Permanente Medicine

MAY 20, 2025

Khang Nguyen, MD, chief transformation officer of the Southern California Permanente Medical Group, discusses how AI can increase clinicians’ joy in medicine and improve patient outcomes with Chris Grant, chief operating offer and executive vice president of Kaiser Permanente, The Permanente Federation, and host of the Permanente Medicine Podcast.

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FDA Law Blog

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

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FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Part 830), post-market surveillance studies (Section 522 of the FD&C Act), medical device tracking (21 C.F.R.

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FDA Law Blog

JANUARY 2, 2022

Lenz, Principal Medical Device Regulation Expert — On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance). Draft Guidance at 5. Calculation verification determines the solution accuracy of a calculation.

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FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.

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FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.

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Medical Consulting Engineering Manufacturing 40

Imperial Center Family Medicine

MAY 5, 2025

It’s similar to revving a car engine for too long while staying still. No matter if it’s through medication, therapy, lifestyle changes, or often a combination, managing depression can translate to measurable heart health gains. However, chronic stress keeps your body in a continuous state of high alert.

Management 52

Management DO Family Medicine Hypertension 52

FDA Law Blog

JANUARY 2, 2022

Lenz, Principal Medical Device Regulation Expert — On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance). Draft Guidance at 5. Calculation verification determines the solution accuracy of a calculation.

Medical 40

Medical Provider Physicals Engineering 40

FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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FDA Law Blog

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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FDA Law Blog

DECEMBER 6, 2023

FDA tries to justify the proposed rule by claiming that LDTs present significant risks, and that the solution is to regulate them all as medical devices. Part 11, the need to hire new laboratory personnel, and engage outside experts such as Contract Research Organizations, biostatisticians, lawyers, and software engineers.

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Engineering Medical Complication IT 59

FDA Law Blog

DECEMBER 15, 2024

In eight pages we get a string of high-level regulatory questions that provide a nice roadmap for CMC product development, which largely align with opportunities to engage with CBER as you progress through the development of cellular and gene therapies (CGT). What can be gained from this new guidance from a CMC perspective is more nuanced.

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Manufacturing Engineering Patient-Centered Provider 52

Physician's Practice

JUNE 27, 2025

This may cause you to question the airline’s attention to details like engine maintenance or losing passenger’s luggage. I refer to this thought transference as the Bathroom Experience (BE), a powerful metaphor for how seemingly minor details can dramatically impact patients’ perceptions of a medical practice. But a dirty one?

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Management Private Practice Patients Medical 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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GeriPal

MAY 5, 2022

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Think about the last time you attended a talk on communication skills or goals of care discussions. Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? I’m guessing not. Alex: (Singing).

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IT Screening Hospital Clinic 102

StorytellERdoc

MAY 7, 2020

The engine is cut. He signs off the last of information on his seventh patient to his replacement, sharing the important medications, vitals, activities, and care-plan in depth. From birth to now, each of us has been touched with the kindness and loving attention that a nurse has provided us. Lights are turned off.

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Medical Xpress

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Food and Drug Administration (FDA). The process could take years. Ibogaine is made from the root of a plant found in Africa. It has been banned in the U.S. Former Texas Gov.

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Mental Health IT Medical Specialization 52

Medical Xpress

JUNE 16, 2025

This cluster of about 20,000 to 40,000 neurons functions like a central watch, coordinating the timing of body functions to follow the 24-hour day. When we cross time zones and experience jet lag, it happens because our internal clock remains set to the old time zone. But the NTU team discovered that it is far more complex.

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Provider Medical Complication Diabetes 109

The Clinical Problem Solvers

JULY 14, 2021

Cultivate tools to sustain a career in traditional and alternative health careers Cultural norms rooted in white supremacy and capitalism create an environment that extracts goods, time, and energy from people without providing a source from which to renew those resources. National Academies of Sciences, Engineering, and Medicine 2021.

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Engineering Finance Clinic IT 52

GeriPal

JULY 21, 2022

We learned this and much more, and I had a great time making engine noises singing the Woody Guthrie song “driving in my car.” . There is a dearth of Certified Driving Rehab Specialists: 12 for the entire state of Colorado! Additional Links: (A to Z – under driving). OT programs). An Advance Directive for When Driving Becomes Unsafe.

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IT Family Families Diagnosis 102

GeriPal

JANUARY 20, 2023

Summary Transcript Summary In April 2022, the National Academies of Sciences, Engineering and Medicine (NASEM) issued a report on how the United States delivers, regulates, finances, and measures the quality of nursing home care. Welcome back to the GeriPal podcast, Mike. I hope I got that right. Mike: You got it right. Great to be back.

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GeriPal

JUNE 15, 2023

Hallucinations, or when the AI lies or b *s, then denies it When the AI approaches sentience, is it ethical to unplug it? I’m sure this is a subject we will return to, given the rapid progress on AI. But then it asked me, “Oh, that sounds really interesting. Who are you going to be talking to?” ” And I said, “Sure.”

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IT Patient-Centered Patients Healthcare 99

GeriPal

NOVEMBER 21, 2024

Acceptance. All of these are ways we cope with stressful situations. Some we may consider healthy or unhealthy coping strategies, but are they really that easy to categorize? Isn’t it more important to ask whether a particular coping behavior is adaptive or not for a particular person,in a particular time or situation? Amanda, welcome to GeriPal.

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Illness IT Patient-Centered Patients 125

GeriPal

MAY 9, 2024

Why focus on the public rather than other health care providers? It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. He’s a palliative care doctor and he is Medical Director of Palliative Care at Ascension Illinois Palliative Care.

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Medical Xpress

JUNE 8, 2025

While many of these procedures provide critical care, we know they are acutely painful. Provided by The Conversation This article is republished from The Conversation under a Creative Commons license. The content is provided for information purposes only. During this time, they receive up to 16 painful procedures every day.

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IT Management Vaccination Medical 53

GeriPal

JUNE 30, 2022

Alex: Today, we are delighted to welcome Joel Weissman, who is a health services researcher and deputy director and chief science officer for surgery at the Center for Surgery and Public Health at Harvard Medical School. Did I get that right? Joel: Oh yeah. Alex: Oh, good. Joel: The Brigham and Women’s Hospital likes me to say that too.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care.

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Family Medicine DO Family Families 40

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories. Folate (folic acid) helps the body form red blood cells.

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GeriPal

AUGUST 1, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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IT Diabetes Patient-Centered Chronic Disease 116

Medical Xpress

JUNE 7, 2025

The content is provided for information purposes only. None of the participants who received the injections got HIV. That early success helped boost Gileads stock by 73% over the past year, The Wall Street Journal reported. "We Explore further Twice-yearly injection cuts HIV risk by 96%, but will cost cut access?

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Medical Xpress

JUNE 8, 2025

million surfs carried out each year in Victoria, researchers estimate that this could equate to more than 70,000 assists and almost 25,500 cases of first-aid provided by surfers annually. This is the first study to quantify surfer beach -safety actions, providing real-world implications of their impact. With more than 6.3

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Medical Xpress

JUNE 23, 2025

Enzymes provide the body with instructions for what it needs to do, and when people lose energy and water, biochemical systems in the body start to fail, Wood says. Officials warn of increased risks for the elderly, outdoor workers and those without AC. Your blood pressure may decrease." Youve lost the ability to dissipate heat," he says.

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Illness Engineering Medical Nurse Practitioner 53

FDA Law Blog

NOVEMBER 8, 2023

The rule established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by an audiologist.

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