Sound Physicians

OCTOBER 30, 2024

I wanted to get back to where we were, to give back to the program that gave my career a place to start, and to provide stability to my fellow providers. When prospective providers visit Mercy Hospital of Buffalo team. They see our cohesiveness, they see the bonds, and they see the way our providers value 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 123

Transportation Patient-Centered Management Finance 123

FDA Law Blog

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law Blog

FEBRUARY 27, 2023

The rule would permit a practitioner using a telemedicine encounter to prescribe controlled substances without an in-person visit under various situations involving both an audio-visual telehealth evaluation, or an in-person evaluation performed by a “referring” provider. Proposed practitioner recordkeeping obligations. Stay tuned.

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

FDA Law Blog

JANUARY 22, 2024

Communication in this area included on-line videos, webinars, summits, conferences, and international outreach. Clinical Trials. We’ve recently discussed FDA’s clinical trial oversight , and OC didn’t miss the chance to emphasize that it has a role in developing policy about how FDA-regulated research should be conducted.

Supply Chain 59

Supply Chain Clinic IT Provider 59

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.,

Medical 45

Medical Patients Healthcare Electronics 45

FDA Law Blog

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. During the October 31, 2023 webinar discussing the proposed rule, stakeholders sought clarity from FDA officials on the Agency’s plan to address the resource gap.

IT 69

IT Medical Patient-Centered Provider 69

FDA Law Blog

OCTOBER 10, 2023

Testing should be in line with the device’s intended duration of implantation, but FDA may consider whether testing results for a shorter duration can be extrapolated to provide information about long-term performance. In cases where devices are expected to be frequently replaced, testing should be guided by the aggregate patient exposure.

Manufacturing 45

Manufacturing Engineering Clinic Patients 45

FDA Law Blog

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Physician's Practice

JUNE 20, 2025

Focus on providing optimum patient care and financial success will follow Rules are made for a reason and should be followed. Focus on providing optimum patient care, and the financial success will follow. Use whatever methods are available (articles, Webinars, videos, social media, podcasts, etc.) Make an informed decision.

Management 52

Management Patient-Centered Appointment Patients 52

FDA Law Blog

FEBRUARY 5, 2025

Appendix A of the Draft AI Guidance (copied here) provides a helpful overview of documentation that should be submitted in a marketing application for an AI-enabled medical device. For training data only, information on data cleaning and processing should also be provided (i.e., User Interface Software Description Section VI.B

Management 95

Management Provider Specialization Clinic 95

GeriPal

JANUARY 26, 2023

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. I was in clinic the other day working with a trainee, and we saw a few patients together, and they happened to be very healthy, community dwelling, older adults, quite active.

IT 92

IT Patient-Centered Healthcare Patients 92

GeriPal

NOVEMBER 17, 2022

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. People saw that there were people who needed to have supportive care, didn’t need to have the level of nursing that was provided in nursing homes, and there was money to be made.

Community 97

Community IT Mental Health Medical 97

GeriPal

SEPTEMBER 14, 2023

That’s focused on older adults who are too frail to get into clinic. And we would provide ongoing longitudinal care to them in the home, much like the Mount Sinai Visiting Doctors programs, and other programs like that. We relied on our clinical experience as geriatricians, that home-based primary care experience.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

FDA Law Blog

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. The materials from this webinar are still available on FDAs website ( here ).

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102