The Direct Doctors Difference

AUGUST 18, 2021

According to DPC Frontier, a site owned by a DPC physician/lawyer who was a founder of the movement, there are now over 1500 clinics doing pure Direct Care across the nation. Looking back to 2014, when we began, there were less than 100. There are likely many more than have been officially labeled on the map.

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Primary Care Healthcare Insurance Government 52

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

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Medical Manufacturing Healthcare Government 75

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. 2014); U.S. Stem Cell Clinic, LLC , 998 F.3d 3d 1314 (D.C.

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Clinic Patient-Centered Asthma Patients 59

PEMBlog

OCTOBER 31, 2024

However, this large study shows that probiotics do not significantly shorten illness duration, improve symptoms, or reduce the need for additional medical visits. 2018 Nov 22;379(21):2002-2014. Parents often use probiotics, like Lactobacillus rhamnosus GG , hoping to reduce the severity of their child’s gastroenteritis. N Engl J Med.

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The Clinical Problem Solvers

JANUARY 18, 2021

Published June 10, 2014. Harvard Medical School Primary Care Blog. Creating a segregated medical profession: African American physicians and organized medicine, 1846-1910. Medical Care. A Historic Day For Black Women, A Historic Day For The American Medical Association. American Medical Association.

Community 52

Community Medical Individual IT 52

FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Clinic Clinical Practice Provider Utilities 64

Adventures of a Sick Doctor

JULY 4, 2024

This had been preceded by a fantastic 24 hours in Madrid with another raft of fabulous females, which had come just after the Medical Women's Federation conference in Cambridge where I met loads of lovely people. Must have had a rough clinic, I supposed; a family of 4 had gone in before me, and that is never good.

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GP Families Family IT 100

FDA Law Blog

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

JANUARY 30, 2025

They also present a more intense focus on the timelines for confirmatory study initiation and completion as well as the feasibility of those studies to verify clinical benefit within those timelines. Certain factors may require some confirmatory studies to be more underway than others. rare disease settings).

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IT Clinic Provider Patients 105

FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here.

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Electronics Manufacturing Provider Medical 59

FDA Law Blog

JUNE 29, 2022

In May 2014, FDA finalized a guidance document entitled “ Expedited Programs for Serious Conditions – Drugs and Biologics ,” (the Expedited Programs Guidance) This guidance noted that a “[d]esignation may be rescinded if it no longer meets the qualifying criteria for breakthrough therapy.” randomization, blinding).” Granted .

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FDA Law Blog

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

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Patients Patient-Centered Clinic IT 52

FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. That did not happen.

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Clinic IT Provider Patient-Centered 59

FDA Law Blog

DECEMBER 11, 2023

6] It is inconsistent to say that LDTs must be regulated as medical devices because of the newness of the tests and then reduce the cost of the proposed regulation by declaring that half of all LDTs will be exempt from premarket review. 2, 2014), [link]. [12] 2, 2014), [link]. [12] 31, 2023), [link]. [10] 11] Jeffrey N.

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IT Medical Patient-Centered Provider 69

Pamela Wible MD

JUNE 20, 2025

(Published 3/18/19, updated 6/20/25) What Is Physician “Burnout”—and Why It Matters Physician “burnout” is a state of emotional, physical, and mental exhaustion caused by prolonged stress in the medical workplace. and it has been linked to rising rates of physician depression , doctor suicide , and medical errors.

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GeriPal

OCTOBER 24, 2024

David is a physician who wrote the book “ Stoned: A Doctor’s Case for Medical Marijuana ” and gave a TED talk on “ A Doctor’s Case for Medical Marijuana ” that was watched over 3 million times. laughter] Alex 01:39 Material here for songs related to medical marijuana or marijuana in general. Eric 01:34 Yeah.

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Medical IT Patient-Centered Healthcare 100

The Medical Futurist

JUNE 21, 2025

Matthew Enevoldson, PR Manager at SkinVision told The Medical Futurist that technology such as their own is becoming more integrated within the health system, to both ensure that those who need treatment are made aware of it and that those who have an unfounded concern do not take up valuable time and resources.

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Patients Healthcare Board-Certified Telemedicine 98

The Clinical Problem Solvers

MARCH 4, 2024

Together, our guests offer context around how the medical and carceral systems are deeply intertwined and go hand-in-hand. Explain the significance of abolition medicine, and the role of the medical system in upholding and perpetuating carceral logics.

Community 52

Community Education Patient-Centered Relationship 52

Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. In fact, most sore throat symptoms resolve in three days for 60-70% of patients, according to March 2025 UpToDate, an evidence-based clinical decision support system used by healthcare professionals.

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ER Telehealth Primary Care Doctor Appointment 52

FDA Law Blog

JUNE 7, 2021

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established.

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Clinic IT Private Practice Utilities 98

The Clinical Problem Solvers

NOVEMBER 6, 2023

Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. Natal alienation is, in part, the under-structure of the wider Medical-Industrial Complex and the gratuitous violence that fat, Black, trans folks experience. is rooted in anti-Blackness.

Community 52

Community Manufacturing Patients Medical 52

GeriPal

MARCH 2, 2023

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. AFP 2019 Gabapentin for chronic neuropathic pain in adults. Eric: Are these generic?

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

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Clinic Telehealth IT Provider 59

The Clinical Problem Solvers

NOVEMBER 16, 2020

37:50​ Race vs. ancestry vs genetics–implications for research and clinical practice 52:02 ​What can we start doing tomorrow? Cartwright’s study influenced the equations that medical professionals still use to calculate the impact of various diseases on lung function. racial essentialism). racial essentialism). The New Press.

Clinical Practice 52

Clinical Practice Clinic Medical Education 52

GeriPal

JULY 21, 2022

I don’t practice clinically in outpatient settings, and often the folks I’m seeing are there for other kinds of issues. Emmy: But we know that physiologic changes with aging, like decreasing night vision and so forth, as well as medications, as well as medical conditions, can all affect whether you can drive.

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IT Families Family Diagnosis 102

PEMBlog

MARCH 27, 2024

She is a member of the Clinical Genome Resource Inborn Errors of Metabolism (IEM) Clinical Domain Working Group, where as a biocurator she assesses the pathogenicity of variants in IEM-associated genes to facilitate expedited genetic diagnosis for IEMs. Brad’s not a pediatric medical geneticist. On clinical presentation.

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Consulting Individual Families Family 59

GeriPal

APRIL 10, 2025

Why this study was a success due to the sheer size (nearly 100,000 patients in about 30 EDs) of the study, and the fact that, as far as the investigators know, all study sites continue to employ the clinical decision support tool. And then we had clinical decision support. What is a clinical decision support? Long overdue.

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Patient-Centered IT Hospital Patients 78

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.” I don’t see a lot of those out there.

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IT Patient-Centered Families Family 99

PEMBlog

JUNE 5, 2024

It was inspired by a hot-off-the-presses publication from the Pediatric Emergency Care Applied Research Network (PECARN) focused on clinical decision rules for cervical spine imaging in children. 2014 May;133(5):e1179-88. If they have no pain in the midline with any of these movements, then the cervical spine is clinically cleared.

Patient-Centered 52

Patient-Centered Patients IT Hospital 52

GeriPal

AUGUST 25, 2022

And yet, we know little about the clinical experience of people with dementia in hospice. Eric: Whenever I hear about for-profit, non-for-profit, the differences between them, mostly everybody turns to, I think, your 2014 paper looking at the differences between for-profit and non-for-profit. What motivated you? Lauren: Yeah.

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Families Family IT Patients 107

GeriPal

FEBRUARY 2, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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Consulting Hospital Patient-Centered IT 122

GeriPal

DECEMBER 7, 2023

AlexSmithMD Additional links: JAMA paper on clinical research risks, climate change, and health Geriatric medicine in the era of climate change Health Care Without Harm: [link] Practice Green Health: [link] Global Consortium for Climate and Health Education: [link] Transcript Eric: Welcome to the GeriPal podcast. Ruth: Right. Ruth: Yeah.

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Healthcare IT Education Community 130

PEMBlog

MAY 9, 2024

Nat Genet 2014; 46:1274. Obviously, you should ask about immunization status and whether or not the child has any underlying medical or neurologic problems or developmental delay. And the clinical clues that a seizure has ended are often subtle. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. So what does the AAP say?

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Illness Vaccination Families Family 59