Total HIPAA

JULY 21, 2020

HIPAA compliance for employers is a complicated and nuanced topic. Plan participants are also allowed to sue under §502(a)(2), (5) 3. According to HIPAA 45 CFR § 164.504(f)(iii) 4 , a plan sponsor is a Covered Entity and is required to work through the appropriate steps towards HIPAA compliance. The Privacy Rule Exceptions.

HIPAA 40

HIPAA Health Insurance Compliance 40

SQA

APRIL 30, 2021

SQA Regulatory Surveillance Summary #3, 2021. 726/2004, 09 March 2021. 726/2004 , which essentially means duplicate MAAs for products authorized via the centralized procedure. By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates. European Commission (EC) – Biologics. Under Article 82(1) of Regulation (EC) No.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

SQA

OCTOBER 18, 2023

The revisions mainly took place in Chapter 3, Inspection Procedures, and Chapter 9, Handling of Inspection Conclusion. While preparing the patient’s compliance pack, the pharmacy misinterpreted the product to contain 500 mg of Calcium Carbonate when each tablet actually contained 500 mg of elemental Calcium.

FDA 40

FDA Compliance Licensing World Health 40

Drug & Device Law

FEBRUARY 11, 2022

In CvM four state agencies, led by the Department of Environmental Resources banded together to sue defendants who, prior to 1977, had manufactured certain chemicals (polychlorinated biphenyls (“PCBs”)) that allegedly had “toxic and environmental persistence.” CvM was one of those. 2021 WL 6139209, at *1-2.

Governance 72

Governance Compliance 72