The Clinical Problem Solvers

SEPTEMBER 28, 2019

s Vivek Murthy, Bridget O’Brien, and Gurpreet Dhaliwal sought to answer this question in a 2018 study. This is a peer-nominated group of academic clinicians renowned for their medical knowledge, teaching & communication skills, professionalism, and high-quality patient care.

Lab Testing 52

Lab Testing Clinic Education Clinical Practice 52

FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

Medical 111

Medical Clinic Patients IT 111

FDA Law Blog

JULY 7, 2021

Gibbs — In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban. In 2018, a Massachusetts court upheld the use of GEDs in treating patients with SIB/AB, finding the device to be effective in treating refractory patients.

Medical 52

Medical Patient-Centered Patients IT 52

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18.

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

Medical 64

Medical Electronics Manufacturing Utilities 64

Aspiring Minority Doctor

DECEMBER 8, 2021

This year, I started using the CariPro electronic toothbrush and my mouth definitely feels cleaner. ProCompression Socks Throwback pic from one of my 2018-2019 24hr call shifts I swear by Pro Compression socks! To add more awesomeness to the mix, I was recently sent a water flosser to try out and I am loving it.

Electronics 52

Electronics Healthcare Professional IT Medical Student 52

FDA Law Blog

NOVEMBER 9, 2021

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. This pilot program, which utilized FDA’s eSubmitter electronic submission template, ended in May 2021.

Electronics 40

Electronics Physicals Provider Utilities 40

FDA Law Blog

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

Manufacturing 40

Manufacturing Specialization Provider Medical 40

FDA Law Blog

AUGUST 29, 2021

This policy, announced by then Associate Attorney General Rachel Brand in 2018 was referred to as the Brand Memo. electronic formatting for regulatory submissions), scientific (e.g., As a matter of administrative law, the Brand Memo made good sense from the perspective of FDA-regulated industry, as we described here.

Government 52

Government Electronics IT Clinic 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.

Provider 75

Provider IT Engineering Medical 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. Population Studied Inclusion criteria were ages 16-45 with a DME performed between 2018 and 2023.

DO 130

DO Family Medicine Complication Families 130

Annals of Family Medicine

NOVEMBER 20, 2024

The exposure was COVID-19 era (pre = March 10, 2018-March 10, 2020; during = March 11, 2020-March 11, 2022). Setting: Electronic Medical Record data from primary care clinics in the University of Toronto Practice Based-Research Network Data Safe Haven and Northern Ontario School of Medicine Research Toward Health Hub (Ontario, Canada).

Primary Care 130

Primary Care Electronics Clinic Medical 130

FDA Law Blog

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. Then, in 2016, FDA noted its goal to streamline MDR requirements in the Medical Device User Fee Amendments of 2017 (MDUFA IV) commitment letter.

Medical 59

Medical Manufacturing Individual Provider 59

GeriPal

SEPTEMBER 7, 2023

William: So ASCO decided to make a high priority this year to redo the guidelines, which were originally released in 2018. 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.

Patient-Centered 129

Patient-Centered IT Patients Clinic 129

GeriPal

JULY 21, 2022

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. 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. Weren’t those the days?

Families 102

Families IT Family Diagnosis 102

FDA Law Blog

JUNE 10, 2025

One commenter, without providing details, asserted that the chemical may have uses in the medical field. Public comments must be submitted electronically or postmarked on or before July 3, 2025. and lacks accepted safety for use under medical supervision, the criteria for schedule I placement. 23,477 (June 3, 2025).

Specialization 69

Specialization Manufacturing Electronics PCP 69

GeriPal

JULY 13, 2023

Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. I wonder if we can just start off just going back a little bit because we had Randy on back in 2018 talking about Jumpstart, priming patients to do goals of care conversations. Am I summarizing that right?

Patient-Centered 84

Patient-Centered IT Hospital Patients 84

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.

Primary Care 79

Primary Care IT Clinic Illness 79

GeriPal

FEBRUARY 24, 2022

And so the definition of advance care planning really switched in, I think, 2017, 2018, there was kind of a United States definition and then an international consensus definition. And then you can make a medical recommendation that matches with what they’ve told you. What are your values? You have to hear what they understand.

Illness 98

Illness Patient-Centered IT Families 98

Physician's Weekly

JUNE 25, 2025

Dozens of insurance companies, including Cigna, Aetna, Humana, and UnitedHealthcare, agreed to several measures, which include making fewer medical procedures subject to prior authorization and speeding up the review process. Insurers also pledged that medical professionals would continue to review prior authorization denials.

Insurance 52

Insurance Patient-Centered Government Patients 52

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.

Insurance 52

Insurance Patients Behavioral Health Services Diagnose 52

Physicians News Digest

APRIL 3, 2025

Survey data gathered by AHRQ provides much of what is known about hospitalizations for motor accidents, measles, methamphetamine, and thousands of other medical issues. Medical errors caused by missed diagnoses, drug errors, hospital infections, and other factors kill and maim tens of thousands of Americans each year. Kennedy Jr.

Patient-Centered 52

Patient-Centered Hospital Diagnose Medical 52