FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

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Manufacturing Provider Medical IT 98

FDA Law Blog

JUNE 22, 2022

In the second case, occurring from January to May 2020, a registered nurse, admitted to daily tampering of fentanyl vials and hydromorphone injectables wherein she removed the drugs from the vials replacing them with saline solution. DEA regulations require “adequate security” but do not specially require cameras in health care facilities.

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Board-Certified Provider Government Management 52

FDA Law Blog

MAY 4, 2023

This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ). mobile applications to capture patient-reported outcomes through questionnaires). DHTs include monitoring instruments (e.g.,

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Clinic Telehealth Provider Electronics 59

GeriPal

JANUARY 12, 2023

Which patients are eligible to go to an ACE unit? So I picked the Ed Sheeran song, The A Team, because it reminds me of our ACE team that goes around the hospital and cares for our older patients. And a light bulb just went off in my head, like, yes, this makes sense as a model for how we should care for more complex older patients.

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Hospital Patient-Centered IT Nurse Practitioner 100

Physician's Weekly

JUNE 19, 2025

On Fridays, Stephanie Johnson has a busy schedule, driving her navy-blue Jeep from one patient’s home to the next, seeing eight in all. Forget a lunch break; she often eats a sandwich or some nuts as she heads to her next patient visit. “Our patient isn’t just the older adult,” Johnson said. “Hello.

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Nurse Practitioner Families Family Primary Care 52

Medical Xpress

JUNE 16, 2025

Ibogaine shows potential for promoting neuroplasticity and aiding recovery, though it carries cardiac risks that require careful management. The initiative aims to attract additional private investment and facilitate FDA approval. This summary was automatically generated using LLM.

Mental Health 52

Mental Health IT Medical Specialization 52

ABIM

JUNE 4, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) or Canada to become eligible for ABIM Board Certification.

Diabetes 52

Diabetes Board-Certified Telehealth Government 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. 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 122

ABIM

JUNE 11, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. In June, ABIM issued notice about an opening on the Infectious Disease Board for a public member with patient or caregiver experience in infectious disease for a term beginning July 1, 2025.

Board-Certified 52

Board-Certified Government Community Education 52

GeriPal

FEBRUARY 8, 2024

Hospital Chaplains, Spirituality, and Pain Management: A Qualitative Study. Pain Manag Nurs. I think even the word patient, patient, I think, comes from the word suffer, the one who suffers. I’ve had a patient in one room, they have stage four breast cancer. 2023 Dec 20:S1524-9042(23)00202-3. 2023.11.004.

IT 137

IT Families Family Physicals 137

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 Hospital IT Patients 77

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. I could learn this.

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IT Patient-Centered Patients Healthcare 95

FDA Law Blog

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

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Supply Chain Manufacturing Government Hospital 59

GeriPal

FEBRUARY 20, 2025

If you want a deeper dive, check out the following resources: Our Nature of Suffering podcast with BJ Miller and Naomi Saks Dani Chammas Annals paper on countertransference and why we shouldnt say that the patient was difficult rather than that I felt frustrated. Eric 04:55 Does it need an experience directly? I guess that’s an event.

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Patient-Centered IT Screening Patients 66

GeriPal

DECEMBER 7, 2023

Big heat waves in England in 2020, 2,224 excess deaths in the obits over the age of 65. I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. So how are your patients going to deal with extreme heat and cold? They can save a lot of money.

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Healthcare IT Education Hospital 129

GeriPal

APRIL 21, 2022

Poetry puts us in our patient’s shoes. Poetry holds us in that liminal space so many of our patients are in. Look also for a forthcoming article by Mike and Redwing in Journal of Pain and Symptom Management on poetry as a healing modality, to be published mid May (will add link when out). Alex: Mm-hmm (affirmative).

Patient-Centered 93

Patient-Centered IT Community Illness 93

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.” Everything.

Patient-Centered 125

Patient-Centered IT Families Family 125

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. But we ended up doing, basically, a case series of… I think it was 18 or 20 patients or so.

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Hospital Patient-Centered Supply Chain IT 115

GeriPal

JULY 14, 2022

Two-thirds of the patients in the home now have COVID-19. Seventeen of your patients are dead. The other physicians who previously saw patients in the nursing home are no longer coming to your facility because you have COVID positive patients. You’re short on gowns and facemasks. Eric: Welcome to the GeriPal Podcast.

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Nurse Practitioner Patient-Centered Vaccination Emergency Room 136