2001, Compliance and Governance - Health Care Compliance Brief

Managing Healthcare Compliance in West Virginia

MedTrainer

DECEMBER 7, 2023

State-specific governing bodies, such as the West Virginia Department of Health and Human Resources (DHHR) and the Bureau for Medical Services (BMS) , oversee and enforce these regulations. Effective management of healthcare compliance in West Virginia requires consistent adherence to both federal and state agency standards.

Compliance

Compliance Licensing Medicaid Medicaid

Guide to a Proactive Healthcare Cybersecurity Stance

Healthcare IT Today

APRIL 25, 2024

About Troy Hawes Troy is a managing director with the Cybersecurity Consulting practice at Moss Adams and has been providing IT consulting services since 2001. He is adept at working with the specialty IT compliance and security needs of hospitals and providers, private businesses, government and tribal entities.

Ransomware

Ransomware Compliance Fraud Governance

Healthcare & Life Sciences Private Equity Deal Tracker: TPG to Take Convey Private for $1.1 Billion

McGuire Wood

JULY 5, 2022

Founded in 2001, the company solutions, designed for government-sponsored health plans, are designed to support member interactions, compliance and Medicare processes. Convey , based in Fort Lauderdale, Fla., is a specialized healthcare technology and services company.

Medicare

Medicare Medicare Governance Compliance

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

MORE WEBINARS

Interview: Dotty Bollinger, Founder, Integrity Healthcare Advisors

HIPAA Journal

JANUARY 9, 2024

Dotty Bollinger, Founder, Integrity Healthcare Advisors The HIPAA Journal has spoken with Dotty Bollinger, who is a healthcare compliance consultant and founder of Integrity Healthcare Advisors. Dotty Bollinger is an Executive Partner on the Compliance & Risk Management at SCALE Healthcare. What is your current position?

HIPAA

HIPAA Compliance Compliance Officers Regulatory Compliance

SQA Regulatory Surveillance Summary 3 | Monthly Update 2021

SQA

APRIL 30, 2021

In addition, considering the fact that one marketing authorization application is submitted in accordance with Article 8(3) of Directive 2001/83/EC and the other marketing authorization application is submitted under an abridged procedure (e.g., European Medicines Agency (EMA) – Biologics.

COVID-19 Vaccine

COVID-19 Vaccine COVID-19 Compliance Governance

Contract Claim Based on Alleged FDCA Violation Held Not Impliedly Preempted

Drug & Device Law

JANUARY 23, 2024

Ohio 2023)), the question the court would have had to decide was whether a product was manufactured in compliance with the FDA’s Current Good Manufacturing Practices (CGMP) regulations. After several alleged violations, plaintiff entered into a Voluntary Compliance agreement with the State to bring itself into compliance.

FDA

FDA Compliance Governance

Contract Claim Based on Alleged CGMP Violations Held Impliedly Preempted

Drug & Device Law

SEPTEMBER 21, 2023

337(a) bars enforcement of a private contract that requires compliance with the FDCA. 4, 353 (2001). The question before the Thogus court was whether 21 U.S.C. § As a reminder, § 337(a) states that all actions to enforce the FDCA “shall be by and in the name of the United States.” Buckman Co. Plaintiffs’ Legal Committee , 531 U.S.

FDA

FDA Governance Compliance

Thinking About the FDA’s Alternative Summary Reporting Program

Drug & Device Law

SEPTEMBER 18, 2023

But what if the manufacturer allegedly failed to make its reports in compliance with the FDA’s restrictions on what types of adverse events were subject to ASR reporting? 341 (2001). Those are the allegations that we see in cases like Bell , 2023 WL 3006175, at *6, and Gravitt , 2022 WL 17668486, at *3. at 353.

FDA

FDA Fraud Governance Compliance

Another Update on Medical Abortion Litigation

Drug & Device Law

SEPTEMBER 11, 2023

341 (2001), is so important. If the laughably low standing standards permitted in Hippo III are, in fact, the law, then our side’s ability to assert preemption, compliance, and other defenses that presuppose the validity of FDA decisions will be threatened. That’s why Buckman Co. Plaintiffs Legal Committee , 531 U.S.

FDA

FDA Doctors Malpractice COVID-19

Another Update on Medical Abortion Litigation

Drug & Device Law

AUGUST 28, 2023

341 (2001), is so important. If the laughably low standing standards permitted in Hippo III are, in fact, the law, then our side’s ability to assert preemption, compliance, and other defenses that presuppose the validity of FDA decisions will be threatened. That’s why Buckman Co. Plaintiffs Legal Committee , 531 U.S.

FDA

FDA Doctors Malpractice COVID-19

How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

JULY 31, 2023

Since digital files were not “articles” under the statute, the government could not rely on this statute to prevent their importation. 2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). 2001) (applying Illinois law); Serpico v. at 1291-93 (construing 19 U.S.C. at 1291-92.

Governance

Governance Payment Systems Hospitals Licensing

Logical Contradiction Doctrine: Buckman for Textualists

Drug & Device Law

JANUARY 30, 2023

341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Davidowitz , 312 U.S. Moran , 536 U.S. Dow Agrosciences LLC , 544 U.S.

FDA

FDA Fraud Governance Medicare

Health Care Compliance Brief

Managing Healthcare Compliance in West Virginia

Guide to a Proactive Healthcare Cybersecurity Stance

Webinars

Trending Sources

Healthcare & Life Sciences Private Equity Deal Tracker: TPG to Take Convey Private for $1.1 Billion

Webinars

Interview: Dotty Bollinger, Founder, Integrity Healthcare Advisors

SQA Regulatory Surveillance Summary 3 | Monthly Update 2021

Contract Claim Based on Alleged FDCA Violation Held Not Impliedly Preempted

Contract Claim Based on Alleged CGMP Violations Held Impliedly Preempted

Thinking About the FDA’s Alternative Summary Reporting Program

Another Update on Medical Abortion Litigation

Another Update on Medical Abortion Litigation

How the Fifty States View Electronic Data as a “Product”

Logical Contradiction Doctrine: Buckman for Textualists

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