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. link] Tsai J.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

JUNE 3, 2025

We received a response to our post on the prescribing red flags indicating the likelihood of certain prescriptions filled by Walgreens pharmacies were invalid because they lacked a legitimate medical purpose or were not issued in the usual course of professional practice. Recommendation 1. at Background.

Clinical Practice 59

Clinical Practice Patient-Centered Patients Clinic 59

FDA Law Blog

APRIL 22, 2024

When DEA denied marijuana rescheduling petitions in August 2016, cannabis was listed as a schedule I and schedule IV substance under the Single Convention. marijuana manufacturers, importers, exporters, and distributors will be required to obtain DEA registrations, and prescriptions will be required for dispensing marijuana to individuals.

Manufacturing 59

Manufacturing Consulting IT Individual 59

FDA Law Blog

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. The final rule emphasizes risk management activities and risk-based decision making. The new § 820.10

Manufacturing 59

Manufacturing Management Medical IT 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.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The CDS Guidance interprets the Cures Act’s definition of “medical software” that is excluded from the statutory “device” definition, as it relates to CDS software.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law Blog

JUNE 29, 2022

For CDER specifically, the division must discuss the proposed rescission with CDER’s Medical Policy Council prior to notifying the sponsor. The Medical Policy Council’s role, as described in the MAPP, is to discuss decisions to rescind to ensure consistency in policy implementation across review divisions. Fiscal Year.

IT 52

IT Clinic Provider Medical 52

FDA Law Blog

JUNE 23, 2021

As someone who studied in the fields of public health, medical sociology, and biomedical ethics, I was impressed with how quickly the pharmaceutical and biotechnology arena caught up with what took many decades to occur in the context of the physician-patient relationship. What’s Next for Patient-Focused Drug Development? 25, 2014).

Patients 52

Patients Patient-Centered Clinic IT 52

Annals of Family Medicine

NOVEMBER 20, 2024

DDI exposures were considered incident if the individual was not exposed to a DDI in the year preceding cohort entry. or 7,498/63,834 individuals in the cohort were exposed to at least one high-priority DDI over 12 months in 2015-2016. 2) Hazard ratio for an adverse event (emergency room visit, hospitalization, or death).

Primary Care 130

Primary Care Emergency Room Insurance ER 130

FDA Law Blog

APRIL 13, 2021

The monologue above raises a few key points that we will address individually. This was the strategy employed when the emergency was declared for the Zika virus back in August 2016. We’re now making nine decisions a day. Not all decisions are authorizations. How many of the decisions are Authorizations?

Individual 40

Individual IT Medical 40

FDA Law Blog

MARCH 17, 2022

We blogged on the final 2016 guideline here on March 17, 2016). As explained more fully below, CDC concedes that states, insurers, pharmacies and pharmacy benefit managers have implemented laws, regulations and policies that have misapplied the 2016 guideline. 2016 Guideline. Purpose of the Proposed Guideline.

Patient-Centered 75

Patient-Centered Clinical Practice Patients Individual 75

Annals of Family Medicine

NOVEMBER 20, 2024

Population Studied – The Vizient® Clinical Data Base was queried for inpatient discharges between January 2016 and February 2024 with an ICD-10-CM diagnosis code for naegleriasis (B60.2). fowleri infections, reporting a broader age spectrum of affected individuals than traditionally reported.

Diagnosis 130

Diagnosis Patients Clinic Individual 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.

Medical 40

Medical Holistic Care Healthcare Healthcare Professional 40

The Motivated MD

SEPTEMBER 19, 2024

For the better half of 2024, I have been periodically writing posts that are individual articles that double as potential chapters to a future book. Before we discuss each individual savings account, let us first highlight exactly what it means to ‘automate’ your savings. So yes, humans make mistakes.

Finance 52

Finance Individual Education Healthcare Professional 52

FDA Law Blog

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. Then, in 2016, FDA noted its goal to streamline MDR requirements in the Medical Device User Fee Amendments of 2017 (MDUFA IV) commitment letter.

Medical 59

Medical Manufacturing Individual Provider 59

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

The Clinical Problem Solvers

DECEMBER 20, 2021

Fields Guests: Thu Quach, PhD, and Tung Nguyen, MD Time Stamps 00:00 Introduction 04:00 How Dr. Thu Quach’s and Dr. Tung Nguyen’s journeys shape their work 11:40 Policy work as a way of mitigating burnout 12:55 Balancing individual and communal focus (include?) provision in only English +/- Spanish), limitations of medical technology (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

FDA Law Blog

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. and lack accepted safety for use under medical supervision.

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95

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. Eric: Yeah.

Community 115

Community Transportation IT PCP 115

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. This is Eric Widera.

Illness 144

Illness IT Medical Provider 144

FDA Law Blog

JUNE 24, 2021

Cato — On June 18th, FDA published a draft guidance document titled Remanufacturing of Medical Devices , which has been several years in the making. In 2016, FDA opened a docket seeking comments on “service, maintenance, refurbishment, and alteration of medical devices” by third parties (see our blog post here ).

Manufacturing 52

Manufacturing Medical Provider IT 52

PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. 2016 Jan;37(1):3-15; quiz 16-7, 47.

Consulting 59

Consulting Individual Families Family 59

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. Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

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

GeriPal

APRIL 3, 2025

Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. Annie 05:16 So if you look back in history, I think Eric and Ken have been doing this since 2016. But in spite of that, it is a lot of work for three individuals to pull all this together.

IT 64

IT Hospital Screening Patients 64

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.” 10, 2016); East Main Street Pharmacy; Affirmance of Suspension Order, 75 Fed.

IT 40

IT Insurance Government Patients 40

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

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.

Patient-Centered 98

Patient-Centered Patients IT Illness 98

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.

Illness 136

Illness IT Patient-Centered Families 136

GeriPal

DECEMBER 8, 2022

And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. So like I said, I got to meet Thor, I believe it was May, 2016. Depends om my audience. Eric: And what are you doing as far as a research project? Heather: Yeah. Oh my gosh.

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

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

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

MARCH 30, 2023

We’ve also love to hear from you on twitter and facebook your own experiences writing for the medical world (and please include links!) And so, it’s about going live on stage in the medical audience, and everything from the whiteboard in the surgery room saying, “Here’s the lineup. This is Eric Widera.

IT 96

IT Patient-Centered Patients Healthcare 96

GeriPal

DECEMBER 15, 2022

And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. So like I said, I got to meet Thor, I believe it was May, 2016. Depends om my audience. Eric: And what are you doing as far as a research project? Heather: Yeah. Oh my gosh.

IT 105

IT Patient-Centered Healthcare Illness 105

GeriPal

AUGUST 25, 2022

Nurse case management, social worker case management, medications, medical equipment, a home health aid, all that stuff goes away. Melissa: The other scenario that exists is just disenrollment because an individual is hospitalized. They only started having to publicly report these in 2016.

Families 106

Families Family IT Patients 106

Annals of Family Medicine

NOVEMBER 20, 2024

Objective: To describe individual characteristics and healthcare use in older adults with SMI across home care services (HCS) profiles before and after the first dementia diagnosis. Dataset: Health administrative data from 380,124 Quebecers between 1996 and 2016. Study Design and Analysis: Retrospective cohort study.

Diagnosis 130

Diagnosis Healthcare Illness Primary Care 130