Sound Physicians

NOVEMBER 19, 2024

It is, by design, built into the ways we educate, train, and support our clinical leadership. Fostering leadership potential While not every clinician aspires to be a leader , it ’ s crucial to provide avenues for those who do. Excellent leaders rise to the occasion when opportunities are open and available to them.

Hospital 52

Hospital Telemedicine Clinic Management 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 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.

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

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

IT 69

IT Medical Patient-Centered Provider 69

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

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. requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners). The endpoints must be novel (i.e.

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 financial success will follow Rules are made for a reason and should be followed. I have successfully found 10,000 ways that will not work."

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

NOVEMBER 17, 2022

And which journal again? Ken Covinsky: JAMA Network Open. Eric: JAMA Network Open. Kenny Lam: Yeah, yeah. JAMA Network Open. Eric: But before we do, we have a song request. Luckily, it’s not going to go to Ken Covinsky, because he would do a Chicago Cubs song. Alex: Kenny Lamb. Eric: Kenny, do you have a song request? Kenny Lam: Yeah.

Community 97

Community IT Mental Health Medical 97

GeriPal

JANUARY 26, 2023

Eric: So we’re going to be talking about the intersection between structural racism and ageism, but before we go into that topic, Ramona, I think you have a song request for Alex. Ramona: I do. It’s called A Change Is Gonna Come by Sam Cooke. Eric: And can you describe why you picked that song? Alex: Thank you. I love this song.

IT 92

IT Patient-Centered Healthcare Patients 92

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