FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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Manufacturing Hospital Healthcare Medical 81

The Clinical Problem Solvers

DECEMBER 20, 2021

[link] CPSolvers: Anti-Racism in Medicine Series Episode 13: Centering Asian Americans: Racism, Violence, and Health Show Notes by Naomi F. Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures. Insufficient language services (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

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. My Life, My Story: VA’s healthcare improvements through deliberate storytelling – YouTube. Storytelling Helps Hospital Staff Discover The Person Within The Patient.

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Patient-Centered Illness Healthcare IT 115

GeriPal

OCTOBER 10, 2024

And they begin on today’s podcast with one clinical ask: everyone should be a generalist and a specialist. They are looking to build on both their research and clinical programs and are interviewing candidates for the Associate Chief of Research and for full-time physician faculty to join them in the inpatient and outpatient setting.

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Screening IT Family Families 119

The Clinical Problem Solvers

MAY 30, 2022

This discussion is hosted by Naomi Fields, MD, Chioma Onuoha, and Victor Lopez-Carmen MPH, as they interview Dr. 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.

Community 52

Community Patient-Centered Family Families 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. CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R., MMWR Recomm Rep 2022;71(No.

Patients 52

Patients Patient-Centered ER Individual 52

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

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . 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 is both a research and a clinical interest of yours. Right, Katie?

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Illness Patient-Centered IT Patients 102

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

GeriPal

MARCH 28, 2024

Ten years ago we would have been hard pressed to find 3 clinical trial abstracts submitted to the annual meeting, much less high quality randomized trials with robust measures, sample sizes, and analytics plans. And we have Kate Courtright, who’s at University of Pennsylvania, the PAIR Center. I’m just stunned even writing that!

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Consulting Patient-Centered IT Patients 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.

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IT Patient-Centered Illness Education 126

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. AMA PRA Category 1 credit(s) ™.

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Community Transportation IT PCP 114

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

BMJ

FEBRUARY 8, 2021

The proximity to campus health clinics may also afford college students greater accessibility to healthcare providers for prescription medications such as stimulants which could end up being misused. For healthcare providers, there should be a recognition that holistic care involves more than just prescribing medications.

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Medical Holistic Care Healthcare Healthcare Professional 40

GeriPal

JUNE 30, 2022

You have a patient with dementia severe enough that she cannot recognize relatives. A huge part of this decision rests on (1) her previously stated wishes, values, and goals (prior to the onset of dementia); and (2) the outcomes of surgery for patients with dementia. Summary Transcript Summary. She falls and breaks her hip.

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Patient-Centered Complication Patients IT 101

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

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. So I identified myself, and was working in our local cancer center.

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Patient-Centered Patients IT Illness 98

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. Alex: We’re delighted to welcome Leonie Herx, who’s a palliative care physician and clinical professor at the University of Calgary.

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Illness IT Medical Provider 144

GeriPal

MARCH 30, 2023

This week we’ve invited three guests to share their stories about storytelling that’s written for healthcare providers. 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.

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IT Patient-Centered Patients Healthcare 95

GeriPal

OCTOBER 5, 2023

I love this article as it specifically discusses what’s wrong with “ need ” statements and how we can shift our communication and thinking to create space for deliberation about patients’ priorities and the best course of action. And it’s always centered on a need for a particular life-sustaining treatment. This is Eric Widera.

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Illness IT Patient-Centered Family 136

FDA Law Blog

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

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Physicals Medical Clinic Emergency Room 69

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. Eric 04:39 Yeah, I see it used on inpatient, side on consult clinics in hospices. Why do this? AMA PRA Category 1 credit(s) ™. Liz 01:04 I do have the song.

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Family Families Patient-Centered IT 106

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.”

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Patient-Centered IT Family Families 125