FDA Law Blog

OCTOBER 18, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. electronic thermometers, single lumen needles, piston syringes).

Medical 52

Medical Electronics Complication Clinic 52

BMJ

AUGUST 20, 2021

Donors, government ministries, agencies and academic partners regularly cascade requests for data that multiply and complicate the simple interaction into a complex, and often redundant, set of data requirements for the same singular interaction. Digital uptake is more prevalent in high-volume and urban hospital networks.

Patient-Centered 40

Patient-Centered Clinic Provider Patients 40

33 Charts

OCTOBER 2, 2021

The zero-sum medical day In many healthcare systems the Epic feature is turned on and health professionals are expected to respond. The problem is that doctors work in what I call a zero-sum medical day. While this may help the zero-sum medical day on one level, compensation models don’t necessarily fix the problem of human bandwidth.

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Patients IT Provider Family Doctor 75

Annals of Family Medicine

NOVEMBER 20, 2024

The Centers for Disease Control and Prevention recommends discussing family planning and preconception counseling at the domestic medical exam (DME), yet there is little guidance on specific counseling needs in this population. Context Refugees and other newcomers may face fragmented prenatal care during resettlement.

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DO Family Medicine Complication Families 130

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. We’re very datified.

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Screening Primary Care Patient-Centered IT 120

FDA Law Blog

FEBRUARY 28, 2023

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. 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. By Adrienne R.

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Provider Electronics IT Complication 52

FDA Law Blog

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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Provider IT Engineering Medical 75

Mesa Family Physician

MARCH 6, 2025

Identifying health concerns before symptoms appear gives us tremendous advantages in treatment success and minimizing long-term complications. Evidence-based screening tests based on current medical guidelines, your age, and risk factors. I encourage all my patients to prioritize these visits, even when feeling perfectly healthy.”

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Preventative Care Preventive Care Appointment Screening 100

Annals of Family Medicine

NOVEMBER 20, 2024

Objective: 1) Demonstrate the feasibility of collecting data from prescription drug monitoring programs (PDMPs) for population health reporting, 2) analyze trends in PDMP and electronic health record patient data relative to CDC guidelines and 3) identify use of patient-centered measures for pain management in primary care.

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Patients Patient-Centered Primary Care Electronics 130

Medical Xpress

JUNE 16, 2025

But what we observed was much more complicated." The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. The traditional model is simple: SCN neurons were believed to act like runners in a relay race, passing the light signal along in a linear chain. What are the consequences?

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Provider Medical Complication Diabetes 109

Medical Xpress

JUNE 16, 2025

The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. Learn more Your name Note Your email address is used only to let the recipient know who sent the email. Neither your address nor the recipients address will be used for any other purpose. What are the consequences?

Mental Health 52

Mental Health IT Medical Specialization 52

GeriPal

JUNE 30, 2022

Should she have an operation, and risk the pain, potential complications, and attendant delirium associated with the operation? And I came to the now I think naive conclusion that fixing and avoiding complications was the secret. They were more likely to have a major inpatient surgical complication. She falls and breaks her hip.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

OCTOBER 19, 2023

And we have Scott Halpern, who is Professor of Medical Ethics and Health Policy and Director of the Palliative and Advanced Illness Research Center or Payer Center at the University of Pennsylvania. So now it’s just POLST, the word POLST, Portable Medical Orders. Hey, it’s National POLST Collaborative now. Good to know.

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Patient-Centered IT Patients Illness 127

GeriPal

SEPTEMBER 7, 2023

So pretty soon, I hope, we’ll be able to do this all electronically by anyone who wants to. He had a very aggressive lymphoma, highly aggressive, with a lot of different medical conditions. I slowly introduced higher doses as he recovered from his medical conditions that were acute. Or electronically, to fill out, right?

Patient-Centered 130

Patient-Centered IT Patients Clinic 130

GeriPal

JULY 21, 2022

If they’re in a major car crash, they’re going to have more long-term complications probably than a 20-year-old would. Emmy: But we know that physiologic changes with aging, like decreasing night vision and so forth, as well as medications, as well as medical conditions, can all affect whether you can drive.

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IT Families Family Diagnosis 102

GeriPal

JULY 28, 2022

And so I went into medical school wanting to cure cancer. I entered medical school and I did a course that was offered that’s called living with a life threatening illness. I entered medical school and I did a course that was offered that’s called living with a life threatening illness.

Illness 111

Illness Hospital Patient-Centered Patients 111

GeriPal

JUNE 15, 2023

Audio: [electronic voice] Alex Smith has been taken over by an artificial intelligence. And maybe there aren’t medications or procedures, but there could be some early interventions that perhaps could slow down the disease course. This is Eric Widera.

IT 100

IT Patient-Centered Patients Healthcare 100

GeriPal

APRIL 10, 2025

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. Do they have documents in the record like medical orders for life sustaining treatment or a healthcare proxy? Yeah, that’s a more complicated story. What does that mean?

Patient-Centered 78

Patient-Centered IT Hospital Patients 78

GeriPal

MARCH 28, 2024

Kate: So it was an embedded alert in the electronic health record and they just clicked those two answers very quickly. It’s complicated because right now there’s no mechanism other than cost avoidance. Eric: And how did you do that? So the question is, how do you pay for it? Your stem cell transplant patient.

Consulting 116

Consulting Patient-Centered IT Patients 116

GeriPal

JUNE 9, 2022

I was always critical care bound since medical school. I’m controlling everything your placebo versus medication trials. But there’s no real system and systematic electronic way to identify need-based palliative care right now. That gets really complicated as well. Kate: So it was a little windy path.

Consulting 100

Consulting Patient-Centered Diagnosis IT 100

GeriPal

SEPTEMBER 5, 2024

And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985. Alex 15:13 This is really complicated. Bill 16:55 First of all, I just have to go back to Dax, because Dax in 1973 is when I first came out here as a senior medical student and met Al Johnson. Bill 00:53 Thank you, Alex.

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Patients IT Patient-Centered Hospital 98

FDA Law Blog

MAY 21, 2024

The 2016 reviews concluded that marijuana continued to meet schedule I criteria for having a high potential for abuse, no currently accepted medical use in treatment in the U.S., and lacked accepted safety for use under medical supervision. Currently Accepted Medical Use in Treatment in the U.S. 21 U.S.C. § 21 U.S.C. §

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Physicals Medical Clinic Emergency Room 69

GeriPal

MARCH 27, 2025

But most people with dementia are initially diagnosed and medically managed in primary care, and they really desire clinicians to initiate these conversations but there are a number of really important barriers for these conversations taking place. Sydney 22:01 Well, it’s what’s in the electronic health record.

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Primary Care IT Clinic Illness 80

GeriPal

FEBRUARY 24, 2022

And I think the advanced planning debate is really a question of, how do we help this very complicated situation? And then you can make a medical recommendation that matches with what they’ve told you. We see how hard it is. We see when they don’t understand. We wonder if they were told. And that skill is hard.

Illness 98

Illness Patient-Centered IT Patients 98

Physician's Weekly

JUNE 17, 2025

But that’s when his family began fighting another adversary: their health insurer, which decided the treatment was “not medically necessary,” according to insurance paperwork. Prior authorization mostly happens behind the scenes, almost always electronically, and nearly all requests are quickly, or even instantly, approved.

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Insurance Patients Behavioral Health Services Diagnose 52