MedTrainer

JANUARY 26, 2024

Get a comprehensive list of required training by role for ambulatory surgery centers.

Compliance 52

Compliance Informed Consent Fraud HIPAA 52

MedTrainer

NOVEMBER 5, 2023

Colorado Healthcare Compliance Resources Let’s start with the important state government agencies you’ll need to work with: The Colorado Department of Public Health and Environment (CDPHE) plays a crucial role in promoting and safeguarding the health and wellbeing of Coloradans.

Compliance 52

Compliance Licensing Informed Consent Public Health 52

Healthcare Law Blog

MARCH 17, 2022

IRB approved protocols, enrollment criteria, informed consent process and other rules and regulations governing good clinical trial practice). Notably, the Requestor would not advertise the arrangement but only denote it on trial informed consent forms.

US Department of Health and Human Services 52

US Department of Health and Human Services Informed Consent Medicare Medicare 52

MedTrainer

OCTOBER 4, 2023

Regulatory compliance involves following legal mandates and legislation as directed by governing bodies. Corporate compliance refers to the ways in which a company ensures they are following their own internal compliance structure. Here’s an easy way to think about it: Regulatory compliance acts as a roadmap for healthcare.

Compliance 52

Compliance Regulatory Compliance ADA Informed Consent 52

Bill of Health

FEBRUARY 29, 2024

However, severe climate hazards coupled with institutional and structural barriers and limited government responses are challenging their ability to adapt. Additionally, women and girls with disabilities, the deafblind, and persons with psychosocial, intellectual, and other complex disabilities lack effective government support.

Informed Consent 201

Informed Consent Governance Compliance Public Health 201

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. There were seven (7) observations with respect to the following: Quality Control Department: The establishment and/or the maintenance of a data governance plan was inadequate.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

SQA

APRIL 30, 2021

generic, biosimilar, or hybrid application), informed consent is irrelevant provided that both applications relate to a medicinal product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form. Russia – Ministry of Health of the Russian Federation.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

Drug & Device Law

MAY 25, 2023

For several years, we have blogged about the controversy over whether the American Law Institute (“ALI”) should put its Restatement Third of Torts imprimatur on no-injury medical monitoring. Here’s the latest update, as that effort nears culmination. Wheeler Medical Monitoring Motion, at 6.

Informed Consent 59

Informed Consent Malpractice Governance 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. This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert.

FDA 105

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

Drug & Device Law

FEBRUARY 26, 2024

We blogged about this outcome in the district court, and its precedential affirmance is even more significant. First of all, only one of the plaintiffs ever sought vaccination, so the rest were never entitled to informed consent at any time. 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