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%

Compliance 59

Compliance Medical Billing HIPAA Due Diligence 59

The Health Law Firm Blog

AUGUST 22, 2023

Board Certified by The Florida Bar in Health Law On June 15, 2023, a United States District Judge sentenced a Florida man to 15 years in prison for his role in an HIV prescription drug fraud scheme that amassed more than $230 million in two years. By George F. Indest III, J.D.,

Fraud 52

Fraud FDA Licensing Nurses 52

The Health Law Firm Blog

AUGUST 8, 2023

Board Certified by The Florida Bar in Health Law On June 15, 2023, a United States District Judge sentenced a Florida man to 15 years in prison for his role in an HIV prescription drug fraud scheme that amassed more than $230 million in two years. By George F. Indest III, J.D.,

Fraud 52

Fraud FDA Licensing Nurses 52

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.

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FDA Compliance Licensing World Health 40

The Health Law Firm Blog

JULY 17, 2023

Board Certified by The Florida Bar in Health Law On June 15, 2023, a United States District Judge sentenced a Florida man to 15 years in prison for his role in an HIV prescription drug fraud scheme that amassed more than $230 million in two years. By George F. Indest III, J.D.,

Fraud 52

Fraud FDA Licensing Nurses 52

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%

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52

The Health Law Firm Blog

JUNE 26, 2023

Board Certified by The Florida Bar in Health Law On June 15, 2023, a United States District Judge sentenced a Florida man to 15 years in prison for his role in an HIV prescription drug fraud scheme that amassed more than $230 million in two years. By George F. Indest III, J.D.,

Fraud 52

Fraud FDA Licensing Nurses 52

SQA

JUNE 10, 2021

ANVISA has also released a set of 106 proposals for Regulatory Projects that will compose the 2021-2023 Regulatory Agenda. The CDSCO has postponed deadlines for regulating implantable devices and other medical products for which manufacturers or importers have already applied for licenses under the Medical Device Rules 2017.

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FDA COVID-19 COVID-19 Vaccine Compliance 52

SQA

DECEMBER 16, 2022

The changes will serve to strengthen the country’s medical device registration regulations upon their effective date of 01 March 2023. The new Annex 1 will begin on 25 August 2023 with the exception that the deadline for Chapter 8.123, “Product transfer/ loading/unloading areas for lyophilizers” is 25 August 2024.

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FDA Compliance COVID-19 Licensing 40

Healthcare Law Blog

OCTOBER 25, 2023

As of October 1, 2023, a pharmaceutical manufacturer that employs individuals as pharmaceutical representatives must register as a pharmaceutical marketing firm with the CT DCP and renew their registration annually, and by no later than June 30 th of each year. What Do Pharmaceutical Manufacturers Need to Do?

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Licensing Compliance FDA Public Health 52

SQA

SEPTEMBER 2, 2022

effective as of 01 July 2023. United States Food and Drug Administration (FDA) – Regulations and Guidances. FDA Proposes Benefit-Risk Considerations for Product Quality Assessments, 20 June 2022. The European Pharmacopoeia (Ph. Commission held its 173rd session on 21 and 22 June 2022. Supplement 11.2,

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FDA COVID-19 Nursing Homes Compliance 91

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

DECEMBER 10, 2021

Based on these projections, Class IV device registrants would face a December 2023 deadline for UDI compliance. Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products – General Principles, 15 September 2021. The EMA and FDA have agreed to the following principles for the pilot program.

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FDA Compliance Public Health Hospitals 52

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

Healthcare Law Blog

AUGUST 25, 2022

The drug publication date for 2026 will be chosen by September 1, 2023. Drugs eligible for negotiation must be FDA-approved for at least 7 years and marketed in conformance with the Federal Food, Drug, and Cosmetic Act. For more information on this final rule, see our blog. Negotiation-Eligible Drugs.

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Medicare Medicare Medicaid Medicaid 52

Healthcare Law Blog

NOVEMBER 13, 2023

On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). Please refer to our January 5, 2023 , November 4, 2022 and May 16, 2022 blog posts for more information.

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Medicare Medicare Medicaid Medicaid 59

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%

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

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.

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FDA Governance Telemedicine Licensing 52

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

HealthLaw Prof Blog

AUGUST 2, 2023

2023): In April 2023, a federal court in Texas preliminarily invalidated the license for mifepristone, the abortion drug approved by the FDA more than two decades. Lars Noah (University of Florida), Listening to Mifepristone, 80 N.Y.U.

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FDA Licensing 52

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. . .

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FDA Licensing Hospitals Governance 59