Annals of Family Medicine

MARCH 24, 2025

METHODS We used electronic health records from the PRIME registry to identify patients with diagnosis codes or positive test results for chlamydia and/or gonorrhea from 2018 to 2022. We examined how well chlamydia and gonorrhea treatment in primary care settings adhered to guidelines.

Primary Care 130

Primary Care Patients Patient-Centered Families 130

Physician's Weekly

JUNE 19, 2025

“This study uncovered negative and positive provider, treatment, and system-related factors that contribute to these patients’ experiences and offered recommendations for improving care experiences.”

Mental Health 52

Mental Health Physicals Patient-Centered Patients 52

Physician's Weekly

JUNE 25, 2025

Insurance companies have promised changes like these before, in 2018 and 2023, but many didn’t follow through, Dr. Mehmet Oz , head of the Centers for Medicare & Medicaid Services (CMS), said. By 2027, at least 80% of electronic prior authorization requests will be answered in real time, and the process will be easier to do online.

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FDA Law Blog

NOVEMBER 29, 2021

Currently, DEA regulations do not address transfer of controlled substance prescriptions — whether paper or electronic — between pharmacies for the initial filling of the prescription. As with other DEA recordkeeping requirements, the electronic record must be maintained for two years. The proposed rule also just makes sense.

Electronics 52

Electronics Patients IT 52

FDA Law Blog

OCTOBER 5, 2022

The development of an electronic submission template for 510(k) submissions is significant in that: eSTAR submissions are not expected to go through the refuse to accept (RTA) process. Exemptions from the electronic submission requirements apply to interactive review responses and some amendments (e.g., add-to-files).

Electronics 45

Electronics Medical Screening IT 45

The Clinical Problem Solvers

SEPTEMBER 28, 2019

Dr.’s Vivek Murthy, Bridget O’Brien, and Gurpreet Dhaliwal sought to answer this question in a 2018 study. From the perspective of an early career learner, I find these acts of diagnostic prowess to be awe-inspiring, if not a bit intimidating. Were they simply born with superior brains? How did they get this good?

Lab Testing 52

Lab Testing Clinic Education Clinical Practice 52

The Medical Futurist

JUNE 21, 2025

Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018. Harbisson received a specialised electronic eye, his “eyeborg” to be able to render perceived colours as sounds on the musical scale.

Diabetes 98

Diabetes Patient-Centered IT Patients 98

FDA Law Blog

MAY 13, 2024

RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology. In fact, in 2018, FDA emphasized that leveraging the use of RWD and RWE in regulatory decision-making is “a top strategic priority for the FDA.”

Medical 111

Medical Clinic Patients IT 111

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 11, 2023

The electronic Submission Template and Resource (eSTAR) program, which we blogged about here and here , also makes the highlight reel given its aim to improve consistency and efficiency in how 510(k)s are prepared.

Medical 64

Medical Electronics Manufacturing Utilities 64

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

OCTOBER 20, 2021

Reynolds (RJR) Vapor Company’s Vuse Solo electronic nicotine delivery system (ENDS) device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% By David B. Clissold — On October 12, 2021, FDA authorized the marketing of R.J.

Electronics 52

Electronics Provider Manufacturing IT 52

FDA Law Blog

SEPTEMBER 26, 2022

FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. The list of alternative mechanisms for complying with Part 211 in this FR Notice is not different from what was proposed in the 2018 FR Notice. or that FDA proposes can satisfy the requirements in § 4.4 much like an FDA guidance document.

Manufacturing 40

Manufacturing Specialization Provider Medical 40

FDA Law Blog

JULY 7, 2021

In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to treat patients with severe self-injurious and aggressive behaviors (SIB/AB), but did not restrict the use of these same devices for other purposes, like smoking cessation. FDA cleared 510(k)s for GEDs in the 1990s.

Medical 52

Medical Patient-Centered Patients IT 52

FDA Law Blog

NOVEMBER 20, 2024

of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18. Submit either electronic or written comments on the draft guidance by December 19, 2024, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Provider 59

Provider Medical Manufacturing Consulting 59

Annals of Family Medicine

NOVEMBER 20, 2024

Setting or Dataset: American Family Cohort, a data asset including electronic health records of 8 million patients from family practices across 50 US states. Population Studied: Patients with ≥1 visit between January 2018 and December 2019 and who remained in the cohort until at least May 2020. Measurements.

Primary Care 130

Primary Care Patients Diagnosis Family Practice 130

Annals of Family Medicine

NOVEMBER 20, 2024

Setting/Dataset Data were extracted from the electronic health records at a Family Medicine practice in Philadelphia, PA. Population Studied Inclusion criteria were ages 16-45 with a DME performed between 2018 and 2023.

Family Medicine 130

Family Medicine DO Complication Families 130

FDA Law Blog

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 As demonstrated by the statistics over the past five years (Table 2), the average number of Total Days (FDA Days + Industry Days) ranged from 127 to 159 calendar days. Average Number of Industry Days to MDUFA IV Decision 54.69

Provider 75

Provider IT Engineering Medical 75

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

In August 2018, FDA published a notice in the Federal Register granting an alternative under 21 C.F.R. When FDA initially implemented the VMSR Program, in 2018, the Agency reviewed all product codes to determine eligibility for the program. Summary malfunction reports should be submitted electronically on Form FDA 3500A.

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. Or electronically, to fill out, right? ” And we can by targeting these supportive care interventions.

Patient-Centered 130

Patient-Centered IT Patients Clinic 130

GeriPal

JULY 21, 2022

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. Or have electronic health record prompts so people remember to ask it? I think I’m really drawn to hard conversations. So then it’s just been a really fun area to work in. Weren’t those the days?

IT 102

IT Families Family Diagnosis 102

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 Patients Hospital 84

FDA Law Blog

JUNE 10, 2025

Public comments must be submitted electronically or postmarked on or before July 3, 2025. In March 2018 the Commission on Narcotic Drugs voted to add 4-FA to schedule II of the 1971 Convention on Psychotropic Substances, requiring signatories including the U.S. 23,477 (June 3, 2025).

Specialization 69

Specialization Manufacturing Electronics PCP 69

GeriPal

MARCH 27, 2025

So we have to collect what information we have available from Health Information exchange and electronic health records. Sydney 21:41 So we did find increased documentation of the primary outcome in the electronic health records. Sydney 22:01 Well, it’s what’s in the electronic health record. Eric 22:03 Okay.

Primary Care 80

Primary Care IT Clinic Patient-Centered 80

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. Tell me what would you… Juliet: Fully Integrated electronic medical records system that made this very easy for clinicians to do. Eric: On EHR?

Illness 98

Illness Patient-Centered IT Patients 98

Physician's Weekly

JUNE 25, 2025

They will require insurers to respond to requests within seven days or 72 hours, depending on their urgency, and to process prior authorization requests electronically, instead of by phone or fax, among other changes. He noted that health insurers made “past promises” to improve prior authorization in 2018.

Insurance 52

Insurance Patient-Centered Patients Government 52

FDA Law Blog

FEBRUARY 5, 2025

This proposed rule follows FDAs March 2018 advance notice of proposed rulemaking (ANPRM) regarding a potential maximum nicotine level for cigarettes. It would not apply to electronic nicotine delivery systems (ENDS) smokeless tobacco products, nicotine pouch products, or other non-combusted tobacco/nicotine products.

Manufacturing 66

Manufacturing Engineering Electronics IT 66

Physician's Weekly

JUNE 17, 2025

Prior authorization mostly happens behind the scenes, almost always electronically, and nearly all requests are quickly, or even instantly, approved. The Right to Try Act, signed by President Donald Trump in 2018, entitles patients with terminal illnesses to try experimental drugs, but it does not obligate insurance companies to pay for them.

Insurance 52

Insurance Patients Behavioral Health Services Diagnose 52

Physicians News Digest

APRIL 3, 2025

Singh devises ways to integrate technologies like telemedicine and artificial intelligence into electronic health records to alert doctors to potential prescribing errors or misdiagnoses. AHRQ-funded researchers such as Hardeep Singh at Baylor College of Medicine have chipped away at patient safety risks for more than two decades.

Patient-Centered 52

Patient-Centered Hospital Diagnose Medical 52