FDA Law Blog

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. Walsh & Sophia R. Gaulkin & Steven J. This scrutiny was enhanced after the Fourth Circuits ruling in United States v. Mallory , 988 F.3d

Referral 59

Referral Relationship Government Healthcare 59

FDA Law Blog

JANUARY 12, 2025

FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance. Moreover, it was also interesting to see how FDA discussed the concept of unmet medical need in the limited fashion that it did in this new guidance.

Clinic 64

Clinic Relationship Provider IT 64

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).

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 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).

Lab Testing 40

Lab Testing Referral Individual Patient-Centered 40

ABIM

JUNE 4, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) Community Practice in ABIM Governance* Erica N.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

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. When I was a medical student at Baylor College of Medicine, I participated in their Ethics track. What I loved about my ethics classes was the focus on the four pillars of medical ethics.

Family Physician 52

Family Physician Family Families Healthcare Professional 52

The Clinical Problem Solvers

FEBRUARY 14, 2022

Unfortunately, medical practice does not always allow us to slow down and take this time to listen. 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.

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. There have been multiple subsequent government reports on nursing home care, most recently was about eight, nine years ago from the OIG. So I am requesting The Sifters by Andrew Bird. Eric: Can I ask why?

Finance 95

Finance Board-Certified IT Provider 95

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?

Individual 85

Individual Community IT Chronic Condition 85

FDA Law Blog

JUNE 4, 2025

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59

GeriPal

MARCH 6, 2025

We discuss the principles of harm reduction, social determinants of health, and trauma informed care. link] Kensington Hospice & ‘Radical Love’ Equity-Oriented Hospice Palliative Care Naheed Dosani also serves as the Medical Director of Kensington Hospice, Torontos largest hospice. those experiencing homelessness).

Healthcare 100

Healthcare IT Community Illness 100

GeriPal

JANUARY 11, 2024

Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). Panelists Bill Gardner, Sonu Gaind, Leonie Herx have stated they have no relationships to disclose. What’s up with Medical aid in dying in Canada? Four percent. Transcript Eric: Welcome to the GeriPal Podcast.

Illness 144

Illness IT Medical Provider 144

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.

Government 52

Government Medical Student Community Patients 52

GeriPal

SEPTEMBER 5, 2024

And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985. Bill 16:55 First of all, I just have to go back to Dax, because Dax in 1973 is when I first came out here as a senior medical student and met Al Johnson. And it’s not the same, but it does provide information.

Patients 98

Patients IT Patient-Centered Hospital 98

GeriPal

JUNE 26, 2025

And the government can do something about that?!? Disruptive events are medical, surgical. And there is this bidirectional relationship between wealth and health shocks. And then I was inspired by this paper and then really interested in looking at the bidirectional relationship between the two of them. And health shocks.

Illness 93

Illness Hospital IT Patient-Centered 93

GeriPal

APRIL 18, 2024

Then, it was like, well, it does as well as, and now, better than humans passing the medical boards, passing the law boards, doing great on the SAT, all that stuff. It was specific to the relationship with the patient, the patient’s social context in which they might take this information. Bob: It’s not bad.

Electronics 139

Electronics IT Patients Healthcare 139

GeriPal

DECEMBER 7, 2023

So if you look at government websites about heat for example, it’s got a line of buttons across the top with affected populations, outdoor workers, athletes and older people are in there. And it is going to affect, if it hasn’t already, our food quality, the food that’s available, our medications. Ruth: Right.

Healthcare 129

Healthcare IT Education Hospital 129

GeriPal

JULY 6, 2023

I’ve been on a quest to build those services and support so that people can make true, informed decisions for themselves and their families. We’re selling objectivity, information, independence and choice. I knew them, I developed a relationship with them. Take some time to get trust, to get real information.

Community 89

Community Nurse Practitioner Provider IT 89

Maine Academy of Family Physicians

JUNE 21, 2024

Please consider getting involved here in Maine - the Maine Medical Association & the Maine Osteopathic Association have a joint Legislative Committee that meets weekly during the session (usually January - May). Family Physicians Relieved SCOTUS Preserves Patient-Physician Relationship The June 13 U.S.

Family Physician 40

Family Physician Family Medicine DO Primary Care 40

GeriPal

AUGUST 22, 2024

Something which draws on some idea of what a human being is, which many of our citizens will disagree with, holding a different philosophical or religiously informed review about that. That also speaks to a lot of the particular family relationships and, of course, in that case, allegations of mistreatment along racial lines and so forth.

IT 113

IT Families Family Patient-Centered 113

The Clinical Problem Solvers

MAY 2, 2023

Together, our guests explain how trauma shows up in those who experience resettlement, and the role of trauma-informed and culturally-responsive care for refugee, asylee, and immigrant population in clinical practice.

Healthcare 52

Healthcare Provider Clinical Practice Clinic 52

GeriPal

JUNE 2, 2022

But we have very little information, almost no information. People who had had long standing relationships with their doctors wanted to change doctors. And their death rate was so high during Omicron because they had distrust to the vaccine and distrust to the government. We are going to have a massive outbreak in China.

Vaccination 100

Vaccination IT Hospital Management 100

FDA Law Blog

MAY 26, 2025

Even if otherwise truthful, the promotion of off-label uses of hormones-including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses-run afoul of the FDAs prohibitions on misbranding and mislabeling. Driehaus , 573 U.S. 149, 158 (2014). See 21 U.S.C.

Manufacturing 59

Manufacturing Provider Medical IT 59