FDA Law Blog

AUGUST 23, 2023

A DHT is considered “a system that uses computing platforms, connectivity, software, and sensors for healthcare and related uses.” DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites.

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Patient-Centered Clinic Medical Utilities 52

GeriPal

MARCH 14, 2024

This simple challenge was focused on putting ourselves in the shoes of our patients with dysphagia who are prescribed thickened liquids. Eric: Well, before we talk about dysphagia and revisit it, which is also interesting, because this is our first podcast, I think on dysphagia, but we’ve talked about it before on GeriPal, in our blog.

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Hospital IT Patient-Centered Individual 124

PEMBlog

MAY 20, 2025

Learning Objectives Demonstrate the ability to use shared decision-making strategies when discussing imaging options with families of pediatric patients presenting to the Emergency Department. Optimizing Advanced Imaging of the Pediatric Patient in the Emergency Department: Policy Statement. Pediatrics. 2024;154(1):e2024066854.

Families 101

Families Family Hospital Patient-Centered 101

FDA Law Blog

OCTOBER 14, 2021

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes.

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Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. Whether academic medical centers should be treated differently than other laboratories offering LDTs.

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Provider Manufacturing IT Medical 64

Physician's Practice

JUNE 20, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

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Management Patient-Centered Appointment Patients 52

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Combination products might be part drug, part device, or part software or hardware.

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Manufacturing Patient-Centered Provider Telehealth 59

FDA Law Blog

APRIL 13, 2025

By Sarah Wicks & Dara Katcher Levy FDAs Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). Mirati) about a healthcare professional branded website for KRAZATI (adagrasib). What Happened?

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Provider Healthcare Professional Patient-Centered Clinic 52

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. 220 and was described on HP&M’s blog here. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(e)(2).

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Lab Testing Referral Individual Patient-Centered 52

FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP). One noticeable difference from years past is the option for virtual site visits.

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Patient-Centered Insurance Manufacturing Provider 40

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. 220 and was described on HP&M’s blog here. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(e)(2).

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Lab Testing Referral Individual Patient-Centered 40

FDA Law Blog

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. syringes), to any individual without a patient-specific prescription. plies for administration (e.g.,

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Supply Chain Individual Provider Patient-Centered 52

Rao Doctor

APRIL 3, 2025

Infrared thermometers, which measure temperature from the forehead or ear, are also prevalent in clinical settings. Rectal method is more appropriate for infants, children and unconscious or comatose patients who are not able to hold the thermometer in their mouth. A comprehensive history includes: A body temperature exceeding 100.4°F

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Diagnosis Management Illness Diagnose 130

GeriPal

DECEMBER 8, 2022

Clinicians “catching” patient life stories. . Our patients aren’t “the 76 year old with heart failure in room 202,” as Heather Coats astutely noted. My Life, My Story: VA’s healthcare improvements through deliberate storytelling – YouTube. Storytelling Helps Hospital Staff Discover The Person Within The Patient.

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Patient-Centered Illness Healthcare IT 115

GeriPal

JANUARY 18, 2024

We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. And you wrote, actually, a beautiful GeriPal blog about it a while ago.

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Illness Patient-Centered Screening Clinic 136

ABIM

JUNE 11, 2025

Representatives from the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) joined for a portion of the meeting*. Visit the ABIM Blog for reports of prior meetings. ABIM’s website features expansive sections on research related to assessment and clinical outcomes.

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Board-Certified Government Community Education 52

GeriPal

DECEMBER 15, 2022

Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? Eric: So patient narrative storytelling, independent of what we call it, I’d like to turn to both of you and just how you got interested in this as a subject. She was a heart failure patient.

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IT Patient-Centered Healthcare Illness 105

ABIM

JUNE 24, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. A representative from the American Society of Hematology (ASH) joined for a portion of the meeting*.

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Board-Certified Board-Certified Physicians Government Community 40

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. This is both a research and a clinical interest of yours. Right, Katie?

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Illness Patient-Centered IT Patients 102

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

The Clinical Problem Solvers

MAY 30, 2022

This discussion is hosted by Naomi Fields, MD, Chioma Onuoha, and Victor Lopez-Carmen MPH, as they interview Dr. 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.

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Community Patient-Centered Families Family 52

FDA Law Blog

NOVEMBER 29, 2022

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. CDC received some 5,500 comments from patients, caregivers, clinicians and interested organizations to the proposed guideline update it issued in February. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R., MMWR Recomm Rep 2022;71(No. RR-3):1–95.

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Patients Patient-Centered ER Individual 52

GeriPal

FEBRUARY 9, 2023

For example, we spend the first half talking about a RCT simulation study of clinician verbal and non-verbal communication with a seriously ill patient with cancer. In one room the physician under study interacts with a white patient-actor, and in another room interacts with a Black patient-actor. Amber: Thank you guys.

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Patient-Centered Patients IT Healthcare 111

GeriPal

SEPTEMBER 22, 2022

Have you ever had that moment when talking to a patient, when you realized that the phrase you just uttered, which you’ve uttered a hundred times before, came out rote and scripted? And in response, the family or patient looked at you like you were from another planet? Summary Transcript Summary. Yeah, I’ve been there too.

Illness 101

Illness IT Patient-Centered Patients 101

GeriPal

MARCH 30, 2023

This week we’ve invited three guests to share their stories about storytelling that’s written for healthcare providers. Liz wrote a fabulous perspectives piece in the NEJM titled “ Deciding on My Dimples ” which talks about her experience as a patient doing shared decision making during neurosurgery for resection of an astrocytoma.

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IT Patient-Centered Patients Healthcare 95

FDA Law Blog

JANUARY 18, 2024

FDA’s Center for Drug Evaluation and Research Controlled Substances Staff conducts the scheduling analysis and makes recommendations. Those findings are: The drug’s relative abuse potential to other drugs; Whether the drug has a currently accepted medical use in treatment in the U.S. HHS forwards FDA’s analysis and recommendation to DEA.

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Medical Physicals IT Healthcare Professional 69

GeriPal

DECEMBER 19, 2024

A NY Times article titled Should Patients Be Allowed to Die From Anorexia ? That’s how do we treat the mental health needs of patients with serious medical illness? So in those cases, can we adopt an approach to mental health care that centers primarily around quality of life of patients and their families?

Illness 101

Illness Mental Health IT Patient-Centered 101

FDA Law Blog

JUNE 14, 2023

The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach market, whether due to reimbursement and/or physician or patient preference. Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level.

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Manufacturing Medical Appointment Patient-Centered 45

GeriPal

MARCH 3, 2022

This idea that for critically ill patients in the ICU, geriatric conditions like disability, frailty, multimorbidity, and dementia should be viewed through a wider lens of what patients are like before and after the ICU event was transformative for our two guests today. GeriPal podcast with Linda Fried on frailty.

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Patient-Centered Patients IT Hospital 96

GeriPal

JANUARY 11, 2024

In further contrast to the United States, MAID in Canada is almost entirely administered by a clinician, whereas in the United States patients must self administer. Alex: We’re delighted to welcome Leonie Herx, who’s a palliative care physician and clinical professor at the University of Calgary.

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Illness IT Medical Provider 144

PEMBlog

APRIL 26, 2023

Kit Carney and Dr. Kristen Humphrey discuss gun violence, its impact on our patients and their families, as well as practical tips on advocating for safe storage of firearms, and how we can support victims of violence. I’m Dr. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center.

Family 52

Family Families Mental Health Healthcare 52

GeriPal

MARCH 20, 2025

Recently, discussion has emerged about how these issues intertwine in caring for patients with advancing dementia who have stated that they would not want to continue living in that condition: for those with an advanced directive to stop eating and drinking, how do we balance caring for their rational past self and their experiential current self?

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IT Patient-Centered Patients Medical 87

GeriPal

SEPTEMBER 19, 2024

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. This is Eric Widera. Jennifer 04:25 I can take that on.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

GeriPal

APRIL 11, 2024

This podcast was initially sparked by Josh’s “Note From a Family Meeting” Substack post titled “ Ambivalence in Clinical Decision-Making ,” which discussed Bryanna’s and Jenny’s 2022 article titled “ Two Minds, One Patient: Clearing up Confusion About Ambivalence.” I was a clinical ethics fellow at Baylor College of Medicine.

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Patient-Centered IT Patients Consulting 128

FDA Law Blog

MAY 21, 2024

Scientific Evidence of Marijuana’s Pharmacological Effects, If Known HHS found that marijuana abuse can lead to negative consequences that include addiction and the need for medical attention through poison center calls or emergency room visits. Basis at 18; NPRM at 44,605. Basis at 24. NPRM at 44,607. Basis at 7-8; NPRM at 44,614.

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Physicals Medical Clinic Emergency Room 69

GeriPal

APRIL 26, 2024

Who spends the most time with the patient in the infusion center? Alex: We are delighted to welcome Bryanna Moore, who is a philosopher and bioethicist, and she’s at the University of Texas Medical Branch where she also directs the clinical Ethics Fellowship. I was a clinical ethics fellow at Baylor College of Medicine.

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Patient-Centered IT Patients Consulting 119