Plum Health

MAY 19, 2023

Plum Health DPC has a primary care solution designed just for you: Embrace the Benefits of Direct Primary Care Direct Primary Care is a membership-based healthcare model that emphasizes a direct relationship between patient and doctor.

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Primary Care Insurance Medical Advice Healthcare 52

FDA Law Blog

OCTOBER 8, 2023

As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing (1) controlled substances generally and (2) for buprenorphine use in opioid treatment.

Telemedicine 64

Telemedicine Relationship IT Mental Health 64

Priority Physicians

JANUARY 27, 2025

It may affect your performance and relationships. Pursue supportive relationships: We’re social beings. Find a caring primary care doctor: As a direct primary care physician, I devote time to sit down with patients and learn about their lifestyles, hopes, desires, worries, and concerns.

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Primary Care Doctor Primary Care Board-Certified Physicals 52

Noreta Family Medicine

MARCH 20, 2024

You need to be able to trust your doctor and build a relationship with them. Patients value having an accessible primary care doctor—they like to know that they can quickly and easily get on the doctor’s schedule when they need to be seen. Does the doctor’s office offer online scheduling? Can you text message with your doctor?

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Primary Care Primary Care Doctor Primary Care Physician Family Physician 52

Family Physicians of Greeley

MAY 17, 2023

In this blog, we will explore effective strategies for improving mental health and nurturing a positive mindset. Cultivate Supportive Relationships: Building and maintaining healthy relationships is essential for our mental well-being. Maintaining good mental health is essential for our overall well-being.

Mental Health 40

Mental Health Physicals Healthcare Professional Relationship 40

GeriPal

MAY 19, 2022

A patient is on morphine and you want to convert it to another opioid like hydromorphone (dilaudid). Dr. Akhila Reddy and colleagues study looking at converting hospitalized cancer patients from IV hydromorphone to PO morphine, PO hydromorphone, or PO oxycodone. Step four is adjusting it for your patient. How do you do that?

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IT Patients Individual Relationship 139

FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E. The practice of medicine was viewed as paternalistic.

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Patients Patient-Centered Clinic IT 52

Vascular Physician

APRIL 22, 2024

Prevention begins with understanding the relationship between these two conditions. Unfortunately, high blood pressure does not always present with symptoms that are noticeable by the patient. As many as half of all American adults suffer from high blood pressure without knowing it.

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ER Hypertension Primary Care Medical 52

FDA Law Blog

JANUARY 12, 2025

As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority. First, patients may be exposed to safety risks from a drug that subsequently fails to demonstrate clinical benefit.

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Clinic Relationship Provider IT 64

FDA Law Blog

MAY 10, 2023

Palmer — We blogged earlier this week here that DEA is reconsidering its proposed rules for telemedicine prescribing of controlled substances and buprenorphine. effective May 12, 2023 through November 11, 2024, Telemedicine relationships that are included in this period must be “in effect” as of November 11, 2023. By Karla L.

Telemedicine 52

Telemedicine Telecommunication Relationship Mental Health 52

FDA Law Blog

MAY 7, 2025

Regulatory Framework The AKS makes it a criminal felony to knowingly and willfully offer or pay any remuneration, directly or indirectly, to induce a person to order or refer patients for medical care that is reimbursable under a federal healthcare program (e.g., Medicare or Medicaid). Marchetti , 96 F.4th 4th 818 (5th Cir.

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Referral Relationship Government Healthcare 59

Priority Physicians

FEBRUARY 3, 2025

At Priority Physicians, your relationship with your primary care doctor encourages openness on this subject. Joseph Regional Medical Center in South Bend, IN and has a passion for putting his patients first in his practice. Are you considering replacing alcohol with weed or THC? Let us know how we can help.

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Board-Certified Primary Care Doctor Primary Care Individual 52

FDA Law Blog

FEBRUARY 27, 2023

The Ryan Haight Act did not limit the ability to prescribe controlled substance medications by telemedicine so long as the patient and prescriber had a least one in-person visit. a prescriber that engages in telemedicine with the patient), including a review of PDMP data for the past year.

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Telemedicine Telecommunication Telehealth Medical 59

FDA Law Blog

NOVEMBER 28, 2023

The timing of this meeting has certainly raised more than a few eyebrows, particularly given its relationship to the proposed LDT rule (see our prior posts here , here , and here ). Although comments submitted after November 15 won’t be presented to the panel, FDA says it will still take them “into consideration.”

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Relationship Screening IT Clinic 64

FDA Law Blog

JULY 7, 2021

In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to treat patients with severe self-injurious and aggressive behaviors (SIB/AB), but did not restrict the use of these same devices for other purposes, like smoking cessation. Circuit Court of Appeals to overturn the ban.

Medical 52

Medical Patient-Centered Patients IT 52

FDA Law Blog

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. These clearances are based on short-term (30 day) patient follow up.

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Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

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Manufacturing Provider Medical IT 98

FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

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Manufacturing Provider Patients IT 52

FDA Law Blog

OCTOBER 10, 2023

HP&M has long respected Dr. Beitz and enjoyed a professional working relationship with her during her distinguished FDA career. I always found her to be immensely thoughtful, knowledgeable, and insightful, and I am confident our clients will appreciate her approach,” said Dr. Unger. “HP&M

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Patient-Centered Relationship Clinic Management 49

FDA Law Blog

SEPTEMBER 6, 2022

For this last question, FDA explains that it anticipates the sponsor would charge the patient directly or would charge a payor if reimbursement were available, but clearly states that FDA has no authority in this arena. Authorization for Charging in the Clinical Trial Context.

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Clinic Manufacturing Patients IT 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. § S&G Labs Haw., Graves , 2021 U.S.

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

FDA Law Blog

OCTOBER 2, 2023

Several of these approvals, including examples in which we were directly involved—Relyvrio for ALS and Skyclarys for Friedreich’s Ataxia—expanded upon the examples FDA previously provided to illustrate their interpretation of the single study plus confirmatory evidence statutory standard (see our earlier blog posts here and here ).

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IT Clinic Provider Medical 64

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

JULY 5, 2023

As explained in the Draft Guidance, the prohibition on wholesaling “preserves important distinctions between outsourcing facilities, which are intended to compound drugs for patients whose medical needs cannot be met by approved drugs, from conventional manufacturers, which generally engage in mass manufacturing of FDA-approved drug products.”

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 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. § S&G Labs Haw., Graves , 2021 U.S.

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

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. Gastroesophageal reflux disease is when the patients have severe symptoms that persist and cause long term issues.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

Pamela Wible MD

JUNE 20, 2025

Characterized by cynicism, exhaustion, and reduced job satisfaction, physician burnout can lead to devastating personal and professional consequences, including strained relationships, substance abuse, early retirement, and even suicide. Dr. Shay’s original definition was based upon his patients’ war narratives and Homer’s Iliad (762 B.C.)

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Medical Student Diagnosis Physicals Medical 246

Doctor Rachel

NOVEMBER 21, 2022

Here are the tools I use in my practice to support my patients with significant sadness or depression. See my blog Sweet Dreams for help with sleep strategies. leave the destructive relationship, don’t see unhelpful friends, find a new job, stop the addiction, get out of the house, get off of social media (it increases depression).

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Consulting Relationship IT Medical 130

ABIM

JUNE 4, 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. Learn More Subscribe to the ABIM Blog to stay on top of the latest news. The following is a summary of the spring meeting.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

GeriPal

FEBRUARY 29, 2024

Widera and Smith have no relationships to disclose. Guest hosts Lynn Flint and Anne Kelly have no relationships to disclose. I actually wrote a blog post about this when we were a blog. We were a blog? Alex: And, I like Diane Meyer’s “Matching treatment to patient goals.” Alex: Okay.

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IT Patient-Centered Illness Education 127

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments.

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Family Medicine DO Families Family 40

GeriPal

JANUARY 18, 2024

Panelists Katie Fitzgerald Jones and Jessica Merlin have no relationships to disclose. And you wrote, actually, a beautiful GeriPal blog about it a while ago. Today’s podcast tackles these issues and more with three amazing guests: Katie Jones, Jessica Merlin, and Devon Check. So, I don’t think we should have these silos.

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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. Eric’s blog post on Dignity Therapy from 2011. Because that really is what this is about.

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Patient-Centered Illness Healthcare IT 116

GeriPal

AUGUST 31, 2023

He studies the mental health system in the ways in which it has failed children and adolescents, and he writes about his experience with cancer in a blog, the Billgardner.substack.com, Billgardner, one word. ” Somebody in the comments on their blog response said, “Did you check the date? Bill: Thank you. Was it April 1st?”

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Illness IT Diagnose Medical 129

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? How can I get the patient to make a decision? Josh: Mm-hmm.

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Illness IT Patient-Centered Patients 102

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

The Clinical Problem Solvers

MAY 30, 2022

We all must recognize the codification of racism within our institutions and work to unlearn these hierarchies in order to better care for Black and Indigenous patients. Clinicians are able to shape the environment in which people give birth by caring for the earth and their patients. Health Affairs Blog. 2020;47(1):3-7.

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Community Patient-Centered Families Family 52