The Clinical Problem Solvers

JUNE 26, 2023

Calac June 22, 2023 Summary : This episode highlights a selection of antiracism research presentations at a live recording of the podcast at the 2023 SGIM Annual Meeting. Identify strategies to mitigate bias and stigma in the electronic health record as a trainee and medical practitioner.

Electronics 52

Electronics Internal Medicine Patient-Centered Healthcare 52

Physician's Weekly

JUNE 16, 2025

Oncology providers vary widely and diverge from guidelines in their preferred treatments of adults with diffuse large B-cell lymphoma (DLBCL) and pre-existing cardiomyopathy, according to the results of a nine-country survey demonstrate. “In 44% of respondents would order an echocardiogram only if heart failure signs or symptoms developed.

Routine Screenings 52

Routine Screenings Patient-Centered Screening Provider 52

Maine Academy of Family Physicians

JULY 6, 2023

In Maine, Anopheles mosquito vectors are present. Providers should encourage confirmed and suspected patients with malaria to avoid activities that would put them in contact with local mosquitoes. Providers should remain vigilant throughout the year for potential cases. READ Maine CDC Health Advisory (PDF)

Electronics 52

Electronics Provider Patients IT 52

Annals of Family Medicine

NOVEMBER 20, 2024

Background Researchers use card studies to obtain observational data about primary care provider (PCP) knowledge, attitudes, and behaviors on a variety of topics. In 2022, Bunce et al embedded "card" questions into an electronic health record (EHR) with responses saved to the EHR database.

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PCP PCP Primary Care Clinical Practice 130

FDA Law

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Transfer of Electronic Prescriptions for Schedule II-V Controlled Substances Between Pharmacies for Initial Filling, 88 Fed. By Larry K.

Electronics 52

Electronics Patients IT Provider 52

The Clinical Problem Solvers

SEPTEMBER 22, 2020

[link] Episode Description Dr. Joshua Inglis presents a Human Dx case to Sharmin , Vivek Nair and Joshua Morris. He spent his third year doing an MA in design that cemented his passion for using creativity and innovation to better deliver care and information to patients and providers. Take our Episode Quiz here.

Medical Student 52

Medical Student Medical Electronics Education 52

Today's Hospitalist

MAY 9, 2025

Since the mid-1990s, our capacity for innovation has never stopped as hospitalists navigate a complex landscape of acute illnesses, interprofessional collaborations and the imperative to provide efficient, high-quality care. We have seen explosive growth and become a cornerstone of modern health care systems.

Patient-Centered 52

Patient-Centered Telemedicine Clinic Electronics 52

FDA Law

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

Provider 59

Provider Electronics Manufacturing IT 59

FDA Law

DECEMBER 12, 2022

While the methodology for determining if your product is a medical device has not changed, FDA’s Digital Health Policy Navigator (“Navigator”) provides a convenient and efficient framework for developers to assess software functions. Please check out FDA’s presentation on this very topic – Is My Product a Medical Device?

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Medical Manufacturing Electronics Provider 23

The Clinical Problem Solvers

SEPTEMBER 19, 2024

Cooper September 19, 2024 Summary : This episode highlights a selection of antiracism research presentations at a live recording of the podcast at the 2024 SGIM Annual Meeting. Clinician Response to Patient Medication Prices Displayed in the Electronic Health Record. References Ogunwole, S. Zakaria, S., Vaught, A. Toth-Manikowski, S.

Internal Medicine 52

Internal Medicine Patient-Centered Specialization Community 52

FDA Law

NOVEMBER 20, 2024

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. FDA is extending the comment period on the notice published September 20, 2024 ( 89 FR 77162 ).

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. Providers should be aware of the other drugs prescribed to their patients. By Larry K. Holiday CVS, L.L.C.

Treatment Plan 139

Treatment Plan ER Government Patient-Centered 139

FDA Law

AUGUST 8, 2023

The Guidance, which provides details about nitrosamines and FDA’s experience regulating them, explicitly applies to all finished drug products (including Rx, OTC, and unauthorized drugs), to “prescription and OTC drug products in clinical development,” and to both API and drug manufacturers.

Manufacturing 74

Manufacturing Electronics Provider Clinic 74

FDA Law

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. To request an FEI Number, laboratories will need to provide a long list of identifying information to FDA via email ( feiportal@fda.hhs.gov ) ( see slide 23 of the FDA’s presentation for the complete list).

Manufacturing 64

Manufacturing Electronics Provider Management 64

PEMBlog

AUGUST 30, 2023

Many of the children you will evaluate during your shift are among the estimated 10 million United States (US) ED visits made by children with asthma, bronchiolitis, and croup, the most common pediatric respiratory conditions presenting to acute care settings.

Asthma 52

Asthma Electronics Utilities Clinical Practice 52

FDA Law

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests.

Medical 52

Medical Electronics Provider Screening 52

FDA Law

OCTOBER 24, 2022

These data are routinely collected from a variety of sources, such as electronic health records, providing information on health and healthcare in actual patients, rather than in the controlled environment of a clinical trial. This value is potentially even greater for rare diseases, where there are limited sources of data.

Electronics 78

Electronics IT Healthcare Patients 78

FDA Law

SEPTEMBER 17, 2023

Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees. If FDA is slow in providing that list, it is fine to send a follow-up email requesting a list of FDA attendees in advance of the meeting. Be ready with backup options (e.g.,

Screening 59

Screening Transportation Provider Electronics 59

FDA Law

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. Table 1 below shows the 510(k) submission process based on the MDUFA III Performance Goals.

Provider 75

Provider IT Engineering Medical 75

GeriPal

JULY 19, 2024

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. There has to be effective support provided behind any type of screening strategy in order for it to truly be effective. Joe, your thoughts?

Screening 119

Screening Primary Care Patient-Centered IT 119

The Motivated MD

OCTOBER 10, 2024

So, with this chapter, I hope to briefly touch on the basics of market investing and describe why simple diversification and index fund investing are the most effective ways for busy clinical physicians and healthcare providers to invest with the expectation of long-term gains. Don’t try to beat the market; be the market.

Finance 52

Finance Individual Management IT 52

FDA Law

MARCH 7, 2023

Lenz, Principal Medical Device Regulation Expert — As we discussed in our prior post , the electronic Submission Template And Resource (eSTAR) template will take getting used to in terms of form. However, not providing the appropriate type of information and level of detail the Agency expects is still possible with eSTAR.

Management 59

Management Electronics Consulting Provider 59

FDA Law

JUNE 27, 2023

To provide transparency to industry, and to assist FDA prioritize and conduct its review, FDA should bolster its website to include specific examples of appropriate information to include in voluntary submissions. The electronic form does not allow for attachments; it requests that you separately email any attachments; 2.)

Manufacturing 59

Manufacturing Utilities Electronics IT 59

FDA Law

SEPTEMBER 27, 2023

The biggest changes are the addition of Type D and Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings to the four types already present (Types A, B, B (end of phase), and C), and the addition of additional meeting formats.

IT 64

IT Manufacturing Provider Clinic 64

FDA Law

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. There are additionally places to provide attachments for test reports and other supporting documents. Performance Testing Summaries No Longer Needed?

Provider 52

Provider Electronics IT Complication 52

FDA Law

MARCH 20, 2022

The Guidance provides detail on a recalling firm’s responsibilities, preparations, and communications and how the Agency can assist a firm with carrying out its recall responsibilities. The Guidance provides practical guidelines for both firms and direct accounts. Product coding (e.g.,

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. The investigators select the drugs they will audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. The investigators select the drugs they will audit.

Management 40

Management Consulting Provider Physicals 40

Physician's Weekly

JUNE 16, 2025

MONDAY, June 16, 2025 (HealthDay News) — In a policy statement issued by the American Academy of Pediatrics and published online June 16 in Pediatrics , updated recommendations are presented for providing adolescent patients with contraceptive counseling and methods. ” Abstract/Full Text Copyright © 2025 HealthDay.

Patient-Centered 52

Patient-Centered Education Electronics Insurance 52

FDA Law

FEBRUARY 7, 2024

Also, a DEA Form 452 report must be electronically filed within 15 days after the order is shipped. According to the eBay settlement agreement, the government contends that from October 2015 to the present, eBay did not comply with any of “the CSA’s reporting and recordkeeping obligations” involving thousands of transactions.

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Government Electronics Education Individual 116

The Clinical Problem Solvers

DECEMBER 20, 2021

difficulty of sending patient messages through the electronic medical record in languages other than English), limited healthcare literacy, and English-only signage on healthcare campuses are just a few of the structurally racist barriers faced by many Asian folks seeking healthcare. Insufficient language services (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

GeriPal

DECEMBER 8, 2022

Many links: VA Presents: My Life, My Story: George: A Voice To Be Heard on Apple Podcasts. Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol. Connection — The Integration of a Person-Centered Narrative Intervention into the Electronic Health Record : An implementation study.

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

FDA Law

JULY 7, 2024

To be sure, Table 2 provides a handy visual of the categories of LDTs, the timeline for phaseout, and the scope of enforcement discretion for each test category. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. On clinical presentation.

Consulting 59

Consulting Individual Family Families 59

GeriPal

DECEMBER 15, 2022

And which of those experiences would you like to share with us that we could then write into a story that we’ll share with providers? It started here at Madison at one and it’s also spread outside the VA now to hospitals in Boston, Providence and now starting up actually in California and UCLA and UCSF. And then came back.

IT 105

IT Patient-Centered Healthcare Illness 105

GeriPal

JUNE 19, 2025

Knowing that the community is really underrepresented in sort of our knowledge, what we do, how we provide care that’s truly inclusive and welcoming. You present your. And so as I was launching my research career in San Francisco, I specifically wanted to better understand being a gay person and non binary one. Just how you.

Individual 85

Individual Community IT Chronic Condition 85

GeriPal

JULY 21, 2022

And I’ve been to some presentations that use that same breaking bad news model for having these driving conversations, as are used in palliative care. So that’s a piece that I think is important for providers anywhere along that process to be asking about driving. Eric: Also from the provider standpoint. Absolutely.

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Family Families IT Diagnosis 102