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Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

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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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COVID-19 Informed Consent FDA Licensing 98

Bill of Health

DECEMBER 20, 2022

FDA Approval. Food and Drug Administration (FDA), which “ regulates the sale of medical device products (including diagnostic tests) in the U.S. ” Although it is questionable whether the FDA would ever approve the Sarco machine as a medical device, it turns out the FDA may not need to. .”

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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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Bill of Health

DECEMBER 1, 2023

But Toomey makes a critical distinction: while physical biomatter is ownable, biological information , including genetic information, is not. According to Toomey’s framework, though, the actual “value” we might wish to protect, the value-generating biological information, therefore comes from something that cannot be owned.

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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Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data.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

Organoids generate information and data, and a single organoid model can even be hooked up to a “system” with other organoids to model systems and interrelated processes at once. In December 2022, the FDA Modernization Act 2.0 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

OCTOBER 27, 2023

By Adithi Iyer In my last piece , I discussed the hypothetical successor of 23andme — a tissue-based direct-to-consumer testing service I’ve called yourtissueandyou — and the promise and perils that it might bring in consumer health information and privacy. Consumer protections for this type of information are, in a word, complicated.

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HIPAA FDA Informed Consent Health Insurance 162

Bill of Health

APRIL 7, 2022

His writing will be informed by his experience with the war on drugs and community mental health, both as a patient and a clinician. Ismail Lourido Ali , J.D. (he/him Jonathan Perez-Reyzin is a law student at Yale Law School interested in health justice, criminal law, and the intersection of law and philosophy.

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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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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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Health Populi

MAY 30, 2018

The poll results are published in Public Perspectives on Personalized Medicine , with the top-line finding that life science industry innovators must better educate and inform consumers on the opportunities and benefits of personalized medicine. This picture of U.S. into the precision medicine category. 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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Bill of Health

JANUARY 24, 2022

Food and Drug Administration (FDA)-approved product for a different population, use or dosage than it was approved for, is very common in medicine. At that point, physicians and parents could make informed decisions as to whether to administer a COVID-19 vaccine or wait until they’ve received an EUA for young children.

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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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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. This important US document is to be reviewed for possible regulatory relevance to Annex 11.

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Healthcare IT Today

JUNE 13, 2024

Questions surrounding the sharing of proprietary information and the risk of algorithmic compromise or manipulation heighten ethical concerns. Data security also remains a pervasive worry, with insufficient reassurance to allay fears of breaches or unauthorized access to sensitive patient information.

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Bill of Health

AUGUST 29, 2022

If one of the goals of the foster care and juvenile justice system is to prepare youth to live independently, make informed decisions, and navigate the world, then the interests of society are best served by involving and praising the voices of youth in these decisions. Victoria Kalumbi received her JD from Harvard Law School in 2022.

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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

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

AUGUST 8, 2022

This goes beyond the attacks on industry groups for disseminating information that plaintiffs didn’t like, which we had previously thought to be a liability frontier. Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. Such power rests solely with the FDA.”

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Drug & Device Law

JUNE 6, 2022

He also testified that even if the warning label contained all of the information suggested by [plaintiff’s] expert, he would still have prescribed the medication for [plaintiff]. 2009), reversed a plaintiff’s verdict for entry of judgment n.o.v. Lineberger v. Wyeth , 894 A.2d 2d 141 (Pa. precludes Plaintiffs’ inadequate warning claims.

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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). The document was admissible, but “the information therein confirming [plaintiff] was one of the thirty-three individuals the article” was declared “confidential and limited solely to this case.” 11-17 (Jan. This effort largely failed.

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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

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

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

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

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

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

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. Note that we said “almost.”

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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. At her second appointment, her surgeon informed her that her MRI revealed a uterine fibroid that required surgery. The FDA data showed that approximately.28% In Rivera v. Valley Hospital, Inc.

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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. In Francisco , the plaintiff sued a medical practice for failing to inform him of the potential risks of taking ciproflaxin.

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