Healthcare IT Today

APRIL 25, 2024

For a healthcare entity, the data and information are viewed as extremely valuable as it includes PII as well as other health information that can be used for insurance fraud and identity theft. Troy serves clients in a variety of industries including communications and media, technology, health care, and higher education.

Ransomware 122

Ransomware Compliance Fraud Governance 122

C&M Health Law

SEPTEMBER 11, 2023

The proposed rule represents the first time the federal government has proposed comprehensive nationwide nursing home staffing requirements, although various states have already enacted their own staffing requirements. The 2001 recommendation of 4.1 Proposed Staffing Standard – 3.0 hours of nursing staff per resident per day, or 3.0

Nursing Homes 98

Nursing Homes Nurses Medicaid Medicaid 98

Drug & Device Law

SEPTEMBER 18, 2023

341 (2001). So, if a plaintiff contends that a defendant abused the ASR program, that is a Buckman -preempted fraud on the FDA claim. Conversely, violation claims involving the ASR program are paradigmatic examples of agency fraud/private FDCA enforcement that are impliedly preempted by Buckman.

FDA 59

FDA Fraud Governance Compliance 59

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. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

NOVEMBER 28, 2022

2001) (Kilburn); and Wade-Greaux v. I-Flow Corp. , 2d 1092, 1119-25 (D. 2010) (Matsen); Nelson v. Tennessee Gas Pipeline Co. 1998 WL 1297690, at *4, 7-8 (W.D. 31, 1998), aff’d , 243 F.3d 3d 244 (6th Cir. Whitehall Laboratories, Inc. , 1441, 1559-62 (D.V.I. 1994), aff’d mem. , 3d 1120 (3d Cir. 1994) (Gilbert). It got worse.

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

FEBRUARY 24, 2022

341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § Plaintiffs’ Legal Committee , 531 U.S. Plaintiffs constantly try to evade Buckman. Medtronic, Inc. ,

FDA 72

FDA Governance Fraud 72