Healthcare IT Today

JANUARY 16, 2023

The model works by garnering informed consent to collect health data on behalf of people participating in clinical research from any healthcare organization touching their care. The company was founded in 2021 and is backed by leading institutional and angel investors. For more information, please visit crescendo.health.

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Bill of Health

FEBRUARY 20, 2023

Notably, in 2021, New York repealed provisions granting healthcare providers immunity amid the pandemic.) While early in the pandemic a number of states granted hospitals and other providers sweeping immunity from liability, many of these provisions have been rolled back.

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MedTrainer

APRIL 11, 2024

Food and Drug Administration Patient Rights Violations Incidents involving breaches of patient confidentiality, informed consent issues, or disregard for patient autonomy and dignity. million in 2021 and 51.9 Fact: In 2023, hackers and thieves exposed, stole, or impermissibly disclosed 133 million patients records.

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HIT Consultant

APRIL 27, 2022

But the move to decentralized trials accelerated dramatically in 2020 and 2021–and it’s not slowing down. By the end of the year, I expect the majority of sites will have an electronic Investigator Site File (eISF) and electronic informed consent (eConsent).

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Health Populi

JULY 31, 2023

The biggest drops in confidence between 2018 and 2021 occurred with peoples’ trust in Facebook, Amazon, and Google above other institutions. The bar chart (labeled Figure 2 from Brookings’ report) shows the percentage loss in mean confidence in various institutions from largest decline to smallest.

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Healthcare IT Today

SEPTEMBER 3, 2022

In addition, claims denials saw a 2x increase from 2020 to 2021. Read more… Addressing Informed Consent Challenges in the ICU. Patients in intensive care are often unable to provide consent , which means they may miss opportunities to receive investigational treatments.

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Bill of Health

AUGUST 29, 2022

31, 2021), [link] (describing a record number of pediatric COVID-19 hospitalizations due to the omicron variant). [2] 8] Young people under age 18 in California detention centers need parental consent to receive the vaccine. 24, 2021), [link]. [9] 1] E.g., Anna Edney, Kids’ Covid Hospitalizations Hit Record in U.S.

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AIHC

OCTOBER 11, 2021

Workplace-based testing should not be conducted without the employee’s informed consent. Encourage and answer questions during the consent process. Consult legal counsel when developing your informed consent form for employees. settings where healthcare is delivered, including home health.

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Bill of Health

DECEMBER 20, 2022

Having been launched in Switzerland in 2021, the Sarco is reportedly available for use in the country’s legal assisted suicide clinics. And to the outrage of many, Nitschke has recently begun campaigning for legislative backing of the Sarco in Scotland.

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Healthcare Law Blog

MARCH 17, 2022

This is the third AO in a recent series of AOs ( see AO 21-17 on November 19, 2021 and AO 21-13 on October 4, 2021 ) focused on Medicare cost subsidies in a clinical trial setting for serious conditions that affect large portions of the population in the US.

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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. per 100,000 people in 2021. per 100,000 people in 2021.

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Healthcare Law Today

JANUARY 20, 2022

The applicable informed consent should clearly identify the data being collected and how that data will be used. The FDA encourages stakeholders to submit comments under docket number FDA-2021-D-1128. The sponsor should consider the clinical investigation population (e.g., The last day to submit comments is March 22, 2022.

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Health Law RX

APRIL 25, 2022

District Court for the Eastern District of Texas set aside portions of the October 7, 2021 interim final rule with comment period (the “ Interim Rule “) relating to the creation of an Independent Dispute Resolution (IDR) process. April 4, 2022 – Continued Litigation Movement. As a reminder, on February 23, 2022, the U.S.

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Healthcare IT Today

APRIL 16, 2023

The inaugural report on consumer technology software and services from the Consumer Technology Association (the folks who put on CES) named digital therapeutics as the fastest-growing software and services market, with 25% growth from 2021 to 2022 and 19% growth from 2022 to 2023.

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HIPAA Journal

JANUARY 16, 2023

Although specific concerns differ by organization, the concerns can generally be categorized as informed consent to use data, safety and transparency, algorithmic fairness, and data privacy. . These concerns are not unique to the United States nor to the healthcare industry. Promote AI that is responsive and sustainable.

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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). The Warning Letter was issued after the FDA review of a response to a Form FDA 483 (reviewed by FDA on 03 November 2021).

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AIHC

JANUARY 5, 2022

Written by: Joanne Byron , BS, LPN, CCA, CHA, CHCO, CHBS, CHCM, CIFHA, CMDP, COCAS, CORCM, OHCC, ICDCT-CM/PCS As a result of the 2021 Consolidated Appropriations Act, several No Surprises Billing Act regulations went into effect on January 1, 2022, for providers, facilities and air ambulance services.

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Bill of Health

JANUARY 24, 2022

Back at the start of 2021, pregnant women were told to make an informed decision with their physicians about a vaccine that had never been tested in that population. But we can recapture some of this data through registries and cohort studies.

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SQA

FEBRUARY 15, 2023

It includes aspects such as home health visits, remote monitoring and diagnostics, direct-to-patient shipment of study drugs, and electronic informed consent. In FY 2021, fewer warning letters followed onsite inspections, as the pandemic halted many inspections, except for those deemed mission critical.

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Drug & Device Law

DECEMBER 21, 2023

Bexis’ amicus efforts this year in Mallory obviously came to naught, and we’ve had our own cases on this list before (see, e.g. , 2013-2 and 2021-10 ). Also, given other recent rulings in Zostavax ( 2022+10 ; 2021+19 ), the remaining plaintiffs in Zostavax aren’t likely to profit from that mistake. Good riddance.

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Drug & Device Law

DECEMBER 29, 2023

Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Due to the complexity of the Zantac MDL, it took a while just to obtain the requisite final appealable orders, but appeals from several Zantac orders ( 2022+4 , 2021+10 , and 2021+18 ) are now pending (we think). 23-1032).

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Drug & Device Law

MAY 30, 2022

2021) (applying Louisiana law). 2021) (no causation where prescriber “testified unequivocally that she would have prescribed the drug regardless of any changes made to its warning label because it was such an effective treatment for the type of cancer from which [plaintiff] was suffering”) (applying Colorado law). 3d 704 (5th Cir.

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Drug & Device Law

AUGUST 8, 2022

2021) (hence the Pennsylvania reference above). Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. 2021), the Third Circuit reversed. 2020), leave to amend denied , 2021 WL 4267667 (S.D.W. 20, 2021). March 23, 2020), vacated , 15 F.4th

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Drug & Device Law

SEPTEMBER 9, 2022

Larkin did not discuss the standard for proximate causation or suggest, as Thacker implies, that informed consent is part of the inquiry. Sexton , 2021 WL 4138399, at *4; Huskey , 29 F.Supp.3d 2021) (citations as in the original). Pfizer, Inc. , 3d 758, 769-70 (Ky. The second was the decision below. 3d 736 at 743.

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Drug & Device Law

JUNE 6, 2022

2021), held that the implanting surgeon’s testimony “shut[] down” the plaintiff’s warning claim because, warnings “containing more information on the risks posed by [defendant’s device] would not have altered his decision to use the implant in [plaintiff’s] surgery.” Smithkline Beecham Corp. , 2021) (applying Louisiana law).

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Drug & Device Law

JANUARY 28, 2022

His timely post concerns an excellent decision by the Connecticut Supreme Court from December, 2021 – a decision that we, frankly, missed initially. 3d —-, 2021 WL 5989909 (Conn. Fajardo , 2021 WL 5989909, at *12-*13 (citations omitted). Fajardo , 2021 WL 5989909, at *11, *18. Fajardo , 2021 WL 5989909, at *19-*20.

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Drug & Device Law

AUGUST 22, 2022

This time, plaintiff pleaded “1) violation of [defendant’s] premarket approval; 2) breach of implied warranty; and 3) lack of informed consent (failure to warn).” Id. 2021); Weber v. Mentor Worldwide, LLC , 2021 WL 1173279 (E.D. March 29, 2021); Webb v. March 31, 2021); Diodato v. 2021); Tinkler v.

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Drug & Device Law

FEBRUARY 29, 2024

The other defendant manufactures a rheumatoid arthritis medicine, tocilizumab, but contracted with the federal government to conduct clinical trials regarding its use in treating COVID-19 leading to an Emergency Use Authorization in June 2021 and full approval for COVID-19 use in December 2022.

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Drug & Device Law

FEBRUARY 26, 2024

In reopening after its pandemic shut-down in 2021, “Rutgers announced that student vaccination would be a condition of attending fall classes in person or having physical access to campus resources.” First of all, only one of the plaintiffs ever sought vaccination, so the rest were never entitled to informed consent at any time.

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HealthLaw Prof Blog

MARCH 24, 2022

Suter (George Washington University), Wendy Uhlmann (University of Michigan), Aaron Scherer (University of Iowa), The Goldilocks Conundrum: Disclosing Discrimination Risks in Informed Consent, SSRN (2021): Informed consent is a foundational ethical and legal.

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