FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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Patients Patient-Centered Clinic Medical 59

ABIM

APRIL 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. Representatives from the American College of Rheumatology (ACR) joined for a portion of the meeting*. McDonald affirmed as a long-term goal.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

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.

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Family Families Hospital Patient-Centered 102

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

APRIL 6, 2025

Naomi Lowy joins HPM as a Principal Drug Regulatory Expert after 18 years at the FDAs Center for Drug Evaluation and Research (CDER), most recently as the Deputy Director, Division of General Endocrinology. We look forward to her development and future success here, said HPM Managing Director J.P. Ellison.

IT 59

IT Nurse Practitioner Patient-Centered Government 59

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. § 18 U.S.C. §

Lab Testing 52

Lab Testing Individual Referral Patient-Centered 52

FDA Law Blog

OCTOBER 9, 2023

We previously blogged about this lawsuit last year. To help patients afford the copays and deductibles for specific medications, some drug manufacturers offer direct financial assistance, often as coupons, to subsidize the patient’s purchase of the drug at the point of sale.

Insurance 40

Insurance Manufacturing Patient-Centered Individual 40

FDA Law Blog

APRIL 23, 2023

Because an external control can involve the use of real-world data (“RWD”), the Draft Guidance notes that this guidance is being issued to satisfy, in part, requirements from the 21st Century Cures Act on the use of real-world evidence (“RWE”) in regulatory decision-making, similar to other recent efforts in this arena that we have blogged about.

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Patient-Centered Clinic Patients Provider 49

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.

Board-Certified 52

Board-Certified Provider Government Management 52

PEMBlog

OCTOBER 2, 2024

I’ll make the important distinction between gastritis – which is diagnosed only via endoscopy – and dyspepsia, the term best used to describe the symptoms many patients experience. The role of lifestyle and dietary modifications in management. Gastroesophageal Reflux: Management Guidance for the Pediatrician.

Diagnosis 52

Diagnosis Management Patient-Centered IT 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).

Patient-Centered 40

Patient-Centered Insurance Manufacturing Provider 40

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

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. § 18 U.S.C. §

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. Thus, it is wholly unrealistic for the Third-Party Review Program to provide any meaningful reduction in Agency workload. Certain points are indisputable.

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IT Medical Patient-Centered Provider 69

Common Sense Family Doctor

FEBRUARY 1, 2025

Since the turn of the century, the rise of hospitalists and the corresponding decline in the number of office-based family physicians who provide inpatient care for their own patients has magnified the value of optimizing the handoff from hospital-based teams to primary care physicians.

Hospital 52

Hospital Management Primary Care Primary Care Physician 52

Rao Doctor

APRIL 3, 2025

When assessing a fever, we doctors employ a systematic approach to ensure accurate diagnosis and effective management. Rectal method is more appropriate for infants, children and unconscious or comatose patients who are not able to hold the thermometer in their mouth. What are the Management and Treatment Options in a case of fever?

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Diagnosis Management Illness Diagnose 130

FDA Law Blog

MARCH 17, 2022

Houck — The Centers for Disease Control and Prevention (“CDC”) issued a voluntary practice guideline on opioid prescribing for clinicians treating chronic pain five years ago. (We We blogged on the final 2016 guideline here on March 17, 2016). By Larry K. Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed.

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Patient-Centered Clinical Practice Patients Individual 75

FDA Law Blog

JUNE 10, 2024

We also became aware that First Choice Surgical, an ambulatory surgical center in Cedar Rapids, Iowa, agreed to pay $125,000 to resolve allegations it failed to maintain complete and accurate records and failed to provide effective controls to guard against theft and diversion of controlled substances.

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Management Patient-Centered Hospital Healthcare 59

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. AMA PRA Category 1 credit(s) ™. Katie, welcome back to GeriPal.

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Illness Patient-Centered Screening Clinic 137

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. Storytelling Helps Hospital Staff Discover The Person Within The Patient. A few data based publication links from Person-Centered Narrative Intervention Program of Research: .

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Patient-Centered Illness Healthcare IT 116

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. Learn about using the low dose buprenorphine patch: . Low-Dose Buprenorphine Patch for Pain – Fast Fact. Transcript.

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Illness Patient-Centered IT Patients 103

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 127

ABIM

JUNE 11, 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. The following is a summary of the spring meeting.

Board-Certified 52

Board-Certified Government Community Education 52

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. This policy reflects a societal belief that humans are not valuable unless they provide a service.

Community 52

Community Patient-Centered Family Families 52

FDA Law Blog

NOVEMBER 29, 2022

CDC received some 5,500 comments from patients, caregivers, clinicians and interested organizations to the proposed guideline update it issued in February. We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). They do apply, however, to prescribing for pain management upon discharge.

Patients 52

Patients Patient-Centered ER Individual 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 106

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

FDA Law Blog

MAY 16, 2024

A registered nurse also admitted she replaced fentanyl and hydromorphone with saline solution for administration to patients. Press Release – DEA alleged that Pikeville Medical Center (“PMC”) failed to maintain complete and accurate schedule II inventories and dispensing records that allowed a pharmacy tech to divert 62,780 schedule II doses.

Hospital 59

Hospital Patient-Centered Medical Provider 59

GeriPal

DECEMBER 19, 2024

We invited Dani Chammas , a palliative care physician and psychiatrist at UCSF (and a frequent guest to the GeriPal podcast), as well as Brent Kious , a psychiatrist at the Huntsman Mental Health Institute, focusing on the management of severe persistent mental illnesses. Eric 05:46 So I got a question. So it’s a lot of palliation.

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Illness Mental Health IT Patient-Centered 102

FDA Law Blog

OCTOBER 28, 2021

In some instances, however, this is only the first hurdle to make innovative products available to patients. In 2010, the Patient Protection and Affordable Care Act (ACA) established a mandate requiring coverage for women’s preventive services including contraceptives. 300gg-13(a)(4).

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Insurance Utilities Individual Provider 40

FDA Law Blog

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” 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 Patient-Centered Appointment 45

PEMBlog

JUNE 5, 2024

Sasser SM, Hunt RC, Faul M, Sugerman D, Pearson WS, Dulski T, Wald MM, Jurkovich GJ, Newgard CD, Lerner EB; Centers for Disease Control and Prevention (CDC). Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. Let’s go ahead and pivot to initial management.

Patient-Centered 52

Patient-Centered Patients IT Hospital 52

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

Illness 144

Illness IT Medical Provider 144

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 102

Illness IT Patient-Centered Patients 102

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. 2022, March 18).

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Family Families Mental Health Healthcare 52