NY Health Law

APRIL 15, 2021

While the laws governing telehealth were becoming gradually more permissive, progress was slow. diminished quality of care, increased opportunity to violate scope of practice or informed consent laws, etc.) seem not to have been a major concern.

Informed Consent 52

Informed Consent Malpractice Telemedicine Medicaid 52

HIPAA Journal

JANUARY 16, 2023

It is hoped that, as a tool for public health, AI can be used in the future to predict and track the spread of other infectious diseases by analyzing data from government, healthcare, and other sources. Ethics of AI in Healthcare . These concerns are not unique to the United States nor to the healthcare industry.

Governance 67

Governance HIPAA World Health Informed Consent 67

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

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

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. Plaintiff knew about it, too, since he signed an informed consent document mentioning it. In 2023, these include United States ex rel.

FDA 105

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

Drug & Device Law

APRIL 8, 2022

That’s why we’re pleased with the ruling in Informed Consent Action v. The government initially tried to accommodate the antivaxxers. The government initially tried to accommodate the antivaxxers. Becerra , 2022 WL 992814 (S.D.N.Y.

Informed Consent 72

Informed Consent Governance 72

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.

COVID-19 52

COVID-19 COVID-19 Vaccine Informed Consent FDA 52

Drug & Device Law

FEBRUARY 29, 2024

Not all that long after the PREP Act passed, the COVID-19 pandemic started, quickly confirming the importance of freeing government and industry to work together to deploy every type of desperately needed medical resource. The government issued the necessary “public health emergency” declaration in March 2020, and the PREP Act kicked in.

COVID-19 59

COVID-19 Informed Consent FDA Governance 59