FDA Law Blog

SEPTEMBER 22, 2024

SCF : LDT, unmet need within an integrated healthcare system. After a lab submits an MDR, FDA said that laboratories should save the electronic “Acknowledgement 3” (Ack3) generated after submitting an MDR in the MDR event files. is it the lab itself, the healthcare provider, or the patient?). SCH : LDT, approved by NYS CLEP.

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Manufacturing Electronics Provider Management 64

FDA Law Blog

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. The contemplated activities here would not in any event affect the “quality” of the compounded formulation.

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

GeriPal

JANUARY 23, 2025

And our next guest is Amy Linsky, who’s a physician and researcher at the VA Boston Healthcare System and associate professor at Boston University University. So acupuncture, Tai Chi, Yoga, mindfulness and physical therapy, chiropractor. Emily, welcome to the GeriPal Podcast. Emily 00:23 Thanks for having me. Alex 00:24 Great.

Specialization 119

Specialization IT Patient-Centered Medical 119

GeriPal

DECEMBER 2, 2022

Ab: I learn from them, and I tell sometimes the family members that the person with dementia, your loved one, is fine and you are replaying the event that happened a week ago and you’ve replayed that event 100 times and that’s causing a distress. How about transforming care in healthcare institutions? But we have to.

Community 101

Community IT Individual Patient-Centered 101

GeriPal

MAY 5, 2022

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. And nurses and other healthcare practitioners knew nothing about it. Over-the-counter hearing aids: What will it mean for older Americans?

IT 102

IT Screening Hospital Clinic 102

GeriPal

OCTOBER 13, 2022

It’s Lona Mody who is a translational infectious disease researcher at the University of Michigan and VA Ann Arbor Healthcare System. Alex: And we are also delighted to welcome Devika Nair, who is a nephrologist at Vanderbilt University Medical Center in Tennessee Valley VA Healthcare System. Our first guest is a repeat guest.

Complication 97

Complication Patient-Centered IT Patients 97

GeriPal

JULY 27, 2023

Cathy: Actually, many years ago, I did some research on delirium and then I was doing some research on nursing home residents and we were doing work looking at, I was interested in how sleep problems and nighttime events might lead to delirium, and then I just became very, very interested in sleep. Cathy: Well, yeah.

Illness 85

Illness IT Medical Clinic 85

Physician's Weekly

JUNE 12, 2025

Pediatric clinicians and healthcare systems have an urgent responsibility to advocate for evidence-based solutions to address the climate crisis,” Shalini H. Globally, flooding is the most common type of extreme weather event (EWE) and >500 million children reside in flood zones worldwide. Shah, DO, and Maya I.

Asthma 52

Asthma Mental Health Illness Chronic Disease 52

The Clinical Problem Solvers

DECEMBER 20, 2021

difficulty of sending patient messages through the electronic medical record in languages other than English), limited healthcare literacy, and English-only signage on healthcare campuses are just a few of the structurally racist barriers faced by many Asian folks seeking healthcare. Insufficient language services (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

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. They were stunned by the number of calls for lift assistance for older adults who had fallen. AMA PRA Category 1 credit(s) ™. Carmen: Thank you.

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Community Transportation IT PCP 114

FDA Law Blog

JULY 7, 2024

Timeliness is critical not only for developing appropriate corrective actions but also for evaluating and, when necessary, submitting reportable events to FDA as discussed below. establish and maintain adverse event files.” [9] report certain device malfunctions, and.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

GeriPal

FEBRUARY 20, 2025

Kate and Ashwin talked about their research on the prevalence of lifetime trauma and its association with physical and psychosocial health among adults at the end of life. So there’s an event or a series of events. So there’s an event or a series of events. I guess that’s an event.

Patient-Centered 66

Patient-Centered IT Screening Patients 66

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.

IT 137

IT Families Family Physicals 137

GeriPal

OCTOBER 26, 2023

Physical therapy had walked with him that day and noted improvement compared to previous walks, suggesting that he should be discharged to a skilled nursing facility for rehabilitation on discharge. At the end of the day, I lamented that physical, occupational, and speech therapists aren’t more tightly integrated with palliative care teams.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

GeriPal

MAY 22, 2025

A music therapist would use music deliberately to achieve a rehabilitation goal, just like a physical therapist or an occupational therapist. Just encourage patients and families to bring music into their healthcare experience. There’s a small book called Music and Creativity in Healthcare Settings written by Hilary Moss.

Patient-Centered 96

Patient-Centered IT Patients Board-Certified 96

GeriPal

SEPTEMBER 12, 2024

On today’s podcast, we talk with Jane Thomas , Naomi Saks , and Ishwaria Subbiah about the concepts of wellness, well-being, resilience, and burnout, as well as what can be done to truly improve the lives of healthcare providers and bring, I dare say it, joy into our work. I mean, in other work, hard work environments as well.

IT 110

IT Healthcare Healthcare Professional Patient-Centered 110

GeriPal

MARCH 6, 2025

-Alex End Well Talk [link] Resources on the PEACH Program Program Review Paper A recent publication in Longwoods Healthcare Quarterly reviewing the PEACH model. I always knew that I wanted to get into healthcare, to use healthcare as a springboard for social change in our communities. Have you thought about that?

Healthcare 100

Healthcare IT Community Illness 100

GeriPal

JULY 11, 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.

Patient-Centered 109

Patient-Centered Patients IT Clinic 109

GeriPal

OCTOBER 20, 2022

It’s Lona Mody who is a translational infectious disease researcher at the University of Michigan and VA Ann Arbor Healthcare System. Alex: And we are also delighted to welcome Devika Nair, who is a nephrologist at Vanderbilt University Medical Center in Tennessee Valley VA Healthcare System. Our first guest is a repeat guest.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

JUNE 13, 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.

Illness 133

Illness Patient-Centered Patients IT 133

GeriPal

MARCH 3, 2022

This idea that for critically ill patients in the ICU, geriatric conditions like disability, frailty, multimorbidity, and dementia should be viewed through a wider lens of what patients are like before and after the ICU event was transformative for our two guests today. GeriPal podcast with Linda Fried on frailty. Lauren: Really?

Patient-Centered 96

Patient-Centered Patients IT Hospital 96

GeriPal

OCTOBER 17, 2024

If they’re frail, if they’re falling, if they have cognitive impairment, they’re at higher risk of adverse drug events. Another study looking at the benefits of physical rehabilitation in patients with HFpEF. From my standpoint, you want to think practically, okay? A pill organizer, having family. Alex 45:43 Okay.

Primary Care 113

Primary Care Patient-Centered IT Patients 113

GeriPal

MARCH 13, 2025

Alex Smith Links Link to the McGill National Grand Rounds Series on Palliative Care , Michael Kearney as initial presenter, and registration for future events. You’re talking about a paradigm shift in healthcare. Ive got a name. No, you dont need to be Canadian. Canadians are welcoming. It’s not just enough to be very.

IT 104

IT Patient-Centered Families Family 104

GeriPal

JULY 28, 2022

And as a resident, I just was drawn, similar to many oncology clinicians and fellows, to just be traumatic and difficult experience of patients with blood cancers during prolonged and intense hospitalizations, where they experience a lot of physical symptoms, emotional trauma related to the diagnoses. ” Right? But we have to.

Illness 110

Illness Hospital Patient-Centered Patients 110

GeriPal

JUNE 22, 2023

We start off part one by interviewing Michele DiTomas, who has been the longstanding Medical Director of the Hospice unit and currently is also the Chief Medical Executive for the Palliative care Initiative with the California Correctional Healthcare Services. These older patients are costing a ton in healthcare costs. Michele: Yep.

Families 132

Families Family IT Community 132

GeriPal

APRIL 3, 2025

So if you haven’t been to this event, there is a literature review where we. And this complete lack of attention to the real needs of persons with dementia is really kind of a shameful part of US healthcare. Alex, you’ve probably penned about 50 songs, which is also amazing. And very frail. The post GeriPal Takeover!

IT 64

IT Hospital Screening Patients 64

GeriPal

JUNE 26, 2025

Those disruptive events or shocks often portend a major decline in function from which people with dementia never fully recover. Today we talk about disruptive events, or health and wealth shocks. Wait, so one key message is that social health is linked to physical and cognitive health?!? What’s a disruptive event?

Illness 93

Illness Hospital IT Patient-Centered 93

FDA Law Blog

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition. FDA encourages sponsors to consult patients and healthcare providers to assist in developing such strategies.

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Clinic Provider Individual IT 59

GeriPal

OCTOBER 12, 2023

The problem is, that’s actually not a very good narrative for nearly everything we take care of in healthcare. Well, there’s this descriptive phase where there’s a verbal and physical examination and the conditions discussed, and then, procedures are discussed. This is broken, and I have this thing that will fix it.

IT 128

IT Families Family Patient-Centered 128

GeriPal

OCTOBER 5, 2023

And I think when COVID started, I was in a number of meetings about how we were going to think about CPR from this point forward, given that it was would really expose healthcare workers to easy transmission of this virus that we didn’t fully understand yet. And yet, it’s so hard to be able to draw a boundary.

Illness 136

Illness IT Patient-Centered Families 136

GeriPal

SEPTEMBER 5, 2024

And Bill Andereck is still haunted by the decision he made to have the police break down the door to rescue his patient who attempted suicide in the 1980s, as detailed in this essay in the Cambridge Quarterly of HealthCare Ethics. So in some ways, it was an iatrogenic event. So, yes, they could fix it. We can make this better.

Patients 98

Patients IT Patient-Centered Hospital 98

GeriPal

OCTOBER 27, 2022

So the two examples that I would talk about are treatment for osteoporosis that hinges on the 10 year risk of fracture, and then treatment for hyperlipidemia that hinges on predicted 10 year cardiovascular events. So the idea here is that generally the risks of bad things, like side effects, are pretty constant throughout the population.

IT 95

IT Clinic Screening Patients 95

GeriPal

DECEMBER 7, 2023

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. So the things that Karl mentioned, but also access to healthcare during a disaster or even heat. Ruth: Yeah. Ruth: Yeah.

Healthcare 129

Healthcare IT Education Hospital 129

GeriPal

SEPTEMBER 19, 2024

We did not just rely on a physical symptom measure, which many of our colleagues are doing. It’s not just about physical symptom management. Additionally, in case patients didn’t step up, we did have sort of events where they were scheduled to see palliative care. You sort of had a month after all of those events.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

GeriPal

NOVEMBER 3, 2022

That was the lesson I learned from reading a new book edited by Matt Loscalzo along with Marshall Forstein called “ Loss and Grief: Personal Stories of Doctors and Other Healthcare Professionals ”. Eric: We’re going to be talking about loss and grief and the role of debriefing for healthcare providers. Turns out, it’s maybe not.

Healthcare Professional 102

Healthcare Professional Healthcare IT Relationship 102

GeriPal

APRIL 20, 2023

These were usually very physically demanding, low paid, often usually non-union work, that they worked their whole lives and were hanging on by their fingernails. Sometime after the age of 50, we could identify an event where the folks who were first homeless before 50, there wasn’t a clear crisis that precipitated it.

Mental Health 123

Mental Health IT Community Individual 123

GeriPal

JULY 25, 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.

Families 106

Families Family Patient-Centered Patients 106