FDA Law Blog

SEPTEMBER 22, 2024

The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ). By Steven J.

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Manufacturing Electronics Provider Management 64

FDA Law Blog

APRIL 12, 2023

will present a webinar entitled “ Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC.” On Thursday, April 20, from 1:30-3:00pm, John Claud of Hyman, Phelps & McNamara, P.C.

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ABIM

MARCH 27, 2025

To help advance this mission, ABIM and the ABIM Foundation are proud to sponsor the American Board of Medical Specialties (ABMS) Visiting Scholars Program , a year-long, part-time research program that supports early career physicians and researchers as they strive to become leaders in their field.

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Board-Certified Medical Specialty Internal Medicine Education 52

Altitude Family & Internal Medicine

JULY 10, 2023

Altitude Family & Internal Medicine (303) 730-2167 Nutritional Supplements for Robust Immunity Nutritional Supplements for Robust Immunity Thanks for watching one of our most popular webinars. Today Dr. Hansen discussed the specific nutritional supplements that he uses to keep his immune system.

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Internal Medicine Families Family Medical 130

Sound Physicians

APRIL 28, 2025

This ensures our team — from medical director to clinician — has skin in the game. Compared with industry-standard annual subsidy increases of between 4.2 percent and 5.7 percent, our average increase over five years is just 0.5 percent annually. Why the gap? Physician compensation is tied to quality of care. All rights reserved.

IT 52

IT Hospital Telemedicine Clinic 52

Sound Physicians

NOVEMBER 5, 2024

For hospitals, this means investing in cutting-edge medical interventions and partnerships that help them transition to the modern best-practice of dedicated ICU management. Led by specially trained medical, team leadership is armed with the tactical knowledge needed to drive high-quality care and highly effective practice management.

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Management Hospital Telemedicine Board-Certified 52

Sound Physicians

MARCH 12, 2025

Posted in Critical Care Share Article Subscribe to the Sound Physicians Blog A trusted source for todays healthcare needs. All rights reserved. Terms of Use | Privacy Policy | Patient Privacy | Compliance Search Submit Subscribe to the Op-Med blog! Receive blog updates directly to your inbox. 

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Telemedicine Community Hospital Patients 52

Sound Physicians

NOVEMBER 19, 2024

Emerging Leaders Dr. Charles Charman, medical director and overseer of the Emerging Leaders program, presents at the 2024 EmLe cohort session at MDS. Enter the associate medical director. This unique leadership role provides another layer of leadership to support the medical director and even act as chief in their absence.

Hospital 52

Hospital Telemedicine Clinic Management 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.

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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.

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Transportation Patient-Centered Management Finance 122

FDA Law Blog

MAY 15, 2024

In this webinar you’ll learn: Significant changes between the proposed and final rule How the current enforcement discretion approach for LDTs will affect you A timeline for the rollout of the rule’s five phases Get your questions answered by the experts during the live Q&A Don’t delay, click here to register today!

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Government IT Medical 59

FDA Law Blog

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 ). Valentine & Larry J.

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Patients Clinic Medical Patient-Centered 52

FDA Law Blog

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.

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Telemedicine Telecommunication Telehealth Medical 59

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.

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Mental Health Management Patient-Centered Finance 98

PEMBlog

MAY 31, 2023

However, medications can be adjuncts to non-pharmacologic means to help keep agitated children safe from harm. When we think of managing agitated patients we think of medicines – but that shouldn’t be our first option. It is also episode 3 in a 5 episode series focused on agitation in children and adolescents. Government.

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Management Patient-Centered Finance Transportation 89

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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Medical Patients Healthcare Electronics 45

FDA Law Blog

OCTOBER 8, 2023

HPM also conducted a 90-minute webinar addressing the “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps.” Temporary Rule: Second Temporary Extension of COVID–19 Telemedicine Flexibilities for Prescription of Controlled Medications, 88 Fed. 69,879, 69,880 (Oct. 10, 2023) (emphasis added).

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Telemedicine Relationship IT Mental Health 64

FDA Law Blog

MAY 7, 2023

HPM also conducted a 90-minute webinar addressing the “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps.” DEA and HHS have submitted a draft Temporary Rule to the Office of Management and Budget titled “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.”

Telemedicine 52

Telemedicine IT Management Medical 52

FDA Law Blog

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]

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IT Medical Patient-Centered Provider 69

FDA Law Blog

MARCH 7, 2022

At this time, FDA is continuing to grant applicants an automatic 360 days to respond to requests for additional information pursuant to its Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers (Revised) (June 2020).

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Manufacturing IT Relationship Medical 52

Physician's Practice

JUNE 20, 2025

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction. For example, practices have adopted electronic medical records (EMR) systems only to find that productivity in the practice ground to a halt.

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Management Patient-Centered Appointment Patients 52

FDA Law Blog

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.”

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Manufacturing Engineering Clinic Patients 45

Altitude Family & Internal Medicine

OCTOBER 10, 2023

In this webinar, Dr. Hansen discusses: If you have enjoyed this webinar, next you may want to. Altitude Family & Internal Medicine (303) 730-2167 COVID-19: Fall and Winter 2023 Update COVID Fall and Winter 2023 Update Thanks for watching our latest COVID-19 Update.

Internal Medicine 130

Internal Medicine Families Family Vaccination 130

FDA Law Blog

SEPTEMBER 20, 2021

STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. Many of the indirect activities include fostering industry development activities through external outreach, workshops, public meetings, webinars, as well as updating guidance and SOPPs, amongst others.

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. These medications are truly life-changing for many patients.” Nor should they be.

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Hospital Management Diabetes Patients 66

FDA Law Blog

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). FDA plans to host a webinar to discuss the Draft Guidance. By Adrienne R.

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Management Provider Specialization Clinic 95

PEMBlog

MAY 24, 2023

For more information, please visit HRSA.gov To learn more about the Emergency Medical Services for Children Innovation and Improvement Center visit [link] Email km@emscimprovement.center Follow on Twitter @EMSCImprovement References Berzlanovich AM, Schöpfer J, Keil W. Government.

Management 54

Management Patient-Centered Physicals Finance 54

FDA Law Blog

DECEMBER 21, 2023

2024 brings a host of Hyman, Phelps & McNamara, P.C. (“HPM”)

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Finance Government Medical IT 59

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. But why I decided to look at medical and mental health care and assisted living. I mean we know medical care has been really important to people who live in assisted living communities.

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Community IT Mental Health Medical 97

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.

IT 92

IT Patient-Centered Healthcare Patients 92

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

You can continue to use your insurance for medications and for labs as well. However, with DPC you can find discounts on medications, labs, imaging, and supplements that are passed on to you. webinar":{"type":"Static","pageId":"dxdvv"},"./in-the-know":{"type":"Static","pageId":"rp7qt"},"./direct-primary-care":{"type":"Static","pageId":"b42ky"},"./zo-3-step-peel":{"type":"Static","pageId":"xj7v1"},".

Family Medicine 40

Family Medicine DO Family Families 40

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

webinar":{"type":"Static","pageId":"dxdvv"},"./in-the-know":{"type":"Static","pageId":"rp7qt"},"./direct-primary-care":{"type":"Static","pageId":"b42ky"},"./zo-3-step-peel":{"type":"Static","pageId":"xj7v1"},". For healthy plate recipes or more information, please visit me at www.faithfullyrootedinhealth.com Follow me on Instagram Here !

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Referral Family Medicine DO Primary Care 40

FDA Law Blog

FEBRUARY 20, 2025

In contrast, AMP and ACLA both asserted that the rule would harm medical care. The first phase of the rule, which takes effect in less than three months, requires laboratories to have certain policies and procedures in place to begin handling complaints, reporting Medical Device Reports, and reporting corrections/removals.

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Patient-Centered Consulting Government Clinic 102

GeriPal

SEPTEMBER 14, 2023

And we then did a bunch of work to develop medical criteria, to choose the right patients for hospital-at-home. I have a painting, that he did, of… He crashed a car into a fence, and he’s walking away, towards the house, with his black medical bag, left the car there, on the snow drift, crashed into the fence.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

FDA Law Blog

MAY 26, 2025

Hull & JP Ellison At our webinar earlier this month, we talked about Administration priorities as they relate to the FDC Act and noted that we expect much to remain the same with respect to enforcement. FGM is defined as any procedure performed for non-medical reasons. By Andrew J. 116(e) (emphasis added).

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Manufacturing Provider Medical IT 59