FDA Law Blog

MAY 8, 2023

Although FDORA gave FDA express authority to allow PCCP , FDA had already been considering creating a mechanism for manufactrurers to prespecify modifications for AI/ML-based software subject to 510(k) premarket notification and de novo classification for several years.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature). By Asking Them.

Patients 52

Patients Patient-Centered Clinic IT 52

GeriPal

NOVEMBER 9, 2023

The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life. We’re doing a lot of interactive relationship building. Beth: Right now, I’m actually just doing individual coaching, but we are writing a grant to start group coaching next year. What does it mean to you?”

Board-Certified 111

Board-Certified IT Primary Care Referral 111

The Clinical Problem Solvers

APRIL 5, 2022

This is the last of three episodes interrogating the relationships between race, place, housing, and health. Push back against individual narratives that blame individuals for systemic injustice. Published April 5, 2019. January 18, 2019. Push back against dehumanizing language. Rothstein, R. Segregated by Design.

Community 52

Community Patient-Centered Emergency Room Medical 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. The foundational literature in this area has furthered stigma and bias, especially towards Black birthing persons.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

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. James 01:34 Yeah, right on.

Illness 109

Illness IT Patient-Centered Patients 109