The Medical Futurist

MAY 18, 2025

We have seen a number of examples, Canada experimenting with robot-comrades since the 2016 introduction of Ludwig , and some elderly care facilities in Ireland introducing Stevie to their residents. Robotic medical dispenser systems, medication management solutions help any given facility “right-size” its system for its volume.

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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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The Clinical Problem Solvers

APRIL 24, 2025

The episode also explores how digital tools can help youth manage their mental health, while also noting the need for culturally relevant care providers. 2016 Mar;67(3):324-31. Fontanella CA, Hiance-Steelesmith DL, Bridge JA, Lester N, Sweeney HA, Hurst M, Campo JV. Psychiatr Serv. doi: 10.1176/appi.ps.201500104.

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FDA Law Blog

MARCH 6, 2022

Part 820, with a newly named Quality Management System Regulation (QMSR). The QMSR omits many of the specific QSR requirements that currently appear in the regulations, and instead incorporates by reference an international standard for medical device quality management systems.

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The Clinical Problem Solvers

DECEMBER 16, 2020

However, the diagnostic approach used to determine changes in clinical management of renal disease (i.e. Additionally, research has shown that using symptom-prompted modifications to management, in the context of shared decision-making, can improve outcomes. 2016 Jul;91(7):916-20. September 12, 2018. Race Matters?

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FDA Law Blog

APRIL 11, 2022

Shapiro — One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. Medtronic Warning Letter) provides an important reminder from FDA as to the correct estimation of risk associated with malfunctions. By Jeffrey K.

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FDA Law Blog

MAY 31, 2021

Manufacturers provide patient savings programs at the pharmacy counter to defray the patient’s out-of-pocket costs such as co-pays and deductibles. In addition, CMS proposes to extend the effective date of a 2016 regulation that requires AMP and Best Price to include sales to purchasers in the U.S.

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FDA Law Blog

APRIL 20, 2021

Remove non-device software functions intended for storing and retrieving, so that a medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. By McKenzie E. Remove non-device software functions intended for transmitting, receiving, and displaying data.

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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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FDA Law Blog

FEBRUARY 22, 2023

And HF‑related AI requests are especially nerve‑racking to manage, because of the ever‑present threat that the study must be repeated to adequately respond. FDA says the primary purpose of this draft guidance is to smooth 510(k) reviews by providing more granular information about how to address the requirement. By Jeffrey K.

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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. 7,838 (Feb.

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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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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. Of the 669 participants, the mean age from studies was 45.4 years, and 91% of the participants were Black women with HIV.

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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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The Clinical Problem Solvers

MAY 30, 2022

Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center. 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.

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FDA Law Blog

FEBRUARY 5, 2024

If expanded choices are desirable, FDA recommends following the standards from the 2011 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status and provides more detailed categories from that guidance. The comment period ends on April 29, 2024.

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FDA Law Blog

MAY 5, 2024

The White House Office of Management and Budget will review the rescheduling proposal. 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.

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GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . Management of chronic pain in the elderly: focus on transdermal buprenorphine. 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.

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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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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. You get me with one-finger-chords on the guitar if you’re watching on YouTube (best I could manage). Four percent. AMA PRA Category 1 credit(s) ™.

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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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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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PEMBlog

MARCH 27, 2024

This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. 2016 Jan;37(1):3-15; quiz 16-7, 47. As always, I’m your host, Brad Sobolewski, and this episode focuses on the management of children with metabolic disorders who present to the emergency department.

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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

JULY 28, 2022

But at that time I was struck by how in that field, there wasn’t a focus or really interest in symptom management and support for patients and their families. They supported patients, they gave them a holding environment, they did symptom management, yada, yada, yada, like all the things we know palliative care clinicians do.

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Illness Hospital Patient-Centered Patients 111

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. As a nurse case manager in hospice, half of my patients had dementia. Basically, what it comes down to is that there was a fair amount of hospice to hospice provider variation.

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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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PEMBlog

DECEMBER 14, 2023

Learn all about diagnosis and management of this common problem in this brief podcast episode. 2016 Apr;83:78-83. So this management is conservative, includes upright feeding, antireflux therapy, so alterations to how you Feed, burp, and position. Isaac A, Zhang H, Soon SR, Campbell S, El-Hakim H. Int J Pediatr Otorhinolaryngol.

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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 106

GeriPal

JUNE 30, 2022

Should she be treated non-operatively, with aggressive symptom management? What does it mean for functional status, symptom management, location of care? 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.

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Patient-Centered Complication Patients IT 101

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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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. Summary Transcript Summary Two weeks ago on the GeriPal podcast we talked about why and how to write for the general public.

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IT Patient-Centered Patients Healthcare 96

BMJ

JUNE 25, 2021

This can also be seen in the sequential treatment decisions in managing cardiac risk 3 and the alternating statin therapy usage. Health Survey for England 2016: Prescribed Medicines.; 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. 16 Figure 1. Eur Heart J.

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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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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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GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” 2015, 2016.

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GeriPal

APRIL 20, 2023

So someone who’s got, let’s say, a psychotic disorder and a substance use disorder, those services are going to be pretty intense case management to help them just manage their life. So it’s subsidized with either onsite or closely linked supportive services that meet the need of the individual. Margot: Yeah.

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