Healthcare Law Blog

MAY 31, 2022

Medical devices are regulated by the Food and Drug Administration (“FDA”) and many of the applications and technologies used to deliver or access healthcare in the metaverse may be classified as a medical device. [3] 4] CDRH Proposed Guidances for Fiscal Year 2022 (FY2022) | FDA. [5] Medical Device Regulations. 1, 2021). [2]

FDA 90

FDA HIPAA Medicare Medicare 90

Healthcare IT Today

MAY 6, 2023

Each week, we’ll be providing a look back at the articles we posted and why they’re important to the healthcare IT community. Read more… Preventing Genetic Testing Fraud: 5 Actions for Health Plans. Welcome to our Healthcare IT Today Weekly Roundup. Technology’s Role in Helping Us Achieve Health Equity. at Valencell.

Fraud 96

Fraud Doctors Medicare Medicare 96

Healthcare IT Today

FEBRUARY 28, 2023

(President Biden, in his State of the Union speech, warned “we remain vigilant” while calling for an end to the emergency, but quickly switched the subject from the urgency of public health to prosecuting fraud.) This article summarizes their responses. Pinho called for real-time decision making as well.

Public Health 104

Public Health COVID-19 FDA Governance 104

MedTrainer

APRIL 22, 2024

In this article, I’ll discuss why supplier compliance is as critical as legal and regulatory adherence for healthcare organization employees. For example, a healthcare IT vendor should include items related to HIPAA, while a checklist for a food vendor should focus on FDA or USDA regulations.

Compliance 52

Compliance HIPAA Licensing Fraud 52

Hall Render

JANUARY 11, 2023

The Tool is a result of collaborative efforts between the FTC, HHS Office for Civil Rights (“OCR”), HHS Office of the National Coordinator for Health Information Technology (“ONC”) and the Food and Drug Administration (“FDA”). Regulatory Landscape.

Compliance 40

Compliance HIPAA FDA Due Diligence 40

AIHC

JUNE 6, 2023

According to Investopedia’s article “ Understanding Machine Learning: Uses, Example ,” machine learning is the concept that a computer program can learn and adapt to new data without human intervention and is a field of artificial intelligence that keeps a computer’s built-in algorithms current regardless of changes in the worldwide economy.

Compliance 59

Compliance Medical Billing HIPAA Due Diligence 59

AIHC

JUNE 6, 2023

According to Investopedia’s article “ Understanding Machine Learning: Uses, Example ,” machine learning is the concept that a computer program can learn and adapt to new data without human intervention and is a field of artificial intelligence that keeps a computer’s built-in algorithms current regardless of changes in the worldwide economy.

Compliance 52

Compliance Medical Billing HIPAA Due Diligence 52

Health Law Advisor

MARCH 1, 2023

1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306.

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 52

Drug & Device Law

MARCH 3, 2022

In the coming weeks, there are sure to be many articles looking at what Judge Brown Jackson has written and what that might suggest about the future jurisprudence of the United States Supreme Court if she is confirmed. We will not predict what will happen in confirmation. 3d at 167-73. at 174.

FDA 59

FDA Fraud Governance 59

Drug & Device Law

AUGUST 8, 2022

The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud. Such power rests solely with the FDA.” Typically overblown MDL claims for “fraud” and “conspiracy” also failed. According to the opinion, he repeatedly sought to defraud the ECFMG ? at 229-30 (citations and quotation marks omitted).

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

NOVEMBER 28, 2022

While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). The article stated that each of the thirty-three individuals had no known asbestos exposure other than talcum powder. That article has “junk science” red flags flying all over it. So Dr. Moline set out to fill that void.

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

JUNE 8, 2022

The plaintiffs brought a class action essentially trying to ban the sale of homeopathic products as a “health fraud” in violation of California’s Unfair Competition Law and California’s Food, Drug, and Cosmetic Law, which is known (confusingly for those of us who also do antitrust work) as the Sherman Law.

Fraud 59

Fraud FDA 59

Drug & Device Law

NOVEMBER 10, 2022

3, 2002) (to be published), the California Court of Appeal held that federal law preempts state law failure-to-warn claims alleging that branded and generic drug manufacturers did not ensure that patients received FDA-approved Medication Guides for amiodarone, a heart medicine. This is not a new idea. at *5 (citing the statute). at *12-*13.

FDA 52

FDA Doctors Fraud Governance 52

Drug & Device Law

NOVEMBER 7, 2022

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease ( Fabry Disease ). Genzyme Corp. 2022 WL 4237528 (D.

FDA 72

FDA Fraud Doctors 72

Drug & Device Law

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. 2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. At bottom, plaintiffs were improperly seeking to have courts second-guess the FDA’s methods and conclusions.

FDA 105

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

Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

FDA 52

FDA Fraud Informed Consent 52

Drug & Device Law

MARCH 22, 2022

Her current lawsuit brought claims under the Connecticut Product Liability Act (CPLA) and for common law fraud. The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval. The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval.

Fraud 59

Fraud FDA Doctors 59

Drug & Device Law

OCTOBER 25, 2023

We don’t remember what the legislation was about, but we do remember the consumer affairs guy regaling us with stories about how easy it was for state investigators to find all sorts of violations of consumer fraud regulations. 7, 2023), is a defense-favorable cosmetic opinion with good implications for drug/device consumer fraud cases.

Fraud 59

Fraud FDA 59

Drug & Device Law

FEBRUARY 11, 2024

FDA litigation that is now before the Supreme Court. FDA , 78 F.4th quoting FDA appellate brief ). Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. 4th 210 (5th Cir.

FDA 59

FDA Fraud Pharmaceutical Industry Doctors 59