Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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FDA Licensing Hospitals Medicaid 98

Healthcare IT Today

MAY 3, 2023

Moreover, the market for FDA-approved BP monitoring solutions that encourage routine measurements is well into the billions [ 22 , 23 ]. For some R&D efforts, the answer is quite simple – FDA approval has simply not been achievable due to the inability to pass critical performance standards.

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FDA Public Health Licensing Telemedicine 117

SQA

SEPTEMBER 2, 2022

Borderline products must meet the MDR definition and scope of a medical device or accessory to a medical device to fall under the Regulation’s requirements. Products must meet MPD definitions of a medical product to meet 2001/83/EC requirements: Any substance or combination of substances with properties for treating or preventing disease.

FDA 91

FDA COVID-19 Nursing Homes Public Health 91

Bill of Health

JUNE 20, 2024

The Court concluded that neither group had a significant concrete interest affected by the FDA’s approval to warrant standing. On the merits, it is a non-decision about this specific challenge to the FDA approval; the approval remains in effect. States can be expected to make many different arguments to avoid preemption.

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FDA Licensing Governance 124

SQA

DECEMBER 10, 2021

For the drug-device combination products whose attributes cannot be determined, the applicants shall apply for attribute definition to Center for Medical Device Standards Management, NMPA (CMDSM) prior to registration application. The EMA and FDA have agreed to the following principles for the pilot program. The EMA and the U.S.

FDA 52

FDA Compliance Public Health Hospitals 52

SQA

AUGUST 1, 2024

This document is intended to aid manufacturers in the preparation of scientific information to be provided in support of claimed shelf-life, in use stability and shipping studies for IVDMD license applications, and post-approval change applications filed pursuant to the Medical Device Rule, 2017 (MDR-2017). Kappin Ltd.

FDA 40

FDA Licensing Compliance World Health 40

SQA

DECEMBER 16, 2022

In addition to definitions of chromatographic features, the revision to General Chapter 2.2.46. Since health authorities have not yet published guidelines for a comprehensive control strategy specific to microbiological topics for ATMPs, it is up to the individual ATMP sponsor or license holder to apply these compendial references properly.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

MAY 24, 2023

The company did not have a written procedure in place for the provision of information related to serious risk of injury to health, contrary to what was committed to on it establishment license application. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

SQA

MAY 24, 2023

The company did not have a written procedure in place for the provision of information related to serious risk of injury to health, contrary to what was committed to on it establishment license application. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections.

FDA 40

FDA Compliance Licensing World Health 40

SQA

OCTOBER 18, 2023

At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. FDA ensures that broad-spectrum sunscreens protect against both Ultraviolet A (UVA) and Ultraviolet B (UVB) radiation and are safe and effective. Understanding CDERs Risk-Based Site Selection Model.

FDA 40

FDA Compliance Licensing World Health 40

SQA

JUNE 10, 2021

The essential oils general monograph has been completely overhauled to expand, among others, the definition, production, test, and labelling sections, providing additional detail and clarification. FDA plant inspection and pay $50 million in fines and forfeiture. Guidance on the Licensing of Biosimilar Products, 06 May 2021.

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COVID-19 FDA COVID-19 Vaccine Compliance 52

Healthcare Law Blog

JANUARY 12, 2022

At this point, providers using the Clover Assist system (and their members) are tethered to Clover but that is likely to change as Clover looks into licensing its software to other plans and providers. Definitely an interesting initiative to watch. One interesting area is biosimilars. Better Living through Chemistry” anyone?

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US Department of Health and Human Services Doctors Nurses Medicare 52

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

FDA 52

FDA Compliance COVID-19 Public Health 52

SQA

FEBRUARY 26, 2024

This edition is aligned with the latest regulatory guidelines, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practices, and the FDA Draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases.

FDA 40

FDA Compliance COVID-19 Public Health 40

AIHC

AUGUST 2, 2022

Two vaccines may be used for the prevention of Monkeypox virus infection: JYNNEOS (also known as Imvamune or Imvanex), licensed (or approved) by the U.S. Map & Case Count as well as a Monkeypox outbreak Global Map reporting the CDC’s tracing of cases.

US Department of Health and Human Services 98

US Department of Health and Human Services FDA Licensing Compliance 98

Innovaare Compliance

OCTOBER 6, 2022

MAOs have to ensure that TPMOs use a standardized disclaimer in their marketing materials that meet the definition of marketing whether they are in print, on the website, or in television advertising. New third-party marketing organization (TPMO) oversight requirements will go into effect on October 1, 2022.

Medicare 52

Medicare Medicare Compliance Public Health 52

SQA

JUNE 3, 2024

The Administrative Measures are comprised of the following seven chapters, encompassing a total of 79 articles that mainly address the administration of drug supply licenses, obligations of businesses supplying drugs and medical institutions using drugs, as well as regulators supervision of stakeholders in drug supply and use.

FDA 40

FDA COVID-19 Licensing Nurses 40

SQA

OCTOBER 18, 2022

The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada. The packaging of the counterfeit kits resembles authentic (licensed) BTNX Inc. products in color and typeface and uses the BTNX Inc. device identifier “COV-19C25.”

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

Hall Render

SEPTEMBER 1, 2023

operating margin, $1B net gain halfway through its first year Illinois public health officials warn of “rising COVID-19 activity” St. Warner, Kaine announce nearly $1.4M operating margin, $1B net gain halfway through its first year Aspirus Health seeking merger partners beyond St.

COVID-19 40

COVID-19 Nurses Nursing Homes Hospitals 40

Healthcare Law Blog

AUGUST 9, 2023

8] The court in Members of the Medical Licensing Board of Indiana, et al. The bill amends the existing Women’s Right to Know Act with the expansion of the definition of abortion. United States FDA , 2023 U.S. Licensing Bd. 6] A complaint challenging the constitutionality of H.B. 13] Kansas : H.B. for Hippocratic Med.

Licensing 52

Licensing Informed Consent Nurses FDA 52

Hall Render

AUGUST 16, 2024

Luke’s Behavioral Health ARKANSAS LaDonna Johnston Named CEO of Unity Health Update: Hearing to Approve Sale of Wadley Regional Medical Center Rescheduled How Arkansas Children’s is diversifying its workforce Sale hearing for Steward Health, Debtors’ Hospitals in Louisiana and Arkansas moved to Aug. Therapist pleads guilty to $1.6M

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Hospitals Nurses 40

Hall Render

AUGUST 16, 2024

Luke’s Behavioral Health ARKANSAS LaDonna Johnston Named CEO of Unity Health Update: Hearing to Approve Sale of Wadley Regional Medical Center Rescheduled How Arkansas Children’s is diversifying its workforce Sale hearing for Steward Health, Debtors’ Hospitals in Louisiana and Arkansas moved to Aug. Therapist pleads guilty to $1.6M

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Hospitals Nurses 40

Hall Render

MAY 31, 2024

Vincent Named President of the Association of Black Cardiologists Arkansas Children’s Hires Morse as Chief Administrator for ACNW Children’s Miracle Network Hospitals partners raise $5.4 healthcare workforce finds lack of diversity St. operating income, 4.1% operating income, 4.1%

Nursing Homes 40

Nursing Homes Nurses Hospitals Medicaid 40

Hall Render

DECEMBER 22, 2023

health care spending hits $4.5 Million in Retaliation Suit John Muir, Tenet scrap hospital deal after FTC challenge Kaiser to lay off 79 administrative employees Leaning toward big wins in schizophrenia and vaccines, venture group raises new fund of $389 million Madera hospital creditors want to be paid, including CEO. health care spending hits $4.5

Nursing Homes 40

Nursing Homes Nurses COVID-19 Hospitals 40

Hall Render

NOVEMBER 17, 2023

Grifols gets FDA approval for new facility in Clayton Invitae pledged $115M, 374-job investment in North Carolina. Million Individuals Affected by MOVEit Hack MARYLAND Adventist HealthCare, Montgomery College form partnership to address need for qualified nursing workforce Harford Memorial Hospital closing set for Feb.

Nursing Homes 40

Nursing Homes Nurses Hospitals Doctors 40

Hall Render

AUGUST 4, 2023

FDA grants expedited review for Francis Medical prostate cancer treatment Merger failure post-mortem: What’s next for Fairview and Sanford? 4 Rankings show average health across Northeast Michigan MINNESOTA Essentia Health Opens $900M Replacement Hospital In Duluth, Minn.

COVID-19 40

COVID-19 Nursing Homes Hospitals Nurses 40

Hall Render

SEPTEMBER 8, 2023

Margaret’s files Chapter 11 bankruptcy for Peru, Spring Valley hospitals Why an Illinois hospital CEO laid off 20% of its leadership Illinois Department of Public Health predicts the outlook for the COVID-19 virus Tough choices at Memorial Health HSHS says system outage caused by cyberattack Physician convicted in $9.5M

Nursing Homes 40

Nursing Homes COVID-19 Nurses Hospitals 40

Hall Render

OCTOBER 27, 2023

economy Cataldo Ambulance to expand operations, buys property on Worcester’s West Side Saint Vincent Hospital brings back volunteer program New England Regional Headache Center moves to Harvard St. with historic building purchase MICHIGAN Bronson raises capital campaign goal to $4.5M RHODE ISLAND Lifespan, largest hospital owner in R.I.,

US Department of Health and Human Services 40

US Department of Health and Human Services Nurses Nursing Homes COVID-19 40

Hall Render

JANUARY 21, 2022

Fauci says FDA could authorize Pfizer’s Covid vaccine for kids under 5 in the next month. It’s definitely unprecedented’: Paramedics say hospital diversions straining EMS services. Maryland nurses say license delays started before cyberattack. COVID-19 emergency could end this year, WHO says. IU Health gives Ivy Tech $8.75

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COVID-19 Nursing Homes COVID-19 Vaccine Nurses 40

Hall Render

MAY 12, 2023

has gotten worse over last two years Massachusetts hospitals ‘pummeled’ by workforce shortage, driving $1.52 billion in temporary labor costs UMass Chan ranked 13 for primary care education in US News & World Report One hospital in central Mass.

COVID-19 40

COVID-19 US Department of Health and Human Services Nurses Hospitals 40

Hall Render

JANUARY 24, 2025

NATIONAL 2025 ushers new era in physician unions CMS faces renewed legal pressure on drug price negotiation program DOJ sues Walgreens for knowingly’ filling millions of prescriptions that lacked legit medical purposes Employer cost-cutting pushes tech companies to merge Expect more hospital mergers in 2025, with deals driven by distress and (..)

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Hall Render

MARCH 28, 2025

It Renewed His License Twice. Johns BayCare improved operating margin to 9.6% Louis Childrens Hospital gets $38M donation | FOX 2 MONTANA Bill could increase access to doula care in Montana Montana Examines Ways To Ease Health Care Workforce Shortages Montana officials monitoring U.S.

US Department of Health and Human Services 40

US Department of Health and Human Services Nurses Nursing Homes Hospitals 40

Hall Render

APRIL 21, 2023

Nevada, currently the wild west of birthing, is considering licensing midwifery NEW HAMPSHIRE Dartmouth Health opens new 5-story patient pavilion Report: Anthem has yet to process nearly $300 million in N.H. no longer calls for masks at all health care facilities to fight COVID-19, Gov.

US Department of Health and Human Services 40

US Department of Health and Human Services COVID-19 Nursing Homes Nurses 40

Hall Render

FEBRUARY 14, 2025

Opposes Bankrupt Prospect Medical’s ‘Plunder’ CT medical device company raises $9.3M to community organizations ChristianaCare: Hospital review board erodes Delaware corporate brand ChristianaCare invests $1.6

Nursing Homes 40

Nursing Homes Nurses Hospitals Doctors 40

Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original).

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COVID-19 Vaccine COVID-19 FDA Public Health 59

Drug & Device Law

MAY 15, 2023

took judicial notice of “declarations issued by the Secretary and FDA declaring [that this] vaccine [w]as a vaccination contemplated under the PREP Act.” Plaintiff sued because her daughter obtained the vaccine without her consent – thus, by definition, her claims involved “the administration or use of covered countermeasures.”

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COVID-19 COVID-19 Vaccine Licensing Nursing Homes 59