AIHC

JUNE 6, 2023

OpenAI’s ChatGPT 2023 & the National Institutes of Health AI is developing at lightning speed. OpenAI’s ChatGPT 2023 & the National Institutes of Health AI is developing at lightning speed. Can ChatGPT Replace a Physician? The article asks the same question – can ChatGPT replace physicians? Furthermore, approximately 1.2%

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Compliance Medical Billing HIPAA Due Diligence 52

SQA

MAY 24, 2023

ANVISA Resumes Inspections in the Area of Technovigilance, 29 March 2023 In partnership with local Health Surveillance, ANVISA technical teams carried out in March 2023 two (2) medical device manufacturer inspections with an aim to strengthen the monitoring of these products in Brazil, ensuring their safety, performance, and quality.

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SQA

OCTOBER 18, 2023

The measure, adopted through Resolution – RE 2910/2023 , was made after the Agency was informed by the Sanitary Surveillance of Goiás about the occurrence of serious adverse events associated with the incorrect use of the products.

FDA 40

FDA Compliance Licensing World Health 40

SQA

JUNE 10, 2021

ANVISA has also released a set of 106 proposals for Regulatory Projects that will compose the 2021-2023 Regulatory Agenda. Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021. FDA plant inspection and pay $50 million in fines and forfeiture.

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FDA COVID-19 COVID-19 Vaccine Compliance 52

Bill of Health

NOVEMBER 15, 2023

drug policy using a whole-of-government (W-G) approach to assess where these misalignments are occurring among different agencies at the same level of government (referred to as horizontal W-G), and across different levels of government (referred to as vertical W-G). Code § 1701 et seq.

Governance 167

Governance Public Health Telemedicine Medicaid 167

Healthcare Law Blog

DECEMBER 11, 2023

December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. When an invention is made with federal assistance, the federal government may exercise its “march-in” rights to license the patented invention to another party, even when the patent owner disagrees.

Governance 52

Governance FDA Licensing 52

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

SQA

OCTOBER 18, 2022

List Health Advance as an “Official Canadian Distributor” Include the text “Health Canada Approved” (Claims of endorsement by government authorities, such as Health Canada, are not permitted.). PIC/S Sub-Committees have been elected for a two-year term starting on 01 January 2022 and ending on 31 December 2023.

US Department of Health and Human Services 40

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

SQA

FEBRUARY 26, 2024

The action was held from 26 to 28 September 2023, at the city’s international entry points. ANVISA Publishes New Measures to Prohibit Cosmetic Products Used in Injectable Form, 10 October 2023 ANVISA published two resolutions that suspended the trade, distribution, manufacture, advertising, and use of products from PHD Cosméticos Ltda.

FDA 52

FDA Compliance COVID-19 Public Health 52

Hall Render

APRIL 14, 2023

NATIONAL 94% of Organizations Experienced a Cyberattack in 2022 AHA blog: Strengthening crisis management in rural health care Biden signs bill ending Covid-19 national emergency Cancer drug shortages are creating dire circumstances for some patients CMS Releases FY24 IPPS Proposed Rule, Seeks to Boost Rates by 2.8%

Nursing Homes 40

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

Healthcare Law Blog

APRIL 14, 2023

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S.

FDA 52

FDA Governance 52

Health Law Advisor

JULY 21, 2023

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) announced its proposed “Transitional Coverage for Technologies” (TCET) pathway—the Biden administration’s highly anticipated take on a mechanism to expedite coverage for certain devices designated by the U.S. Food and Drug Administration (FDA) as breakthrough devices. [1]

FDA 52

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Hall Render

MARCH 16, 2022

2471 ) that funds the federal government for the remainder of FY 2022. The measure includes funding for health care-related agencies, such as HHS, CMS, HRSA and the FDA, as well as several health care policy riders and provisions that address issues like 340B and telehealth waivers. A section of the bill that would have provided $15.6

COVID-19 40

COVID-19 Medicare Medicare FDA 40

Healthcare Law Blog

JUNE 15, 2023

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. April 10, 2023: DOJ seeks clarification from the court regarding the FDA’s obligations in light of the Texas ruling.

FDA 52

FDA Governance Telemedicine Licensing 52

Drug & Device Law

FEBRUARY 1, 2023

We call ourselves the Drug and Device Law Blog, but sometimes we cover cases outside the drug and device field because such cases can sometimes be helpful or inspiring. But preemption was another reason why the plaintiffs lost and since when has this blog been able to resist the temptation to talk about a good preemption case?

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FDA Medicare Medicare Governance 59

Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

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FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

MAY 12, 2023

We suspect this will cause little grief for readers of this blog (the Drug and Device Law Rock Climber and other family members and close friends long ago reached their “Luca talk” saturation point), but we have appreciated this outlet for our excitement about this unexpected adventure and our pride in our beautiful baby boy. Pardini, — F.4

FDA 64

FDA Governance 64

Drug & Device Law

DECEMBER 20, 2023

We are even more likely to blog about a case if it follows up on an earlier decision about which we scribbled. Facteau , 2023 WL 8641918 (1st Cir. We have blogged about this prosecution twice before. The FDA took the position that such a 510(k) clearance would involve a combination drug/device product. Yes, of course.

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FDA Governance 52

Drug & Device Law

JULY 14, 2023

well, because we are the Drug and Device Law Blog, where there are some weeks when we write on preemption every day. 2023), the plaintiffs relied on an outside lab to claim that the defendant’s product was not what it purported to be. We care about federal preemption because. In Hollins v. Walmart Inc. , 4th 1011 (9th Cir.

FDA 52

FDA Governance 52

Drug & Device Law

JANUARY 23, 2023

2023 WL 239395 (D.N.J. Jan 18, 2023), the plaintiff was implanted with the defendant’s textured breast implant after undergoing a mastectomy. D’Addario , 2023 WL 239395 at *4 (internal punctuation and citation to Riegel omitted). In D’Addario v. Johnson & Johnson , et al., In other words, “where a.

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FDA Fraud Doctors Governance 111

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

FDA 59

FDA Licensing Hospitals Governance 59

Drug & Device Law

NOVEMBER 29, 2023

We’re not one of those blogs. 3d , 2023 WL 7502499 (Pa. 14, 2023), holding that the cost of legal, physician-prescribed medical marijuana is legitimate medical expense reimbursable through the Pennsylvania Worker’s Compensation system, notwithstanding such products’ complete lack of FDA approval. at *1-2.

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