FDA Law

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. The PR states that LDTs are not the “practice of medicine,” with which FDA generally may not interfere.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

The Clinical Problem Solvers

AUGUST 25, 2020

Pearls Defining Structural Racism Structural racism is a term that acknowledges that racism is perpetuated beyond individual interactions and interpersonal racism, but is present in the systems and policies that govern our everyday lives. Links References discussed throughout episode Hardeman RR, Karbeah J, Kozhimannil KB.

Community 52

Community Patient-Centered Education Relationship 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?

Diabetes 73

Diabetes Management Patient-Centered Family 73

GeriPal

JUNE 12, 2025

Summary Transcript CME Summary If you’re anything like me, you might find the process of what happens to patients when they visit a radiation oncologist somewhat mysterious. Anish 01:02 Well, I speak, you know, from a physician lens of some of the patients that I get referred, and by the time there’s. This is not a good option.

Patient-Centered 102

Patient-Centered Referral Patients IT 102

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. 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. Who do we have with us today? Devon, welcome to GeriPal.

Illness 136

Illness Patient-Centered Screening Clinic 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. I guess the VA is federal though.

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. He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life.

Patient-Centered 122

Patient-Centered IT Illness Patients 122

GeriPal

SEPTEMBER 22, 2022

Have you ever had that moment when talking to a patient, when you realized that the phrase you just uttered, which you’ve uttered a hundred times before, came out rote and scripted? And in response, the family or patient looked at you like you were from another planet? Summary Transcript Summary. Yeah, I’ve been there too.

Illness 101

Illness IT Patient-Centered Patients 101

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. Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol.

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

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

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. This week we dive into the challenges with communication when it comes to life sustaining treatments and CPR. This is Eric Widera. Alex: This is Alex Smith.

Illness 136

Illness IT Patient-Centered Family 136

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.

Telehealth 105

Telehealth Patient-Centered IT Patients 105

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

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? What to make of that?

Patient-Centered 116

Patient-Centered Hospital IT Illness 116

GeriPal

FEBRUARY 23, 2023

Summary Transcript Summary You know when you walk out of a patient’s room and have that sense, “This isn’t going to go well.” The patient is sick and getting sicker, and refuses to let you talk with family or other members of her inner circle. Should you stop at “no?” That’s a huge amount of news all at once. This is Eric Widera.

Family 97

Family Families Patient-Centered IT 97

GeriPal

OCTOBER 26, 2023

Within hours of recording this podcast, I joined a family meeting of an older patient who had multiple medical problems including cancer, and a slow but inexorable decline in function, weight, and cognition. The patient’s capacity to make decisions was marginal, and his sons were shouldering much of the responsibility.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

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.

IT 105

IT Patient-Centered Healthcare Illness 105

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? Is the patient in your descriptor?

Patient-Centered 109

Patient-Centered IT Patients Healthcare 109

GeriPal

JUNE 9, 2022

Palliative care, in contrast, saw explosive growth in US hospitals. The National Palliative Care Research Center (NPCRC)and Palliative Care Research Cooperative (PCRC)were founded in part to meet this need. (see We can’t possibly meet the needs of all people with newly diagnosed serious illness. What is a pragmatic trial ?

Consulting 99

Consulting Patient-Centered Diagnosis Referral 99

GeriPal

OCTOBER 19, 2023

Certainly SOME of those avoided hospitalizations, CPR, and ICU stays were due to documentation of those orders in the POLST. 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. This is Eric Widera.

Patient-Centered 126

Patient-Centered IT Patients Illness 126

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. Alex: And the Brigham and Women’s Hospital. Transcript.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

FEBRUARY 27, 2025

Today we talk with experts Janet Ho, Sach Kale, and Julie Childers about opioid use disorder and serious illness. We address: Why is caring for patients with this overlap so hard? Sach Kale set up an outpatient clinic focused on substance use disorder for patients with cancer. What is making this hard for me? What do they do?

Patients 72

Patients Clinic Patient-Centered Illness 72

GeriPal

JULY 11, 2024

It’s a jampacked 50 minutes, filled with pearls on taking care of patients with liver disease. Kirsten 04:16 So, in emergency medicine, obviously, we are interacting and caring for these both exciting and interesting, but also very complex and humbling patients to care for in the ED setting. What’s the connection and why?

Patient-Centered 109

Patient-Centered IT Patients Clinic 109

GeriPal

NOVEMBER 7, 2024

If the purpose of initiating dialysis is improving function – our complex, frail, older patients are likely to be disappointed. Are we seeing people like more older adults, more nursing home patients starting dialysis, and even at a higher gfr? Let it be (hint hint). So I wonder if I could turn to either of our nephrologists.

Management 116

Management Patient-Centered Patients IT 116

GeriPal

OCTOBER 20, 2022

And, who within ASPE guides aging policy and connects policy to every day health challenges experienced by patients and clinicians? Alex: And we are delighted to welcome Rasheeda Hall, who is a physician scientist in the division of nephrology at Duke University School of Medicine, and sees patients at the Durham VA.

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 28, 2024

And we have Kate Courtright, who’s at University of Pennsylvania, the PAIR Center. What we did was ask clinicians earlier in the ICU stay for very sick patients to document prognosis, and for those who they thought would survive, to document six-month functional prognosis. Kate: These are very sick patients. Kate: Sure.

Consulting 115

Consulting Patient-Centered IT Patients 115

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

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.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

GeriPal

MAY 9, 2024

all of whom focus their efforts on educating the general public about living and dying with a serious illness. And one of the most common things that I would hear from patients, family caregivers would be I’d ask them at the end of the encounter, “What questions do you have?”

Education 127

Education IT Illness Healthcare 127

GeriPal

JANUARY 11, 2024

In further contrast to the United States, MAID in Canada is almost entirely administered by a clinician, whereas in the United States patients must self administer. A planned expansion of MAID to include people with mental illness was placed on hold until March 2024. They could have a prognosis of years, or decades. Alex: Thank you.

Illness 144

Illness IT Medical Provider 144

GeriPal

MAY 25, 2023

Others cited the call from communities to meet them where they are – be they senior centers, Black-owned businesses, or churches (we have a podcast planned in the fall with Fayron Epps and Karen Moss on the church setting). Health care system drives where you end up, which hospital, which state you live in. Eric: And we have L.J

Community 95

Community IT Patient-Centered Primary Care 95

GeriPal

MARCH 13, 2025

Summary Transcript CME Summary As far as weve come in the 50 years since Balfour Mount and Sue Britton opened the first palliative care at the Royal Victoria Hospital in Quebec, have we lost something along the way? In todays podcast we welcome some of the early pioneers in palliative care to talk about the roots of palliative care.

IT 104

IT Patient-Centered Family Families 104

GeriPal

MARCH 3, 2022

A little over a decade ago, Ken Covinsky wrote a GeriPal post about a Jack Iwashyna JAMA study finding that older adults who survive sepsis are likely to develop new functional and cognitive deficits after they leave the hospital. Shunichi Nakagawa’s Tweet that went viral on responding a patient request to drink ice water before death.

Patient-Centered 96

Patient-Centered Patients IT Hospital 96

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. Just an extraordinary cast of individuals who were really so incredibly inspiring.

Patient-Centered 98

Patient-Centered Patients IT Illness 98