provider Medical 59

FDA Law Blog

OCTOBER 2, 2023

The eagerly anticipated guidance, Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (i.e., In the December 2019 Guidance, FDA writes that the clinical context for a disease (i.e., As articulated by FDA, “[t]he quantity (e.g.,

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IT Clinic Provider Medical 64

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. §

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

MARCH 16, 2023

This device is indicated for the following use: for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., In the best tradition of teasers, keep reading our blog.

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Healthcare Professional Specialization Transportation Diagnosis 40

PEMBlog

SEPTEMBER 6, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not. 2015;34(5):812-818 Chun TH.

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Lab Testing Medical Patients Mental Health 52