The Clinical Problem Solvers

DECEMBER 16, 2020

19:05 Clarifying the “ethics vs science” argument and critiquing research techniques 22:00 Resurgence of race-based speculation in COVID-19-related research 25:57 Implantation of ideas about innate racial inferiority within medicine 28:32 Will removal of race from algorithms potentially harm our patients?

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Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

APRIL 25, 2023

Note that section 3060(a) of the 21st Century Cures Act in 2016 amended section 520 of the FD&C Act and removed certain software functions from the statutory definition of a medical device. It applies whether the software is the entire device (i.e., Software in a Medical Device, or SiMD).

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The Clinical Problem Solvers

APRIL 24, 2025

The episode also explores how digital tools can help youth manage their mental health, while also noting the need for culturally relevant care providers. A Culturally Informed Approach to Supporting Suicidal Minoritized Patients. 2016 Mar;67(3):324-31. Child and Adolescent Psychiatric Clinics of North America. doi:10.1016/j.chc.2022.01.002

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Mental Health Community Hospital Appointment 52

FDA Law Blog

APRIL 11, 2022

Shapiro — One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. It would seem, though, that FDA is right that total shipments of affected product could potentially overstate the number in actual use by patients, thereby underestimating the risk.

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Medical Management Manufacturing Patients 40

FDA Law Blog

MAY 31, 2021

PhRMA Sues CMS Challenging MDRP Rule Curbing Patient Assistance. Manufacturers provide patient savings programs at the pharmacy counter to defray the patient’s out-of-pocket costs such as co-pays and deductibles. In December 2020, CMS published a final rule making several changes to the MDRP regulations.

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Manufacturing Insurance Patients IT 52

PEMBlog

SEPTEMBER 24, 2024

At that point, he was referred to pulmonology who started the patient on albuterol, manual chest physiotherapy, and a steroid inhaler with a plan for a fourth chest x-ray four weeks later. On arrival, the patient was febrile to 38.3C. Bronchopulmonary sequestration Our patient was diagnosed with bronchopulmonary sequestration (BPS).

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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. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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FDA Law Blog

FEBRUARY 22, 2023

And HF‑related AI requests are especially nerve‑racking to manage, because of the ever‑present threat that the study must be repeated to adequately respond. By Jeffrey K. Shapiro — More than a decade ago, FDA began systematically to incorporate review of human factors (HF) design validation within 510(k) reviews.

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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. Data from chemical characterization studies must be evaluated in a separate TRA following ISO 10993-17 guidelines.

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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. 7,838 (Feb.

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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. CDC received some 5,500 comments from patients, caregivers, clinicians and interested organizations to the proposed guideline update it issued in February. RR-3):1–95.

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Permanente Medicine

APRIL 29, 2025

Early screening helps erase racial health disparities The study showed a significant reduction of colorectal cancer deaths among Black patients, which decreased from 52 per 100,000 in 2009 to 23.5 Deaths per 100,000 for Hispanic, white, and Asian patients decreased to 20 during the same time period.

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Screening Checkup Integrated Care Electronics 52

Physician's Weekly

JUNE 11, 2025

Despite the emphasis on U=U as a key HIV prevention strategy since 2016, none of the included studies explicitly described U=U or U=U messaging as an intervention component,” the researchers wrote. PW: How can clinicians improve the care of these patients? Patients are in a very vulnerable state when they enter the healthcare setting.

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Mental Health Healthcare Professional Community Healthcare 114

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . Management of chronic pain in the elderly: focus on transdermal buprenorphine. 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.

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Illness Patient-Centered IT Patients 102

GeriPal

MARCH 28, 2024

What we did was ask clinicians earlier in the ICU stay for very sick patients to document prognosis, and for those who they thought would survive, to document six-month functional prognosis. Eric: And who are the patients including in this trial, again? Kate: These are very sick patients. And that’s it. Kate: Sure.

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GeriPal

OCTOBER 10, 2024

And it not only leads to better outcomes for patients, it leads to our better sustainability. In 2018, survey data revealed that only 41% of survey adult practices had the full complement of funded core team members, which is up from 25% of 2016. So we totally forget that all of us are symptom managers as well.

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GeriPal

JULY 28, 2022

But at that time I was struck by how in that field, there wasn’t a focus or really interest in symptom management and support for patients and their families. Eric: And what a research agenda that you’ve done, including one of the most seminal papers that we have in palliative care in lung cancer patients.

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Illness Hospital Patient-Centered Patients 110

The Clinical Problem Solvers

MAY 30, 2022

Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center. Clinicians are able to shape the environment in which people give birth by caring for the earth and their patients. Published April 20, 2016.

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Community Patient-Centered Families Family 52

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.

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IT Hospital Screening Patients 64

GeriPal

DECEMBER 8, 2022

Clinicians “catching” patient life stories. . Our patients aren’t “the 76 year old with heart failure in room 202,” as Heather Coats astutely noted. Storytelling Helps Hospital Staff Discover The Person Within The Patient. She was a heart failure patient. Because that really is what this is about. What’s in a story?

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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. Alex: Okay.

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IT Patient-Centered Illness Education 126

FDA Law Blog

MAY 5, 2024

The White House Office of Management and Budget will review the rescheduling proposal. FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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Medical Manufacturing Physicals Healthcare Professional 95

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. Going into patient’s homes was eye opening. It was eyeopening to see patients in their own home. And so that really triggered my interest.

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GeriPal

JUNE 30, 2022

You have a patient with dementia severe enough that she cannot recognize relatives. Should she be treated non-operatively, with aggressive symptom management? And there’s been some recent research specifically about in fractures for patients that are very frail or have dementia and it’s sort of the same thing.

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Patient-Centered Complication Patients IT 101

GeriPal

APRIL 10, 2025

I asked emergency medicine clinicians what they thought when a patient who is seriously ill and DNR comes to the ED, and some responded, (paraphrasing), what are they doing here? Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it.

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Patient-Centered IT Hospital Patients 77

GeriPal

DECEMBER 15, 2022

Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? Eric: So patient narrative storytelling, independent of what we call it, I’d like to turn to both of you and just how you got interested in this as a subject. She was a heart failure patient.

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IT Patient-Centered Healthcare Illness 105

GeriPal

AUGUST 25, 2022

Second, Hospice was originally designed for patients with advanced cancer, but the fastest growing admitting diagnosis is dementia. Krista Harrison found , to her surprise, that caregivers of people with dementia who died rated hospice as well as similar patients without dementia who died on hospice. AlexSmithMD. Transcript.

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Families Family IT Patients 106

FDA Law Blog

FEBRUARY 9, 2022

10, 2016); East Main Street Pharmacy; Affirmance of Suspension Order, 75 Fed. In Gulf Med , DEA emphasized that “[r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm.” Improper Dosing for Pain Management. 27, 2010).

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PEMBlog

DECEMBER 14, 2023

Learn all about diagnosis and management of this common problem in this brief podcast episode. Tracheomalacia and bronchomalacia in children: incidence and patient characteristics. 2016 Apr;83:78-83. Maybe up to three out of five patients will need a trach due to ongoing airway obstruction. 2005 Nov;128(5):3391-7.

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Diagnosis IT Diagnose Patients 52

PEMBlog

MARCH 27, 2024

This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. 2016 Jan;37(1):3-15; quiz 16-7, 47. As always, I’m your host, Brad Sobolewski, and this episode focuses on the management of children with metabolic disorders who present to the emergency department.

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Consulting Individual Families Family 59

GeriPal

JANUARY 11, 2024

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. You get me with one-finger-chords on the guitar if you’re watching on YouTube (best I could manage). Four percent. But that was separate from MAID.

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Illness IT Medical Provider 144

GeriPal

AUGUST 24, 2023

Harvey is probably best known for his work in developing dignity therapy, a psychological intervention designed specifically to address many of the psychological, existential, and spiritual challenges that patients and their families face as death approaches. Scientific American Letter to the Editor: Response to Downar et al.

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Patient-Centered Patients IT Illness 98

GeriPal

MARCH 30, 2023

Liz wrote a fabulous perspectives piece in the NEJM titled “ Deciding on My Dimples ” which talks about her experience as a patient doing shared decision making during neurosurgery for resection of an astrocytoma. But my piece in the New England Journal is about being a patient right before awake brain surgery. I could learn this.

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IT Patient-Centered Patients Healthcare 96

BMJ

JUNE 25, 2021

9 The availability of electronic health records makes it easier to follow up on patients’ health information for an extended period. In clinical practice, patients are not fixed on a certain treatment regime and can start and stop at any time. Health Survey for England 2016: Prescribed Medicines.; 2017;390(10100):1345-1422.

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GeriPal

JULY 25, 2024

The PPS is one of the most widely used prognostic tools for seriously ill patients, but the prognostic estimates given by the PPS are based on data that is well over a decade old. It is appropriate for all patient populations, and it is developed specifically for the palliative care and hospice populations. Why do this?

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Families Family Patient-Centered Patients 106

FDA Law Blog

FEBRUARY 11, 2024

There has been no evidence that marijuana’s schedule should change since the last rescheduling review in 2016. Thousands of doctors in the 38 states that permit the medical use of cannabis recommend marijuana to their patients and millions of patients consume medical marijuana under healthcare professionals’ guidance each year.

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Medical Healthcare Professional Community IT 59

GeriPal

APRIL 20, 2023

Today we talk with Margot Kushel about how we got here, including: That sense of powerlessness as a clinician when you “fix up” a patient in the hospital, only to discharge them to the street knowing things will fall apart. It was in the mid-nineties, and about half of the patients that we cared for in the inpatient service were homeless.

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