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.

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Manufacturing Hospital Healthcare Medical 81

GeriPal

AUGUST 4, 2022

My take home from this is that while the most preferred explanation for deprescribing statins and sedative-hypnotics is one focused on the risk of side effects, we also need to individualize it to the patient and the medication that they are taking. But how to talk to patients about the risk and benefits when starting.

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Specialization Medical Patient-Centered Provider 105

FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E. The practice of medicine was viewed as paternalistic.

Patients 52

Patients Patient-Centered Clinic IT 52

GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. And we invited Tamryn Gray from the Dana Farber joins us to ask insightful questions, including: What blood sugar range should we target for patients in the nursing home or hospice?

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Diabetes Management Patient-Centered Families 74

GeriPal

NOVEMBER 9, 2023

A 2020 RCT of coaching for primary care physicians shows that coaching improves burnout well-being during the intervention and has a sustained duration at 6 months of follow up. If they’re a beginning fellow, that’s a very different coaching situation than coaching the chief medical officer or the president of a medical center.

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Board-Certified IT Primary Care Referral 111

The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. This discussion is hosted by Ashley Cooper, Sudarshan Krishnamurthy, and new team member Gillette Pierce.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

The Clinical Problem Solvers

MARCH 4, 2024

During this episode, we hear from Zahra Khan, an educator and editor who has written extensively on abolition in medicine, and Dr. Sayantani DasGupta, a physician-educator, prolific children’s book author and faculty at the Center for the Study of Ethnicity and Race and the Institute for Comparative Literature and Society at Columbia University.

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Community Education Patient-Centered Relationship 52

The Clinical Problem Solvers

FEBRUARY 14, 2022

[link] CPSolvers: Anti-Racism in Medicine Series Episode 14: Race, Place, and Health: Clinician and Community Perspectives Show Notes by Alec Calac February 15th, 2022 Summary: This episode highlights how racism manifests in the built environment, and how community and individual-level efforts can mitigate these inequities. Be curious.

Community 52

Community Individual Mental Health IT 52

GeriPal

JANUARY 30, 2025

In one corner, weighing in at decades of experience, well known for heavy hits of bedside assessments, strong patient-family relationships, and a knockout punch of interdisciplinary collaboration, we have in-person palliative care consults. But watch out! Travel time can leave this champ vulnerable to fatigue and no-shows.

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Telehealth Patient-Centered IT Patients 106

FDA Law Blog

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” hurricane) or public health emergency (e.g.,

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Clinic Supply Chain Clinical Practice Patient-Centered 64

GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life.

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Patient-Centered IT Illness Patients 123

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. A few data based publication links from Person-Centered Narrative Intervention Program of Research: .

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Patient-Centered Illness Healthcare IT 116

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 Families Family 52

ABIM

JUNE 11, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. ABIM’s website features expansive sections on research related to assessment and clinical outcomes.

Board-Certified 52

Board-Certified Government Community Education 52

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

ABIM

JUNE 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Preliminary data show that 90% of respondents are clinically active with the majority in hospital- or system-owned practice (38%), academic faculty practice (32.9%) and private practice (26.8%).

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Board-Certified Board-Certified Physicians Government Community 40

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. Besides the risks to an individual, there are also population-level harms from normalizing certain harmful behaviors (e.g.,

Medical 40

Medical Holistic Care Healthcare Healthcare Professional 40

GeriPal

OCTOBER 26, 2023

Summary Transcript Summary Often podcasts meet clinical reality. But rarely does the podcast and clinical reality meet in the same day. The patient’s capacity to make decisions was marginal, and his sons were shouldering much of the responsibility. Dear listeners, if you have a podcast idea, feel free to reach out to us.

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Patient-Centered Hospital Patients IT 133

GeriPal

SEPTEMBER 12, 2024

Eric 04:44 Could just make you a little bit more resilient, you can increase your Rvus so you can see more patients. But we can’t lose sight of the system level, the x individual outside of the individual, the system level factors that inform our day to day workplace experience. If you were just.

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IT Healthcare Healthcare Professional Patient-Centered 112

GeriPal

OCTOBER 19, 2023

Caveat as well that RCTs should not be placed on pedestal as the only answer- often patients enrolled in RCTs do not represent real world patients – observational studies do. For a trial to have value, it should not exclude patients over age 80, or those with dementia, or patients residing in nursing homes.

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Patient-Centered IT Patients Illness 127

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 78

GeriPal

FEBRUARY 20, 2025

We also explored several questions with them, including how to define trauma, its prevalence in older adults, the impact of past traumatic experiences, the potential triggers of trauma screening, and the application of trauma-informed principles in clinical practice. Some of them are really deeply individual experiences.

Patient-Centered 67

Patient-Centered IT Individual Screening 67

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.

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IT Patient-Centered Patients Healthcare 96

GeriPal

NOVEMBER 2, 2023

We have the new geriatric surgical verification process where they’re, I think now eight or so level one geriatric surgical centers with 40 more somewhere in that process of becoming certified. And I met with the clinical pharmacist who worked in that clinic and she told me, “You know what? Eric: Can I just add it?

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Board-Certified IT Community Medical Student 91

GeriPal

FEBRUARY 8, 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 Families Family Physicals 137

GeriPal

SEPTEMBER 21, 2023

Feyron has centered her work in Black/African American faith communities and churches – a program she titled Alter. I started going to the literature and I noticed that communities of color, those with the Hispanic background, Black individuals were disproportionately impacted by dementia, and I couldn’t believe it.

Community 129

Community Families Family IT 129

GeriPal

FEBRUARY 13, 2025

How to be sensitive to the risks of stereotyping based on recommendations from the few members of the board to the many heterogeneous patients served? I’m Marie Bakitas, and I’m a professor at the University of Alabama at Birmingham and also the associate Director of the center for Palliative and Supportive Care.

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Consulting Community Patient-Centered Families 64

Medical Xpress

JUNE 8, 2025

Long-term effects of pain in early life We collected data on the number of procedures, clinical exposures and sucrose doses from three NICUs across Canada. Sucrose is thought to activate centers of the brain that modulate pain and lead to the release of endorphins , but the exact mechanism remains unclear.

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IT Management Vaccination Medical 53

GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. Alex: And we’re delighted to welcome Ruth McDermott-Levy, who is Professor in the College of Nursing at Villanova University and Co-Director of the Mid-Atlantic Center for Children’s Health and the Environment.

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Healthcare IT Education Community 130

Physician's Weekly

JUNE 24, 2025

The observed decline in CVD mortality among patients with IMIDs is encouraging, yet sex disparities persist. Declining IMID mortality mirrors broader CVD improve­ments, suggesting shared care benefits,” wrote lead study author Issam Motairek, MD , of the Cleveland Clinic, and colleagues. per 100,000 in 2020. P <0.01).

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Patient-Centered Hypertension Management Diagnosis 52

GeriPal

JULY 6, 2023

It could be in housing, it could be a standalone senior center, home delivered meals, nutrition counseling and nutrition education done by registered dieticians. I have 24,500 veterans on our caseload, 14,000 individuals with diagnosed mental health issue, 8,500 with an alcohol and substance abuse. To Susan’s point.

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

DECEMBER 29, 2022

For an ever deeper dive into the subject of negotiation and dispute resolution, check out the following links (and for any caregivers interested in participating in the randomized clinical trial of the NegotiAge training, feel free email the NegotiAge Research Team at negotiage@northwestern.edu ): . Journal of Patient Experience.

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Families Family IT Patient-Centered 96

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.”

Patient-Centered 126

Patient-Centered IT Families Family 126

GeriPal

SEPTEMBER 14, 2023

We talk with Bruce Leff and Tacara Soones about the hospital-at-home movement, which has been shown to reduce costs, improve outcomes and improve the patient experience. 2020 Hospital at Home-Plus: A Platform of Facility-Based Care. That’s focused on older adults who are too frail to get into clinic. Annals of Int Med.

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Hospital Patient-Centered Supply Chain IT 115