FDA Law Blog

OCTOBER 8, 2023

That First Temporary Rule also provided a one-year grace period, through November 11, 2024, for any practitioner-patient telemedicine relationships established on or before November 11, 2023. DEA next hosted Telemedicine Listening Sessions on September 12 and 13, 2023, for which it receive over 180 requests to present.

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Telemedicine Relationship IT Mental Health 64

Permanente Medicine

MAY 20, 2025

” “Whether you’re the call center agent, the receptionist, [or] the lab tech, you participate and you provide the input into innovation,” said Dr. Nguyen. The Southern California Permanente Medical Group is one of the largest medical groups in the nation with more than 8,800 physicians providing care for over 4.8

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FDA Law Blog

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Medicare or Medicaid).

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FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs application and use of accelerated approval has evolved dramatically since it was first developed by the Agency to help address the HIV/AIDS epidemic in the late 1980s.

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Clinic Relationship Provider IT 64

Tiny Physician

JULY 3, 2022

The use of this remedy as per homeopathic textbooks is to break down emotional barriers and boost relationships. If this is true, then the North and South Korean leaders should have this simultaneously in order to improve relationships between them. Yeah, you heard it right, moon.

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FDA Law Blog

JUNE 8, 2023

The pandemic also deeply impacted how industry and the government conduct their operations. An estimated timeline for the return of in-person meetings has not been provided by CDRH. The pandemic had changed the way people live, work and communicate. Such changes are not limited to personal circumstances.

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Relationship Government Screening Medical 53

FDA Law Blog

JANUARY 6, 2022

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added).

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Lab Testing Referral Individual Patient-Centered 52

FDA Law Blog

SEPTEMBER 6, 2022

As the new Federal Register notice explains, FDA issued the 2016 Guidance in question and answer format to respond to the most frequently asked questions about charging for investigational drugs provided under an IND for either clinical trials or expanded access for treatment use under 21 CFR section 312.8. Changes from the 2016 Guidance.

Clinic 52

Clinic Manufacturing Patients IT 52

FDA Law Blog

JANUARY 6, 2022

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added).

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Lab Testing Individual Referral Patient-Centered 40

Annals of Family Medicine

NOVEMBER 20, 2024

Objective To evaluate public perceptions of uncertainty and disagreement among experts in healthcare recommendations and whether it is associated with decreased trust in health entities as providers of accurate health information. Adults aged 18 and older were respondents to the survey (unweighted n=5842, representing 241 million adults).

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Education Government Patients Relationship 130

ABIM

JUNE 4, 2025

Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

GeriPal

JUNE 19, 2025

Just today (June 17th) as we record this podcast: Ezra Klein released a wonderful interview with Sarah McBride , the first openly transgender member of congress A judge ruled that cuts to NIH grants focused on minority groups, including transgender people, were illegal and ordered the government to restore funding. Can you tell me about that?

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Individual Community IT Chronic Condition 82

The Clinical Problem Solvers

FEBRUARY 14, 2022

By preventing Black and Brown people from developing relationships with the land and using it as a way of forming social connection, as well as communal sustenance, structural racism manifests along lines of race and place. Funding structures, especially from government agencies, are not exactly permissive of this. Be curious.

Community 52

Community Individual Mental Health IT 52

GeriPal

JANUARY 20, 2023

Jasmine: It’s an imaginative love story that deconstructs age through an intergenerational friend relationship. Jasmine: It’s an imaginative love story that deconstructs age through an intergenerational friend relationship. Welcome back to the GeriPal podcast, Mike. I hope I got that right. Mike: You got it right.

Finance 95

Finance Board-Certified IT Provider 95

Vida Family Medicine

JUNE 29, 2022

I care deeply about each and every one of my patients, and I do not want a difference in opinion to create a wedge in our relationship. The healthcare system must provide care in a just way so that those who need care have access to it. When I was a medical student at Baylor College of Medicine, I participated in their Ethics track.

Family Physician 52

Family Physician Families Family Healthcare Professional 52

GeriPal

MAY 12, 2022

Raj faced in pain management: access to opioids, corruption, a system that doesn’t see addressing suffering as a priority. Prognosis communication and the subtle ways we may communicate it without intention. Social pain and loneliness. Community-based palliative care networks . Raj’s reflections on the state of palliative care in the US. Transcript.

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Community IT Relationship Healthcare 115

FDA Law Blog

MARCH 13, 2024

1.740), stating that: If the applicant for patent term extension was not the marketing applicant before the regulatory agency, then there must be an agency relationship between the patent owner and the marketing applicant during the regulatory review period. must demonstrate its agency relationship with the NDA holder (Biogen, Inc.)

Relationship 59

Relationship Provider IT Government 59

GeriPal

APRIL 13, 2023

Check out some of their recent work, including: Dr. Holt-Lunstad’s and Dr. Perissinotto’s powerful perspective piece in the New England Journal of Medicine which provides a clinical framework for addressing loneliness and social isolation. Welcome back, Ashwin. Ashwin Kotwal: Excited to be back. Eric: Now, it’s interesting. All right.

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IT Community Patient-Centered Medical 99

GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. Today we discuss: What is the best terminology? Homelessness? Marginally housed? What makes palliative care for people experiencing homelessness challenging? What makes it rewarding? those experiencing homelessness).

Healthcare 100

Healthcare IT Community Illness 100

GeriPal

JANUARY 11, 2024

Panelists Bill Gardner, Sonu Gaind, Leonie Herx have stated they have no relationships to disclose. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Four percent. To many this rapid expansion will represent autonomy run amok. Oh my gosh.

Illness 144

Illness IT Medical Provider 144

Tiny Physician

MARCH 30, 2022

A doctor-patient relationship is mandatory in the case and this can be proven by cross-checking the duty list or from the patient’s case sheet. For example, a doctor working at a primary health center may not able to provide adequate care for a pre-term newborn child. She was admitted and Dr.Archana conducted the delivery.

Hospital 52

Hospital Government Patient-Centered Medical 52

GeriPal

SEPTEMBER 5, 2024

But before we go into all of that, I think, Bill, you have a song request for Alex. Bill 01:52 I do. Bill 01:53 Alex asked me for a song that was resonating in my head at the time, and it would be Guy Clark’s song, T he Cape. Eric 02:01 Why guy Clark’s the Cape? Bill 02:03 Oh, it’s a long story. I’ll make sure. Here we go.

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Patients IT Patient-Centered Hospital 98

Doctors for America

MAY 5, 2025

FOR IMMEDIATE RELEASE Doctors for America PO Box: 21161 2300 18th St NW Lbby Washington, DC 20009-9996 May 5, 2025 Doctors, Local Governments File Brief to Defend Reproductive Health Care Privacy Rights Brief Argues that Upending HIPAA Privacy Rights Would Contradict Decades of Established Precedent WASHINGTON, D.C.

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Government Medical Student Community Patients 52

GeriPal

JUNE 26, 2025

And the government can do something about that?!? Tsai-Chin’s article, published in Lancet Healthy Longevity, found a tantalizing hint that countries with stronger safety nets had lower incidence of wealth shocks, and less of a deleterious impact of the wealth shock on cognitive function. This is Eric Widera. Alex 00:12 This is Alex Smith.

Illness 73

Illness Hospital IT Patient-Centered 73

GeriPal

DECEMBER 7, 2023

Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US. My kids ask – why don’t adults care about this issue the same way that they and their friends care about it? Ruth: Thank you.

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Healthcare IT Education Community 129

GeriPal

JULY 6, 2023

Summary Transcript Summary You may have heard of Area Agencies on Aging, but do you really know what they do or how they do it? What about State Departments of Aging or state master plans for aging? Do you know how these agencies fit in with programs like Meals-on-Wheels or other nutritional support programs? Susan: It is my anthem.

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

AUGUST 22, 2024

Why does this issue keep coming up? Why is it unresolved? Today we put these questions to Winston Chiong, a neurologist and bioethicist, and Sean Aas, a philosopher and bioethicist. We’ll have a link to that in our show notes. We’re gonna double up on that subject. Alex 01:07 We haven’t figured it out. Alex 01:48 All right.

IT 113

IT Families Family Patient-Centered 113

Maine Academy of Family Physicians

JUNE 21, 2024

Providers of abortion and gender affirming care in Maine are effectively shielded from laws in other states by the passage of protection by the legislature. This bill would preclude the government from charging interest on their loans during when they are unable to afford payments on the principal. LD 227 was signed by Governor Mills.

Family Physician 40

Family Physician Family Medicine DO Primary Care 40

The Clinical Problem Solvers

MAY 2, 2023

[link] CPSolvers: Antiracism in Medicine Series Episode 21 – Psychosocial and Cultural Considerations for Providing Healthcare to Immigrant and Refugee Populations Show Notes by Kiersten T. A lot of compounding trauma occurs at the border that has potential downstream mental health implications for individuals and their families.

Healthcare 52

Healthcare Provider Clinical Practice Clinic 52

GeriPal

JUNE 2, 2022

Well, on today’s podcast we invite Monica Gandhi to sum up the evidence to date about how best to prevent getting COVID (or at least the severe outcomes of the disease) and how to treat it, including the role of Paxlovid in symptomatic disease. A good twitter criticism of the CDC 1 in 5 COVID survivors have long COVID study. Transcript. Alex: Great.

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Vaccination IT Hospital Management 100

FDA Law Blog

MAY 26, 2025

Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care. Department of Health & Human Services purporting to provide a comprehensive review of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria.

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Manufacturing Provider Medical IT 59