HIPAA Journal

NOVEMBER 17, 2022

Caroline Cook, Privacy Consultant, GDH Government Consulting Services, has shared her thoughts. My first professional experience in healthcare was as a licensed social worker in an acute care hospital. I’m a Privacy Consultant employed by GDH Government Consulting Services. I’ve always been drawn to healthcare.

Governance 88

Governance HIPAA Compliance Nursing Homes 88

SQA

FEBRUARY 22, 2021

in Brampton, Ontario, has been selling personal protective equipment (PPE), including gowns, masks, and gloves, via social media and websites such as Kijiji without the required Medical Device Establishment License (MDEL) from Health Canada. Health Canada is warning Canadians that the company Maskopia (formerly known as Medkem Canada Inc.)

COVID-19 52

COVID-19 Compliance Licensing Governance 52

SQA

MAY 24, 2023

The company did not have a written procedure in place for the provision of information related to serious risk of injury to health, contrary to what was committed to on it establishment license application. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

Health Law Advisor

AUGUST 10, 2023

5] But that Interstate Commerce Clause needs to be viewed also in balance with the 10th Amendment of the Constitution, which reserves to the states any powers not delegated to the federal government. Implementing a Constitutional limit, FDA does not regulate a licensed practitioner who makes devices for use in his or her own practice.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

FEBRUARY 26, 2024

This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies. These are requirements of the Therapeutic Goods (Medical Devices) Regulations 2002. More than ever, businesses today need a framework to guide them on their AI journey.

FDA 52

FDA Compliance COVID-19 Public Health 52

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. 2002), held that Connecticut law would follow the definition of “product” as “tangible personal property distributed commercially for use or consumption.” at 1291-93 (construing 19 U.S.C. at 1291-92.

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

JUNE 13, 2022

That requirement comes with an exception: Provided, however , That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Bard, Inc. , 3d 1272 (11th Cir.

FDA 59

FDA Licensing Doctors Nurses 59