HIPAA Journal

NOVEMBER 17, 2022

HIPAA Journal is conducting interviews with healthcare professionals and service providers to find out more about their compliance journeys, how the HIPAA Rules have affected their working lives, and the successes and challenges they have faced with HIPAA compliance. Tell the readers about your career in the healthcare industry.

Governance 82

Governance HIPAA Compliance Nursing Homes 82

SQA

FEBRUARY 22, 2021

Compliance with UDI requirements will now be enforced for the first batch of devices in the agency’s phased implementation plan. Since the introduction of the exemption in 2002, the technology and manufacturing processes used to produce medical devices have changed dramatically.

COVID-19 52

COVID-19 Compliance Licensing Governance 52

SQA

MAY 24, 2023

The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers. The written procedure for recall was inadequate and this procedure had not been implemented.

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

The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot. This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies.

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