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. While the final guidance continues to borrow some IMDRF concepts, it no longer limits Non-Device CDS to software that informs clinical management (per the IMDRF 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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Patient-Centered Clinical Practice Patients Individual 75

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.,

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Patients Patient-Centered ER Individual 52

GeriPal

FEBRUARY 15, 2024

So it’s just a wide-opening lens that most of us never really get to see if we’re on the hospital-based side. I was like, “I have all these things I’m doing in the hospital to try to make people better and then I might be sending them right back to a big hazardous environment.” Alex: The Wayback Machine.

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Community Transportation IT PCP 116

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. Dr. Kozhimannil discusses her work on rural maternity care and the lack of hospital-based obstetric services. Published April 20, 2016.

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Community Patient-Centered Families Family 52

GeriPal

JULY 28, 2022

Alex: And we are also delighted to welcome Areej El-Jawahri, who is an oncologist at Massachusetts General Hospital as well, who specializes in blood cancers. 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.

Illness 111

Illness Hospital Patient-Centered Patients 111

GeriPal

MARCH 28, 2024

Kate: It was done in 10 hospitals, 17 ICUs in Atrium Health down in North Carolina. Asking clinicians to document prognosis did not change the primary outcome of hospital length of stay or really any of the secondary outcomes, which I’ll get into. Also the same hospital system? That’s when they got enrolled.

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Consulting Patient-Centered IT Patients 116

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 65

GeriPal

APRIL 10, 2025

Today we discuss: Why the study was negative for the primary (hospitalization) and all secondary outcome (e.g. Tammie 03:04 Depends on how long they were pre-hospital. I think back in what, May 2016, you published a randomized controlled trial, first author, palliative care and the ED randomized study, cancer patients.

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Patient-Centered IT Hospital Patients 78

GeriPal

DECEMBER 8, 2022

As Thor notes, capturing patient stories has face validity as positively impacting the patients who share their stories and have them documented, and for the clinicians who get to truely and deeply know their patients in far greater depth than “what brought you to the hospital?” Within the VA it’s now at 70 VA hospitals.

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Patient-Centered Illness Healthcare IT 116

GeriPal

OCTOBER 10, 2024

Of note: these lessons apply to geriatrics, primary care, hospital medicine, critical care, cancer care, etc, etc. 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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Screening IT Families Family 121

GeriPal

JUNE 30, 2022

Should she be treated non-operatively, with aggressive symptom management? Joel: The Brigham and Women’s Hospital likes me to say that too. Alex: And the Brigham and Women’s Hospital. And she was rushed to the hospital. They stayed in the hospital for longer. Did I get that right? Joel: Oh yeah.

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Patient-Centered Complication Patients IT 101

GeriPal

APRIL 14, 2022

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. And how am I going to manage their pain? Two great videos on buprenorphine initiation. Transcript.

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Illness Patient-Centered IT Patients 103

GeriPal

DECEMBER 15, 2022

Been in the hospital four times, vented, been told the story to her family, she won’t live. Within the VA it’s now at 70 VA hospitals. It started here at Madison at one and it’s also spread outside the VA now to hospitals in Boston, Providence and now starting up actually in California and UCLA and UCSF.

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IT Patient-Centered Healthcare Illness 106

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. Eric: Yeah. Eric: Please.

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Illness IT Medical Provider 144

GeriPal

AUGUST 25, 2022

For-profit hospices having much higher rates of their patients visiting the emergency department and being hospitalized, in addition to disenrollment. As a nurse case manager in hospice, half of my patients had dementia. Melissa: The other scenario that exists is just disenrollment because an individual is hospitalized.

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Families Family IT Patients 107

GeriPal

MARCH 30, 2023

As I was cleaning up my office, I found something I’d written in 2016. She’s not in hospice, and you’re talking about admitting her to the hospital. We have these quality metrics like hospitalization days before death, used hospice, enrolled in hospice, and days before death. And so, how can this be?

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IT Patient-Centered Patients Healthcare 96

GeriPal

AUGUST 24, 2023

So tiny, tiny, in a hospital bed. We published a nice piece, I think it was in the Journal of Pain and Symptom Management. So when patients express a wish to die, that’s not just something that began in 2016 when legislation came into effect. And really the only thing in the room was a picture of him as a bodybuilder.

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Patient-Centered Patients IT Illness 98

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. We would admit them to the hospital. Who doesn’t want to leave the hospital? Alex: Oh, yeah.

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Mental Health IT Community Individual 124

GeriPal

JULY 25, 2024

First time on the GeriPal podcast, Liz Lilley, who’s a surgeon and faculty in surgery at the Brigham Women’s Hospital and Harvard Medical School. Eric 07:03 And those classic studies, were those done in the hospital and PALP care units and clinic? God, it must have been like 2015, 2016. And we have some great guests.

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Families Family Patient-Centered Patients 108

GeriPal

DECEMBER 21, 2023

This model will give participating programs a per-member-per-month payment to offer care management, care coordination, and other services such as caregiver training, disease education, and respite. I didn’t know how to manage it. Malaz: … to restrain them in the hospital. 2015, 2016. And I was terrified.

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Patient-Centered IT Families Family 126

GeriPal

JANUARY 5, 2023

Robert was first asked by one of his own patients for assistance in dying in 1991, far before aid in dying was legalized in California in 2016. To examine how clinicians might act in the face of such bans, we turn to Lori Freedman, who wrote a book about clinicians (primarily Ob-Gyn’s) who work in Catholic Hospitals.

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Provider Medical Hospital Patient-Centered 19

FDA Law Blog

NOVEMBER 8, 2022

Fellow panelist, August Bencke Geyer, who serves as Deputy General Manager of the Medical Devices Office at ANVISA (Brazilian Health Regulatory Agency) expressed enthusiasm and indicated that Brazilian regulators are watching closely to see how the program unfolds. It’s an easy way to manage the transition.”.

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Medical Manufacturing Patient-Centered Provider 59

Physicians News Digest

APRIL 3, 2025

Helen Haskell’s 15-year-old son, Lewis, died after surgery in 2000 because weekend hospital staffers didn’t realize he was in shock. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals. are tested for jaundice before discharge from hospitals.

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Patient-Centered Hospital Diagnose Medical 52

FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

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Manufacturing Supply Chain Patient-Centered Utilities 98