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 123

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 ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

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Patients Clinic Medical Patient-Centered 52

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

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

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. That seems very unlikely to be the case, because exemptions apply only to well-established tests.

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IT Medical Patient-Centered Provider 69

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By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program.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

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. STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs.

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Patient-Centered Manufacturing Clinic Provider 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

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

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Management Provider Specialization Clinic 95

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.

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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. Eric: Yes.

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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.

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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. In contrast, AMP and ACLA both asserted that the rule would harm medical care.

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Patient-Centered Consulting Government Clinic 102