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. Yet this expansion has come with a significant administrative burden, particularly that of clinical documentation.

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FDA Law Blog

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).

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Physicians Alliance of Connecticut

MAY 27, 2025

Opportunities for healthcare admin assistants across Connecticut are growing, from clinics and hospitals to private practices like the Physicians Alliance of Connecticut. Their role improves the patient experience and helps doctors, nurses, and other providers work more efficiently. What Does a Healthcare Administrative Assistant Do?

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Healthcare Private Practice Electronics Management 52

Barton Associates

MAY 8, 2025

In this blog, we’re going to outline four key ways temporary medical staff such as locum tenens providers can help healthcare facilities maintain continuity of high-quality patient care in the face of growing shortages. Enter temporary medical staff, such as locum tenens providers. Many healthcare facilities in the U.S.

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FDA Law Blog

SEPTEMBER 11, 2023

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510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

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The Clinical Problem Solvers

SEPTEMBER 19, 2024

Describe the positive impacts of qualitative methods on healthcare provision and/or policies in clinical settings. Interconception Care for Primary Care Providers: Consensus Recommendations on Preconception and Postpartum Management of Reproductive-Age Patients With Medical Comorbidities. Zakaria, S., Vaught, A. Toth-Manikowski, S.

Internal Medicine 52

Internal Medicine Patient-Centered Specialization Community 52

FDA Law Blog

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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Clinic Telehealth Provider Electronics 59

Physician's Weekly

JUNE 24, 2025

Deana Hendrickson, 66, who provides daily care for three young grandsons in Los Angeles, sought an additional MMR shot, though she was vaccinated against measles, mumps, and rubella as a child, in case her immunity to measles had waned. .” “I’m sort of hectoring,” she acknowledged.

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FDA Law Blog

OCTOBER 5, 2022

eSTAR will be mandatory October 1, 2023 for all 510(k) submissions and subsequent supplements and amendments (e.g. 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. add-to-files).

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The Clinical Problem Solvers

MARCH 14, 2025

Dr. Benton mentors clinical and research physicians, fellows, and postdoctoral trainees. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital. Child and Adolescent Psychiatric Clinics of North America.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

FDA Law Blog

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

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FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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FDA Law Blog

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g.,

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FDA Law Blog

OCTOBER 7, 2024

FDA has civil money penalty authority relating to clinical trials, devices, foods, drugs, and tobacco; although with the exception of tobacco, FDA has not recently exercised that authority with regularity. If FDA is prohibited from pursuing the relatively small dollar value tobacco penalty cases administratively, it could affect enforcement.

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Electronics IT Government Clinic 59

FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

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Manufacturing Patient-Centered Provider Telehealth 59

FDA Law Blog

FEBRUARY 15, 2023

FDA is making these updates in part due to recognition that some of the records and reporting requirements are unnecessary to comply with the Electronic Product Radiation Control (EPRC) program (sections 532, 534(a)(1), and 537(b) of the FD&C Act (21 U.S.C. The final rule will be effective February 21, 2023.

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Manufacturing Electronics Medical Clinic 52

FDA Law Blog

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.

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Electronics IT Healthcare Patients 78

FDA Law Blog

OCTOBER 18, 2022

On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ). electronic thermometers, single lumen needles, piston syringes). The 2013 guidance documents include, but are not limited to, in vitro diagnostic and clinical trial considerations.

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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. There are additionally places to provide attachments for test reports and other supporting documents. New Labeling Requirements.

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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. delta +1.4 [95%CI

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Patients Patient-Centered Primary Care Electronics 130

Medical Xpress

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Other states like Oregon and Colorado have already launched legal clinics using psilocybin, the compound found in mushrooms, The Times reported. The content is provided for information purposes only.

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Mental Health IT Medical Specialization 52

Medical Xpress

JUNE 16, 2025

DOI: 10.1038/s41467-025-58661-1 Journal information: Nature Communications Provided by National Taiwan University Citation : Rewiring the body clock: Deep brain imaging reveals unexpected complexity in jet lag adjustment (2025, June 16) retrieved 16 June 2025 from [link] This document is subject to copyright. Your feedback is important to us.

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Provider Complication Medical Diabetes 109

GeriPal

MAY 18, 2023

Summary Transcript Summary Hot off the press is a brand spanking new updated 2023 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Alex: And we’re delighted to welcome Todd Semla, who is a clinical pharmacist and associate professor at the Feinberg School of Medicine at Northwestern University.

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PEMBlog

MARCH 27, 2024

She is a member of the Clinical Genome Resource Inborn Errors of Metabolism (IEM) Clinical Domain Working Group, where as a biocurator she assesses the pathogenicity of variants in IEM-associated genes to facilitate expedited genetic diagnosis for IEMs. Updated 2023 Jul 17]. On clinical presentation.

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Medical Xpress

JUNE 8, 2025

While many of these procedures provide critical care, we know they are acutely painful. Long-term effects of pain in early life We collected data on the number of procedures, clinical exposures and sucrose doses from three NICUs across Canada. The content is provided for information purposes only. Read the original article.

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IT Management Vaccination Medical 53

GeriPal

APRIL 6, 2023

To provide context, we are joined by Karen Steinhauser, a social scientist at Duke who has been studying spirituality for years (and published one of the most cited papers in palliative care on factors considered important at the end of life , as well as one of my favorite qualitative papers to give to research trainees ).

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FDA Law Blog

MAY 21, 2024

The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. Public comments must be submitted electronically or postmarked on or before July 22, 2024, 60 days after publication in the Federal Register. 29, 2023) (“Basis”); NPRM at 44,603. 21 U.S.C. §

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GeriPal

AUGUST 15, 2024

This question, while providing an opportunity to talk about direct and indirect experiences, can be asked of all patients, and opens the door to conversations about anti-semitism, islamophobia, or anti-Black racism. I had fun trying to make a danceable version with electronic drums for the audio-only podcast.

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Mental Health Community IT Screening 116

GeriPal

JULY 13, 2023

Randy died February 26, 2023. And I think that his research was informed by his clinical practice, his clinical practice was informed by his research. And if I remember that study correctly, it was priming both patients and providers in the outpatient setting to do goals of care conversations. Erin: Mm-hmm. Eric: Yeah.

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Patient-Centered IT Patients Hospital 84

Physician's Weekly

JUNE 26, 2025

His clinical study was ending. CDC vaccine safety officer Robert Chen built on VAERS to create the Vaccine Safety Datalink, which looks for evidence of vaccine harms in electronic health records. In 2001, the CDC set up the Clinical Immunization Safety Assessment project, through which a network of eight U.S.

Vaccination 52

Vaccination Patient-Centered Government IT 52

GeriPal

JULY 20, 2023

See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. What was life for you as a provider pre-pandemic? And so we’re able to provide access to those patients that may be home-bound or home limited or have a lot of struggles to get in. Stories trump data.

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