Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. On August 15, 2023, the U.S.

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Bill of Health

OCTOBER 17, 2023

With cell-based and other regenerative therapies entering the market (making up an entire FDA subgroup ), it well worth considering how cell-based medicine can advance the world of personalized consumer testing. In other words, could a corporate, direct-to-consumer cell-based testing service be the next 23andMe?

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Healthcare IT Today

AUGUST 9, 2022

The use of AI is revolutionizing the delivery of healthcare, but its use comes with significant ethical challenges that cannot be ignored, the most important of which involve bias and informed consent. . Another major ethical concern of AI use surrounds the principle of informed consent. About Natalie C. About Carly C.

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Natalia Mazina

AUGUST 16, 2022

Recently – on July 6, 2022 – the FDA amended the Emergency Use Authorization (EUA) for Paxlovid, an orally-administered COVID-19 therapeutic drug. This form should notify patients of potential side effects, drug interactions, and other information pertaining to taking Paxlovid.

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Bill of Health

DECEMBER 1, 2023

There’s a great value to be found in, say, shifting the conversation to informed consent regimes to address the transaction at the center of tissue provision in the first place. To be clear, I tend to agree that in this classification paradigm, it seems more trouble than it’s worth to go after ownership exclusively in human tissue.

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Healthcare Law Today

JANUARY 20, 2022

Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data. The FDA, however, does not regulate all DHT products because the products do not always meet the definition of a medical device, e.g., a general wellness device.

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Bill of Health

FEBRUARY 26, 2024

In December 2022, the FDA Modernization Act 2.0 formally ended the FDA’s 1938 mandate to use animal models and opened the doors for organoids to be used as a full replacement for animals in pre-clinical trials. Would they classify as a medical device or biologic under FDA guidelines, or perhaps as a combination product?

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Bill of Health

APRIL 7, 2022

Jonathan Perez-Reyzin is a law student at Yale Law School interested in health justice, criminal law, and the intersection of law and philosophy. Justin is currently engaged in clinical work seeking to expand the reach of harm reduction services in New Haven.

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Natalia Mazina

SEPTEMBER 20, 2021

The associations reminded the public that (1) ivermectin is not approved by the FDA for human use to prevent or treat Covid-19 and (2) Clinical trials and observational studies to evaluate the use of ivermectin to prevent and treat COVID-19 in humans have yielded insufficient evidence to recommend its use.

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Bill of Health

OCTOBER 27, 2023

This, of course, makes FTC mediation of privacy in biotech especially salient until other tools — FDA guidelines, HIPAA expansions, and state privacy laws — start to address these concerns. After all, data collection and use is the bread and butter of these services.

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Hall Render

SEPTEMBER 14, 2023

Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

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Health Populi

MAY 30, 2018

This is important because in 2017, one in four new drugs approved by the FDA were designed to treat a small population, falling. Autonomy refers to data subjects’ (patients’) informed consent as a precondition of collecting personal health information agreeing to further uses. They are certainly inter-related.

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SQA

MAY 17, 2022

For Investigator Sites, the subject areas are Organizational Aspects, Informed Consent of Trial Participants, Review of Trial Participant Data, and Management of Investigational Medicinal Product(s). United States Food and Drug Administration (FDA) – Regulations and Guidances.

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HIT Consultant

NOVEMBER 17, 2021

Recent statements by the FDA and EMA support this emphasis, calling out the need for education and training of all constituents in a clinical trial to reduce unwanted protocol deviations and improve overall quality in clinical trial operations. Most ICFs are lengthy and can be challenging for patients to follow.

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Healthcare Law Blog

MARCH 17, 2022

The three-component Therapy includes the following: (1) a device to process patient bone marrow (after an extraction procedure); (2) a device to re-inject processed bone marrow into cardiac tissue; and (3) an FDA-approved guide catheter to facilitate placement of processed bone marrow into cardiac issue.

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Healthcare IT Today

JUNE 13, 2024

Data security also remains a pervasive worry, with insufficient reassurance to allay fears of breaches or unauthorized access to sensitive patient information. Enhancing the interpretability of AI models and promoting informed consent empower patients to understand and control how their data is used in AI applications.

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Bill of Health

AUGUST 29, 2022

By Victoria Kalumbi. Despite pediatric COVID-19 vaccine availability, many youth remain unvaccinated , and are thus at higher risk of life-altering outcomes as a result of contracting COVID-19. [1].

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SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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Healthcare Law Blog

AUGUST 9, 2023

The now-active provisions include a prohibition on abortions after 12 weeks of pregnancy (with limited exceptions), 72-hour informed consent requirements, pre-abortion gestational age verification, and reporting requirements for abortions after 12 weeks. [21] United States FDA , 2023 U.S. for Hippocratic Med. 7, 2023). [2]

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Hall Render

FEBRUARY 10, 2023

over Claims Practices Where things stand in Central California 1 month after a community hospital’s closure California hospital names Kelly Linden CEO Upcoming California health bills to watch, including a conversation with Rep. Blue Shield of California is counting on it.

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Kaiser Health News

NOVEMBER 27, 2023

Transgender Care Florida Under DeSantis, Florida passed a law this year banning gender-affirming health care for trans minors and mandating that adult patients sign informed consent forms before starting or continuing hormone treatment.

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Drug & Device Law

FEBRUARY 29, 2024

Not to mention, it is a powerful defense for our clients in product liability matters because it can foreclose liability and plaintiffs’ use of tort lawsuits (invariably creatures of state law origin) to impose requirements on medical devices or pharmaceuticals that the federal FDA did not. What could be better than preemption?

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Drug & Device Law

FEBRUARY 26, 2024

As much as we like preemption, no basis for preemption exists based with respect to the informed consent requirement of the statute’s provision governing emergency use authorized (“EUA”) products, such as (at the time) COVID-19 vaccines. Second, the FDCA (21 U.S.C. CHDI , 2024 WL 637353, at *5. Cuomo , 592 U.S. 14, 18 (2020)).

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Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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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.

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Drug & Device Law

JUNE 14, 2023

Of course, on the defense side, we’re usually as happy as clams if we can show that the Food and Drug Administration (FDA) has already decided which warnings are necessary, so let’s call it a day. There is no carve-out for informed consent. And therein, in a strange way, lies our interest in Francisco v. 2023 WL 3589654 (Ariz.

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Drug & Device Law

APRIL 21, 2023

The FDA regulates medical devices, including 3d-printed medical devices when made by medical device manufacturers (see here for more information). The FDA, or state-level regulatory commissions, or plaintiffs’ attorneys applying tort law, or all of the above? There is no intermediary!

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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). Jaqueline Moline, and her increasingly questionable paper “Mesothelioma Associated with the Use of Cosmetic Talc,” 62 J. 11-17 (Jan. may well be factually applicable to Dr.

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Drug & Device Law

AUGUST 30, 2022

But it involves the interplay between an FDA “Safety Communication” and punitive damages, so we thought it was worth looking at. The FDA data showed that approximately.28% Within days, the hospital convened a “power morcellation group” tasked with drafting an informed consent form that would reflect the FDA’s concerns.

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Drug & Device Law

AUGUST 22, 2022

The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.” 341 (2001).

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Drug & Device Law

AUGUST 8, 2022

Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. Such power rests solely with the FDA.” Of course, when one sees this kind of ridiculous no-injury claim, one knows a class action is involved – why we’ve repeatedly advocated the abolition of Fed.

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Drug & Device Law

JUNE 7, 2022

Plaintiff argued this conflicted with the learned intermediary rule because the FDA requires warnings to consumers when manufacturers market drugs to consumers. The FDA also requires warnings to physicians. Doctors are charged with discussing the risks and benefits of treatment and obtaining informed consent from their patients.

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Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . 8, 2019) (no causation where prescriber “testified that none of the additional risk information. . . 3d 812, 816 (11th Cir.

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Drug & Device Law

MARCH 9, 2022

Speaking of clothing, sometimes plaintiff regulatory experts engage in cosplay, donning a quasi-military uniform from their service in the FDA many decades ago. This masquerade occurs despite the fact that the expert’s prior FDA position had little or nothing to do with the subject of the litigation. No Informed Consent.

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