FDA Law

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

Patients 52

Patients Clinic Medical Patient-Centered 52

Sound Physicians

OCTOBER 30, 2024

Osman Saleem Osman Saleem, MD Medical Director, Mercy Hospital of Buffalo We’re honored to host, and even launch, the careers of so many incredible healthcare professionals who are not only experts in their field but also dedicated to the health and vitality of their community. Most of all, I saw how they supported each other.

Hospital 52

Hospital Telemedicine Healthcare Provider 52

PEMBlog

JUNE 7, 2023

There are protocols in place that assist highly trained Emergency Medical Service providers in assuring that agitated children are safely transported to their destination. NASEMSO: Clinical care and restraint of agitated or combative patients by emergency medical service practitioners.

Transportation 122

Transportation Patient-Centered Management Finance 122

FDA Law

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.,

Medical 45

Medical Patients Healthcare Electronics 45

PEMBlog

JUNE 14, 2023

This episode is a co-production of the Emergency Medical Services for Children Innovation and Improvement Center whose mission is to minimize morbidity and mortality of acutely ill and injured children across the emergency continuum. Government. McEnany, Olutosin Ojugbele, Julie R. Pediatrics March 2023; 151 (3): e2022057383. 10.1542/peds.2022-057383

Mental Health 98

Mental Health Management Patient-Centered Illness 98

FDA Law

FEBRUARY 27, 2023

The Ryan Haight Act was enacted to address the legal “grey area” in which prescribers and pharmacies operated via the creation of two new statutory requirements: 1) the at least one “in-person” medical evaluation requirement for prescribing practitioners, 21 U.S.C. § 829(e); and 2) the modified registration requirement for online pharmacies.

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

Physician's Practice

JUNE 20, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

Management 52

Management Patient-Centered Appointment Patients 52

FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

Manufacturing 45

Manufacturing Engineering Clinic Patients 45

FDA Law

DECEMBER 11, 2023

6] It is inconsistent to say that LDTs must be regulated as medical devices because of the newness of the tests and then reduce the cost of the proposed regulation by declaring that half of all LDTs will be exempt from premarket review. FDA, Performance Report to Congress: Medical Device User Fee Amendments FY 2022, at 13-18, [link]. [14]

IT 69

IT Medical Patient-Centered Provider 69

FDA Law

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Today's Hospitalist

JUNE 7, 2025

Because many medications can cause weight gain, doctors should consider more weight-neutral alternatives. Medical societies and hospitals are weighing in on periprocedural concerns in patients taking GLP-1s who need procedures or surgeries. Key takeaways: Hospitalists will increasingly have to manage inpatients taking GLP-1s.

Hospital 65

Hospital Management Diabetes Patients 65

FDA Law

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R. User Interface Software Description Section VI.B

Management 95

Management Provider Specialization Clinic 95

GeriPal

JANUARY 26, 2023

Alex: And we are delighted to welcome Sharon Brangman, who is a geriatrician and chair of the Department of Geriatrics at Upstate Medical University. I was involved in the ethics committee with Tim, and we started creating a series of webinars with an awesome group of collaborators that addressed implicit bias. Eric: Yes.

IT 91

IT Patient-Centered Healthcare Patients 91

GeriPal

NOVEMBER 17, 2022

You’re independent, drive in and out, and the more help you need, so for example, now you need somebody to help with medication administration. And when I was getting my PhD, I wanted to find something that spoke to me, and I had been doing clinical work in nursing homes. So you have your room and board, very little help.

Community 97

Community IT Mental Health Medical 97

GeriPal

SEPTEMBER 14, 2023

We talk with Bruce Leff and Tacara Soones about the hospital-at-home movement, which has been shown to reduce costs, improve outcomes and improve the patient experience. JAGS Hospital-at-Home Interventions vs In-Hospital Stay for Patients With Chronic Disease Who Present to the Emergency Department: A Systematic Review and Meta-analysis.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

FDA Law

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. In contrast, AMP and ACLA both asserted that the rule would harm medical care.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102