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. Always consult with a healthcare professional for any medical condition or health concern.

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Primary Care Insurance Medical Advice Healthcare 52

Noreta Family Medicine

MARCH 20, 2024

You need to be able to trust your doctor and build a relationship with them. Care for children; some may also provide prenatal care iii. Stay tuned for Part two next month as we delve deeper into this important topic, providing you with more valuable insights to guide your healthcare decisions. Dispensing of medicines iv.

Primary Care 52

Primary Care Primary Care Doctor Primary Care Physician Family Physician 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. DEA next hosted Telemedicine Listening Sessions on September 12 and 13, 2023, for which it receive over 180 requests to present.

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. If anticipatory anxiety strikes — or, more importantly, persists — your Priority Physicians will provide guardrails to get you back to your best self. Are you one of these adults concerned about how to stop fearing the future?

Primary Care Doctor 52

Primary Care Doctor Primary Care Board-Certified Physicals 52

Vascular Physician

APRIL 22, 2024

Prevention begins with understanding the relationship between these two conditions. Unless they are seeing their primary care provider for regular check-ups, they may not be made aware of their high blood pressure until they present for evaluation for another medical condition.

ER 52

ER Hypertension Primary Care Medical 52

Noreta Family Medicine

FEBRUARY 12, 2025

The film talks about some of the escape fires of healthcare, including non-opioid pain treatments, nutrition programs, strong doctor-patient relationships, among others. Both he and I are providing care for patients using escape fires – I have a Direct Primary Care office and he has an acupuncture office. minutes long.

Healthcare 52

Healthcare Primary Care DO Family Medicine 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

FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. 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.

Clinic 64

Clinic Relationship Provider IT 64

FDA Law Blog

MAY 7, 2025

The Seventh Circuit took a more lenient approach than the Fourth Circuit, focusing its rationale on whether an independent contractor had improper influence over a healthcare providers independent healthcare decisions. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th

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Referral Relationship Government Healthcare 59

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

JUNE 8, 2023

CDRH As of this blog post, CDRH has not made any official announcements regarding the resumption of in-person meetings. An estimated timeline for the return of in-person meetings has not been provided by CDRH. Any meeting requests received before June 12, 2023, or meetings already scheduled, will not be converted to in-person format.

Relationship 53

Relationship Government Screening Medical 53

FDA Law Blog

MAY 27, 2024

Jennifer’s combination of experiences as in-house counsel for both large and start-up companies as well as outside counsel provides clients invaluable expertise and problem-solving skills. (HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice.

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Management Manufacturing Utilities Relationship 59

Priority Physicians

FEBRUARY 3, 2025

At Priority Physicians, your relationship with your primary care doctor encourages openness on this subject. MORE BLOGS ← PREVIOUS NEXT → Learn more about membership with Priority Physicians For more details on our services and the concierge care we provide to our members, contact us today. Let us know how we can help.

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Board-Certified Primary Care Doctor Primary Care Individual 52

FDA Law Blog

MAY 8, 2023

FDA recommends that PCCPs specify only a “limited number” of modifications but does not provide a limit on the number of modifications that can be included. If the proposed performance evaluation methods are different from the original methods used, the manufacturer should describe the differences and provide a justification for the changes.

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Manufacturing Provider Medical IT 98

FDA Law Blog

OCTOBER 2, 2023

A brief explainer on confirmatory evidence: how we got here Before we dive into the specifics of the new guidance, we should explain that the statutory standard we allude to is the requirement that an applicant provide “substantial evidence of effectiveness” to obtain approval of an NDA or BLA.

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IT Clinic Provider Medical 64

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

JANUARY 6, 2022

220 and was described on HP&M’s blog here. Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”

Lab Testing 52

Lab Testing Individual Referral Patient-Centered 52

FDA Law Blog

FEBRUARY 27, 2023

The rule would permit a practitioner using a telemedicine encounter to prescribe controlled substances without an in-person visit under various situations involving both an audio-visual telehealth evaluation, or an in-person evaluation performed by a “referring” provider. within 30 days) in the doctor-patient relationship.

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

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. In this safety communication, FDA states: The U.S. 21 U.S.C. §

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

DECEMBER 12, 2022

In an appendix, FDA provides a model “decision check list” for patients. You should place your initials in the location provided next to each item to indicate that you have read and understood the item. intrusion [into] the doctor-patient relationship. After reviewing the information. This proposal is a[n].

Manufacturing 52

Manufacturing Provider Patients IT 52

FDA Law Blog

JUNE 23, 2021

As someone who studied in the fields of public health, medical sociology, and biomedical ethics, I was impressed with how quickly the pharmaceutical and biotechnology arena caught up with what took many decades to occur in the context of the physician-patient relationship. The practice of medicine was viewed as paternalistic. 3, 2020).

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

SEPTEMBER 20, 2021

Torrente, explained in a previous post , in-person meetings create important opportunities for building rapport, and lead to more robust dialogue and collegial relationships between the Agency and sponsors. Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

FEBRUARY 14, 2023

Gaulkin & Riëtte van Laack — Chocolate-lovers and hopeless romantics rejoice: FDA has announced that it does not intend to object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease.

Relationship 40

Relationship Provider IT Individual 40

FDA Law Blog

SEPTEMBER 6, 2022

As the new Federal Register notice explains, FDA issued the 2016 Guidance in question and answer format to respond to the most frequently asked questions about charging for investigational drugs provided under an IND for either clinical trials or expanded access for treatment use under 21 CFR section 312.8. Changes from the 2016 Guidance.

Clinic 52

Clinic Manufacturing Patients IT 52

FDA Law Blog

JULY 7, 2021

Given that FDA has only sought to ban devices two other times (prosthetic hair fibers and powdered gloves), the court’s construction of the relationship between the ban provision and section 396 may have limited effect. In April 2020, JRC and the parents and guardians of its patients petitioned the D.C.

Medical 52

Medical Patient-Centered Patients IT 52

FDA Law Blog

JULY 5, 2023

While section 503B expressly does not require a patient-specific prescription, FDA clarifies that Congress evidently did contemplate a “connection” (our words…) between an outsourcing facility and the prescriber; the more attenuated that relationship, the more an outsourcing facility starts to resemble a conventional drug manufacturer.

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

FDA Law Blog

MARCH 7, 2022

We urge FDA to clarify the relationship of this policy and the proposed transition plan in the final guidance. The guidance provides additional details on how manufacturers who intend to cease distribution should disposition their devices. Devices Marketed Under an EUA.

Manufacturing 52

Manufacturing IT Relationship Medical 52

PEMBlog

OCTOBER 2, 2024

Join me as I scope out the nuances of gastroesophageal reflux and gastritis and provide practical insights for clinicians in the emergency setting. So you could start that in the emergency department if the symptoms are severe enough, provided that they have primary doctor follow ups. That also provides symptomatic relief.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

Mesa Family Physician

JUNE 11, 2025

In this blog, we’ll break down what preventive care involves, explore its relationship with short-term health insurance, and explain why it’s a critical part of staying healthy at any stage of life. Your primary care provider (PCP) is the one who helps you implement a preventive strategy and adjust it as your needs evolve.

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Illness Preventative Care Preventive Care Insurance 100

ABIM

JUNE 4, 2025

Visit the ABIM Blog for reports of prior meetings. Levine, MD, President of APDEM, reported that more than 40% of APDEM members are volunteering on committees , including diversity, equity and inclusion and health equity subcommittees, and a new committee forming to strengthen relationships with partner societies.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

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.

Family Medicine 40

Family Medicine DO Families Family 40

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? I’m most proud that when we started the blog, there was some tension between Geriatrics and Palliative care.

IT 126

IT Patient-Centered Illness Education 126

FDA Law Blog

MARCH 13, 2024

1.740), stating that: If the applicant for patent term extension was not the marketing applicant before the regulatory agency, then there must be an agency relationship between the patent owner and the marketing applicant during the regulatory review period. must demonstrate its agency relationship with the NDA holder (Biogen, Inc.)

Relationship 59

Relationship Provider IT Government 59

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. Health Affairs Blog. See Reference 20 below for additional information. link] Katy B.

Community 52

Community Patient-Centered Family Families 52

GeriPal

DECEMBER 8, 2022

Eric’s blog post on Dignity Therapy from 2011. Tell me how your illness has impacted your relationships with others, your healthcare team, your family, friends, your beliefs, your values, your preferences. A few Dignity Therapy- Harvey Max Chochinov links. About us – Dignity in Care. Research Team – Dignity in Care.

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Patient-Centered Illness Healthcare IT 115

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. Anybody with a DEA and… I should be very careful because this is different for physicians and advanced practice providers. AMA PRA Category 1 credit(s) ™.

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Illness Patient-Centered Screening Clinic 136