FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Moreover, center patients not only in discussions about individual decision-making but in constructing and drawing meaning from the research. 2016 Jul;91(7):916-20. All If you are interested in health equity, recognize that there is a breadth of research established in the fields of health equity, disparities, and structural racism.

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Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

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IT Clinic Provider Medical 52

FDA Law Blog

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The guidance provides no rationale for hinging the device status of CDS software on the frequency with which medical information is collected.

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Clinic Medical Provider Patients 52

FDA Law Blog

JUNE 23, 2021

For example, we know that cancer patients have a high tolerance for toxicity when offered a chance at improved survival, a risk tolerance that would not be shared by individuals suffering from the common cold. However, in the coming days we hope to do so and may provide our thoughts in subsequent posts.

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Patients Patient-Centered Clinic IT 52

FDA Law Blog

JANUARY 26, 2022

Component 1 was a disease state component – identified as “The Journey Forward: Ryan Murphy” or “The Journey Forward: Allysa Seely.” (Note that Allysa Seely is a Paralympian gold medal triathlete, and swimmer Ryan Murphy is a 2016 Olympian and gold medalist.)

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IT Education Utilities Patient-Centered 40

FDA Law Blog

MARCH 17, 2022

We blogged on the final 2016 guideline here on March 17, 2016). As explained more fully below, CDC concedes that states, insurers, pharmacies and pharmacy benefit managers have implemented laws, regulations and policies that have misapplied the 2016 guideline. 2016 Guideline. Proposed 2022 CDC Practice Guideline, 7,839.

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Patient-Centered Clinical Practice Patients Individual 75

The Motivated MD

SEPTEMBER 19, 2024

For the better half of 2024, I have been periodically writing posts that are individual articles that double as potential chapters to a future book. Before we discuss each individual savings account, let us first highlight exactly what it means to ‘automate’ your savings. So yes, humans make mistakes.

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Finance Individual Education Healthcare Professional 52

The Clinical Problem Solvers

DECEMBER 20, 2021

Fields Guests: Thu Quach, PhD, and Tung Nguyen, MD Time Stamps 00:00 Introduction 04:00 How Dr. Thu Quach’s and Dr. Tung Nguyen’s journeys shape their work 11:40 Policy work as a way of mitigating burnout 12:55 Balancing individual and communal focus (include?) Remember that more deeply understanding your patients can provide meaning!

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Community Patient-Centered Relationship Healthcare 52

FDA Law Blog

NOVEMBER 29, 2022

Houck — On November 4th, CDC issued its revised guideline on prescribing opioids for pain as an expansion and update of its 2016 CDC Opioid Prescribing Guideline. We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). By Larry K. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R.,

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Patients Patient-Centered ER Individual 52

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And yet, after assisting the older adult to their feet, the EMS providers would leave. I think, as providers, we don’t get to see that.

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FDA Law Blog

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. The draft guidance provides instructions for completion of this form, including an appendix with a sample report.

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The Clinical Problem Solvers

MAY 30, 2022

As healthcare providers, we must listen to our patients and use the power of our presence to see birthing people’s full humanity and empowerment. She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. Published April 20, 2016. Healthcare. 2020;8(1):100367. link] Norris L.

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BMJ

FEBRUARY 8, 2021

The proximity to campus health clinics may also afford college students greater accessibility to healthcare providers for prescription medications such as stimulants which could end up being misused. Besides the risks to an individual, there are also population-level harms from normalizing certain harmful behaviors (e.g., Pediatrics.

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FDA Law Blog

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. By Larry K. 30, 2024). 53,688 (Aug. 53,767 (Aug.

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Medical Manufacturing Physicals Healthcare Professional 95

GeriPal

FEBRUARY 29, 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 Patient-Centered Illness Education 126

FDA Law Blog

JUNE 24, 2021

In 2016, FDA opened a docket seeking comments on “service, maintenance, refurbishment, and alteration of medical devices” by third parties (see our blog post here ). In an appendix to the draft guidance, FDA provides some helpful examples of the type of information that should be included in such an internal memo.

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Manufacturing Medical Provider IT 52

GeriPal

JANUARY 11, 2024

The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). Four percent. AMA PRA Category 1 credit(s) ™.

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Illness IT Medical Provider 144

PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. 2016 Jan;37(1):3-15; quiz 16-7, 47.

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GeriPal

DECEMBER 8, 2022

And which of those experiences would you like to share with us that we could then write into a story that we’ll share with providers? It started here at Madison at one and it’s also spread outside the VA now to hospitals in Boston, Providence and now starting up actually in California and UCLA and UCSF. Heather: Yeah.

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GeriPal

JUNE 30, 2022

Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. Eric: And what do we know about the outcomes of individuals getting these procedures, especially those with cognitive issues and dementia. Welcome to the GeriPal podcast, Samir. Samir: Thanks, Alex and Eric.

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Patient-Centered Complication Patients IT 101

GeriPal

AUGUST 24, 2023

Just an extraordinary cast of individuals who were really so incredibly inspiring. And then the final category, the third category is what we called the dignity conserving repertoire, which really has to do with kind of the spiritual, and psychological landscape and makeup of that individual. I mean, I was very much a clinician.

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Patient-Centered Patients IT Illness 98

GeriPal

DECEMBER 15, 2022

And which of those experiences would you like to share with us that we could then write into a story that we’ll share with providers? It started here at Madison at one and it’s also spread outside the VA now to hospitals in Boston, Providence and now starting up actually in California and UCLA and UCSF. Heather: Yeah.

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IT Patient-Centered Healthcare Illness 105

GeriPal

APRIL 3, 2025

Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. Annie 05:16 So if you look back in history, I think Eric and Ken have been doing this since 2016. But in spite of that, it is a lot of work for three individuals to pull all this together.

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IT Hospital Screening Patients 64

GeriPal

AUGUST 25, 2022

I think that there are some really great for-profit hospices out there that are actually able to provide more services and more open access for patients. Although I saw that hospice was providing a lot of really great quality care for these patients, I also saw a lot of problems. And then at the regional level-. Eric: A minute.

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Family Families IT Patients 106

GeriPal

APRIL 10, 2025

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. I think back in what, May 2016, you published a randomized controlled trial, first author, palliative care and the ED randomized study, cancer patients. And you improved quality of life.

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Patient-Centered IT Hospital Patients 77

GeriPal

MARCH 28, 2024

Kate: The problem is we communicate late, we share prognosis late, we elicit goals and values late, so all the time while they’re in the ICU getting prolonged intensive care, we don’t really know that we’re providing goal concordant care, so we wanted to nudge it a little upstream. Eric: Nudge it. Kate: Nudge it.

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Consulting Patient-Centered IT Patients 115

GeriPal

OCTOBER 5, 2023

Sunita: Honestly, I’d be happy to provide the vocals. ” Jacky: One of the ways we start, when I think about this need problem that a lot of doctors use it as a headline, which we know from Bob, thank you, that that’s a great best practice in communication is to provide a headline. But next time, maybe we’ll try.

Illness 136

Illness IT Patient-Centered Family 136

PEMBlog

DECEMBER 14, 2023

2016 Apr;83:78-83. In the child with more severe symptoms or you’re worried about tracheomalacia, direct laryngoscopy including a diagnostic bronchoscopy in the OR under general anesthesia may provide a more comprehensive look at the Airway and the upper aerodigestive tract. Isaac A, Zhang H, Soon SR, Campbell S, El-Hakim H.

Diagnosis 52

Diagnosis IT Diagnose Patients 52

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. And that’s a lot easier if all providers were X waivered too.

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Illness Patient-Centered IT Patients 102

GeriPal

JULY 28, 2022

The model is predominantly physicians, advanced practice providers. Areej: I think it was 2016. Eric: 2016. We needed to build the relationships and trust and really provide a really good example of the value of palliative care outside of end of life care and advanced care planning. I loved Areej’s article.

Illness 110

Illness Hospital Patient-Centered Patients 110

GeriPal

MARCH 30, 2023

This week we’ve invited three guests to share their stories about storytelling that’s written for healthcare providers. As I was cleaning up my office, I found something I’d written in 2016. I’m an empowered patient advocate, individual, and I feel like the motions, the feels were not necessarily in my essay at all.

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IT Patient-Centered Patients Healthcare 96

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. There have been a few severe cases and one individual died with H5N1 infection. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed.

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Patient-Centered Provider Manufacturing Screening 130

BMJ

JUNE 25, 2021

With landmark analysis, survival can be visualised by plotting the Kaplan-Meier survival curves for the risk groups of interest to provide information about the absolute and relative risks, whereas this is not straightforward for time-dependent Cox regression. Health Survey for England 2016: Prescribed Medicines.; 16 Figure 1.

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Primary Care Clinical Practice Electronics Clinic 40

GeriPal

JULY 25, 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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Family Families Patient-Centered Patients 106

GeriPal

APRIL 20, 2023

What are the structural factors and individual factors that contribute to homelessness? ” On that grand rounds, you differentiated structural factors from … I forget what the word was, individual- Margot: Individual risk factors. Why do we say “over 50” is “older” for homeless persons, why not 65? Margot: After 50.

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Mental Health IT Community Individual 123

FDA Law Blog

FEBRUARY 11, 2024

The three letters together provide the range of actions DEA may take: no rescheduling from schedule I (former drug officials), rescheduling to schedule III (Democratic state attorneys general), or descheduling altogether (Democratic senators). Letter 1 is signed by former DEA administrators and Directors of National Drug Policy.

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Medical Healthcare Professional Community IT 59