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. 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

33 Charts

OCTOBER 2, 2021

According to Epic, the number of patient messages spiked 151 percent nationally from the period covering the first 11 weeks of 2020 through the end of the year. Why MyChart messages create a challenge for hospital systems So more contact and connection between doctors and patients seems like a good thing, right? Absolutely.

Patients 75

Patients IT Provider Family Doctor 75

FDA Law Blog

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. FDA-2020-E-1840 (July 13, 2020). FDA-2020-E-1840 (Mar. 2020) , has not yet—and to our surprise—ended up in court.

Patients 59

Patients IT Provider Individual 59

GeriPal

JUNE 8, 2023

So a lot of these patients that I care for are at risk for mortality or poor prognosis in general, and wanting to know how do we still provide them with quality care without giving them too many pricks, too many titrations when it comes to insulin. So not only do they give you a number, they give you trends. Nadine: No poking and prodding.

Diabetes 74

Diabetes Management Patient-Centered Family 74

FDA Law Blog

JUNE 22, 2023

Regarding COVID-19, Tim Stenzel, Director of CDRH’s Office of In Vitro Diagnostics, has stated that “in-home testing and home collections is a top priority” ( June 2020 FDA Virtual Town Hall ); “obviously home over-the-counter tests including rapid antigen tests are a high priority” ( February 2021 FDA Virtual Town Hall ). seeking treatment).

Manufacturing 59

Manufacturing Clinic IT Transportation 59

Medical Xpress

JUNE 16, 2025

The law directs Texas universities and hospitals to lead the research. The content is provided for information purposes only. However, we do not guarantee individual replies due to the high volume of messages. It also makes sure the state keeps a share in future profits if the drug is approved. Your feedback is important to us.

Mental Health 52

Mental Health IT Medical Specialization 52

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 123

Patient-Centered IT Illness Patients 123

The Clinical Problem Solvers

MAY 30, 2022

As healthcare providers, we must listen to our patients and use the power of our presence to see birthing people’s full humanity and empowerment. She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. Published online August 2020. Published January 16, 2019. link] Katy B.

Community 52

Community Patient-Centered Family Families 52

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?” Within the VA it’s now at 70 VA hospitals.

Patient-Centered 116

Patient-Centered Illness Healthcare IT 116

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 133

Patient-Centered Hospital Patients IT 133

ABIM

JUNE 24, 2025

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%). Advanced Practice Providers in the Hematology-Oncology Workforce* Guinevere Z. ASH has engaged in lobbying efforts in Washington, D.C.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

GeriPal

MAY 26, 2022

They argue that the current guidelines, which prioritize immunocompromised people and unvaccinated older people on the same level, should be re-done to prioritize the immunocompromised first, and additionally move up older vaccinated individuals or vaccinated persons with comorbidities. What’s wrong with that? Why not prioritize them?

Vaccination 88

Vaccination Individual IT Healthcare 88

ABIM

JUNE 11, 2025

A workgroup convened in 2020 found that the existing practice categories candidates could choose were inadequate to the real scope of community practice and proposed updates drawn from the American Medical Association and the Diplomate Professional Profile. Society guests departed at this point in the meeting.

Board-Certified 52

Board-Certified Government Community Education 52

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 106

Telehealth Patient-Centered IT Patients 106

GeriPal

MARCH 2, 2023

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. Eric: And we have Tasce Bongiovanni, who is an acute care trauma surgeon at UCSF and the San Francisco General Hospital. JAGS 2022 Trends in Antipsychotic and Mood Stabilizer Prescribing in Long-Term Care in the U.S.:

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

APRIL 10, 2025

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. Today we discuss: Why the study was negative for the primary (hospitalization) and all secondary outcome (e.g. Tammie 03:04 Depends on how long they were pre-hospital. hospice use).

Patient-Centered 78

Patient-Centered IT Hospital Patients 78

FDA Law Blog

APRIL 8, 2024

To address the underlying causes of shortages, the White Paper suggests that the creation (by Congress) of two programs that link inpatient hospital purchasing and payment decisions to supply chain resilience practices would better incentivize investments in mature manufacturing practices. methylphenidate, dextroamphetamine).

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

GeriPal

SEPTEMBER 21, 2023

Karen has a Cambia Sojourns award to pilot an intervention in which Black/African American former caregivers are trained to provide peer support to current caregivers (Peer2Care). Learned later on, as Fayron indicated, about the disparity related to Black and African American individuals as it relates to dementia, it being a fatal disease.

Community 129

Community Family Families IT 129

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!

Patient-Centered 127

Patient-Centered IT Patients Illness 127

GeriPal

SEPTEMBER 12, 2024

I must admit, though, sometimes it just feels off… inauthentic, as if it’s not a genuine desire to improve our lives as health care providers, but rather a metric to check off or a desire to improve productivity and billing by making the plight of workers a little less miserable. We were often the only ones left in the hospital.

IT 112

IT Healthcare Healthcare Professional Patient-Centered 112

GeriPal

FEBRUARY 20, 2025

Summary Transcript CME Summary Trauma is a universal experience, and our approach as health care providers to trauma should be universal as well. And you can’t really predict how each individual might react to the same experience. Alex 04:42 It’s very individual, so it’s highly subjective in some sense.

Patient-Centered 67

Patient-Centered IT Individual Screening 67

GeriPal

JANUARY 20, 2023

You were on a National Academy of Sciences committee started in 2020? To me, I think the Greenhouse folks have proven that you can provide quality care in a home-like environment cost effectively if it’s done right. Eric: All right, let’s jump into this topic. Improving nursing home quality. Jasmine: Yes. Is that right?

Finance 95

Finance Board-Certified IT Provider 95

GeriPal

MARCH 30, 2023

This week we’ve invited three guests to share their stories about storytelling that’s written for healthcare providers. Since my mom died in 2020 until I wrote this piece in the fall of last year, I had not ever expected or intended to write about my experience. The first guest is Liz Salmi. But some things haven’t changed much.

IT 96

IT Patient-Centered Patients Healthcare 96

GeriPal

NOVEMBER 2, 2023

I was very close with my grandparents growing up, and then I actually was exposed to geriatrics as a pre-med student at Yale New Haven Hospital as one of the volunteers and Dr. Sharon Inouye’s initial help trial and had a fabulous role model Dr. Verano, who I wanted to be. Ryan: Actually, a very similar story as to Jerry. Yes, I own it.

Board-Certified 91

Board-Certified IT Community Medical Student 91

GeriPal

FEBRUARY 13, 2025

Marie 03:08 So, living in Alabama, which is our palliative care desert in the south, there were no palliative care services in any of the small rural hospitals. We went to a hospital in Mississippi, one in Alabama, and one in South Carolina. The black individuals wanted to have a separate one from the white individuals.

Consulting 64

Consulting Community Patient-Centered Family 64

Medical Xpress

JUNE 8, 2025

While many of these procedures provide critical care, we know they are acutely painful. As is the case internationally, sucrose is used widely in New Zealand, but there is considerable variation in protocols of use across hospitals. The content is provided for information purposes only. Whats more, pain isnt always managed.

IT 53

IT Management Vaccination Medical 53

GeriPal

FEBRUARY 8, 2024

Hospital Chaplains, Spirituality, and Pain Management: A Qualitative Study. So there’s this, what is suffering to the individual, and is there some threshold that we could say, “This is real suffering,” or “This is the suffering we talk about in geriatrics or palliative care”? Pain Manag Nurs. 2023.11.004.

IT 137

IT Family Families Physicals 137

BMJ

MAY 10, 2022

Family physicians and family health workers, considered reliable sources of vaccine information, have a unique position where individuals in rural and urban areas can access frequently, uninterruptedly, cheaply, and easily [2]. Individuals over 65 years of age at home Yes 23 (65.7) Jour Turk Fam Phy 2020; 11 (1): 95-101.

Vaccination 40

Vaccination Healthcare Professional Healthcare Primary Care 40

Family Medicine Initiative

APRIL 10, 2024

GPs Are the Backbone of Effective Healthcare Systems Countries with a stronger focus on primary care and family medicine, rather than on hospitals and specialists, enjoy better health, 1 , 2 lower health inequalities, 2 , 3 and prevent hospitalizations. 2 , 4 I believe this is crucial and that all politicians should know about it.

Family Physician 130

Family Physician Family Families GP 130

GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. And so we do see hospital admissions for heat exposure and certainly cardiovascular and respiratory problems related to air pollution with climate change and also cognitive problems.

Healthcare 130

Healthcare IT Education Hospital 130

GeriPal

JULY 6, 2023

It was designed to really balance what Medicaid at the time was to provide nursing homes and Medicare is obviously health insurance. Equally as important, is if you wind up in an ED or being hospitalized or wind up in rehab, eventually you’re going to be discharged back home. But, what you need is a community-based game there.

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

DECEMBER 29, 2022

December 2020. I was also working there at an adult day center for individuals with Alzheimer’s and other related dementias. In social work, it’s called self-determination of the client, meaning at the end of the day, I can provide resources to this older adult or to this caregiver, whoever it may be. Geriatrics.

Family 96

Family Families 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 Family Families 126

GeriPal

SEPTEMBER 14, 2023

Summary Transcript Summary Hospitals are hazardous places for older adults. These hazards include delirium, malnutrition, falls, infections, and hospital associated disability (which about ⅓ of older adults get during a hospital stay). 2020 Hospital at Home-Plus: A Platform of Facility-Based Care. Bruce: Yeah.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

GeriPal

OCTOBER 31, 2024

Summary Transcript CME Summary In March 2020, we launched our first podcast on COVID-19. Eric 03:29 Lona, I am not sure you remember this, but over four years ago, March, mid March of 2020, we did a podcast on a novel respiratory virus that was coming out of Wuhan. And we don’t see hospitals being strained as much anymore.

Vaccination 128

Vaccination IT Patient-Centered Patients 128

GeriPal

JUNE 2, 2022

We’ve lived through lockdowns, toilet paper shortages, mask mandates, hospital surges where ICU’s overflowed, a million COVID deaths, prolonged school closures, development and roll out of novel vaccines, an explosion of social isolation and loneliness, and the invention of the “zoom meeting.” . it was April, 2020. I’m anxious.

Vaccination 100

Vaccination IT Hospital Management 100

GeriPal

APRIL 17, 2025

Farah provides clear examples from the Biden administration, in which having the most diverse cabinet in history was critical to building bridges, empathy, and inspiring others to feel included. I took my kids in 2019, 2020. So it’s 2020. She still remembers that I was in a meeting for hospitalists.

IT 71

IT Community Government Management 71