Annals of Family Medicine

MARCH 24, 2025

PURPOSE We tested for direct and indirect effects that performance-based reimbursement (PBR) in primary care has on perceived individual and organizational quality of care, and the role of illegitimate tasks and moral distress as potential mediators. RESULT Of the 433 participants, 70% reported that PBR negatively impacted their work.

Primary Care 130

Primary Care Primary Care Physician Individual Healthcare 130

Annals of Family Medicine

NOVEMBER 20, 2024

Context: Substance use disorders (SUD) significantly impact the physical, social, and mental health of individuals, their families, and the wider community. Recovery is a unique, multidimensional process where individuals strive to enhance their health and wellness.

Community 130

Community Families Family Individual 130

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. Results: Participants conceptualized professionalism as individualized and highly focused on patient care.

Family Physician 130

Family Physician Families Family Patient-Centered 130

Physician's Weekly

JUNE 26, 2025

When a child has risk factors but has not developed the disease, we must continue to provide preventive care and support for the family and appropriately match intensity and dose of the intervention. What modifications would you recommend to clinicians? This starts with recognition that obesity is a chronic disease.

Families 52

Families Family Preventive Care Preventative Care 52

Annals of Family Medicine

NOVEMBER 20, 2024

The development of a guidance report began in August 2022 and was informed by individuals and organizations within Canada and abroad. The CFPC Board endorsed the guidance report in December 2023. The report provides guidance for the CFPC’s future work to support research and will inform its strategic planning processes.

Family Physician 130

Family Physician DO Family Medicine Families 130

Physician's Weekly

JUNE 19, 2025

When Alyne Diamond fell off a horse in August 2023 and broke her back, her employer-based health plan through UnitedHealthcare covered her emergency care in Aspen, Colorado. The insurer not only stopped paying current claims but also moved to claw back tens of thousands of dollars it had paid to providers in the two years since she turned 65.

Insurance 52

Insurance Patient-Centered Government Provider 52

FDA Law Blog

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. 11, 2023 ( DOJ Press Release ). 11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ).

Treatment Plan 139

Treatment Plan ER Government Patient-Centered 139

Common Sense Family Doctor

DECEMBER 27, 2024

" The Gilded Age of Medicine is Here ," announced the title of a recent New Yorker article about the tactics of private equity firms that provide infusions of cash to struggling hospitals in order to extract hundreds of millions of dollars in profits by slashing costs to the bone and endangering the health of patients. Nevertheless, the U.S.

Primary Care 52

Primary Care Insurance Patient-Centered Medical Student 52

My Green Doctor

APRIL 4, 2025

According to the 2023 report of the Lancet Countdown, mortality caused by extreme heat events increased by 53.7% Behavior Change Happens in the Exam Room Unlike government agencies or corporations, healthcare professionals speak directly to individuals in a trusted, one-on-one setting. from 2000 to 2018 among people over 65 years old.

Healthcare Professional 52

Healthcare Professional Healthcare Community Medical Advice 52

The Clinical Problem Solvers

APRIL 3, 2023

[link] CPSolvers: Anti-Racism in Medicine Series Episode 20 – Medical Racism and Indigenous Peoples Show Notes by Sudarshan (“Sud”) Krishnamurthy April 4, 2023 Summary: This episode highlights the checkered past of medicine and the advancements in the field that have occurred at the expense of the humanity of Indigenous peoples.

Medical 52

Medical Healthcare Individual Community 52

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.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

SEPTEMBER 19, 2023

That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”. And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue. Koblitz & Kurt R.

Manufacturing 105

Manufacturing Provider IT Healthcare 105

Priority Physicians

JANUARY 27, 2025

of adults in the state showed significant symptoms of anxiety or depression in 2023. We all want to know how to stop fearing the future. Although anxiety appears to be the new malady du jour , much of it is natural and normal. Sometimes, it’s even protective. From an evolutionary standpoint, anxiety is an effective survival mechanism.

Primary Care Doctor 52

Primary Care Doctor Primary Care Board-Certified Physicals 52

Aspiring Minority Doctor

FEBRUARY 7, 2023

I’m actually about to land soon and can barely keep my eyes open as I’ve been traveling since yesterday, but I wanted to get this started so that I can finish and hopefully post tomorrow. I figured I didn’t have a chance in hell at winning, but I shared anyway because 1) I’m always happy to share my story with hopes that it uplifts/inspires others.

IT 52

IT Medical Mental Health Patients 52

FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

Physician's Weekly

JUNE 27, 2025

In an email, Vianca Rodriguez Feliciano, a spokesperson for the Department of Health and Human Services, said the agency “is committed to supporting a strong, stable long-term care workforce” and “continues to work with states and providers to ensure quality care for older adults and individuals with disabilities.”

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FDA Law Blog

MAY 19, 2025

For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. By Larry K. Houck Last month the U.S. 81, 86, 251. 81, 89, 251.

Individual 64

Individual Patients Provider Medical 64

FDA Law Blog

OCTOBER 2, 2023

A brief explainer on confirmatory evidence: how we got here Before we dive into the specifics of the new guidance, we should explain that the statutory standard we allude to is the requirement that an applicant provide “substantial evidence of effectiveness” to obtain approval of an NDA or BLA.

IT 64

IT Clinic Provider Medical 64

FDA Law Blog

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. They range from individuals and start-up companies with no in-house legal staff to large multinational corporations.

Government 40

Government Provider Medical Individual 40

FDA Law Blog

FEBRUARY 23, 2025

To help in evaluating device changes, manufacturers commonly refer to FDAs guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, which provides FDAs interpretation of the changes it believes could significantly affect the safety or effectiveness of a device. For example, in an October 13, 2023 WL to ReNovo, Inc.,

Manufacturing 64

Manufacturing Provider Consulting IT 64

FDA Law Blog

MAY 8, 2023

FDA recommends that PCCPs specify only a “limited number” of modifications but does not provide a limit on the number of modifications that can be included. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device).

Manufacturing 98

Manufacturing Provider Medical IT 98

Family Physicians of Greeley

MAY 17, 2023

Surround yourself with supportive and positive individuals who uplift you and provide a sense of belonging. Maintaining good mental health is essential for our overall well-being. In today’s fast-paced and often stressful world, it’s important to prioritize self-care and adopt strategies that promote mental well-being.

Mental Health 40

Mental Health Physicals Healthcare Professional Relationship 40

PEMBlog

MAY 1, 2025

Learning Objectives Describe the classic and atypical clinical presentations of Parvovirus B19 infection in pediatric patients, including erythema infectiosum, arthropathy, transient aplastic crisis, and chronic anemia in immunocompromised hosts. UpToDate , Jun. link] Macri, Angela, and Crane, Jonathan S. Parvoviruses. Erythema Infectiosum.

Complication 83

Complication Patient-Centered Patients Clinic 83

PEMBlog

APRIL 20, 2023

It is therefore no hyperbole to say that Emicizumab has been a life-changing therapy for individuals with hemophilia A who have factor VIII inhibitors (alloantibodies against factor VIII). Emicizumab allows these individuals to have good bleed control, improvement in their joint health and their quality of life.

Individual 52

Individual Patient-Centered Patients IT 52

FDA Law Blog

NOVEMBER 14, 2022

The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the CARES Act. FDA stresses that the law does not provide exemptions or waivers. By Riëtte van Laack & Deborah L. Livornese — Early Nov.

Manufacturing 52

Manufacturing Individual Management Provider 52

FDA Law Blog

JUNE 22, 2023

FDA hailed its authorization of the Lucira OTC home test for influenza and COVID-19 as “underscor[ing] the Agency’s continued commitment to increase availability of accurate and reliable at-home diagnostic tests” ( April 2023 FDA Update to CDC ). By McKenzie E. Cato & Jeffrey N. Gibbs & Allyson B. lay users).

Manufacturing 59

Manufacturing Clinic IT Transportation 59

The Clinical Problem Solvers

DECEMBER 16, 2020

Moreover, center patients not only in discussions about individual decision-making but in constructing and drawing meaning from the research. 13:16 Status of the current conversation on removing race from eGFR calculators: why is it so contentious? Poet Marge Piercy has written, “The work of the world is as common as mud.”

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.

Clinic 59

Clinic Telehealth Provider Electronics 59

FDA Law Blog

JUNE 21, 2023

enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., By Philip Won & McKenzie E.

Medical 45

Medical Patients Healthcare Electronics 45

FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

Provider 59

Provider Screening IT Government 59

FDA Law Blog

JUNE 12, 2023

PFI expressed some of its frustration with the current state of regulation of pet food by individual states in its comments on the Center for Veterinary Medicine (CVM) Virtual Public Meeting FDA and the AAFCO Animal Feed Ingredient Definition Process. Enforcement for these regulations also occurs both by federal and state officials.”

Manufacturing 45

Manufacturing Individual Government Illness 45

FDA Law Blog

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. § 812 (b)(1).

Government 59

Government Medical IT Manufacturing 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. By Deborah L. This is the third topic included in the new draft guidance. This significant opportunity under the Existing FDR Guidance is not offered for monograph FDRs.

Utilities 52

Utilities Provider Individual IT 52

FDA Law Blog

DECEMBER 13, 2023

Sasinowski — On December 12, 2023, FDA announced the creation of a new advisory committee specifically for treatments for genetic metabolic diseases, the Genetic Metabolic Diseases Advisory Committee, or “GeMDAC.” Tobolowsky & James E. Valentine & Charles G. Raver & Frank J.

Patient-Centered 59

Patient-Centered Medical Patients IT 59

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. Acute onset psychosis is relatively rare.

Lab Testing 52

Lab Testing Medical Patients Mental Health 52

FDA Law Blog

APRIL 23, 2023

The Draft Guidance recommends that, where possible, the outcome should be assessed by individuals blinded to treatment status, which may require re-adjudication of externally controlled data. This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources.

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

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

Insurance 52

Insurance Patients Utilities Chronic Condition 52