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

Family Physicians of St. Joseph

SEPTEMBER 25, 2018

Written by Pat Moody on Moody on the Market When it comes to healthcare, and primary care in particular, it has become increasingly difficult to remain successful as a small, independent practice. The good doctors say that to state that stepping outside of the traditional box of healthcare has been challenging would be an understatement.

Family Physician 52

Family Physician Family Families Primary Care 52

Physician's Weekly

JUNE 24, 2025

Dr Vinson: I introduced the phrase in a 2020 essay I published after our initial 2016 case report. Over half of respondents reported dismissive encounters with healthcare providers. PW: Who coined the term “cold drink heart”? Why is skepticism common, and how would you address it?

Physicals 72

Physicals Primary Care Patients IT 72

Medical Xpress

FEBRUARY 6, 2023

Investigators from Brigham and Women's Hospital, a founding member of the Mass General Brigham healthcare system, compared national data on primary care visits from 2006 and 2007 to data from 2016 and 2018, finding that the proportion of visits addressing mental health concerns rose by almost 50 percent.

Primary Care Physician 70

Primary Care Physician Primary Care Mental Health Healthcare 70

The Clinical Problem Solvers

APRIL 24, 2025

Her mission — preparing the next generation of diverse physician leaders in pediatric healthcare and mental health and creating partnerships between communities and academic centers — will be critical for eliminating disparities among minority populations. 2016 Mar;67(3):324-31. Dr. Kevin M. References 1. Psychiatr Serv.

Mental Health 52

Mental Health Community Hospital Appointment 52

PEMBlog

JUNE 14, 2023

This episode is a co-production of the Emergency Medical Services for Children Innovation and Improvement Center whose mission is to minimize morbidity and mortality of acutely ill and injured children across the emergency continuum. Children’s Mental Health Emergency Department Visits: 2007-2016. Government. Pediatrics.

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Mental Health Management Patient-Centered Illness 98

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. KP Medical Device Consulting LLC

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law Blog

APRIL 25, 2023

The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers. Software as a Medical Device, or SaMD) or the software is embedded in a traditional hardware device (i.e.,

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Specialization Provider Medical Manufacturing 105

The Clinical Problem Solvers

MARCH 14, 2025

Her mission — preparing the next generation of diverse physician leaders in pediatric healthcare and mental health and creating partnerships between communities and academic centers — will be critical for eliminating disparities among minority populations. 2016 Mar;67(3):324-31. Dr. Kevin M. 2015;169(7):673-677. Psychiatr Serv.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. These factors include a high-protein diet, muscle mass, creatinine generation, and certain medications.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

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. 812(c)(c)(10). 21 U.S.C. §

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Government Medical IT Manufacturing 59

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

Annals of Family Medicine

NOVEMBER 20, 2024

Objective: Identify patient, provider, and healthcare process and utilization factors associated with rates of secondary acceptance of the HPV vaccine.

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Vaccination Family Medicine DO Primary Care 130

BMJ

FEBRUARY 8, 2021

7 The same degree of focus has not been paid to misuse of other prescription medications which also have high abuse potential among youth, including medications such as prescription stimulants, tranquilizers, and sedatives. misuse of prescription medications). 2 Opioids contribute a large share of this overdose crisis.

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Medical Holistic Care Healthcare Healthcare Professional 40

The Clinical Problem Solvers

DECEMBER 20, 2021

provision in only English +/- Spanish), limitations of medical technology (i.e., Dr. Nguyen encourages us to recognize how such barriers represent assumptions about people’s capabilities, how they can worsen people’s healthcare, and how they communicate exclusion to our Asian patients. Insufficient language services (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

FDA Law Blog

JANUARY 18, 2024

FDA conducted the eight-factor scheduling analysis required by the CSA in 2016 and found that marijuana continued to meet the scheduling criteria for remaining in schedule I. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

Medical 69

Medical Physicals IT Healthcare Professional 69

FDA Law Blog

MAY 5, 2024

Former DEA Administrators and National Drug Policy Directors asserted that the science demonstrating marijuana’s high addictive potential, its lack of accepted medical use, and rescheduling impact on prosecuting drug trafficking organizations required marijuana to remain in schedule I. Letter to U.S. treaty obligations in rescheduling.

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Medical Manufacturing Physicals Healthcare Professional 95

The Motivated MD

SEPTEMBER 19, 2024

In medicine, it is commonly agreed that ‘to err is human’ Most healthcare professionals would agree that humans make mistakes. A study by Johns Hopkins in 2016 found that medical errors may potentially be the third leading cause of death nationwide. So yes, humans make mistakes.

Finance 52

Finance Individual Education Healthcare Professional 52

Permanente Medicine

APRIL 29, 2025

From 2012 to 2016, death rates from colorectal cancer among Black people were nearly 40% higher than in whites and double that seen in Asians and Pacific Islanders, according to the American Cancer Society. Levin, MD , a Kaiser Permanente Division of Research scientist and gastroenterologist with The Permanente Medical Group.

Screening 52

Screening Checkup Integrated Care Electronics 52

FDA Law Blog

NOVEMBER 29, 2022

Houck — On November 4th, CDC issued its revised guideline on prescribing opioids for pain as an expansion and update of its 2016 CDC Opioid Prescribing Guideline. We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). By Larry K. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R.,

Patients 52

Patients Patient-Centered ER Individual 52

GeriPal

OCTOBER 10, 2024

Alex 01:23 And we’re delighted to welcome DorAnne Donesky, who is a palliative care nurse practitioner at Queen of the Valley Medical center in Napa and professor emeritus at the UCSF School of Nursing. It’s all what we signed up for when we signed up on the dotted line to be in healthcare and palliative care.

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Screening IT Family Families 119

GeriPal

DECEMBER 8, 2022

Heather Coats is hard at work establishing the evidence base for the power of capturing patient stories in healthcare settings, for those health systems that need a little more convincing. . My Life, My Story: VA’s healthcare improvements through deliberate storytelling – YouTube. Wonderful work. Every Veteran has a story.

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Patient-Centered Illness Healthcare IT 115

GeriPal

FEBRUARY 29, 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.

IT 126

IT Patient-Centered Illness Education 126

GeriPal

FEBRUARY 15, 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.

Community 114

Community Transportation IT PCP 114

GeriPal

DECEMBER 15, 2022

Tell me how your illness has impacted your relationships with others, your healthcare team, your family, friends, your beliefs, your values, your preferences. And now my program of research is around testing that person-centered narrative intervention or PCNI because you have to give them an acronym in healthcare. Heather: Yeah.

IT 105

IT Patient-Centered Healthcare Illness 105

GeriPal

JANUARY 11, 2024

Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. Four percent. AMA PRA Category 1 credit(s) ™.

Illness 144

Illness IT Medical Provider 144

FDA Law Blog

JUNE 9, 2025

These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care. The FDA Reauthorization Act of 2017 (FDARA) directed FDA to develop guidance to enhance diversity in clinical trials. FDORA further directed FDA to issue guidance on the format and content of DAPs.

Clinic 59

Clinic IT Healthcare Medical 59

GeriPal

APRIL 14, 2022

So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. This delineation of you can use the same medication for one indication without training. Eric: And why Under Pressure. Zachary: It’s it using buprenorphine is much easier.

Illness 102

Illness Patient-Centered IT Patients 102

FDA Law Blog

FEBRUARY 9, 2022

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” at 62,341; see Jones Total Healthcare Pharmacy, L.L.C. Cocktail Medications.

IT 40

IT Insurance Government Patients 40

GeriPal

JUNE 30, 2022

Alex: Today, we are delighted to welcome Joel Weissman, who is a health services researcher and deputy director and chief science officer for surgery at the Center for Surgery and Public Health at Harvard Medical School. And where I’m going with this is even if … Or patient-centered medical home, patient-centered care, right?

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

APRIL 3, 2025

We used all of our political capital to make sure it happens in Chicago, which is where we started for the literature Updates back in 2016, back when it was just me and Ken, and then we brought in Alex, like two years later. Annie 05:16 So if you look back in history, I think Eric and Ken have been doing this since 2016. Go Cubs, go.

IT 64

IT Hospital Screening Patients 64

GeriPal

MARCH 30, 2023

This week we’ve invited three guests to share their stories about storytelling that’s written for healthcare providers. We’ve also love to hear from you on twitter and facebook your own experiences writing for the medical world (and please include links!) What motivated you to reach out to the healthcare audience in this way?

IT 95

IT Patient-Centered Patients Healthcare 95

GeriPal

MARCH 28, 2024

Tom: So we did this study because patients who go through the stem cell transplant process face a lot of misery in terms of physical symptoms, psychological distress, anxiety, depression, and even a risk of PTSD afterwards, sort of like a medical trauma, you might think of it. Eric: And that’s similar to the 2016 JAMA paper, right?

Consulting 115

Consulting Patient-Centered IT Patients 115

GeriPal

APRIL 10, 2025

I think back in what, May 2016, you published a randomized controlled trial, first author, palliative care and the ED randomized study, cancer patients. Eric 04:26 So that 2016 study was in the ED, but it was getting specialty palliative care to see them when they were hospitalized, is that right? Primary outcome was quality of life.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

GeriPal

JULY 28, 2022

And so I went into medical school wanting to cure cancer. I entered medical school and I did a course that was offered that’s called living with a life threatening illness. I entered medical school and I did a course that was offered that’s called living with a life threatening illness. Areej: I think it was 2016.

Illness 110

Illness Hospital Patient-Centered Patients 110

GeriPal

OCTOBER 5, 2023

And I’ve noticed how we can say things like, you’re not a surgical candidate or you’re too weak to get more chemotherapy, but we can never really talk about CPR as a medical procedure in the ways we talk about other procedures and can make recommendations and offer reasoning about those procedures. This is Eric Widera.

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Illness IT Patient-Centered Family 136

GeriPal

AUGUST 24, 2023

Summary Transcript Summary I hear the word dignity used a lot in the medical setting, but I’m never sure what people mean when they use it. Medical Assistance in Dying and Palliative Care: Shared Trajectories Transcript Eric: Welcome to the GeriPal Podcast. And we published in the Journal of the American Medical Association.

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Patient-Centered Patients IT Illness 98