FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. The first scenario is a healthcare facility using a medical device 3D-printing production system.

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Medical Manufacturing Healthcare Government 98

FDA Law

NOVEMBER 30, 2022

The Realtor argued that the government healthcare programs require that drugs not be “adulterated,” which means that Grifols’ manufacturing processes must comply with all applicable GMPs. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

Manufacturing 72

Manufacturing Government Healthcare Management 72

Permanente Medicine

APRIL 16, 2025

We are dedicated to the mission of improving the health of our patients and communities.

Medical 52

Medical Patient-Centered Community Hospital 52

FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. The first scenario is a healthcare facility using a medical device 3D-printing production system.

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Medical Manufacturing Healthcare Government 75

FDA Law

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Medicare or Medicaid).

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Referral Relationship Government Healthcare 59

PEMBlog

JUNE 14, 2023

Government. For more information, please visit HRSA.gov To learn more about the Emergency Medical Services for Children Innovation and Improvement Center visit [link] Email km@emscimprovement.center Follow on Twitter @EMSCImprovement References Fiona B.

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Mental Health Management Patient-Centered Illness 98

33 Charts

OCTOBER 2, 2021

Medicine is facing a crisis of information. Beyond the increase of biomedical information are rising demands for physician response to portal messaging (MyChart messages) and review of wearable generated data. And in my experience the exchange of information from the Cures Act Final Rule has added new dialog around test results.

Patients 75

Patients IT Provider Family Doctor 75

Permanente Medicine

MAY 20, 2025

Contributing to this challenge is the exponential growth of information, an expanding population of older adults, and office visit documentation. Information is coming at clinicians, whether they be doctors, nurses, pharmacists, faster than ever, and there is a transparency that exists around us.

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Patient-Centered Patients IT Medical 52

FDA Law

SEPTEMBER 1, 2021

The results of the diligence inform the Buyer as it weighs the benefits, costs, and risks associated with a potential transaction to determine whether, and on what terms, to proceed. DOJ expects companies to act promptly on information obtained during the diligence process. learned about the alleged conduct in Paragraphs E.1

IT 52

IT Government Healthcare Management 52

Family Physicians of St. Joseph

MARCH 14, 2018

From the Detroit News If there’s any more argument to be made about getting third-party insurers — whether government or private insurance — out of most routine health care, here’s one. 6, 2017, from a lab affiliated with Covenant HealthCare hospital system of Saginaw. And it’s a true story. Zane had the blood drawn on Dec.

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Insurance Medical Primary Care Government 52

GeriPal

JULY 19, 2024

So I think we’re poised now with the guide model and with the evidence we have about healthcare utilization, impact on caregivers, course of dementia, comorbidity management and all of that. I don’t have access to change the levers of government. And either of those could be given to the patient or an informant.

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Screening Primary Care Patient-Centered IT 119

FDA Law

JUNE 16, 2023

Under Minnesota’s Prescription Drug Price Transparency Act , manufacturers must submit detailed pricing information for any generic prescription drug with a WAC of at least $100 for a 30-day supply or shorter course of treatment for which it increased the WAC by 50% or greater over the previous 12-month period.

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Manufacturing Provider Consulting IT 45

FDA Law

JUNE 27, 2024

District Court for the District of Texas on Zarzamora Healthcare LLC for repeatedly dispensing opioids and other controlled substances “by filling prescriptions while ignoring red flags.” The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. 21 U.S.C. § 823(g)(1)(B), (D).

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Insurance Patients Utilities Chronic Condition 52

FDA Law

JANUARY 6, 2022

Note that EKRA’s reach is broader than the Anti-Kickback Statute, which applies only to “federal healthcare programs” — e.g., Medicare, Medicaid, Tricare, etc. His job was governed by an employment contract that contained both salary provisions and restrictive covenants. 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. §

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Lab Testing Referral Individual Patient-Centered 52

FDA Law

JANUARY 6, 2022

Note that EKRA’s reach is broader than the Anti-Kickback Statute, which applies only to “federal healthcare programs” — e.g., Medicare, Medicaid, Tricare, etc. His job was governed by an employment contract that contained both salary provisions and restrictive covenants. 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. §

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Lab Testing Individual Referral Patient-Centered 40

Annals of Family Medicine

NOVEMBER 20, 2024

Objective To evaluate public perceptions of uncertainty and disagreement among experts in healthcare recommendations and whether it is associated with decreased trust in health entities as providers of accurate health information. Only 18% have high trust in the health information on social media.

Education 130

Education Government Patients Relationship 130

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*. Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information.

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Board-Certified Government Community Education 52

ABIM

JUNE 24, 2025

Upgrades to the ABIM website and Physician Portal for 2025, designed to make it easier for both physicians and the public to find information. Community Practice in ABIM Governance* Erica N. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations.

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Board-Certified Board-Certified Physicians Government Community 40

The Clinical Problem Solvers

OCTOBER 11, 2021

In contrast, de jure segregation refers to the involvement of federal, state, and local governments in creating, structuring, designing, reinforcing, and perpetuating segregation. They are a product of deep-rooted man-made policies that extend to many sectors (healthcare, education, criminal justice etc). Benjamins MR, De Maio F.

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Government Community Education Individual 52

FDA Law

NOVEMBER 18, 2021

Then, the other players in the healthcare system may determine whether the tool is right for this pandemic and how best to deploy it. These players include the federal and state public health authorities, the healthcare profession, third party payors, and patients. They can be as short as 24 to 48 hours.

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Screening Healthcare Manufacturing IT 98

FDA Law

MARCH 15, 2023

See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006). Current regulations do not require breast density notification to be part of the healthcare provider report or the lay summary to the patient.

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Healthcare Diagnosis Provider Individual 59

Vida Family Medicine

JUNE 29, 2022

The healthcare system must provide care in a just way so that those who need care have access to it. Wade guaranteed was not just the right of a woman to terminate her pregnancy, but the right of a patient and their physician to consider these four pillars privately and come to a decision together without government interference.

Family Physician 52

Family Physician Family Families Healthcare Professional 52

The Clinical Problem Solvers

FEBRUARY 14, 2022

Warford centered the conversation and reminded the audience that it is not just healthcare systems that are being pushed to the brink. The vision for any community-informed project has to meet community members where they are. Funding structures, especially from government agencies, are not exactly permissive of this.

Community 52

Community Individual Mental Health IT 52

GeriPal

MARCH 6, 2025

We discuss the principles of harm reduction, social determinants of health, and trauma informed care. Alex End Well Talk [link] Resources on the PEACH Program Program Review Paper A recent publication in Longwoods Healthcare Quarterly reviewing the PEACH model. Canadian Press Feature A powerful and widely shared piece on our work.

Healthcare 100

Healthcare IT Community Illness 100

FDA Law

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction.

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Medical Diagnosis Healthcare Clinic 53

GeriPal

JANUARY 20, 2023

There have been multiple subsequent government reports on nursing home care, most recently was about eight, nine years ago from the OIG. Part of it’s what Mike was saying, it’s accountability as a country, as a nation and as the government. Those are evidence-based or evidence-informed tools that have been in practice.

Finance 95

Finance Board-Certified IT Provider 95

GeriPal

JUNE 19, 2025

Just today (June 17th) as we record this podcast: Ezra Klein released a wonderful interview with Sarah McBride , the first openly transgender member of congress A judge ruled that cuts to NIH grants focused on minority groups, including transgender people, were illegal and ordered the government to restore funding.

Individual 85

Individual Community IT Chronic Condition 85

FDA Law

JUNE 9, 2025

Since 1993, Congress has continued to direct the federal government, and in particular FDA, to take steps to close the gap in clinical research representation. Advancing the frontier of scientific knowledge has been an important rationale for diversifying trials. Following a February 11, 2025 temporary restraining order issued by the U.S.

Clinic 59

Clinic IT Healthcare Medical 59

GeriPal

MARCH 24, 2023

We also have Joe Shega, who is a hospice physician, and he is a Chief Medical Officer and Vice President at VITAS Healthcare. This was an investigative report about fraud and healthcare, pure fraud, pure victimization of vulnerable people. Lauren: Thanks for having me. Alex: And she’s going to be a guest host today.

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IT Provider Patients Family 113

GeriPal

JANUARY 11, 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.

Illness 144

Illness IT Medical Provider 144

Doctors for America

MAY 5, 2025

FOR IMMEDIATE RELEASE Doctors for America PO Box: 21161 2300 18th St NW Lbby Washington, DC 20009-9996 May 5, 2025 Doctors, Local Governments File Brief to Defend Reproductive Health Care Privacy Rights Brief Argues that Upending HIPAA Privacy Rights Would Contradict Decades of Established Precedent WASHINGTON, D.C.

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Government Medical Student Community Patients 52

GeriPal

SEPTEMBER 5, 2024

And Bill Andereck is still haunted by the decision he made to have the police break down the door to rescue his patient who attempted suicide in the 1980s, as detailed in this essay in the Cambridge Quarterly of HealthCare Ethics. And it’s not the same, but it does provide information. Eric 33:05 Well, let me ask you this.

Patients 98

Patients IT Patient-Centered Hospital 98

GeriPal

DECEMBER 7, 2023

So if you look at government websites about heat for example, it’s got a line of buttons across the top with affected populations, outdoor workers, athletes and older people are in there. So the things that Karl mentioned, but also access to healthcare during a disaster or even heat. Why is it up to the healthcare system?

Healthcare 129

Healthcare IT Education Community 129

GeriPal

APRIL 18, 2024

Skepticism on the ability of predictive models to transform healthcare Consolidation of EHR’s into the hands of a very few companies, and potential for the drug and device industry to influence care delivery by tweaking AI in ways that are not transparent and already a sort of magical black box. Bob: Exactly. It could be anybody.

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IT Electronics Patients Healthcare 139

GeriPal

MARCH 16, 2023

So this week we’re going to be talking about writing for the lay public, and next week we’ll be publishing a podcast on writing for healthcare providers. He wrote a New York Times bestseller and now we have quality and safety in every aspect of healthcare. Rosanne: I certainly do. So you take it to the people. That helps.

IT 105

IT Healthcare Professional Healthcare Transportation 105

GeriPal

JUNE 26, 2025

And the government can do something about that?!? Like if you had a magic wand, you had healthcare providers, like, one thing they. You want them to do differently with the information from your study. So that’s the macro environment and the role in this government policies, how this could play a role.

Illness 93

Illness Hospital IT Patient-Centered 93

GeriPal

JULY 6, 2023

I’ve been on a quest to build those services and support so that people can make true, informed decisions for themselves and their families. We’re selling objectivity, information, independence and choice. Well, if you are like me, you’ve probably heard of these programs but are at a loss to know exactly what they do.

Community 89

Community Nurse Practitioner Provider IT 89