FDA Law Blog

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

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FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). The first scenario is a healthcare facility using a medical device 3D-printing production system.

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Medical Manufacturing Healthcare Government 75

The Clinical Problem Solvers

MARCH 14, 2025

Her mission — preparing the next generation of diverse physician leaders in pediatric healthcare and mental health and creating partnerships between communities and academic centers — will be critical for eliminating disparities among minority populations. 2016 Mar;67(3):324-31. Dr. Kevin M. 2015;169(7):673-677. Psychiatr Serv.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

The Clinical Problem Solvers

APRIL 24, 2025

Her mission — preparing the next generation of diverse physician leaders in pediatric healthcare and mental health and creating partnerships between communities and academic centers — will be critical for eliminating disparities among minority populations. 2016 Mar;67(3):324-31. Dr. Kevin M. References 1. Psychiatr Serv.

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FDA Law Blog

APRIL 25, 2023

Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” It will be provided in a future eSTAR update. Now, with explicit statutory authority, FDA’s push for cybersecurity has a firm legal footing.

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FDA Law Blog

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 53,688 (Aug. 53,767 (Aug.

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Government Medical IT Manufacturing 59

The Clinical Problem Solvers

DECEMBER 16, 2020

Race, racism, and racial inequality have tangible impacts on people’s livelihoods, much less their experiences in the healthcare system. 2016 Jul;91(7):916-20. Race in eGFR Calculations — Why So Contentious? eGFR equation-building is a complex science. September 12, 2018. link] Tsai J, Ucik L, Baldwin N, Hasslinger C, George P.

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Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. The PR goes on to state that the FD&C Act definition of a device does not turn on where or by whom a test system is “manufactured.”

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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

Annals of Family Medicine

NOVEMBER 20, 2024

Objective: Identify patient, provider, and healthcare process and utilization factors associated with rates of secondary acceptance of the HPV vaccine.

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The Clinical Problem Solvers

DECEMBER 20, 2021

difficulty of sending patient messages through the electronic medical record in languages other than English), limited healthcare literacy, and English-only signage on healthcare campuses are just a few of the structurally racist barriers faced by many Asian folks seeking healthcare. Insufficient language services (i.e.,

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Community Patient-Centered Relationship Healthcare 52

Physician's Weekly

JUNE 11, 2025

“Despite the emphasis on U=U as a key HIV prevention strategy since 2016, none of the included studies explicitly described U=U or U=U messaging as an intervention component,” the researchers wrote. The researchers recommended including community members in intervention design, healthcare systems, and policies.

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Mental Health Healthcare Professional Community Healthcare 114

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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Community Transportation IT PCP 114

The Motivated MD

SEPTEMBER 19, 2024

In medicine, it is commonly agreed that ‘to err is human’ Most healthcare professionals would agree that humans make mistakes. A study by Johns Hopkins in 2016 found that medical errors may potentially be the third leading cause of death nationwide. So yes, humans make mistakes. This is the same for personal finances.

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Finance Individual Education Healthcare Professional 52

FDA Law Blog

JANUARY 18, 2024

FDA conducted the eight-factor scheduling analysis required by the CSA in 2016 and found that marijuana continued to meet the scheduling criteria for remaining in schedule I. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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Medical Physicals IT Healthcare Professional 69

GeriPal

DECEMBER 8, 2022

Heather Coats is hard at work establishing the evidence base for the power of capturing patient stories in healthcare settings, for those health systems that need a little more convincing. . My Life, My Story: VA’s healthcare improvements through deliberate storytelling – YouTube. Wonderful work. Every Veteran has a story.

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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

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. For healthcare providers, there should be a recognition that holistic care involves more than just prescribing medications.

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Medical Holistic Care Healthcare Healthcare Professional 40

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. This policy reflects a societal belief that humans are not valuable unless they provide a service. Healthcare. Published April 20, 2016. 2020;8(1):100367. link] Norris L.

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Community Patient-Centered Family Families 52

GeriPal

DECEMBER 15, 2022

Tell me how your illness has impacted your relationships with others, your healthcare team, your family, friends, your beliefs, your values, your preferences. And now my program of research is around testing that person-centered narrative intervention or PCNI because you have to give them an acronym in healthcare.

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IT Patient-Centered Healthcare Illness 105

FDA Law Blog

MAY 5, 2024

FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. 53,688 (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

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

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

JUNE 30, 2022

Samir: As some of your audience may know, there are new billing codes introduced January 1st, 2016 to start reimbursing for having advance care planning discussions. I mean, financially, the bulk of the American healthcare system is a fee-for-service system. And that really created an opportunity to study this. Alex: Mm-hmm.

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Patient-Centered Complication Patients IT 101

GeriPal

AUGUST 25, 2022

And then secondly, around some of our quality measures, there’s been differences found in multiple papers by many teams around hospice disenrollment, higher rates of hospice disenrollment in for-profit hospices, and higher rates of healthcare utilization. Basically, there’s a lot of variation amongst hospice providers.

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Family Families IT Patients 106

GeriPal

APRIL 3, 2025

We used all of our political capital to make sure it happens in Chicago, which is where we started for the literature Updates back in 2016, back when it was just me and Ken, and then we brought in Alex, like two years later. Annie 05:16 So if you look back in history, I think Eric and Ken have been doing this since 2016. Go Cubs, go.

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IT Hospital Screening Patients 64

GeriPal

AUGUST 24, 2023

And the role of the palliative care provider is to figure out, knowing that different things affect different people, is what causes somebody in that particular instance to feel their dignity is being undermined. And the data was saying, “What is really important is the way you, the care provider, experience that person.”

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Patient-Centered Patients IT Illness 98

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. I’m just stunned even writing that!

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Consulting Patient-Centered IT Patients 115

GeriPal

OCTOBER 5, 2023

Sunita: Honestly, I’d be happy to provide the vocals. And I think when COVID started, I was in a number of meetings about how we were going to think about CPR from this point forward, given that it was would really expose healthcare workers to easy transmission of this virus that we didn’t fully understand yet.

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Illness IT Patient-Centered Family 136

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.

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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. Today we’re going to be talking about narrative writing specifically for healthcare professionals. What motivated you to reach out to the healthcare audience in this way? Liz: That’s right.

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IT Patient-Centered Patients Healthcare 95

FDA Law Blog

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

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Physicals Medical Clinic Emergency Room 69

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

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 IT 106

GeriPal

APRIL 20, 2023

So they need mainstream healthcare, and they need housing support. I remember deep in the recesses, 2016, I think it was, a New England Journal piece came out saying that we need to reframe the debate about cost. But nothing in healthcare. We spend money in healthcare. But they don’t need all the other support.

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