FDA Law Blog

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. In this presentation, FDA suggested the following tips.

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Provider IT Engineering Medical 75

FDA Law Blog

FEBRUARY 28, 2023

FDA announced on October 3, 2022 that the voluntary electronic Submission Template And Resource (eSTAR) templates would be required beginning October 1, 2023, as we blogged about here. As anyone who has ever worked on a lengthy and/or complicated AI response knows, these responses do not always fit neatly in a text box.

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Provider Electronics IT Specialization 52

GeriPal

JULY 19, 2024

But the thing that really motivates me is seeing, you know, and trying to manage later stage, you know, we can call them complications of people who haven’t had a diagnosis are now really in, you know, a world of complexity around other conditions, around managing life and managing practical things. Eric 40:07 Okay, I got a question.

Screening 119

Screening Primary Care Patient-Centered IT 119

GeriPal

SEPTEMBER 7, 2023

So I make the point, they often say, “Oh, you have this special population,” like pediatrics, where it’s 10% or something. So pretty soon, I hope, we’ll be able to do this all electronically by anyone who wants to. Or electronically, to fill out, right? William: Not the future, but the present.

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Patient-Centered IT Patients Clinic 129

GeriPal

MARCH 28, 2024

Well, as a kick off to this year’s first in-person State of the Science plenary, held in conjunction with the closing Saturday session of the AAHPM/HPNA Annual Assembly, 3 randomized clinical trials were presented. Kate: So it was an embedded alert in the electronic health record and they just clicked those two answers very quickly.

Consulting 115

Consulting Patient-Centered IT Patients 115

GeriPal

APRIL 10, 2025

primary palliative care interventions seem to fail, whereas specialized palliative care interventions have a relatively robust track record of success. Corita 09:39 Yeah, so we used the electronic health record, I think, in support. And so we did a similar intervention but using electronic means. Why do so many (most, all??)

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

GeriPal

SEPTEMBER 5, 2024

Alex 15:13 This is really complicated. And he had a deadly fear of being institutionalized, based on his previous present experience. They have a special skill, and when they see someone who needs it, they need to use it. That makes it really special for them and for me. This shouldn’t have happened. And I was.

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Patients IT Patient-Centered Hospital 98