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).

Informed Consent 98

Informed Consent Doctors Hospitals COVID-19 98

AIHC

SEPTEMBER 5, 2023

Telehealth is a subset of e-health and is the use of telecommunications technology in health care delivery, information, and education according to the Health Resources and Services Administration (HRSA). Obtaining informed consent with your patient is typically done before the first appointment.

COVID-19 59

COVID-19 Telemedicine Compliance Informed Consent 59

HIT Consultant

NOVEMBER 2, 2021

A 2020 survey reveals two-thirds of providers and health information exchanges cited data entry errors as the greatest contributor to duplicate records. The ideal digital identification solution merges simple, seamless interfaces with advanced privacy and consent features. Better patient experiences with the tap of a screen.

Informed Consent 98

Informed Consent Patient Satisfaction COVID-19 98

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.

COVID-19 Vaccine 99

COVID-19 Vaccine COVID-19 Medicaid Medicaid 99

HIT Consultant

NOVEMBER 17, 2021

As with countless global industries, clinical trials were forced to move key functions online as COVID-19 swept the world in early 2020. Robert Geckeler, ScienceMedia Product Director. Clinical research operations had to rapidly deploy remote approaches that were previously in the planning or pilot stages.

COVID-19 96

COVID-19 Pharmaceutical Industry Informed Consent Compliance 96

Verisys

JANUARY 27, 2022

was minimal prior to COVID, but since 2020 expansion of telemedicine has skyrocketed as policymakers, insurers, and health systems sought ways to deliver care to patients in their homes. Department of Health and Human Services (HHS), telehealth services had a 63-fold increase with Medicare patients in 2020. According to the U.S.

US Department of Health and Human Services 52

US Department of Health and Human Services Telemedicine Licensing Informed Consent 52

NY Health Law

APRIL 15, 2021

diminished quality of care, increased opportunity to violate scope of practice or informed consent laws, etc.) Patients were enabled to access vital services while minimizing risk of COVID exposure, and some of the concerns about remote healthcare delivery (e.g., seem not to have been a major concern.

Informed Consent 52

Informed Consent Malpractice Telemedicine Medicaid 52

HIPAA Journal

JANUARY 16, 2023

According to a survey conducted by Dataiku in 2020, concerns about the ethics of AI in healthcare is the primary organizational challenge stalling the adoption of AI in healthcare environments.

Governance 67

Governance HIPAA World Health Informed Consent 67

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). Each of the above annexes provides detailed lists of elements to be examined for specific subject areas.

FDA 75

FDA Compliance Informed Consent Hospitals 75

Drug & Device Law

MAY 30, 2022

2020) (applying Georgia law). 692, 694 (5th Cir. 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).

Doctors 59

Doctors Licensing Informed Consent Hospitals 59

Drug & Device Law

DECEMBER 21, 2023

This is the third time that a Valsartan MDL decision has made our bottom ten list ( see 2020-10 ). Unfortunately, the Third Circuit declined a Rule 23(f) interlocutory appeal for unknown reasons. The penalty did not hold up, but the duty did. The logic of the consumer fraud claim made no sense.

FDA 52

FDA Fraud Informed Consent 52

Drug & Device Law

MAY 25, 2023

2020) and New Hampshire , Brown v. That’s what he posted here in early 2020. 2020), in preference to four Connecticut trial court decisions unanimously rejecting no-injury medical monitoring. the City of Chicago , 181 N.E.3d 3d 679 (Ill. Saint-Gobain Performance Plastics Corp. , 3d , 2023 WL 2577257 (N.H. March 21, 2023).

Informed Consent 59

Informed Consent Malpractice Governance 59

Drug & Device Law

AUGUST 8, 2022

Educational Commission for Foreign Medical Graduates , 2020 WL 1330699 (E.D. March 23, 2020), vacated , 15 F.4th Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. 2020), leave to amend denied , 2021 WL 4267667 (S.D.W. National Drug Co. ,

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

DECEMBER 29, 2023

Plaintiff knew about it, too, since he signed an informed consent document mentioning it. In Cates the plaintiff encountered an unusual – so unusual as to be called “paradoxical” − but known, adverse reaction. The device labeling specifically mentioned it. The prescribing cosmetic surgeon knew about it.

FDA 105

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

Drug & Device Law

JUNE 6, 2022

2020), prescription drug decision that affirmed a similar summary judgment under Georgia law: [Defendant] is entitled to final summary judgment as a matter of law. [The 2020 WL 8175427, at *2, 4-5 (D. 2020 WL 1434566, at *4-5 (W.D. March 24, 2020) (no causation where the implanting surgeon “testified ? Ethicon Inc.

FDA 59

FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

NOVEMBER 28, 2022

Moline obtained from her employer’s institutional review board to conduct the article was structured to “reference[] federal regulations governing human subject research,” while simultaneously “waiv[ing] the requirement that Dr. Moline obtain informed consent from the individuals whose cases she planned to study.” 11-17 (Jan.

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

APRIL 8, 2022

That’s why we’re pleased with the ruling in Informed Consent Action v. Well, it’s not just the tort plaintiffs who want to litigate scientific opponents into submission, and it’s not just our clients being targets of such efforts. Becerra , 2022 WL 992814 (S.D.N.Y.

Informed Consent 72

Informed Consent Governance 72

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. 2020); Dietz v. 2020 WL 6220125 (Ill. 8, 2020); D’Addario v. Johnson & Johnson , 2020 WL 3546750 (D.N.J. June 19, 2020); Jacob v.

Informed Consent 59

Informed Consent FDA Doctors 59

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. 14, 18 (2020)). Second, the FDCA (21 U.S.C. CHDI , 2024 WL 637353, at *5. Cuomo , 592 U.S.

COVID-19 52

COVID-19 COVID-19 Vaccine Informed Consent FDA 52

Drug & Device Law

FEBRUARY 29, 2024

The government issued the necessary “public health emergency” declaration in March 2020, and the PREP Act kicked in. One defendant developed and manufactures remdesivir, covered by an Emergency Use Authorization issued by the FDA in May 2020 and full approval in October 2020.

COVID-19 59

COVID-19 Informed Consent FDA Governance 59

HealthLaw Prof Blog

MARCH 29, 2022

Trudo Lemmens (University of Toronto), How the Mantra of Informed Consent in the Canadian Assisted Dying Debate Obscures Somatic Oppression, 52 U.B.C. 241 (2020): This JOTWELL contribution reviews Jonas-Sébastien Beaudry's paper "Somatic Oppression and Relational Autonomy: Revisiting Medical.

Informed Consent 52

Informed Consent 52

HealthLaw Prof Blog

APRIL 9, 2022

Trudo Lemmens (University of Toronto), How the Mantra of Informed Consent in the Canadian Assisted Dying Debate Obscures Somatic Oppression, 52 U.B.C. 241 (2020): This JOTWELL contribution reviews Jonas-Sébastien Beaudry's paper "Somatic Oppression and Relational Autonomy: Revisiting Medical.

Informed Consent 52

Informed Consent 52