FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. This comparison is misplaced. If finalized, the PR may also be subject to broader challenges.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

GeriPal

DECEMBER 2, 2022

So on today’s podcast we invite four brilliant individuals to talk about their perspective on how to change how we as a society and health care system partner with individuals with dementia. We’re going to be talking about things like creative engagement in individuals with dementia. Susan: Yeah, that was me.

Community 101

Community IT Individual Patient-Centered 101

GeriPal

MAY 5, 2022

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Communication techniques we can use when talking to individuals with hearing loss. COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Alex: Great story.

IT 102

IT Screening Hospital Clinic 102

GeriPal

OCTOBER 13, 2022

And so there was a report in 2009 by the Institute of Medicine saying that we need to equip all of these individuals in caring for older person in an evidence based manner. And that led to many specialists doing work and advancing their fields within their professional societies, providing guidance and so on for older adults.

Complication 97

Complication Patient-Centered IT Patients 97

PEMBlog

SEPTEMBER 6, 2023

They carry existing diagnoses and are followed by outpatient mental health providers. Patients with psychosis caused by medical illness usually have abnormal vital signs, altered mental status, and impaired orientation with compromised intellectual function. Laboratory evaluation should be based on individual patient history and exam.

Lab Testing 52

Lab Testing Medical Patients Mental Health 52

GeriPal

JUNE 8, 2023

Should we use Ozempic (if we can find it) in patients with serious illness, which often results in undesirable and profound weight loss? And my hypothesis is that’s because it’s no longer the individual managing their own diabetes, it’s the nursing home staff managing their diabetes. Listen in to learn more!

Diabetes 73

Diabetes Management Patient-Centered Family 73

GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. We’re going to be talking about new research in psilocybin in serious illness. Vincent’s Hospital in Melbourne, Australia. This is Eric Widera.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

JANUARY 18, 2024

We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. AMA PRA Category 1 credit(s) ™. This is Eric Widera. It’s me.

Illness 136

Illness Patient-Centered Screening IT 136

GeriPal

APRIL 14, 2022

On today’s podcast we talk with three experts on buprenorphine on why, when, and how to use it in serious illness. Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . Katie, before we jump into the topic of buprenorphine in serious illness, what’s the song request?

Illness 102

Illness Patient-Centered IT Patients 102

GeriPal

DECEMBER 14, 2023

More recently Sharon Kaufman ‘s book And a Time to Die described the ways in which physicians, nurses, hospital systems, and payment mechanisms influenced the hour and manner of patient’s deaths. Today Liz Dzeng discusses her journey towards studying this issue in detail. Eric: What kind of differences did you see?

Hospital 125

Hospital IT Patient-Centered Patients 125

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. With their regular providers? The article we discuss today, also published in JAMA , addresses these two gaps. In their communities?

Patient-Centered 122

Patient-Centered IT Illness Patients 122

GeriPal

JUNE 12, 2025

Eric 00:42 So on this podcast, we’re gonna be talking about what every healthcare provider should know about radiation oncology. I didn’t know where they existed within the hospital. Eric 07:04 You actually created things like a curriculum for hospital medicine fellows in radiation oncology. Evie, welcome to GeriPal.

Patient-Centered 102

Patient-Centered Referral Patients IT 102

GeriPal

DECEMBER 19, 2024

Still, we havent talked about integrating palliative care into psychiatry or in the care of those with severe mental illness. What does it look like to take a palliative approach to severe mental illness? Is “terminal” mental illness a thing? For more details, please click here. (AP AP Recruit Job No.

Illness 101

Illness Mental Health IT Patient-Centered 101

GeriPal

SEPTEMBER 22, 2022

Coming off as rote and scripted during a serious illness conversation can have a similar off-putting impact on patients and families. One bump is just the classic pitfalls we often talk about in serious illness communication: being very jargony, very information focused, and just providing information. Eric: Yeah.

Illness 101

Illness IT Patient-Centered Patients 101

GeriPal

OCTOBER 5, 2023

Summary Transcript Summary Communicating about a serious illness is hard. Last week’s podcast we talked about the challenge around miscommunication in serious illness. Sunita: Honestly, I’d be happy to provide the vocals. Take for example the simple question: “If her breathing gets any worse, she will need to be intubated.”

Illness 136

Illness IT Patient-Centered Families 136

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?” Bennett, C.R., Schilling, L., Doorenbos, A. PMID: 26701962.

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

GeriPal

AUGUST 29, 2024

Summary Transcript CME Summary Serious illness communication is hard. We must often deliver complex medical information that carries heavy emotional weight in pressured settings to individuals with varying cultural backgrounds, values, and beliefs. Eric 01:42 So we’ ve got an exciting topic today. Eric 05:03 Nice.

IT 132

IT Illness Families Family 132

GeriPal

OCTOBER 26, 2023

Today we talk with Sarguni Singh, hospitalist-researcher at the University of Colorado, Ann Henshaw, Occupational Therapist who teaches at George Washington and works clinically at Georgetown, and Tamra Keeney, Physical Therapist-researcher at Mass General Hospital and Harvard Medical School. Tamra, welcome to the GeriPal podcast.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

GeriPal

JULY 28, 2022

GeriPal post on “fast food” style palliative care in chronic critical illness. 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. Additional links: Editorial on Areej’s study. Palliative care in lung and GI cancers. Transcript.

Illness 110

Illness Hospital Patient-Centered Patients 110

GeriPal

FEBRUARY 23, 2023

Imagine her hearing for the first time that you’re sick, that you’re hospitalized, that you’re in the ICU, and that you can’t make your own decisions? And so the family is there in much more of an advisory role rather than providing say, cognitive scaffolding that they might provide in supported decision making.

Family 97

Family Families Patient-Centered IT 97

GeriPal

JULY 21, 2022

Love to talk about also in the serious illness population. I’ve worked in hospital settings as an occupational therapist, inpatient rehab and outpatient rehab. Emmy: I was seeing people in the hospital setting, saying they had had a massive brain injury. Eric: Well, Terri and Emmy, thank you for joining on this podcast.

IT 102

IT Family Families Diagnosis 102

GeriPal

DECEMBER 15, 2022

So during the dissertation, that was a method for my PhD research and that’s related to… I was learning about African American elders experiences of psych-social-spiritual healing and serious illness. Been in the hospital four times, vented, been told the story to her family, she won’t live. So it sounds like them.

IT 105

IT Patient-Centered Healthcare Illness 105

GeriPal

MAY 15, 2025

Prior podcasts on the ethics of nudging , and a different trial conducted by Kate and Scott in which the default for hospitalized seriously ill patients was to receive a palliative care consult. Many were community hospitals. Participants were critically ill and intubated. What is sludge? The prognosis nudge did nothing.

Patient-Centered 116

Patient-Centered Hospital IT Illness 116

GeriPal

JANUARY 16, 2025

Summary Transcript CME Summary Many older adults lose decision-making capacity during serious illnesses, and a significant percentage lack family or friends to assist with decisions. How should we care for unrepresented individuals in inpatient and outpatient settings? Why not use the older term unbefriended? Eric 14:23 Yeah.

Patient-Centered 109

Patient-Centered IT Patients Healthcare 109

GeriPal

JANUARY 11, 2024

To be eligible in Canada patients must have a “ grievous and irremediable ” condition, including disability ; they do not have to have a terminal illness with a prognosis of less than 6 months. A planned expansion of MAID to include people with mental illness was placed on hold until March 2024. AMA PRA Category 1 credit(s) ™.

Illness 144

Illness IT Medical Provider 144

GeriPal

FEBRUARY 27, 2025

Today we talk with experts Janet Ho, Sach Kale, and Julie Childers about opioid use disorder and serious illness. Eric 00:51 So we’re gonna be talking about caring for people with serious illness and substance abuse. Who has a song request for Alex before we talk about substance use disorder and serious illness?

Patients 72

Patients Clinic Patient-Centered Illness 72

GeriPal

MAY 4, 2023

We remember bucking the rules, figuring out who you are, hair on fire, feeling invulnerable, trying to figure out who you are – and now those adolescents are stuck in the hospital, with doctors and parents telling them what to do, having their autonomy crushed by the medical institution, realizing they’re not invulnerable. Eric: Yeah.

IT 83

IT Family Families Illness 83

GeriPal

MARCH 6, 2025

Michaels Hospital in Toronto, and health justice activist. link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. Michael’s Hospital in the Department of Family and Community Medicine. those experiencing homelessness).

Healthcare 100

Healthcare IT Community Illness 100

GeriPal

JUNE 9, 2022

Palliative care, in contrast, saw explosive growth in US hospitals. We can’t possibly meet the needs of all people with newly diagnosed serious illness. She’s also a member of the PAIR Center, which stands for Palliative Advanced Illness Research Center. I do tend to focus in the hospital setting.

Consulting 99

Consulting Patient-Centered Diagnosis IT 99

GeriPal

MARCH 24, 2023

I think some individuals thought there was cherry-picking of stories that made it seem like hospice is this bad thing, that it’s taking advantage of vulnerable individuals and it didn’t talk enough about the good things that hospice does. She happened to focus on some specific for-profit hospice providers.

IT 113

IT Provider Patients Families 113

GeriPal

JUNE 30, 2022

Joel: The Brigham and Women’s Hospital likes me to say that too. Alex: And the Brigham and Women’s Hospital. Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. And she was rushed to the hospital. Did I get that right? Joel: Oh yeah.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

MAY 9, 2024

all of whom focus their efforts on educating the general public about living and dying with a serious illness. Why focus on the public rather than other health care providers? Summary Transcript Summary On today’s podcast, we’ve invited four hospice and palliative care social media influencers (yes, that’s a thing!),

Education 127

Education IT Illness Healthcare 127

GeriPal

OCTOBER 19, 2023

Certainly SOME of those avoided hospitalizations, CPR, and ICU stays were due to documentation of those orders in the POLST. Additional links mentioned in the podcast: Recent JGIM article on POLST in California nursing homes, hospitalization, and nursing home care Karl’s GeriPal post on appropriate use of POLST Enjoy! Good to know.

Patient-Centered 126

Patient-Centered IT Patients Illness 126

GeriPal

JANUARY 30, 2025

But in reality, given workforce shortages and just the challenges and the resources necessary to be able to provide early integrated palliative care from the time of diagnosis of advanced cancer, the model simply is not implementable, at least not in our current state with our available infrastructure and resources. Eric 10:25 Great.

Telehealth 105

Telehealth Patient-Centered IT Patients 105

GeriPal

OCTOBER 20, 2022

This office is tasked with providing aging policy research and recommendations within ASPE, including long term care and the National Alzheimer’s Project Act. And so there was a report in 2009 by the Institute of Medicine saying that we need to equip all of these individuals in caring for older person in an evidence based manner.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

APRIL 4, 2024

The hospital refused without a court order, and the case eventually made its way to the Supreme Court. The Cruzan ruling led to a flood of interest in Advance Directives, and eventually to the Patient Self Determination Act, which mandates provision of information about advanced directives to all hospitalized patients.

Family 112

Family Families Patient-Centered IT 112

GeriPal

MARCH 24, 2022

Then listen to these prior podcasts with Sean Morrison and Rebecca Sudore about this issue, and we recently discussed differences between Advance Care Planning and Serious Illness Communication with Juliet Jacobsen and Rachelle Bernacki. . Where does POLST fit in with this debate? This is Eric Widera. Alex: This is Alex Smith.

Illness 72

Illness IT Healthcare Patient-Centered 72